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British researchers state “age over 40 was identified as the only significant risk factor for response to splenectomy using the Cox multivariate analysis.”
This study evaluated 61 consecutive patients undergoing splenectomy for chronic ITP. Fifty-four patients were followed for an average time of 7.6 years. Thirty-nine (72%) had an immediate complete response (platelet count rose to >100 x 109 / l.) and 9 (17%) had an immediate partial response (platelet count rose to 30 – 100 x 109 / l.). However there was a constant relapse rate during the first 36 months of follow-up and further relapse starting 70 months after surgery. The researchers used a multivariate model to determine any association of sex, age, platelet count, years of thrombocytopenia, associated disease, time of splenectomy , and the response to medical therapy. They state “age over 40 was identified as the only significant risk factor for response to splenectomy using the Cox multivariate analysis.” While the timing pattern of relapse was similar for both age groups, the rate of relapse was significantly greater for those over 40. Two years out, of the initial 48 responders, 8%of the younger group but 25% of the older group relapsed. More alarming, 15 years out 38% of the less than 40 age group relapsed but 75 % of those in the over 40 age group had relapsed. The authors conclude “splenectomy is an effective treatment for chronic ITP but the response rate decreases with time. Choosing splenectomy for ITP treatment requires individual case analysis because only young age seems to be a predictive factor for a good response.
F. Fabris, et al, “Age as the Major Predictive Factor of Long-Term Response to Splenectomy in Immune Thrombocytopenia Purpura”, British Journal of Haematology, 2001, vol. 112 pp 637 -640.
Note: This study was published in March 2001 but came to our attention as part of Dr. Terry Gernsheimer’s presentation during the ITP Conference 2004 in Baltimore. We are contacted frequently by older patients being considered for splenectomy and we wanted to make more people aware of these findings.
The office of New York State Attorney General, Elliot Spitzer, has unveiled a website offering drug price comparisons at pharmacies across New York State.
The prescription drug website (www.nyagrx.org) reports the prices of 25 commonly prescribed drugs at certain pharmacies across the state. Users will be able to search by zip code and distance or by city or county. The survey includes only pharmacies in New York State. While the prices posted on the website are based on a survey of New York State pharmacies, the information can be useful to anyone shopping for prescription drugs.
From News Services
A new drug being developed by Abbott Laboratories with the designation ABT-874 has shown promise in treating Crohn’s disease and may also be effective in treating other autoimmune diseases.
Researchers at the National Institutes of Health (NIH) and elsewhere found that weekly injections of ABT-874 reduced symptoms in as many as 75% of Crohn’s patients, three times as many as placebo injections. The drug might also be effective in treating other autoimmune diseases such as multiple sclerosis and arthritis. Abbott Laboratories has not decided whether to conduct further tests. The study was headed by Peter Mannon of the National Institute of Allergy and Infectious Diseases. It was reported in the November 11, 2004 New England Journal of Medicine.
Washington Post, November 11, 2004, p.A16.
A study drawing on the medical records of more that 360,000 people found that drugs such as Nexium, Pepcid, and Prilosec used to treat heartburn might increase a person’s chance of getting pneumonia.
Drawing on medical records compiled between 1995 and 2002 for more than 360,000 people, researchers found that those using acid blockers were 4.5 times more likely to develop pneumonia as people of the same age and gender who had never used these drugs. The researchers also matched each of 475 individuals using acid blockers with 10 people of the same age, gender, and general health who had stopped taking the drugs at some earlier date. This analysis demonstrated that a person taking an acid blocker has twice the risk of getting pneumonia as does someone who has stopped taking the drug. Stomach acid aids digestion and kills pathogens. Speculation suggests that reducing stomach acid increases stomach bacteria that can migrate up the esophagus and enter the lungs. These findings are particularly worrisome for individuals with compromised or suppressed immune systems or individuals with chronic lung conditions. This research also raises questions about the long-term use of these medications.
N. Seppa, “Affairs of the Heartburn”, Science News, October 30, 2004, p 277.
(Note: Many ITP treatments suppress the immune system)
“Rare but potentially serious” events such as serum sickness, thrombocytopenia, anaphylactic shock, and seizures prompt officials to recommend continued surveillance of the 7-valent pneumococcal conjugate vaccine, Prevnar.
This vaccine was tested and proved effective in 19,000 infants and children in clinical trials prior to FDA approval. During the two years following approval, there were 4,154 events (13.2 per 100,000 doses) reported to the Vaccine Adverse Event Reporting System (VAERS). Most commonly reported were fussiness, rashes, fever, and injection site reactions. Immune mediated events accounted for 31.3% of the reports, anaphylactic reactions occurred in 14 cases, thrombocytopenia was reported in 14 cases and serum sickness in 6 others. Seizures were reported in 393 cases, mostly in individuals with a previous history of the problem. The FDA and the CDC will continue to monitor reports of adverse events for this vaccine and encourage clinicians to report such events to VAERS.
M. Rauscher, “Continued Surveillance of Pneumococcal Vaccine Adverse Events Warranted”, Medscape from JAMA 2004;292:1702-1710.
Phthalates used in certain plastics and floor coverings were identified as a possible source of environmental triggers for allergies.
Phthalates are used in the manufacture of soft plastics and some vinyl flooring. They are also used in cosmetics and plastic toys. These chemicals separate out from the products that contain them and attach to dust particles. Researchers in Sweden, in an effort to determine whether high concentrations of phthalates in dust correlate with allergies, studied children in 400 homes. They found that children exposed to the greatest concentrations of di-ethylhexyl phthalate (DEHP) were almost 3 times more likely to have asthma as were children exposed to the lowest concentrations. Also in homes with the greatest concentrations of butyl benzyl phthalate, children were approximately 3 times more likely as the other children to have rhinitis and eczema. Other phthalates studied were not associated with these three diseases. The study highlights the different phthalate exposures in children with and without allergy related illnesses. The study does not address or demonstrate a causal relationship between phthalates and the several diseases studied. Other important variables such as the humidity and the cleanliness of the homes was not evaluated or studied.
B. Harder, “Dangerous Dust? Chemicals in plastics are tied to allergies”, Science News, July 4, 2004, pp52-53.
Resources and the political will to support safety research and implement safeguards in hospitals and physician’s offices across the nation are lacking.
The 1999 report of the Institute of Medicine warned of outdated and sometimes nonexistent safety practices that were causing widespread errors in physician’s offices, operating rooms, and pharmacies. The report claimed that between 44,000 and 98,000 lives were lost each year as the result of preventable mistakes. Now, five years later, the debate centers on what to measure not on how to save lives. The reluctance of physicians to share authority with other health care professionals may be at the center of the problem. The report recommended physicians, nurses and other health care professional work as a team. The team work aboard aircraft was cited as a model. A 2000 study reported that 50% of surgeons felt the decisions of the leader in their field should never be questioned when making decisions; less than 10% of pilots responded the same way. Much work remains to be done in this area.
T. Zwillich, “Little Progress Seen in Patient Safety Measures”, Medscape, http//www.medscape.com/viewarticle/493127.
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Good news for patients. The goal of a new website is “to make technical research easier for the public to understand and to empower patients to have a more productive dialogue with their physicians.” The site results from the cooperation of a group of publishers, health societies, and libraries. It will be available this spring at www.patientinform.org. There will be no charge for the service. Initially the site will focus on cancer, diabetes, and heart disease. The site will also make available no-cost links to the full text of papers and other research.
Science News, January 8, 2004, vol. 167, p29.
Trade groups representing drug manufacturers in the United States, Europe, and Japan announced earlier this month that their members plan to release more clinical trial data. The announced plans exclude early stage phase one studies on healthy volunteers. These studies often signal a new direction in product development and it is thought that releasing this data would compromise a company’s strategic direction. There is no obligation to release any results prior to a drugs approval. The plans are, however, quite specific. A company must register trials within 21 days of the start date and provide a unique identifier to permit easy tracking. Results would be required within one year of the drugs approval and for drugs already approved within one year of completion of the study. These plans address the demands of last September by a group of medical-journal editors for more openness by the drug manufacturers.
Medscape, http://www.medscape.com/viewarticle/496973
While the exact mechanism leading to the progression of asbestos-related lung disease (ARD) has not been fully explained, evidence supports that some of the lung pathologies seen with asbestos and silica exposure are immunologically mediated. Both of these substances appear to aggravate autoimmune responses. The researchers at the University of Montana report results from their comprehensive study to assess the prevalence, specificity, and significance of autoantibodies associated with asbestos exposure. The population of Libby, Montana experienced community wide exposure to asbestos that resulted from the mining of vermiculite. The authors compared a sample of subjects from Libby with a sample of subjects from Missoula, Montana where prevailing winds protected the population from the asbestos exposure. They report “significant differences in frequency and titer of positive ANA tests, frequency of positive ENA tests, and higher levels of serum IgA [tests used to diagnose autoimmune diseases] when an asbestos-exposed Libby cohort was compared with one from Missoula with no reported asbestos exposures.” The study data supports the hypothesis that asbestos exposure is associated with autoimmune responses and “provides the foundation and justification for a larger and more extensive study planned to explore these associations.”
