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The Food and Drug Administration granted marketing approval for a new intravenous immunoglobulin (IVIg) for treating patients with primary immunodeficiency and chronic ITP. Privigen, manufactured by CSL Behring (King of Prussia, PA), requires no refrigeration or reconstitution.
Starting in 2008, Baxter (Deerfield, OH) will enable patients to enroll in a program that offers continued access to its two intravenous immune globulin products, GAMMAGARD LIQUID and GAMMAGARD S/D, even if the patient’s physician or other provider changes access to another product.
Dozens of medications can cause drug-induced thrombocytopenia, or low platelet count, according to a review by Wisconsin-based researchers. Oftentimes, when exposure to a drug leads to destruction of circulating platelets and bleeding symptoms in non-hospitalized patients, the patient is treated for autoimmune thrombocytopenia and can have two or three recurrences before the drug causing the disorder is identified. Though uncommon, drug-induced thrombocytopenia can have devastating consequences, which can usually be prevented by discontinuing the causative drug. Corticosteroids are often given, but there is no evidence that they are helpful. Patients should be advised to permanently avoid the medication thought to be the cause. The authors list the drugs most commonly involved, including heparin, quinine, and certain analgesics.
will carry new safety warnings on its label, with FDA approval, to warn that rare cases of thrombotic thrombocytopenic purpura (TTP) have been reported, even after a short period of use. Plavix, clopidogrel bisulfate tablets, is used for certain cardiac patients. TTP is a rare, but serious condition that requires plasmapheresis, or cleansing of the blood through a machine.
http://www.fda.gov/medwatch/SAFETY/2007/May_PI/Plavix_PI.pdf
iGuard promotes itself as “the fastest and easiest way to get personalized safety alerts and updates for your medicines.” The website requires the user to register. It does not seem to require a user fee, but how it is funded is unclear.
Although muscle pain and other side effects occur in up to 30% of patients taking statins (such as Lipitor and Zocor), a recent survey found that when statin patients complained of muscle pain, their doctors often attributed the symptoms to the normal aging process, or dismissed the symptoms altogether. This becomes a problem for the patient, but also for other patients, because if the doctor is not reporting the so-called “adverse event” to the FDA, then the regulatory agency underestimates the problem, and other doctors and patients assume the drug is safer than it is. The study suggested that this pattern of nonreaction goes beyond statins to other drugs. U.S. patients can report side effects to the FDA themselves, via the FDA Website called MedWatch (http://www.fda.gov/medwatch).
MGI Pharma (Minneapolis) has obtained rights to develop AKR-501, a “novel, orally-available small molecule thrombopoietin mimetic” for treatment of low platelet count. It stimulates a receptor on the surface of bone marrow cells called megakaryocytes to boost platelet production. The drug is in a phase 2 trial for ITP.
The FDA approved Zingo to locally reduce pain for IV insertions or blood draws for children ages 3 to 18. Zingo is a lidocaine powder that is administered through a needle-free, pre-filled, disposable device. It reduces pain when given just one to three minutes before a shot or IV procedure.
Because dengue fever, a deadly disease spread by mosquitoes, is hitting countries in Asia and Latin America that are experiencing economic booms, and because the disease does not discriminate between rich and poor, researchers are newly optimistic that drug makers are seeing a strong potential market for developing an effective vaccine. The disease is taking a high economic toll, and so these countries would be willing to pay more for a vaccine.
(Note: Dengue fever can cause thrombocytopenia and bleeding. It is sometimes confused with ITP)
Consumers can now use online services to organize medical bills. Unlike older services that were only available through employers or health plans, newer services are available directly to consumers. Examples include: MedBillManager, which charges $25/year. Steve Case’s Revolution Health charges $129/year to manage medical bills, answer medical questions, and fight disputed claims on a user’s behalf. SmartMedicalConsumer is free. It manages medical bills and provides automatic error detection. Consumers should create and regularly update their own personal health record of important medical information, including when medical bills are paid.
