- Three Clinical Trials Starting Soon
- Transportation to Clinical Trials: Angel Flight of America
- National Heart, Lung, and Blood Institute of NIH has new Director
- Need to Make Financial Conflicts Transparent
- Incidence of ITP in Black Americans
- Blacks Seen as Less Responsive to Steroids
- Folic Acid for Healthy Blood vessels and Maybe Lower Blood Pressure
- Public Access Policy for Publicly Funded Research
THREE CLINICAL TRIALS STARTING SOON
Two clinical trials will start soon for AMG 531. This novel thrombopoietic agent is a protein molecule used to stimulate platelet production. One of these trials will test this molecule in splenectomized ITP patients, the other in non-splenectomized ITP patients. For information about these trials and registration information, go to http://www.amgentrials.com and enter ITP into the search engine window.
Another clinical trial is planned by the National Human Genome Research Institute of NIH. This study (as described on http://www.clinicaltrials.gov/ct/show/NCT00069680 where more information can be located) “will identify and characterize the gene or genes responsible for Gray Platelet syndrome (GPS). Platelets are small blood cells that stick on injured blood vessels to form a plug and stop bleeding. When a blood vessel is injured (like a cut on a finger), platelets release the proteins stored in their sacs to help form a blood clot. Patients with GPS bleed longer than other people because their platelets lack some of these protein-carrying sacs. Platelets without sacs look pale gray under the microscope rather than pink, giving the syndrome its name. Except for rare patients with severe hemorrhage, the bleeding tendency in GPS is usually mild to moderate, with patients experiencing easy bruising, nosebleeds, and, in women, excessive menstrual bleeding.” This study is of interest to ITP patients because some GPS patients carry a diagnosis of ITP or thrombocytopenia of unknown origin for many years before being diagnosed with GPS.
TRANSPORTATION TO CLINICAL TRIALS: ANGEL FLIGHT OF AMERICA
Clinical trials are not always conducted in locations convenient to the patients who may contribute and/or benefit the most. That’s a problem. One solution is Angel Flight of America. This organization provides air transportation for people to obtain a medical procedure or to participate in a clinical trial. For more information go to http://www.angelflightamerica.org/ or call 800-446-1231.
NEW DIRECTOR FOR HEART, LUNG, AND BLOOD INSTITUTE AT NIH
Dr. Elizabeth Nabel assumed the position of Director of the National Heart, Lung, and Blood Institute (NHLBI) February 1st. Dr. Nabel received her medical education at Cornell University Medical College followed by study and training at Brigham and Women’s Hospital and Harvard University. She joined NHLBI in 1999 after serving on the faculty of the University of Michigan (UofM). At UofM Dr. Nabel “became known for her research in the fields of vascular biology and molecular cardiology and for her gene transfer studies in the cardiovascular system.” As the Institute’s Scientific Director of Clinical Research she “initiated a state-of-the-art training and research program in cardiovascular surgery and a program to investigate genetic variation among patients with vascular diseases.” In accepting her new responsibilities she looked to the unprecedented opportunities to advance understanding of heart, lung, blood, and sleep diseases and to improve upon the care and treatment of millions of people.
FYI from the NHLBI, vol. 5, Issue 3, February 2005, p 1.
NEED TO MAKE FINANCIAL CONFLICTS TRANSPARENT
Financial conflicts can influence the work of scientists and the recommendations they make. Jerome P. Kassirer (Author of “On the Take: How Medicine’s Complicity with Big Business Can Endanger Your Health” Oxford University Press, 2004) sites a National Institutes of Health-affiliated panel that promoted broader use of statin therapy for people with high cholesterol. Nine of the ten members acknowledged financial relationships with at least one statin manufacturer. These kinds of conflicts can bias the recommendations of expert panels, he says. Dr. Elias A. Zerhouni, Director of the National Institutes of Health, addressed this issue head on in new ethics rules announced earlier this month see http://www.nih.gov/about/ethics/020105COImemo.pdf and The Washington Post, February 3, 2005, page A25, “NIH Workers Angered by New Ethics Rules”.
B. Harder, “Dangerous Practices: Critics see Flaws in Drug-Safety Monitoring”, Science News, vol. 167, no. 6, February 2005, pp 90 – 92.
INCIDENCE OF ITP IN BLACK AMERICANS
Researchers at the University of Oklahoma observed that the number of black patients in the ITP patient registry they were developing seemed smaller than expected. In reviewing the literature the staff located six studies describing 10 or more individuals that also identified patients by race. The Oklahoma group reports that in each of the six studies “the proportion of blacks among patients with ITP was lower than the proportion of blacks in the population. The authors also point out that another disease registry at the University shows an increased proportion of blacks among patients with Thrombotic Thrombocytopenic Purpura/Hemolytic Uremic Syndrome (TTP/HUS). They conclude that “if the racial disparity among patients with ITP is confirmed, it may indicate a genetic influence on the etiology of ITP.”
D.R. Terrell, K.K. Johnson, S.K. Vesely, and J.N. George, “Is ITP Less Common Among Black Americans?”, Blood, vol. 105, no 3, February 2005, p 1368.
BLACKS SEEN AS LESS RESPONSIVE TO STEROIDS
Racial differences are delicate but they may have the potential to help unlock the mystery of a number of serious diseases. Researchers at the University of Colorado in a study published earlier this month examined the response to glucocorticoids (for example prednisone) by race. Their conclusion “that black asthmatic and non-asthmatic control subjects require greater concentrations of glucocorticoids to suppress T-lymphocyte activation suggests that blacks have a racial predisposition to diminished glucocorticoid responsiveness, which may contribute to their heightened asthma morbidity.”
M.J. Federico, et al, “Racial Differencesin T-Lymphocyte Response to Glucocorticoids”, Chest, vol. 127, February 2005, pp571 – 578.
FOLIC ACID FOR HEALTHY BLOOD VESSELS AND MAYBE LOWER BLOOD PRESSURE
Folic acid is one of the essential B vitamins. Two studies involving over 150,000 women found a significant connection between higher doses of folic acid and lower risk of high blood pressure. One of these studies published in the Journal of the American Medical association has confirmed what other studies involving smaller numbers of enrollees has hinted at that “women who consume large amounts of folate (on the order of 1,000 micrograms a day) have a lower risk of developing hypertension.” The mechanism supporting this relationship is not known. However, folic acid is known to reduce levels of homocysteine, a blood compound that can damage blood vessels.
S. Gupta, “Folate for everybody?”, Time, January 31, 2005.
PUBLIC ACCESS POLICY FOR PUBLICLY FUNDED RESEARCH
The National Institutes of Health (NIH) is moving to enhance public access to the publications that result from the publicly funded research it supports. Dr. Zerhouni describes and defends the new policy in the December 10, 2004 issue of Science. The plan is to make the more than 6,000 comments NIH received in response to this proposed policy change available in a public reading room. Answers to frequently asked questions about the public access draft policy can be found at http://www.nih.gov/about/publicaccess/publicaccess_QandA.htm.
E.A. Zerhouni, “NIH Public Access Policy”, Science, vol. 306, December 10, 2004, p. 1895.