J.C. Pfau, et. al., “Assessment of Autoimmune Responses Associated with Asbestos Exposure in Libby, Momtana, USA”, Environmental Health Perspectives, vol. 113, number 1, January , 2005, pp 25-30.
http://ehp.niehs.nih.gov/press/010405b.html
http://ehp.niehs.nih.gov/docs/2004/7431/abstract.html
There is no known cause or cure for Autoimmune Thrombocytopenia Purpura (AITP). However, as with most autoimmune diseases there is thought in many cases to be a trigger, an agent that initiates a misdirection of the immune system. Researchers at Kagoshima University in Japan report a case of interferon-a [(IFN)-a], a treatment for several hematopoietic [blood] malignancies, triggering a case of AITP. The patient reported by these researchers was being treated for chronic myelogenous leukemia (CML) with INF-a. She showed a complete hematological response and major cytogenetic response. When her platelet count was 54K the INF-a (OIF) was discontinued. After one month, petechiae appeared on her legs and her platelets dropped to 6K. The patient displayed severe thrombocytopenia, marked elevation of platelet-associated immunoglobulin G, and a good response to prednisone. The authors attribute the AITP in this case to the production of autoimmune antibodies against platelets by INF-a (OIF). Therapy was changed from the OIF to Sumiferon and the thrombocytopenia was not detected. The authors suggest that the “subtle differences between the two purified types of INF-a might indicate an etiology of autoimmune antibody production.”
K. Arimura, et. al., “Severe Autoimmune Thrombocytopenic Purpura during Interferon-a Therapy for Chronic Myelogenous Leukemia”, Acta Haematologica, vol. 112, 2004, pp 217 – 218.
Synthetic musks are widely used in fragrances, detergents, soaps, and cosmetics. Routine toxicology screens have always shown these compounds to be nontoxic. However, a recent study raises the possibility that musks may reduce the body’s ability to defend against toxic compounds. Using mussel gill tissue, researcher have found that exposure to synthetic musks inhibits the tissue’s natural defenses against toxic compounds. The effect persisted long after the end of the tissue’s exposure to the synthetic musks. This research raises the possibility that musks which concentrate in fats, including breast milk may remain in human tissue long after exposure. This further suggests that long-term exposure could result in concentrations high enough to impair natural cellular defenses against toxins in humans.
T. Luckenbach and D. Epel, “Nitromusk and Polycyclic Compounds as Long-Term Inhibitors of Cellular Xenobiotic Defense Systems Mediated by Multidrug Transporters”, Environmental Health Perspectives, vol. 113, 2005, pp 17 – 24.
Full text at: http://eph.niehs.nih.gov/members/2004/7301/7301.html
Social occasions that offer opportunities to check in with friends and relatives to exchange ideas and greetings, find a supportive ear or shoulder not only give us immediate pleasure, they also influence our long-term health. Dozens of studies show that people who enjoy social support are happier, have fewer health problems, and live longer. Evidence also suggests that life-enhancing effects of social support benefit giver and receiver alike. The quality and variety of the relationships is important. Remember social contacts in themselves don’t uniformly enhance wellbeing. Take the time; make the effort; cultivate the most meaningful relationships. Exchange ideas, lend an ear or shoulder, and enjoy better health and a longer life not only for yourself but for others as well.
Harvard Women’s Health Watch, “The Benefits of Good Connections”, vol. 12, # 4, December 2004, p 1.
While no independently repeated study has proved that radiation has permanent harmful effects, lab work with human and animal cells has shown a significant increase in single and double-strand DNA breaks. This was damage that could not always be repaired by the cell. The electromagnetic fields to which the cells were exposed were typical those generated by mobile phones. The researchers said the study did not prove any health risks. They added that “the genotoxic and phenotypic effects clearly require further studies … on animals and human volunteers.”
Medscape, http://www.medscape.com/viewarticle/496289
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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.
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.
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.
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.
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.
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 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.
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.
This research study is for men and women 18 years of age or older who have been diagnosed with ITP (Immune Thrombocytopenic Purpura) for at least six months. To be eligible for this study, you must have been unsuccessfully treated with either corticosteroids, immunoglobulins, azathrioprin, danazol, immunomodulators and/or splenectomy. Additional criteria will be assessed by the physician at the research site to confirm eligibility.
Qualified study participants will be asked to take the study drug once a day for six weeks. A total of 11 clinic visits will be scheduled during which participants may undergo evaluations including study-related physical examinations, medical history review, and laboratory tests (i.e. platelet counts).
All study-related medical exams, laboratory tests, and study medication will be provided to participants at no cost. Your participation in this study is voluntary, and you can withdraw at any time.
If you are interested in learning more about this study and if you qualify; please visit www.itpstudy/pdsa or http://www.findclinicalstudy.com/index.cfm?cid=185220&did=901&rfr=pdsa
For more information on ITP clinical trials go to: http://www.itppeople.com/clinical.htm
A Texas physician reports success with two patients with thrombocytopenia who responded quickly (within 2 to 4 weeks) to an “antifungal” program. This included a Phase I diet, Psyllium husks (powder or capsules), and a natural antifungal. Fungi produce mycotoxins. One family of these, the trichothecenes, can contaminate our food and is associated with hematological disorders including thrombocytopenia and leukopenia.
With appreciation we acknowledge and thank a member of PDSA for bringing the following citations to our attention.
R. Froquet, Y. Sibiril, D. Parent-Massin, “Trichothecene Toxicity on Human Megakaryocyte Progenitors”, Hum Exp Toxicol., February 20, 2001, 20(2), 84-89.
D. Parent-Massin, “Haematotoxicity of Trichothecenes”, Toxicol Lett., October 10, 2004, 153(1), 75-81.
H Pylori has been associated with ITP for a number of years and studied in the United States, Europe, and Japan. Some researchers have found that H Pylori eradication has restored platelet counts for ITP patients but others have not been able to reproduce these results. Recently, we heard from a member whose 4 year old granddaughter developed chronic ITP about 3 years ago. She reported that all the usual treatments helped for a couple of weeks but then her granddaughter was back in the hospital. After almost a year of this, doctors recommend a splenectomy. Two weeks after the operation she was back in the hospital her platelets had crashed. She was back to treating her ITP every few weeks. Then after reading an article on the PDSA website, www.pdsa.org, about H-pylori eradication they had her checked and sure enough she was positive. She was treated with antibiotics for a week. Her platelet count responded and she hasn’t needed treatment in almost 2 years. Testing for H Pylori is easy and inexpensive. Even though the research results are mixed, if you have been struggling with a chronic case of ITP, testing for H Pylori can’t hurt.
We thank Holly for sending this information to PDSA.
Researchers at the Institute of Noetic Sciences in Petaluma, California have been studying the lives of individuals experiencing cancer remissions and those described as extended survivors of illness and disease for over twenty years. In the current issue of their magazine, Shift, Marilyn Schlitz reports that “researchers have identified similarities in how survivors account for their hopeful situations.” In summary:
M. Schlitz, “Stories of Hope”, Shift, December 2004 – February 2005, pp 38 – 40.
Approximately nine million platelet-unit concentrates are transfused in the United States each year. An estimated one in 1,000 to 3,000 of these units is contaminated with bacteria. Transfusion-associated bacterial sepsis was the second most frequently reported cause of transfusion-related fatalities in the United States during the period 1990 – 1998. Platelets are particularly vulnerable to bacterial growth because they are stored at room temperature for up to 5 days. Other blood components are refrigerated or frozen. To reduce this risk the American Association of Blood Banks (AABB) adopted a new standard on March 1, 2004. This new requirement requires member blood banks and transfusion services to implement measures to detect and limit bacterial contamination in all platelet components. This can protect not only the potential recipient of the platelet unit, but potential recipients of other blood units, by identification and recall of co-components that also might be contaminated.
MMWR, “Fatal Bacterial Infections Associated with Platelet Transfusions --- United States, 2004, CDC Weekly, February 25, 2005, 54(07), 168 – 170.
Hematology analyzers provide reliable full blood counts but are known to be inaccurate at counting platelets in severe thrombocytopenia. For reasons not associated with the treatment of ITP, a group in the UK compared the platelet counting results of nine different analyzers produced by five different manufacturers. The analyzers studied used optical, impedance, and immunological counting technology. In conducting the study, over 3,000 counts were completed. In the low range, less that 20 X 109/l platelets or what is commonly referred to as 20K, the mean difference (the difference between the average of all counts with a given analyzer and the IRM standard) was small. For all machines the mean difference was less than 5K, for several less than 1K. However the range of readings from each analyzer was much greater. All but one of the analyzers tended to overestimate platelet counts. Eight of the nine analyzers tested overestimated platelet count by 5K or more, even though the mean difference was less. Estimates of two analyzers, on some counts, were as much as 10K over the standard. Four of the nine analyzers also underestimated platelet count by 5K or more for some samples. One underestimated by almost 10K. These results call for ITP patients with low platelet counts to pause before basing treatment exclusively on an analyzer platelet count.
H. C. Segal, et al, “Accuracy of Platelet Counting Haematology Analysers in Severe Thrombocytopenia and Potential Impact on Platelet Transfusion”, British Journal of Haematology, 128, pp520 – 525.