Hospitals are creating advisory councils whose members help “plan new facilities, set hiring standards and interview job candidates.” Patient advisers help plan clinical trials, and review medication safety measures. This move to involve patients in decision-making makes sense, since, starting next year, Medicare will require hospitals to publish customer-satisfaction data on the Medicare Website.
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According to a review of the recent medical literature, the incidence of ITP is five in 100,000 children per year and two in 100,000 adults. Spontaneous remissions occur more frequently in children than adults. Adult patients with chronic disease may have a better prognosis than previously thought.
[A full-length article will appear in PDSA’s Fall 2007 newsletter, The Platelet News.]
Starting in 2008, Baxter (Deerfield, OH) will enable patients to enroll in a program that offers continued access to its two intravenous immune globulin products, GAMMAGARD LIQUID and GAMMAGARD S/D, even if the patient’s physician or other provider changes access to another product.
The author describes four cases (two young girls, one older man, and one adult woman) in which thrombocytopenia seemed to be linked with aspartame consumption. Aspartame is found in diet sodas and other low-sugar foods. With aspartame avoidance, all four improved.
FDA’s new publication, Drug Safety Newsletter, contains findings on “post-marketing drug safety reviews from FDA's Center for Drug Evaluation and Research (CDER). The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities.” It is available free online: http://www.fda.gov/cder/dsn/2007_fall/toc.htm
The Fall 2007 issue contains an article on rituximab (Rituxan) and a fatal viral infection of the nervous system called PML or progressive multifocal leukoencephalopathy. As of December 2006, FDA had received 24 reports of PML in patients taking rituximab. PML occurred an average of four months after discontinuation of rituximab therapy. The report states that the infection may occur after a period of immunosuppression, as occurs with rituximab. The FDA encourages physicians to consider evaluating for PML when new neurological signs or symptoms appear in patients taking rituximab.
The European Commission granted “orphan medicinal product designation” for SM101, a recombinant human soluble Fc-gamma receptor IIb, produced by the German firm SuppreMol, for the treatment of ITP. The immunosuppressive product is in preclinical development and expected to enter phase 1 clinical studies in late 2008. Orphan drug status provides incentives for developing the drug.
Amgen plans to file for marketing approval of its drug, AMG 531, for treatment of ITP. AMG 531 is a protein being investigated for increasing platelet production by activating the thrombopoietin receptor. Phase 3 clinical studies in patients with ITP are completed. The filing is expected to occur in the fourth quarter of 2007.
Effective July 1, 2007, the Centers for Medicare and Medicaid Services (CMS) began reimbursing IVIG by individual brand, to improve patient access. Individual patients have better responses with one brand versus another, therefore, access to all brands appropriately matched to the individual patient is important, according to CMS. “Brand-based reimbursement will eliminate the disincentive to purchase only certain brands within the IVIG class, thus increasing access to all brands of therapy.”
A form of hyperthyroidism called Graves’ disease is associated with ITP in 14% of ITP patients. Both are autoimmune diseases. Sometimes mild thrombocytopenia disappears with treatment of the thyroid problem. Environmental studies are beginning to tie environmental chemical exposures to thyroid problems. To date, those chemicals include: polychlorinated biphenyls (PCBs); triclosan, an antibacterial common in soaps and other products; phthalates, added to plastics to make them soft and to fragrances; perfluorooctanoic acid (PFOA) used in non-stick cookware, stain-resistant clothing, and microwave popcorn bags; polybrominated idphenyl ethers (PBDEs), a chemical flame retardant; perchlorate, a component of rocket fuel found as a groundwater contaminant; and bisphenol A (BPA), found in plastics and canned-food liners. A simple blood test can tell if the thyroid is working properly.
It may be that a 36-year-old woman with arthritis who died during a gene-therapy trial succumbed to an infection she had before the study began, according to a preliminary analysis by an advisory panel to NIH. The woman died in July, raising alarms about the safety of gene-therapy studies. She died 22 days after receiving an injection in her knee of a virus vector that carried a gene for an anti-inflammatory protein, called TNFR:Fc, which inhibits tumor-necrosis factor-alpha. She was overwhelmingly infected with histoplasmosis, an environmental fungus that causes serious infections in people with compromised immune systems. TNFR:Fc (marketed as etanercept or ENBREL) suppresses the immune system.
