Platelet E-News – June 6, 2008

This e-newsletter is a monthly publication of the Platelet Disorder Support Association.  The information in this newsletter is for educational purposes only.  For advice on your unique medical condition, please consult a health care professional.

Contents:

ITP Research and Treatments

General Health and Medicine

Hospitals, Insurance and Medical Care

Nutrition and Exercise

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ITP Research and Treatments

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.

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General Health and Medicine

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

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Hospitals, Insurance and Medical Care

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

www.google.com/health

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.

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Nutrition and Exercise

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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