A newly approved genetic test may soon take some of the guesswork out of prescribing certain drugs. Medications do not work the same in everybody and there are many reasons for this. One is that people metabolize drugs at different rates. Two genes, 2D6 and 2C19, regulate the enzymes the liver produces to metabolize a number of drugs. The AmpliChip CYP450 was cleared by the Food and Drug Administration in December of last year and is expected to be available by June. This DNA chip contains millions of DNA molecules which it uses to analyze genetic material from a patient’s blood. Physicians will be able to send a standard blood sample to a laboratory. The DNA will be extracted and applied to the chip and a detailed report generated. This report will describe how the patient’s genetic variability will affect response to a number of medications including: anti-seizure medications, beta blockers, codeine, the breast cancer drug tamoxifen, and several antidepressants. The new test will identify people who clear drugs from their systems at an abnormal rate—fast or slow. This will enable physicians to make dosages more precise and adjust medications. “In the future physicians may be able to predict with pinpoint precision who will do better on a specific drug, and why.”
P. J. Kiger, “The Right Drugs for Your DNA”, AARP Bulletin, March 2005, p 3.
The HapMap project is an international effort to identify and catalog genetic similarities and differences in human beings. This project will provide information that will help researchers find genes that affect health, disease, and individual responses to environmental factors and medications. The ability to predict individual responses to medications is advancing quickly as reported above. This technology is has been adapted by Perlegen in its genome scanners. These scanners consist of large “gene chips” designed to pick out hundreds of millions of individual segments of DNA simultaneously. This makes it possible to identify millions of single nucleotide polymorphisms (SNPs or single letter differences along a chromosome that vary between individuals) in a matter of days. Perlegen is currently characterizing SNPs in the 270 genomes used as a reference in the HapMap project. Perlegen has announced plans to integrate its own SNPs (a donation of services valued at $1.2 million) into the HapMap and to characterize a total of more than four million SNPs for the project by the end of the year. In addition to contributing to the HapMap project, the company is taking steps to exploit its data in the market place. They “recently licensed a drug that had failed in clinical trials at another company, hoping to figure out what genetic effects contributed to the failure.” If they can, Perlegen could test the drug again in the patients most likely to benefit and if successful rescue a medication the benefits of which otherwise would have been lost.
For information on the HapMap project see: http://www.hapmap.org/
D. Hamilton, “Genetic-Variation Map Gains as Biotech Firm Donates Some Data”, Wall Street Journal, February 25,2005, p B1.
March 28th - Baxter Healthcare and Cangene announced that Baxter is assuming exclusive rights to market and distribute Cangene’s WinRho® SDF in the United States. WinRho® SDF is used to elevate the platelet level in patients with ITP. The Food and Drug Administration approved WinRho® SDF in 1995 for the treatment of chronic ITP in Rh-positive non-splenectomized adults and acute and chronic ITP in Rh-positive children who have not had a splenectomy. Cangene Corporation is one of Canada’s largest biotechnology companies headquartered in Winnipeg, Manitoba.
April 11th - “Baxter Healthcare Corporation and Cangene Corporation announced today that the U.S. Food and Drug Administration (FDA) has approved the liquid formulation of Cangene’s WinRho® SDF [Rho(D) Immune Globulin Intravenous (Human)].” The liquid product provides an alternative therapeutic in treating the same indications as the lyophilized (freeze-dried) product but without the need to reconstitute prior to infusion.
From Baxter/Cangene Press Releases.
To view complete press releases go to http://www.itppeople.com/winrho.htm
Patients without spleens are at increased risk of overwhelming post-splenectomy infection (OPSI) since the spleen is responsible for filtering encapsulated bacteria such as Streptococcus pneumoniae from the blood stream. “The overall incidence of OPSI remains low but death rates from OPSI have been reported to be up to 600 times greater than in the general population, with an estimated lifetime risk for OPSI of approximately 5%.” While in theory the risks of serious sepsis “can be reduced with good advice, immunization, and antibiotic prophylaxis, in practice, such preventive measures may not be followed or may fail.” This study, which came to our attention recently, examined specific associated factors to determine whether currently recommended preventive measures are being followed. The study reports that “few patients had been adequately advised on antibiotic prophylaxis or other measures.” The author concludes that “currently accepted best practice for managing asplenic patients is not being followed.
D.J. Waghorn, “Overwhelming Infection in Asplenic Patients: Current Best Practice Preventive Measures are Not Being Followed”, Journal of Clinical Pathology, 2001, 54:214-218.
Antioxidents are believed to help prevent and repair oxidative stress, a process that damages cells within the body and has been linked to the development of cancer, Alzheimer’s disease, heart disease, and Parkinson’s disease. In the past, blueberries have gotten a big share of the attention when the antioxidant content of foods has been reported. They may have to move aside. A recent analysis of the antioxidant content of common foods shows that disease-fighting antioxidants may be found in unexpected fruits and vegetables, such as beans, artichokes, and even the much-maligned Russet potato. Researchers found that small red beans, red kidney beans and pinto beans are all in the same league with wild blueberries and have more antioxidant capacity that cultivated blueberries.
J. Warner, (reviewed by B. Nazario, MD), “Antioxident Riches Found in Unexpected Foods”, http://my.webmd.com/content/Article/89/100138.htm
Diagnosing autoimmune diseases can be difficult; more so in some cases than others. Misdiagnosis is a problem because in most cases it means mistreatment, not good for the patient or physician. This paper reports a study of 12 children diagnosed with Evans syndrome (ES) a disorder defined by autoimmune destruction of at least two of the three hematologic cell types (red cells, white cells, platelets). ES presents with symptoms similar to another disease, autoimmune lymphoproliferative syndrome (ALPS) a disease that typically includes autoimmune cytopenias, increased risk of malignancies, and other pathology. The 12 ES patients were studied for the laboratory characteristics of ALPS. On the basis of the testing, the researchers found an unexpectedly high (7 of the 12 patients) prevalence of abnormal laboratory findings highly suggestive of ALPS among patients diagnosed with ES. “Our data further suggest that a number of patients with ES may have ALPS, a novel finding with important therapeutic implications.”
D.T. Teachey, et. al., “Unmasking Evans Syndrtome: T-Cell Phenotype and Apoptotic Response Reveal Autoimmune Lymphoproliferative Syndrome (ALPS)”, Blood, 15March2005, 105:2443-2448.
There are three clinical trials and a clinical research study underway of interest to ITP patients. This is exciting news.
AMG531
Amgen is recruiting patients for two clinical trials for AMG531. This novel thrombopoietic agent is a protein molecule used to stimulate platelet production. For information about these trials and registration information, go to http://www.amgentrials.com and use the search engine window in the upper left hand corner of the screen, search on “ITP”. You can also call 1- 866- 57AMGEN (1-866-572-6436) for more information.
Thrombopoietin Receptor Agonist
A clinical research study for adults with chronic (ITP) is recruiting patients to study the safety and effectiveness of an investigational oral drug compared to placebo for the treatment of ITP in adults. This investigational drug is a TPO (thrombopoietin) receptor agonist. For more information including eligibility criteria go to: http://www.itpstudy.com or call 1-877-587-4257
Gray Platelet Syndrome
The National Human Genome Research Institute of NIH is currently recruiting patients for a genetic analysis of Gray Platelet Syndrome. This study (as described on http://www.clinicaltrials.gov/ct/show/NCT00069680 ) will identify and characterize the gene or genes responsible for Gray Platelet syndrome (GPS). 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. For more information you can also call the National Human Genome Project Patient Recruitment and Public Liaison Office 1-800-411-1222 or e-mail prpl@mail.cc.nih.gov
We update our clinical trials page with new information as we receive it. See: http://www.itppeople.com/clinical.htm
Transportation to Clinical Trials
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.
There is mounting pressure to provide health-care consumers with “report cards” and other information to assist them in making decisions. In the face of this pressure, most hospitals are reluctant to publicly report any statistics that might make them look bad. The Dartmouth-Hitchcock Medical Center (DHMC) is rolling out a radical new concept of full disclosure. At DHMC, patients are being provided with the institutions’ success rates, even when they don’t measure up. Other leading institutions are expanding the data made available to patients. But everywhere doctors and hospital executives are questioning how far to go. User surveys of the Dartmouth site have found a common theme among users to be trust. Melanie P. Mastanduno, a Dartmouth-Hitchcock clinical measurement analyst said, “Just the fact that we gave all the information to the public and were not ashamed or embarrassed gave confidence.”
More detailed data on hospital performance can be found at:
Dartmouth-Hitchcock www.dhmc.org
The Cleveland Clinic www.clevelandclinic.org
Colorado Hospital Quality www.hospitalquality.org
NY State Hospital Report Card www.myhealthfinder.com
L. Landro, “Hospitals Give Patients More Data”, Wall Street Journal, April 6, 2005, p.D4.
On April 25, 2005 Merck & Co. launched a discount drug program for uninsured Americans without drug benefits and incomes greater than $19,000. Merck's discounts range from 15% to 40% and are on par with other competitive discounts. They are similar to discounts available through other Merck programs such as one that provides discounts to Medicare recipients without drug coverage. The cholesterol drug Zocor is discounted by 40% from retail prices. The current average price for one month of Zocor at Walgreens is $150; the discount of $60 lowers the price to $90. Fosamax, an osteoporosis medication is discounted by 21%, at Walgreens, that drops the cost from $85 to $67.