Nature vol. 449:20 September 2007
(Note: etanercept has been given to some people with ITP to improve their platelet count)
Cranberries are used to treat urinary tract infections. A study from China suggests it can fight an ulcer-causing bacteria called H. pylori. The bacteria were eradicated in 14% of patients who drank two eight-ounce boxes of cranberry juice daily, compared with 5% who drank a placebo drink. A second study, however, suggests that for patients on antibiotics to treat the H. pylori, cranberry juice does not make a difference. Ocean Spray Cranberries, Inc., funded both studies.
(Note: Treating H. pylori is particularly important for ITP patients because when eradicated, platelet counts can improve in some patients.)
New Jersey residents can now go online or call a toll-free number to compare prescription drug prices. The Prescription Drug Retail Price Registry lists prices at area pharmacies for 150 of the most commonly prescribed drugs. New York and Maryland have similar registries.
Go to http://www.njconsumeraffairs.gov/njpdr or call 1-800-242-5846 (English or Spanish).
A growing number of U.S. medical schools are teaching medical students about alternative therapies. The aim is to expose students to a wide range of practices so they can better communicate with their patients. Roughly one third of accredited North American medical schools are part of the Consortium of Academic Health Centers for Integrative Medicine. Studies indicate that alternative therapies are used by more than a third of Americans, but more than half of those people are not comfortable talking with their doctors about it.
Suburban Hospital, in Bethesda, MD, is offering its cancer patients access to Healing Touch, an alternative therapy based on the energy field that extends outward from the body. The therapy is said to reduce anxiety and fatigue, and may decrease pain in some patients.
http://www.subrbanhospital.org
An analysis of 18 randomized controlled trials published up to November 2006 indicated that taking vitamin D supplements is associated with a decrease in total mortality. The authors call for the confirmation of this review through new, randomized, placebo-controlled trials.
Along with its role of supporting the bones, evidence suggests that vitamin D helps maintain a healthy immune system. The recommended daily intake of vitamin D for children and young adults is 200 IU, but requirements increase with age. Adults over age 50 should consume 400 IU daily, and adults over 70 could have 600 IU per day. Although milk is fortified with vitamin D (1 cup of milk contains about 100 IU of vitamin D), other dairy products generally are not. Ten to fifteen minutes of sun exposure at least two times per week to the face, arms, hands, or back without sunscreen is usually sufficient to provide adequate vitamin D. It is very important for individuals with limited sun exposure to include in their diets other good sources of vitamin D such as salmon, mackerel, tuna, and egg yolks.
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B cell depletion from rituximab therapy is only part of the story of the therapy’s effectiveness in ITP, according to a study from Italy and the U.K. The research suggests that it is the action against abnormal T-cell subsets that correlates with increased platelet counts. In an accompanying Comment, Toronto’s John Semple calls the finding “convincing” and “quite astonishing,” lending credence to the notion that “attacking T cells in ITP, even if via the slaughter of B cells, is perhaps the real way to design successful therapies for this disorder.”
Stasi R, Del Poeta G, Stipa E, Evangelista ML, Trawinska MM, Cooper N, Amadori S. Response to B-cell-depleting therapy with rituximab reverts the abnormalities of T-cell subsets in patients with idiopathic thrombocytopenic purpura. Blood. Oct. 15, 2007; 110(8):2924-2930.
Stemple, JW. Rituximab disciplines T cells, spares platelets. Blood. Oct. 15, 2007; 110(8):2784-2785.
Patients with hepatitis C infection who have low platelet counts are unable to take antiviral therapy to fight the hepatitis C. GlaxoSmithKline is launching two phase 3 studies of eltrombopag to see if platelet counts will rise enough to enable antiviral therapy for these patients. Eltrombopag is an investigational oral platelet growth factor that stimulates growth of megakaryocytes, the bone marrow cells that give rise to blood platelets. Promacta is the proposed trademark name to be used in the U.S. The name Revolade would be used in certain European countries.
