ITP Research and Treatments
- Etanercept may increase risk for serious infections
- Ligand Initiates Phase IIA Clinical Study of LGD4665 for Raising Platelets
- EndoS Can Rescue Mice from Severe ITP
- Early intensive blood pressure lowering may be worthwhile after one type of stroke
- FDA delays decision on Nplate
- Sym001, a novel treatment of hemolytic diseases, moves into second clinical trial
- Former Amgen Executive, Cynthia Schwalm, Named President of Eisai, Inc.
General Health and Medicine
- CDC Says Some People Should Not Get the MMR Vaccine or Should Wait
- New NIH Web Site Helps Seniors Learn About Clinical Trials
- New Research Shows Yoga Helps Prevent Falls in Elderly Women
- Supportive Doctor-Patient Relationship Enhances Placebo Effect in Patients
- U.S. Senate and House Pass the Genetic Information Nondiscrimination Act (GINA)
- A Little Exercise Proves Good For Mental Health
- 1 in 5 Hospitalized Children Harmed by Medical Mix-ups
Health and Nutrition
- Vitamin C Inhibits Ulcer-Causing Bacteria H. pylori
- Insufficient Sleep Leads to Many Health Problems
ITP Research and Treatments
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.
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, email@example.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.
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.
General Health and Medicine
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
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.
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.
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.
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.
Health and Nutrition
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
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,
Insufficient Sleep Associated with Overweight and Obesity, ScienceDaily (Jan 20, 2005).
Perceived Insufficient Rest or Sleep – Four States, 2006, CDC Weekly, Feb 29, 2008.