B. Martinez, Wall Street Journal, April 20, 2005, p5.
The new food pyramid was issued in January by the Department of Health and Human Services and the Department of Agriculture (USDA). It follows the 2005 Dietary Guidelines and is drawing wide acclaim. For the first time, it provides an individual the opportunity to customize the pyramid by age, gender, and activity level and to make decisions about his or her own fitness and diet goals. The drawback, however, is that the new pyramid can only be accessed through the Internet (http://www.mypyramid.gov), thereby missing a significant segment of the population. Still, outreach efforts are underway from both the government and private sector. General Mills will be putting the pyramid on some of its food product labels. And Weekly Reader Corp., the publisher of the schoolchildren magazine, will feature the pyramid in their fall issues. Government-sponsored food programs will also include the pyramid information for lower-income individuals who may not have access to the Internet. The new pyramid represents the same categories as the old horizontal version, using colorful stripes that run vertically to illustrate what food groups an individual should eat. It also has a staircase running up one side, to remind people to be more active.
S. Squires, The Washington Post, April 26, 2005, pF1.
New studies are showing that those who attend religious services at least once a week are generally healthier and less prone to a multitude of illnesses, including depression. Additionally, regular attendance appears to lower the mortality risk of an individual over time. These studies have found that religion helps females more than males. There are many skeptics who say that it's not religion but the social aspect of the attendance that appears to improve health. One expert suggested that attending a bingo club or socializing at the local library might confer the same advantages. Studies have shown that watching a religious program on television doesn't improve health at all. Similarly, some professionals say that a strong religious belief might actually work the opposite way, if someone believes that God has abandoned them in their time of need. Nonetheless, certain aspects of religious services – praying and/or meditation – are an effective way of lowering negative emotion, and some doctors believe that this can only be a good thing.
K. Helliker, Wall Street Journal, May 3, 2005, pD1.
The Center for Medicare and Medicaid Services will soon launch a national survey of hospital patients in an effort to study the current quality of hospital care. The 27-question survey, known as the Hospital Consumer Assessment of Health Plans Survey, asks patients how hospital staff treated them, and it is expected in the long run to hold hospitals more accountable to the patients they serve. Currently, only a few states and hospitals provide information about patient satisfaction. While the survey is voluntary for hospitals, experts believe most will join the effort because participation is a factor in Medicare reimbursement. There are concerns from groups such as the American Hospital Association. Certain groups fear the survey still will not give a clear picture of the state of hospital care because people's standards are so subjective. Current Medicare studies have found that hospital patients value doctor communication skills, a responsive hospital staff, and a clean and comfortable room more than anything else.
L. Landro, Wall Street Journal, April 20, 2005, pD1.
In 2001, about 192,000 patients in China died from taking counterfeit drugs. A report published in PloS Medicine found that up to 15% of all drugs sold worldwide – worth about $35 billion – are fake. That is significantly greater than the 6% that the World Health Organization had previously estimated. More than half of the drugs purchased in parts of Asia and Africa are counterfeit. The report suggested that pharmaceutical companies and governments aren't doing enough to monitor the increasing production of counterfeit drugs, which is vastly underreported. It also accused the pharmaceutical industry of keeping information about counterfeits secret in fear that it would affect sales of name-brand drugs in a highly competitive industry. The report suggested the best way to counter this fraud is for pharmaceutical companies to provide more accessible, effective and inexpensive drugs, and more information about counterfeits. And governments should better enforce regulation of drug manufacturers.
Hematology Oncology News & Issues, April 2005, p8.
Due to pressure from Congress and groups such as the Public Library of Science, the National Institutes of Health (NIH) will be asking the scientists it funds and supports, starting May 2, to begin voluntarily submitting an electronic copy of all their scientific reports – within one year of publication – to PubMed Central (http://www.pubmedcentral.nih.gov). All reports and articles would be available without charge, and registration is not required. PubMed Central will differ from PubMed, the National Library of Medicine's current database of citations and abstracts, which is also free, in that it will provide the full text of the articles. The NIH currently funds 212,000 researchers worldwide, and they publish about 10% of the articles in the nearly 5000 journals indexed at PubMed. The NIH itself hopes to use PubMed Central to track research progress and to determine priorities in funding. Some publishers are concerned about the NIH's new public-access policy because it would take away from their subscription revenues. Additionally, if after a researcher has submitted copies of a final manuscript to both the NIH and the publisher, and the publisher makes more changes, then the NIH's copy is no longer current. The NIH insists it can accommodate corrections, though timing issues crop up especially with articles about patient care. This effort is encouraging the United Kingdom to look into similar policies for its Wellcome Trust and the National Library of Medicine to begin providing public access to scientific research for the UK public as well.
R.Steinbrook, M.D., New England Journal of Medicine, April 28, 2005, p1739.
More and more scientific research is showing that exercise and physical activity yield both physical and mental-health benefits across several diseases and diverse subpopulations. Physical activity is most generally defined as regular light or vigorous exercise, or even household chores. While most studies have documented benefits in cardiovascular disease, recent work has begun to focus on people with other physical illnesses. Researchers have reported benefits among those with type 2 diabetes and cancer patients who also suffer from other co-morbid conditions such as obesity of cardiovascular disease. Benefits were also observed among sedentary men and women over age 60 with knee-hip osteoarthritis who experienced reduced pain. People suffering from chronic fatigue syndrome showed benefits. On the mental health side, those diagnosed with major depression while adhering to a regular exercise regime showed significant improvement in depression.
Physically active older adults were reported to be less likely to develop cognitive impairments. There are limits, however, to what the current research can undoubtedly claim about the benefits of physical activity. Though it seems universal that exercise can improve physical and emotional well-being, experts advocate more studies with bigger sample sizes, and letting more time pass in order to qualify and quantify just what the long-term benefits are. Additionally, the types of exercises vary greatly for a great variety of people. Between yoga and chair exercises, some sort of consensus with regards to how to measure proper treatment or dosage for an individual with a specific ailment needs to be addressed.
F. J. Penedo and J.R. Dahn, Current Opinions in Psychology, 2005; 18 (2): 189-193
An ongoing study of the physical fitness of London-based civil servants in the United Kingdom, known as he Whitehall Project II, found that the most physically active participants had least number of limitations in physical ability as they aged. Nearly nine years of information has been compiled so far regarding fitness levels, chronic disease, and lifestyle habits of the over 6,000 participants between the ages of 39 and 63 via questionnaires and medical screenings. From this information, the participants were classified as “sufficiently active” if they got at least 2 hours of moderate activity or 1 hour of vigorous activity a week, “insufficiently active,” or sedentary. Studies found that the “sufficiently active” participants were less likely to report limitations in physical function. Even those who started the study already having a chronic illness but were considered “sufficiently active” enjoyed better mobility and physical ability, in spite of their illness.
Women's Health Advisor, Weill Medical College of Cornell University. May 2005
The National Academy of Sciences Institute of Medicine and the American Heart Association promotes the consumption of fish rich in healthy omega-3 fats, consumers should be aware that farmed salmon has been found to contain a number of toxins that might actually counteract the benefits of eating the fish. Experts believe farmed salmon tend to contain more PCBs and dioxin because of dioxin-like compounds and other organic contaminants in the feed. Since certification of American fish farming is not yet established, the safest option for consumers is to eat wild fish – provided they can be certain of its wild origin and afford it. Consumers are encouraged to be vigilant, ask questions and find a trusted retailer.
Report in Environmental Health Perspectives recommends further curtailing salmon consumption, May 3, 2005.
D.Wortman, COOL Labeling: Helping Us Make Healthy Salmon Choices?, The Green Guide, May 3, 2005.
Clinical trials that begin enrolling patients July 1, 2005 and thereafter must be fully registered prior to enrolling the first patient for the results of the trial to be published in some leading medical journals in the United States, Canada, Europe, New Zealand, and Australia. The changes follow recommendations from the International Committee of Medical Journal Editors (ICMJE), the World Health Organization, and even the U.S. Congress through its proposed Fair Access to Clinical Trials (FACT) Act. The aim of the changes is to provide as comprehensive and accurate information about the results of clinical trials to the public as possible. Ongoing clinical trials will have until September 13, 2005 to comply with registration requirements in order to be considered for publication. The minimum requirements for registration were set out at a meeting convened by the WHO in April 2004. These can be found at: www.nejm.org. The new policy will be applied primarily to phase 3 trials that seek to determine clinical effectiveness and not to phase 1 trials that assess among other things toxicity. But because these distinctions are sometimes hard to make – in fact, all trials in some way, test for drug safety and effectiveness – the Journal is leaving many publication decisions up to individual editors.
Editorial, The New England Journal of Medicine, June 9, 2005, pg. 2436
http://content.nejm.org/cgi/content/abstract/NEJMe058127
A number of recent studies in several countries have reported that eradicating an H. Pylori infection in ITP patients resulted in an increase in platelet count. These studies so far have not been long term or conducted with large patient pools. However, scientists have known that H. pylori plays a role in other diseases involving autoimmune mechanisms, including acne rosacea, idiopathic chronic urticaria, and atherosclerosis. Scientists studying H. pylori's correlation with ITP have discovered a method for testing the progress made in ITP patients following H. pylori eradication. The ELISA titers of anti-CagA antibody were “significantly higher in the responders than the non-responders, suggesting that an ELISA serum titer of serum anti-CAGA antibody may be a good predictor of platelet recovery.”