Rigel Pharmaceuticals (South San Francisco) reported that its Syk kinase inhibitor, R788, can improve platelet counts in patients with refractory ITP. The single-center, open-label, dose-escalating study showed that R788 (tamatinib fosdium) improved platelet counts in 9 of 14 patients. R788 is being tested in rheumatoid arthritis and ITP.
http://www.rigel.com
Amgen has filed for FDA approval of AMG531 for treatment of thrombocytopenia (low platelet count) in adults with chronic ITP. The filing is under the trade name romiplostim. The company plans to file in the EU, Canada, and Australia by the end of 2007.
Without sleep, people may overreact to negative events, according to brain studies by researchers at Harvard and University of California, Berkeley. They found that lack of sleep elevates activity in the emotional centers of the brain most closely associated with depression. Sleep deprivation has been known to cause a breakdown of the immune system, as well as impair metabolism and learning and memory. Lack of sleep has also been linked to weight gain and increased risk of type 2 diabetes. For tips on how to get a good night’s sleep, read NIH’s guide to healthy sleep at http://www.nhlbi.nih.gov/health/public/sleep/healthysleepfs.pdf
Yoo S, Gujar N, Hu P, Jolesz FA, Walker MP. The human emotional brain without sleep — a prefrontal amygdala disconnect. Current Biology, Oct. 23, 2007. 17(20):R877-R878.
A small but growing number of doctors are helping patients understand their options among diagnostic tests and treatments to improve patient satisfaction and reduce the use of procedures with unclear benefits. Dartmouth Hitchcock Medical Center in Hanover, N.H., a leader in the field, offers 30 decision aids (videos, questionnaires, interactive computer programs) for surgeries such as mastectomy and lumpectomy, prostatectomy, and back surgery. The Foundation for Informed Medical Decision Making has a website with more resources, including many decision aids: http://www.fimdm.org
Brownlee S. Giving patients a larger voice. The Washington Post, October 23, 2007, pg. F1, 4.
Folic acid promotes cell growth, and helps form red and white blood cells. The B vitamin also decreases breast cancer and stroke risk. However, since cereals and other grains began being fortified with the vitamin to reduce birth defects, along with a drop in spina bifida in newborns, epidemiologists have noticed a rise in colorectal cancer rates. The scientists urge caution and debate before further fortification of foods with folic acid. Until then, foods that are natural sources of folic acid are probably the best source: lentils, dried beans and peas, and leafy greens.
Iris Cantor Women’s Health Center Newsletter, October 2007, Pg. 4-5
Tufts University Health & Nutrition Letter, October 2007, Pg. 1-2.
Mason JB, Dickstein A, Jacques PF, Haggarty P, Selhub J, Dallal G, Rosenberg IH. A temporal association between folic acid fortification and an increase in colorectal cancer rates may be illuminating important biological principles: A hypothesis
Cancer Epidemiology Biomarkers & Prevention, July 2007, 16: 1325-1329.
Vitamin D has multiple benefits—and many Americans don’t get enough. Vitamin D helps build bones, preserve muscle strength, prevent falls, and protects against certain cancers and heart disease. Humans can make vitamin D, just by getting some sun without sunscreen for 10 to 15 minutes every few days. But the body’s ability to make vitamin D decreases with age. Food sources include oily fish (salmon and sardines); egg yolks; and fortified milk, soy milk, orange juice, and cereals. Vitamin D also helps regulate immunity. Certain autoimmune disorders are less common in sunny climes. Finally, vitamin D seems to reduce gum bleeding by decreasing inflammation. Experts are beginning to recommend higher intake than the current RDA, which is 400 IU for people ages 51 to 70 and 600 IU for those over age 70. Instead, they recommend that people take between 800 and 1,000 IU each day. If taking supplements to boost vitamin D intake, choose those containing the D3 (cholecalciferol) form of vitamin D, which the body uses more easily than the D2 form.
For more on vitamin D, visit dietary-supplements.info.nih.gov/factsheets/vitamind.asp
(Note: Be sure to discuss supplement taking or complementary treatments with your doctor or health care provider.)
