- PDSA Announces “ITP and Pregnancy” Booklet
- ASH Abstracts Available on Line
- WinRho SDF® Linked to Rare Cases of Intravascular Hemolysis
- Do We Need to Improve Delivery of Better Treatments?
- Personalized Medicine Gets Boost
- Diet and Immunity Linked
- Improve Health: Argue Less, Exercise More
- Registration of Clinical Trials Increases 73% over 5 Month Period
PDSA ANNOUNCES “ITP AND PREGNANCY” BOOKLET
PDSA has available a new patient information booklet, “Frequently Asked Questions - ITP and Pregnancy.” This 12 page booklet contains 31 questions and answers of interest to women and their families about thrombocytopenia and pregnancy. You will also find references to other related material.
The content of the booklet is available on the PDSA web site at http://www.itppeople.com/preg/
To obtain a printed copy, send a self-addressed, 6x9 envelope with a 63 cent stamp to PDSA, PO Box 61533, Potomac, MD 20859. If you would like multiple copies, call us at 1-877-528-3538 or send an e-mail to email@example.com
ASH ABSTRACTS AVAILABLE ON LINE
The annual meeting of the American Society of Hematology was held during the second week of December 2005 and is a showcase for the latest hematology research. The research abstracts are available on line and in print. To view the abstracts go to: http://www.bloodjournal.org and click on ASH Annual Meeting Abstracts. The abstracts are also printed in the journal Blood, Vol. 106, #11, November 16, 2005.
WIN RHO SDF® LINKED TO RARE CASES OF INTRAVASCULAR HEMOLYSIS
The Food and Drug Administration, Cangene Corporation, and Baxter Healthcare Corporation have sent a letter to healthcare professionals warning them of a rare and potentially fatal risk of intravascular hemolysis in patients with ITP receiving intravenous anti-D (WinRho SDF). [The estimated rate of a very serious reaction is 0.005% or 1 in 20,232 infusions.] “Patients should …be advised to immediately report symptoms of back pain, shaking chills, fever, discolored urine, decreased urine output, sudden weight gain, fluid retention/edema, and/or shortness of breath.” The liquid product has been linked to falsely elevated glucose readings on some testing systems because of its maltose content. Patients receiving anti-D are advised to use glucose-specific testing methods.
Note: Physicians and patients are encouraged to report serious side effects from any treatment to the FDA through their MedWatch system. http://www.fda.org/Medwatch/.
DO WE NEED TO IMPROVE DELIVERY OF BETTER TREATMENTS?
According to the New England Journal of Medicine, Americans receive only 55% of recommended health care services. The Commonwealth Fund, a non-profit with a mission to promote a high performing health care system, has reported that nearly one-third of the adult U.S. population (61 million) cannot obtain care because they are uninsured or underinsured. Consistent with this view, Congress gave $29 billion to the National Institutes of Health (NIH) in 2005 and $320 million to the Agency for Healthcare Research and Quality (AHRQ) during the same period. This funding neglect is not only bad for our health but for the economy. The United States spends 15% of its gross domestic product on health care, twice the average per capita spending of all industrialized countries. We may have reached a point where the public would be impressed as much by progress in providing good care as the roll out of a new device or pill.
Woolf, S.H., “Unhealthy Medicine”, The Washington Post, January 8, 2006, p B3.
PERSONALIZED MEDICINE GETS BOOST
One avenue to better delivery may come through genetic testing. The FDA is weighing action that could pave the way for widespread use of genetic tests to help set dosing of the blood- thinner warfarin (Coumadin). This medication is used by more than 2 million Americans to prevent blood clots. Serious side effects result from over or under dosing. This is just one example of how genetic testing can improve healthcare by reducing adverse drug reactions which, by some estimates, claim 100,000 deaths and 2 million hospital admissions each year in the US.
Winslow, R., Mathews, A.W., “New Genetic Tests Boost Impact of Drugs”, The Wall Street Journal, December 21, 2005, p D1.
DIET AND IMMUNITY LINKED
Tryptophan, the substance in turkey that has been linked to Thanksgiving Day afternoon snooze, plays a pivotal role in the immune system according to Lawrence Steinman, MD of Stanford University. Dr. Steinman’s group found when tryptophan breaks down in the body it can alleviate symptoms of multiple sclerosis in mice. Tranilast, a drug that is similar to metabolized tryptophan and suppresses the immune system has been used abroad for other indications.
“The bigger message here is that diet and immunity are inextricably linked.” said Dr. Steinman.
IMPROVE YOUR HEALTH: ARGUE LESS, EXERCISE MORE
Exercising and reducing marital hostility may speed healing according to two studies by Ohio State University researchers. During one study, researchers compared the length of time it took to heal blister wounds on study participants when they talked normally and when they had disagreements. The couples with a higher level of hostile behavior healed at 60% of the rate of low-hostility couples. In another study of adults aged 55 to 77, those who exercised healed in 29 days compared with 39 in the sedentary group.
January W. Payne, “Get Well Sooner; To Speed Healing, Quit Squabbling and Hit the Gym” The Washington Post, Tuesday, January 10, 2006. F1.
REGISTRATION OF CLINICAL TRIALS INCREASES 73% OVER 5 MONTH PERIOD
Undisclosed safety problems with approved drugs have prompted calls for more basic information about clinical trial protocols in a publicly accessible registry and the public identification of all trials. Deborah Zarin and colleagues reviewed clinical trials.gov and examined the number of trials registered on May 20, 2005 and October 11, 2005 and the trials registered between these two dates. They report an increase of 73% in the number of registered trials from 13,153 to 22,714. “...Of the 2,670 studies registered by industry between the two dates, 76 percent provided information in the Primary Outcome Measure field, although these entries varied markedly in their degree of specificity. In the remaining 24% of the records, this field was blank.” They conclude “During the summer of 2005, there were large increases in the number of clinical trial registrations. Overall, the data contained in records were more complete in October than in May, But there still is room for substantial improvement.”
Zarin, D.A., et. al., “Trial Registration at ClinicalTrilas.gov Between May and October 2005” , New England Journal of Medicine, no 26, December 29, 2005, vol. 353:2779-2787.