Franchini, M, et al; Recenti Prog. Med.; March 2005, pg. 151
Suzuki T., et al; Am. J. Gastroenterol.; June 2005, pg. 1265
Gasbarrini A., et al; Am. J. Gastroenterol.; June 2005, pg. 1271
On the whole, there are far more studies done in Europe than in the United States that look at the relationship between cell phone use and potential health risks. Most studies are small and aren't conclusive in whether or not exposure to electromagnetic waves, a form of radiation emitted from cell phones, are dangerous or could cause cancer or Alzheimer's disease. A December 2004 study involving scientists from seven European countries found DNA damage to human and animal cells when exposed to cell phone radiation in a laboratory setting; DNA damage often leads to cancers. In fact, Swedish researchers found that people who used analog-style phones for more than ten years had greater risk of developing acoustic neuroma, a non-cancerous tumor on the auditory nerve linking the brain and the inner year. It's unclear if newer digital phones are similarly risky. The Swedes have also found that cell phone radiation damaged brain cells in rats, and this poses questions about cell phone use and the development of Alzheimer's disease. Nothing is conclusive, however, if you must use your cell phone, it doesn't hurt to pull the antenna all the way out if your phone has a retractable antenna; your phone emits more radiation if it has to work harder to find a signal. Or use hands-free set to limit exposure to radiation signals.
Dr. Andrew Weil’s Self Healing, May 2005, pg. 6
Experts have long touted the benefits of eating foods high in antioxidants as a way of maintaining good health, especially as we age. This is because lifelong exposure to particles called free radicals that come at us both externally (from sun exposure) and internally (from metabolic processes) inevitably lead to a natural breakdown of the body's defenses. Scientists at the University of Washington in Seattle have engineered a variety of mice to produce a specific antioxidant, catalase, and direct it to different parts of the mice's cells in an effort to actually document how antioxidants work to combat aging and the onset of disease. Catalase, when made by the mice naturally, goes to a cell's peroxisomes. These scientists altered the mice to produce extra catalase that would either go into the cell's nucleus or the cell's mitochondria. In mice as well as humans, the mitochondria are where cells convert food to energy, and as a side effect, free radicals are released. The scientists found that in mice where the catalase was directed to the mitochondria – where it doesn't normally occur – the mice live significantly longer than normal mice (about an additional five months to a normal 3-year lifespan) possibly because the catalase neutralized the free radicals before they did any internal damage.
C Brownlee, Science News, May 7, 2005, pg. 292
The non-profit Pew Internet and American Life Project recently released a survey as part of a Pew Research Center initiative that showed an increasing number of health care consumers are researching doctors and hospitals, diet and nutrition, vitamins, experimental treatments, insurance, and prescription drug information online. This has implications on how employers, health plans and patient advocates will go about providing health care in the future because this information is so readily available to consumers. The study acknowledged, however, there a discrepancy between more affluent consumers with high-speed Internet access and poorer consumers who rely on dial-up, in how far they will go in their online research of health information; broadband users will likely hit the Internet first before consulting any health care professional, and some might actually find a doctor through the Internet than through traditional referrals. Experts agree that the Internet provides just a fraction of the information that could be available to consumers but currently isn't, such as detailed descriptions of a particular doctor's care beyond typical credentials and training information. But the Internet is becoming a useful tool for both consumers and health care providers to communicate with each other about certain diseases with an ease that the traditional health care structure didn't allow.
Laura Landro, The Wall Street Journal, May 18, 2005, pg. D7
Though the number of new hepatitis C infections has decreased 90% since 1989, experts at the Centers for Disease Control expect that the number of deaths related to hepatitis C will triple in the next decade. Symptoms lie dormant for years after infection, so many people getting sick today actually contracted the virus in the 1960s through the 1980s and didn't know it. Experts say these patients are mainly baby boomers – white, male and who live above the poverty line – who caught the virus in their youth while engaging in some kind of risky behavior. Hepatitis C is the leading cause of chronic liver disease and liver transplants that is spread through contact with contaminated blood, usually from dirty needles or, less often, unprotected sex. Symptoms can include jaundice, abdominal pain and nausea. In its later states, cirrhosis, a buildup of scar tissue that blocks blood flow through the liver, can occur.
Paul Davies, The Wall Street Journal, May 31, 2005, pg. D1
(Note: People with hepatitis C can have low platelets. Some are misdiagnosed as having ITP)
There are 51 varieties of adenoviruses that threaten humans to different degrees, depending on the virulence strength of the virus as well as the strength of immune defense in a particular human being. Consequently, in the sick, where immunity is weakened, many adenoviruses cause infections that can lead to more illnesses and even death. Immune-compromised children are at great risk for developing adenovirus infections, as are patients who receive transplants, including those for hematopoietic stem cells. Diseases are likely to develop after infection if the adenovirus has multiple sites on and in the human system to reproduce. Current anti-viral therapies prove to be only partially effective, but researchers are looking into engineering T cells, a cell type that is vital to the immune system in fighting bacterial and viral infections, in the laboratory that are specific for a given adenovirus in order to facilitate its eradication.
Ann M. Leen, et al, at the Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX; British Journal of Haematology, 2004, v. 128, pg. 135
Acetaminophen, the active ingredient in the pain killer Tylenol, has been linked to asthma, asthma progression, chronic obstructive pulmonary disease (COPD) and general decreased lung function, according to a study published in the May issue of American Journal of Respiratory and Critical Care Medicine. But the study failed to consider other factors including long-term effects in patients who take acetaminophen for a variety of other diseases. It also lacks quantitative data on dose and duration of use in those patients in which lung function was shown to deteriorate. Further research conducted in a more scientifically organized way, is necessary.
Lauri Barclay, Medscape Medical News, May 3, 2005; http://www.medscape.com/viewarticle/504187
Researchers at Penn State College of Medicine have found that both patients and physicians increasingly look to e-mail as a quick, inexpensive, simple, and convenient way of communicating with each other. The American Medical Association has even released “Guidelines for Patient-Physician Electronic Mail” to better instruct doctors on what is appropriate for e-mail communication. Patients typically e-mail their physicians for prescription refills, non-urgent consultations, and for laboratory results. Though doctors' responses to patient e-mails range from ignoring them to providing detailed information, many physicians find that responding well to patient e-mails cuts down on the number of non-urgent phone calls to the doctors' offices and encourages the patients' learning and participation in making decisions about treatments. There are lingering concerns over privacy, security, and the amount of time physicians will need to devote to answering e-mails rather than actually treating patients. And there is the risk that someone with a serious, acute illness will wrongly resort to e-mail when they should be headed to the emergency room; medical and legal liability are also issues as patients worry about their doctors' response times. But it looks like e-mail communication is poised to reconfigure the traditional doctor-patient relationship and function.
Shou Ling Leong, et al; J. Am. Board Fam. Practice, 2005; v. 18(3) pg. 180; reprinted in Medscape
Contents:
An abnormal platelet sac Clinical Research Study (protocol number 04-HG-0226) at the NIH is recruiting patients. The purpose of this Clinical Research Study is to learn more about bleeding disorders that result from defective blood platelets. The study is open to patients 2 through 80 years of age with the following disorders: gray platelet syndrome; Hermansky-Pudlak syndrome; isolated-storage pool deficiency; combined -storage pool deficiency; Chediak-Higashi syndrome; Griscelli syndrome; Wiskott-Aldrich syndrome; and thrombocytopenia absent radium syndrome.
Contact:
Patient Recruitment and Public Liaison Office
Building 61
10 Cloister Court
Bethesda, Maryland 20892-4754
Toll Free: 1-800-411-1222
TTY: 301-594-9774 (local), 1-866-411-1010 (toll free)
Fax: 301-480-9793
Electronic Mail: prpl@mail.cc.nih.gov
See: http://www.clinicaltrials.gov/ct/show/NCT00086476?order=1
We update our clinical trials page with new information as we receive it. See: http://www.itppeople.com/clinical.htm
Transportation to Clinical Trials
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.
“Blood”, the journal of the American Society of Hematology (ASH), announced that it will provide recently published articles to patients on request. There is no charge for this service. You can request an article by submitting the name of the author(s), title of the article, issue, date, and page number along with your name and email address to publishing@hematology.org. Not only will ASH provide you a copy of the article but if you provide the name of your physician and your physician’s fax number, ASH will fax a copy of the same article to your physician.
In addition to the patient article service, a maximum of five articles from the current issue are available free to everyone. ASH also provides free on-line access to all articles published 12 months ago or earlier.
http://www.bloodjournal.org/misc/Patient_Request.shtml
The Partnership for Prescription Assistance, a coalition of companies, physicians and advocacy organizations, has a program to help qualifying patients who lack prescription coverage obtain the medicines they need. You can call 1-888-477-2669 or visit www.pparx.org to learn more about this program.