Today’s farmers raise more bushels of corn, pecks of apples, and pounds of broccoli from a given piece of land than they did decades ago, according to a September report by the nonprofit Organic Center. However, today’s high-yield crops are less nutritious and deliver fewer nutrients per serving and calorie consumed. Their study goes on to note that organic tomatoes deliver significantly more flavonoids, an antioxidant that protects the heart, than non-organic tomatoes.
The report, “Still No Free Lunch,” is available at http://www.organic-center.org
Mold toxins can affect the nervous and immune systems. A study of close to 3,000 households in Europe found an association between depression and living in a damp, moldy home. A perceived lack of control over the housing environment appeared to play a role.
Shenassa ED, Daskalakis C, Liebhaber A, Braubach M, Brown MJ. Dampness and Mold in the Home and Depression: An Examination of Mold-Related Illness and Perceived Control of One’s Home as Possible Depression Pathways. American Journal of Public Health, August 2007, 97(10):1893-1899.
Although people turn to packaged and processed “convenience foods” to save time on dinner preparation, a 3-year study by UCLA researchers indicates that dinner preparation is no faster but convenience foods add sugar, fat, and salt.
Convenience foods don’t’ save time. Tufts University Health & Nutrition Letter, November 2007, pg. 3.
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(Note: There was much ITP news presented at the recent American Society of Hematology meeting. We will send a special e-mail with some of the findings. See http://www.hematology.org for more information)
Two studies of eltrombopag, a small molecule that binds to the thrombopoietin receptor on megakaryocytes to spur platelet production (called a TPO mimetic), suggest the oral compound can increase platelet counts. The first study, from Cornell Weill Medical Center, was a phase 1, placebo-controlled trial of eltrombopag at 3 different dose levels for people with ITP. The two higher dosages raised platelet counts and decreased bleeding. The second study, from Duke University, tested the drug for thrombocytopenia with cirrhosis due to hepatitis C infection. Platelet counts rose with the drug, enabling initiation of antiviral therapy. But questions remain.
Bussel JB, Cheng G, Saleh MN, et al. Eltrombopag for the treatment of chronic idiopathic thrombocytopenic purpura. N Engl J Med. 2007;357:2237-2247.
McHutchison JG, Dusheiko G, Shiffman ML, et al. Eltrombopag for thrombocytopenia in patients with cirrhosis associated with hepatitis C. N Engl J Med. 2007;357:2227-2236. [Editorial pg. 2299]
Patients with ITP often take glucocorticoids, such as prednisone, to suppress the immune system and block platelet destruction. But a major adverse event is osteoporosis, or thinning of the bones, that increases risk fracture. Patients are usually treated with bisphosphonates, such as alendronate. A study from Alabama suggests that another drug, teriparatide, may work just as well or better for patients with the most severe bone loss. A separate article in the same issue noted that quinolones, a type of antibiotic, may increase risk for tendon injury, more so in the elderly and persons taking corticosteroids.
Saag KC, Shane E, Boonen S, Marin F, Donley DW, Taylor KA, Dalsky GP, Marcus R. Teriparatide or Alendronate in Glucocorticoid-Induced Osteoporosis. N Engl J Med. 2007;357:2028-2039. [Editorial pg. 2084]
Sambrook PN. Anabolic Therapy in Glucocorticoid-Induced Osteoporosis. N Engl J Med. 2007;357:2085-2086.
Ligand Pharmaceuticals (San Diego) has completed a Phase 1 dose-escalation study of its small molecule, non-peptide TPO mimetic, called LGD-4665. Its partner, GlaxoSmithKline, reported it will submit a new drug application to the FDA for eltrombopag (Promacta), another TPO mimetic, by year’s end for treatment of short-term ITP.
CSL Behring (Bern, Switzerland) announced that a stabilizer used in Privigen, the company’s immune globulin intravenous liquid does not cause neurological problems, as has been reported for a different stabilizer. The stabilizer in Privigen, L-proline, is a natural amino acid the enables Privigen to be stored at room temperature up to three years. The FDA approved Privigen in July 2007 for treatment of ITP. It will be available in first quarter 2008.