Infocus, American autoimmune Related Disease Association, Inc., vol. 13, no. 2, June 2005, p6.
We are not picking on Pennsylvania. They were courageous enough to undertake a study to determine just how common hospital-acquired infections are; and there is no reason to think that Pennsylvania is any better or any worse than any other state. The results of the study give pause to anyone in or contemplating being in the hospital. The Pennsylvania study found that 11,668 hospital-acquired infections were associated with an additional 1,510 deaths, 205,000 extra hospital days and $2 billion in hospital charges last year. Data from 173 hospitals was gathered to complete the study.
R.L. Rundle, “Pennsylvania Finds High Toll in Hospital-Acquired Infections”, Wall Street Journal, July 13, 2005, p D4.
Medical journals are experiencing a great deal of criticism of their role as the gatekeepers of scientific findings from medical research. The on-going Vioxx case and a study in the Journal of the American Medical Association (JAMA) published last year highlight the problem. The Vioxx case involves, among many items and issues, the data set from a Vioxx study. The data set was the basis of an article published in a leading medical journal and part of a filing submission to the FDA. Allegations have come from different sources claiming the data sets are not the same, that the results reported in the journal were based on a subset of the data collected during the study and misleading. The data has been analyzed using different statistical tools and the results are tool sensitive. In other words the conclusions depended on the tools used in the analysis.
The JAMA study of 122 medical-journal articles found “65 % of findings on harmful effects weren’t completely reported. It also found gaps in half the findings on how well treatments worked.” The concern of many is the way the results often seem to be slanted and then used in large-scale marketing campaigns. Strong and persuasive arguments are made from very different positions. Sorting it out will not be easy.
A.W. Mathews, “New Protocol Worrisome Ailment in Medicine”, Wall Street Journal, May 10, 2005, p A1.
The results of medical research are being more widely distributed and read by an audience more diverse in knowledge and experience than has been the case historically.
These journal articles are not always easy to understand and it can often be even more difficult to appreciate the implications of the findings for medical practice or treatment. Understanding the studies reported in medical journals is helped by knowing why the study was done, who was studied, the limitations of the study, and the implications of the findings. Things that are important to look for in studies are: Was it a randomized controlled trial? (One group receives a new therapy, a control receives standard treatment or a placebo; subjects are randomly assigned to each arm). Is the study double blinded? (Neither patients nor researchers know who is in which group). Was the sample large? Were subjects followed for a long time? In most cases reading, understanding, and appreciating the implications of medical journal articles is challenging for the lay person. Help is coming from a number of sources. One of the best places to begin is www.patientINFORM.org, a new web site designed to help patients understand medical research.
Laura Landro, “The Informed Patient: New Help Making Sense of Medical Research”, Wall Street Journal, June 15, 2005, p D1.
Medicine or drug interactions are frequently addressed when choosing a medication. Taking prescription medications with or without food or before or after meals is often included on an insert or sticky label on the container you receive from your pharmacist. However, different foods can significantly affect the rates of absorption and metabolism of many prescription medications. This in turn can affect the impact the medication has on the condition or disease you are treating as well as on your overall health.
H. Gordon, et. al., “Food-drug Interactions MATTER”, Hematology & Oncology News & Issues, June 2005, p 33.
For information on food-drug interactions see:
http://www.holistic-online.com/Herbal-Med/hol_herb_med_reac.htm
http://ohioline.osu.edu/ss-fact/0129.html
http://www.healthatoz.com/healthatoz/Atoz/drugdb/drugSearch.jsp
http://www.umm.edu/non_trauma/fooddrug.htm
http://familydoctor.org/121.xml
H-Pylori infection may be involved in the chronic inflammation that can result in atrial fibrillation, a condition where the heart's two small upper chambers (the atria) quiver instead of beating effectively. This is the same bacteria that when present and eradicated in ITP patients has been associated with clearing ITP. This finding, from a case-control study, was reported in the July issue of Heart. The association between atrial fibrillation and H-Pylori was very strong in patients with persistent atrial fibrillation.
L. Barclay, “Helicobacter pylori May Be Associated With Increased Risk of Atrial Fibrillation”, Heart, 2005; 91:960-961.
Its mosquito season for many readers and strategies to avoid the little critters can be very useful. Dr. Andrew Weil recommends wearing light colored, baggy clothing with long sleeves and pants and avoiding strongly scented products. He suggests to not rely too heavily on eating garlic or taking vitamin B-1. There is no solid evidence that either works. As for repellants, most contain the toxic chemical DEET. Dr. Weil prefers products containing geraniol. When the inevitable happens, he suggests a good way to take the itch away is with the Chinese herbal salve Tiger Balm. This product can be found in health food stores.
“Making Mosquitoes Bug Off”, Self Healing, July 2005, p 2.
www.drweil.com
German researchers report that a single dose of rituximab, a treatment that eliminates B cells that produce anti-platelet antibodies, is enough to effectively treat chronic ITP in childhood and should be considered in order to reduce costs and patients' strain, especially for children. Rituximab, as therapy for chronic ITP, is traditionally given in four doses (375 mg/m2 each) – following the more aggressive treatment outlined for cancer patients since B cells are often malignant in these cases. However, these researchers have found that a single dose of the same amount is effective in treating ITP, which involves non-malignant B cells, because it does deplete CD20+ cells in peripheral blood that would otherwise later attack platelets. In fact, the response rate after a single dose was very similar to that after four doses, and likewise, the relapse rate wasn't very different. Researchers tested 22 children who all had previously been treated either with intravenous immunoglobulins (IVIG) and/or steroids, and gave them each a single intravenous dose of rituximab. They found that children who were diagnosed with ITP at an older age were more likely to experience a complete response to the treatment (they defined a complete response as a platelet count greater than 100 x 109 /L).
Tillmann Taube, et al, The Hematology Journal, February 2005, pg. 90.
The British Journal of Hematology is reporting on research of antiphospholipid antibodies (APLA) and their unclear connection to ITP. APLA are non-specific, meaning they don't target any kind of specific antigen, which is unlike autoantibodies that specifically target platelet cells in ITP. Nonetheless, an inverse relationship has been found between platelet count in ITP patients and the concentration of APLA. Antiphospholipid antibodies also occur with other autoimmune conditions such as multiple sclerosis. Scientists monitored ITP patients who were not suffering from any other concurrent disorder or disease. They found that APLA tended to emerge and increase with the onset or exacerbation of ITP, concurrently with new episodes of bleeding. APLA leveled off when ITP became stable, and it became virtually undetectable during remission. The present study was not conclusive, but researchers believe these findings raise the possibility that APLA either plays a role in exacerbating the development of ITP (and bringing about remission), or is simply an aftereffect of the platelet destruction that occurs with ITP.
Carlos J. Bidot, et al, British Journal of Hematology, February 2005, pg. 366.
The prevalence of certain industrial chemicals in the environment has long been linked to a steady rise of various diseases, from breast and prostate cancer to childhood learning disabilities. Traditionally, scientists sought through research to define – for each type of substance – a “maximum exposure” level at which humans can still be in close proximity to these chemicals without experiencing any health effects. However, research now suggests that diseases and other maladies are developing at much lower levels of exposure than the ones government scientists had previously designated as “safe.” If anything, the effects of certain chemicals are less apparent in higher doses than at lower ones. Additionally, the research shows that while low levels of individual chemicals proved to be safe, in a realistic urban environment where many compounds make their way into the air and water regularly, a combination of chemicals can be detrimental. Japan and the European Union are beginning to regulate the use of such chemicals in mass production, but in the U.S., industry experts and the Bush Administration insist that the research is inconclusive. However, the state legislatures in California and New York are looking into bills that would ban the use of certain phthalates in toys and cosmetics and restrict the use of bisphenol A in polycarbonate plastic bottles and food-can linings.
Peter Waldman, The Wall Street Journal, July 25, 2005, pg. A1.
Two developments during June promise to further advance the process of providing standardized health information available to all parties who will likely need to make important personal and professional decisions based on it. The Secretary of the U.S. Department of Health and Human Services announced a national private-public collaboration called the American Health Information Community (AHIC) to provide all Americans with electronic health records within 10 years. The AHIC was formed under the Federal Advisory Committee Act and is tasked with making recommendations to the Department of Health and Human Services about a number of issues, including protecting patient privacy and security and setting up a network of information-sharing that uses the Internet. The Institute of Medicine estimates that medical errors kill 45,000 to 98,000 Americans a year in hospitals. Improved technology is believed to be able to save lives, time, reduce duplication and waste, and improve efficiency with the potential to reduce costs by as much as 10 percent. Also during June, a Senate bill was introduced that would provide $625 million to fund regional and local health care information technology projects. The bill would establish “legal safe harbors allowing hospitals and other organizations to extend their IT systems to doctors and medical groups.”
Guy Bates, Hematology & Oncology News & Issues, July 2005, pg. 9
The New York legislature has approved a bill that sanctions the creation of the nation's first Internet price-comparison Web site for prescription drugs. The bill requires all pharmacies to submit prices for the 150 most commonly prescribed drugs to the state's Department of Health, which will then post that data online. The AARP is among those who support the bill, insisting it will allow patients – especially the elderly – to save hundreds of dollars a month on prescription drugs. Pharmacists oppose the bill, saying many of those needing the drugs don't have Internet access; the measure will cost them a lot of money, and they claim some elderly patients risk taking the wrong drugs if they buy different drugs from different companies, since no one pharmacy can verify that there would not be drug interaction conflicts. New York currently requires pharmacies to produce weekly updated price lists for customers. According to the National Conference of State Legislatures, Maine and Maryland post Medicaid drug prices on state-sponsored Web sites as well.
Guy Bates, Hematology & Oncology News & Issues, July 2005, pg. 10.
A study led by a researcher at Michigan State University has found that only 3% of Americans lead a healthy lifestyle, as defined after considering four factors: not smoking, maintaining a healthy weight, exercising regularly (at least 30 minutes, five times a week), and eating at least five daily servings of fruits and vegetables. Experts had thought the number was higher – somewhere closer to 15%. When each of those factors were considered individually, 76% of Americans don't smoke, 40.1% maintain a healthy weight, 23.3% eat the minimum, daily recommended amounts of fruits and vegetables, and only 22.2% exercise as outlined by health experts. The results were compiled from survey data of more than 150,000 Americans by the Centers for Disease Control and Prevention. Alcohol consumption was not considered in this study because of the ongoing debate over its health risks and benefits. The study also found that those with higher incomes and a college education faired better in maintaining healthy lifestyles. Likewise, women faired slightly better than men. Experts believe leading a healthy lifestyle sharply cuts the risk for developing cardiovascular disease, diabetes, and cancer.
Jennifer Corbett Dooren, Wall Street Journal, April 26, 2005, pg. D6.
Researchers in Michigan have found that some pre-packaged, ready-to-eat spinach that claims to have been pre-washed actually contains a significant number of bacteria that can infect humans. What's worse: The bacteria look to be resistant to several types of antibiotics. The scientists tested several bags of Ready-To-Eat Baby Spinach by pureeing the leaves in a sterile mixer and then spreading the extracts on petri dishes lined with nutrients that encourage bacteria to grow. Bacterial varieties of Staphylococcus, Enterobacter, and Escherichia developed within days, and 95% of them proved to be resistant to two or more common antibiotics such as ampicillin and ciprofloxacin. While researchers will continue testing a number of different types and brands of ready-to-eat salads, they recommend that consumers can still purchase these products and avoid bacterial infection by washing the vegetables – even if the bags says it's already washed – and cooking them.
C.B., Science News, June 25, 2005, pg. 414.
While some people might believe that drinking alcohol, where the dominant intoxicating ingredient is ethanol, can kill off a budding infection, new research is suggesting booze might actually make certain bacteria more virulent. The bacteria Acinetobacter baumanii is responsible for pneumonia, meningitis, and urinary tract infections in humans, and more recently, it has been implicated in blood infections of U.S. soldiers in Iraq. The scientists first looked into interactions between this bacteria and yeast – noting that the bacteria grew better with the yeast around – and traced this effect to the ethanol byproduct the yeast secreted while fermenting sugar. Further research found that alcohol increased the virulence of the bacterium. The researchers note that while some think that drinking alcohol can kill off a budding infection, “drinking may actually make some bacteria more powerful and speed along a nascent infection.”
C.B., Science News, June 25, 2005, pg. 414.
The recent bombing attacks in London have spurred emergency workers and law enforcement worldwide to support the ICE-ing of cell phones. ICE, for “In Case of Emergency,” lets each cell phone owner program ICE phone numbers into his/her unit so that in the event that they are involved in an accident and can no longer communicate, emergency workers need only push a keypad to find a family member of friend who can provide helpful medical or other background information. ICE would also help identify unfortunate victims in case other distinguishing physical features were no longer intact. Due to the popularity of the program, anyone with an ICE number in their phone is likely to be assisted in many places nationwide. And advocates are pressing phone companies to make the ICE feature available for their customers. More information about the ICE program is available on the Internet at www.ICEcontact.com, including wallet cards that carry emergency information.
http://firechief.com/ar/ICE-for-responders080105/.
Dr. David Kuter, of the Massachusetts General Hospital, presented the results of an open-label study evaluating the safety and efficacy of long-term dosing of AMG 531 in subjects with ITP. The presentation was made at the ISTH Congress in Sydney, Australia on August 9, 2005. AMG 531 is a protein molecule that stimulates platelet production. Participants were patients with a platelet count less than 50,000, on long-term corticosteroid use, and over 18 years of age. Dr. Kuter reported 81% of the participating patients achieved the study objective of a platelet count greater than 50,000 and a doubling of their baseline count. This response was durable (greater that 6 months) for 46% of the participating patients. In addition 50% of the participants were able to discontinue all corticosteroid use and 33% of the remaining patients reduced their corticosteroid use by 25%. Half the participants experienced one treatment-related adverse event. The five most frequent adverse events were headache, upper respiratory tract infection, cough, fatigue, and nose bleed.
Amgen is currently enrolling patients for clinical trials of AMG 531. For more information about these clinical trials go to: http://www.amgentrials.com.
Kuter, D.J., “An Open-Label Study Evaluating the Safety and Efficacy of Long-Term Dosing of AMG 531 in Thrombocytopenic Subjects with Immune Thrombocytopenic Purpura, ISTH Congress, Sydney, Australia, August 9, 2005.
Successful treatments often have rare but serious side effects or adverse events associated with their use. Rare events typically emerge only after approval and use by large numbers of patients. Ann Reed Gaines, of the Food and Drug Administration, in a recent paper in the journal “Blood” reported on 6 patients with findings suggestive of disseminated intravascular coagulation (DIC) following intravenous administration of anti-D immune globulin. The exact incidence rate of DIC associated with hemoglobinemia or hemoglobinuria following anti-D infusion for ITP and other thrombocytopenias is not known. The author estimated the rate at 0.005% or 1 in 20,232 infusions. The event is rare but serious. Only one of the 6 patients she identified survived. She concludes that her “review reinforces the suggestion that patients should be closely monitored for signs and symptoms of acute hemoglobinemia or hemoglobinuria, clinically compromising anemia, and renal insufficiency following anti-D infusion for ITP.” She also recommends monitoring patients experiencing those events for DIC.
Gaines, A.R., “Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hmoglobinuria Following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura”, Blood, 1 September 2005, vol 106, no 5, pp1532-1537.
Caangene Corporation and Baxter Healthcare, the companies that manufacturer and distribute anti-D, released the following statement in response to the “Blood” article:
Cangene Corporation and Baxter Healthcare Corporation acknowledge that this case series highlights the importance of recognizing that IVH and hemoglobinemia are an etiological factor in the development of DIC. This review article reinforces that patients should be closely monitored for signs and symptoms of IVH, clinically compromising anemia, and renal insufficiency (as outlined in the package insert for WinRho SDF). Early recognition of IVH and DIC may lead to enhanced therapeutic options for clinicians to treat these potentially serious but rare events. The author suggests that DIC following anti-D administration for ITP is at most a rare event. According to FDA the reporting rate of IVH 0.1% (1/1115 doses) (Ann Gaines: Blood, April 2000 vol. 95, #8) and the reporting Rate of DIC with hemoglobinemia 0.005% (1/20,232 doses) (Ann Gaines: Blood Sept, 2005) Cangene and Baxter are working with FDA to promote awareness of this issue by including precautionary information in the package insert of WinRho SDF. If your physician would like to know more information about WinRho or about these cases please contact Baxter medical affairs at 1-800-4winrho (1-800-494-6746).
Researchers at the University of North Carolina report a study suggesting that hugs may have benefits beyond just comfort and affection. They recruited 59 women who had been living with a spouse or monogamous partner and during a multi-phase set of interactions including a stressor phase they measured blood pressure, heart rate, and oxytocin levels before and after each phase. Women who said they got more hugs from their partners generally had higher oxytocin levels at all phases of testing. They concluded that oxytocin may be a link between hugging and lower blood pressure. Blood pressure is a key risk factor for cardiovascular disease. The findings from this study may explain why individuals with emotional support from a spouse or partner are less likely to die from heart disease.
Harvard Women’s Health Watch, September 2005, p7.
“A Consumer Guide to Handling Disputes with Your Employer or Private Health Plan, 2005 Update” was released recently by the Kaiser Family Foundation and Consumer Union. The publication “includes information about how consumers can take advantage of their health plans’ internal (grievance) processes to resolve disputes, as well a external review processes allowed under state laws.” You can find the guide at: http://www.kff.org/consumerguide/7350.cfm.
Earlier this summer the President signed the Patient Navigator bill into law. The new legislation authorizes $25 million in grants over five years to establish programs that will help patients with chronic illnesses to make medical decisions, especially uninsured and low income patients, and those who live in rural communities. More information can be found at: http://www.medicalnewstoday.com/medicalnews.php?newsid=27221
NORD on-line, September 2005.