Rigel Pharmaceuticals reported its phase 2 study of R788, the oral Syk kinase inhibitor, improved platelet counts in patients with ITP for whom other treatments had failed. Primary side effects were gastrointestinal.
President Bush signed a new law in September to overhaul FDA monitoring of drug safety. The main improvement, according to its proponents, is that drug makers will now be required to post all their clinical trial results for marketed drugs in an NIH-supported database [clinicaltrials.gov]. It also gives FDA power to demand clinical trials on marketed drugs, fine companies for noncompliance, and establish a database of electronic medical records of 100 million people so that experts can look for emerging problems with drug safety. The law is in response to a rash of safety issues that have surfaced in the past few years.
Wadman M. New Law Gives FDA More Influence To Monitor Drug Safety. Nature Medicine. November 2007; 13(11):1269.
Harvard-based scientists used special microscopy to watch how platelets are generated in the bone marrow of mice. Megakaryocytes in the bone marrow are the source of platelets. Their images showed that when blood flows through the microvessels in the marrow, so-called “proplatelets” are sheared off of the megakaryocytes and sent into the blood stream.
Junt T, Schulze H, Chen Z, Massberg S, Goerge T, Krueger A, Wagner DD, Graf T, Italiano JE, Shivdasani RA, von Andrian UH. Dynamic Visualization of Thrombopoiesis Within Bone Marrow. Science. September 21, 2007;317(5845):1767-1770.
Chronic stress has been linked with elevated IL-6 (interleukin-6, a particular cytokine), an inflammatory marker, according to findings of the Multi-Ethnic Study of Atherosclerosis (MESA), a large cross-sectional study. The MESA study, with 6,814 participants, measured the inflammatory markers: C-reactive protein, IL-6, and fibrinogen. The study found elevated IL-6 concentrations in subjects with higher levels of chronic stress. The study’s lead author, Dr. Nalini Ranjit (University of Michigan), said “…problems of psychosocial stress and lifestyle risk factors—particularly obesity—should be considered together during management of CVD (cardiovascular disease) and other inflammation-related chronic disorders.”
Ranjit N, Diez-Roux AV, Shea S, et al. Psychosocial factors and inflammation in the Multi-Ethnic Study of Atherosclerosis. Arch Intern Med 2007; 167:174-181.
Vitamin D may reduce risk for aging and inflammation-related diseases by protecting the ends of chromosomes, according to a British study of more than 2,000 women. Poor vitamin D status is associated with increased risks for diseases involving inflammation, including multiple sclerosis, rheumatoid arthritis, and type 1 diabetes. One marker of chronic inflammation and aging is decreased length of telomeres, the ends of chromosomes that keep the DNA on the chromosome stable. The researchers measured blood levels of vitamin D and the length of the telomeres of white blood cells and found that women with higher vitamin D levels had longer telomeres—evidence that optimal vitamin D status may provide a benefit during the aging process.
Richards JB, Valdes AM, Gardner JP, et al. Higher serum vitamin D concentrations are associated with longer leukocyte telomere length in women. American Journal of Clinical Nutrition November 2007;86:1420–25.
Physical activity can reduce fatigue among cancer patients, according to a review of 17 studies. The study was specific to cancer-related fatigue, but people with ITP are known to experience fatigue as well. Studies of cancer patients indicate that exercise can reduce fatigue by improving heart and lung fitness and muscle strength.
Medscape, November 2, 2007.
www.medscape.com/viewarticle/565276
Health providers and insurance companies are beginning to offer reminders and other health information via text messaging on cell phones. One service, via Intelecare Compliance Solutions in New Haven, CT, offers reminders to take pills, refill prescriptions, take vital signs, or keep appointments.
Zimmerman, R. Don’t 4Get Ur Pills: Text Messaging for Health. The Wall Street Journal, November 20, 2007, Page D1.
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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
[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.]
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):471-77ASPARTAME 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/
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