The New York City health department has taken a stand. They have adopted an educational, not a legislative, approach toward the goal of reducing or eliminating trans fats in the preparation of food in New York City restaurants. Most scientists and nutrition experts agree that trans fats are the most dangerous fats in our diet today. The recommendation from these quarters is to use alternatives like olive oil, peanut oil, and sunflower oil. A survey found that 30 to 60 percent of the city’s restaurants use partially hydrogenated oil in food preparation. The city health department and the New York State Restaurant Association which represents 7,000 restaurants across the state have a common goal to reduce the use of trans fat in the preparation of food in New York City restaurants. We can all benefit by eliminating trans fat from our diet by substituting the oils mentioned above in preparing food, by checking labels on the prepared food we buy, and by requesting the restaurants where we dine to join in this campaign.
Santora, M., “Hold That Fat: New York Asks Its Restaurants
Many hair dyes, shampoos, and conditioners contain ingredients that are known allergens and worse, some that pose cancer risks. Catching the most troublesome ingredients is not easy because companies get around listing them on the label by claiming they are a trade secret and use terms like “fragrance” on the label. The top four ingredients to watch for and to avoid are phthalates, parabens, coal tar, and two sulfates; sodium lauryl sulfate (SLS), and sodium laureth sulfate (SLES). You can go to http://www.thegreenguide.com/doc.mhtml?i=110&s=hair to find safe alternatives for shampoos, conditioners and dyes.
Ryan, M., Safe, Not Sorry, Hair: The Case for Nontoxic Shampoos, Conditioners and Colors”, The Green Guide, September/October 2005, http://www.thegreenguide.com/.
Two renowned physicians, Dr. James Bussel and Dr. Douglas Cines, both known for their ITP research and clinical work with ITP patients, explain how they treat ITP in an article in the journal “Blood”. The article is available without charge on an American Society of Hematology website, www.bloodjournal.org. You may have to register before the article is available. Once you have registered, if required, the article is available at the following URL:
http://www.bloodjournal.org/cgi/reprint/106/7/2244
This article, “How I Treat ITP” will be of interest to patients newly diagnosed with ITP as well as patients who have been dealing with the disease for a number of years. In the article Drs. Cines and Bussel set forth their opinion, and they emphasize that it’s their opinion, regarding the best approach to “manage adults with primary idiopathic (autoimmune) thrombocytopenic purpura (ITP).”
The article addresses questions such as: Who gets ITP? How is it diagnosed? Who is treated? Who should be hospitalized? What treatments are the treatments of choice? The article also addresses persistent ITP, splenectomy, approaches to treating chronic ITP, and ITP and pregnancy.
Cines, D.B. and Bussel, J.B., How I Treat Idiopathic Thrombocytopenic Purpura (ITP), Blood (1 October 2005, Vol 106, no 7, pp2244 – 2251).
Gamunex® was introduced in the fall of 2003. It was the first completely new IGIV therapy in more than a decade. Product purity of Gamunex® is enhanced through the use of the Caprylate/Chromatography process that helps to preserve the biologic activity of the product by replacing the solvent-detergent method used in previous generations of IGIV products. Gamunex® is indicated as replacement therapy of primary humoral immunodeficiency disease (PI) and as immunomodulatory therapy for ITP.
Talecris Press Release
This study “evaluated whether repeated courses of high-dose methylprednisolone (HDMP) [prednisone] affect the lumbar spine bone mineral density (BMD) in children with chronic ITP.” The study was a retrospective analysis of 24 chronic ITP patients treated between 1992 and 2002. There were 15 male and 9 female patients included. The children were diagnosed and started treatment at a mean age of 6.7 years. They were divided in to three groups with respect to the number of courses of HDMP they received. The authors conclude that HDMP had a significant affect on lumbar BMD. While the affected lumbar BMD was not clinically significant, “some problems related to the decreased BMD might occur in these patients in the future, and we believe that they should be followed-up closely in the adult life.”
Dilber, C, et.al., Reduced Bone Mineral Density in Childhood Chronic Idiopathic thrombocytopenic Purpura treated with High Dose Methylprednisolone, Bone, 35, 2004, pp 306-311.
The Green Guide in a recent issue offered tips for a safer Halloween. Among a much longer list of suggestions were the following: 1. Make sure your kids can both see and be seen. No masks or hats that make it difficult to see. And bright clothing or flashlights that make them visible especially to drivers. Avoid glow sticks as they may pose a health risk if they leak. 2. Avoid polyvinyl chloride masks, costumes, and accessories. They are potential health risks. 3. Decorate pumpkins with non-toxic materials. Turn to the Green Guide for a more comprehensive list of suggestions.
You can find the article at: http://www.thegreenguide.com/doc.mhtml?i=110s=costumes.
A new website (www.ifpma.org/clinicaltrials) has been launched by the International Federation of Pharmaceutical Manufacturers and Associations to report the results of clinical studies. Phase 1 studies on healthy volunteers are exempt and there is no obligation to report results of studies before a drug is approved. There is an obligation to publish results within one year of approval. For drugs already approved, study results are to be published within one year of the completed trial. The hope is that this site will address criticism of the pharmaceutical industry and head off governmental legislation.
http://www.medscape.com/viewarticle/513195
Doctor-patient communication is one of most basic components of the care we receive from our physicians. To facilitate this communication, patients must be clear and as complete as possible regarding the problem or problems for which they seek help. Doctors must use the limited time available carefully, creatively, effectively, and efficiently. Health care provider Kaiser Permanente developed a program a number of years ago to provide interview training to physicians. The Kaiser program is known as the Four Habits model. While it was developed to train physicians, it provides a learning opportunity for patients who want to get the most out of their visits to their doctor. In short, the model focuses on building rapport quickly, prioritizing concerns, and looking at the problem from the patient perspective. The model emphasizes the importance of empathy and emotions in the communication. Finally the model advocates delivering the diagnosis clearly and in terms of the original concern. The end of the visit should provide a rationale for tests and treatments, summarize the visit, and indicate the next steps.
Details of the model can be found at the two sites below:
Landro, L, “Teaching Doctors How to Interview”, Wall Street Journal, September 21, 2005, p D5.
New standards from the Accreditation Council for Graduate Medical Education (ACGME) are proving to be an incentive to medical schools to move more aggressively to train doctors to be more empathetic, considerate, compassionate, in-short…nicer. Medical educators recognize a culture, a “hidden curriculum” in residency training programs that contradicts everything they have been taught about ethical behavior, compassionate care, and professionalism. The behavior that residents observe every day in the medical school environment is more important in forming attitudes and practices than the information taught in the formal course materials. This culture often includes the lessons that lead to behavior that has been described as “cold, intimidating, authoritarian, narrow-minded and disrespectful of subordinates and patients.” Fortunately this problem is being addressed. Leading medical schools are moving to incorporate standards and an evaluative process to assess progress in training “nicer” doctors. For more information see: www.acgme.org.
Landro, L, “Teaching Doctors to Be Nicer”, Wall Street Journal, September 28, 2005, p D1.
We are currently planning our regional meetings for the fall and winter season. We will host a meeting in Seattle November 5, 2005, in Atlanta December 8, 2005, and in Miami on January 21, 2006. You can find the agenda and specific location of the meetings on http://www.itppeople.com/calendar.htm. We update this information as it is finalized.
These meetings are a wonderful way to learn about ITP and meet others.
A message from one of our members in New Orleans
“Have you ever been to New Orleans? Didn't you just LOVE it! Maybe you saw Mardi Gras? Or the Jazz Fest? Came for a vacation, a wedding, enjoying the fabulous food, tapping with the music, tasting and toasting everything... It is our passion and duty on earth to assure that everybody we know "pass a good time". And it was always a good time in New Orleans, regardless.
But there's a HUGE problem. Similar to the ravaging effects ITP, which introduced its horrible self to me with a platelet count of 1000, Katrina is threatening our very ability to survive. Entire families are scattered across the States.
Businesses are disappearing into the bloodstream of their new post-evacuation locations. As a PDSA member for five years, it is immediately obvious no medication, IV drip, or spleen removal will stop the bleeding.
But YOU can stop it, you REALLY can! Please log on to www.desirenola.org. Read what we are doing to increase our count. Desire NOLA (New Orleans, LA) is not-for-profit, led by young professionals like myself, who want to help small businesses to come back, re-open and thrive. Like the place where you tried your first gumbo, or ate your first po-boy, dunking powdered-sugar beignets into freshly-dripped cafe au lait. We know the cure. Money is the cure. Buy a shirt, share the desire, save our City. Our world-famous "joie-de-vivre" is still palpable, but the count must be increased by thousands of thousands if recovery is to be achieved. PLEASE HELP New Orleans once again say, with each one of our hearts, "Ya'll come back, real soon!"
GMA161 – Genzyme Corporation in collaboration with MacroGenics, Inc. is currently conducting a Phase I research study for people over the age of 17 years who have been diagnosed with chronic idiopathic thrombocytopenic purpura (ITP). The study is designed to investigate the safety of a single infusion of GMA161, a monoclonal antibody, as well as the way the drug enters and leaves the body. In addition, throughout the study, platelet counts and other blood cell numbers will be measured.
For more details about eligibility criteria and contact information for participating medical centers, please visit: http://www.clinicaltrials.gov/ct/show/NCT00244257.
You can find a listing of this and other clinical trials at: http://www.itppeople.com/clinical.htm.
Italian investigators demonstrate that slow breathing can reduce blood pressure. They explain that this is accomplished by enhancing baroreflex sensitivity, the sensitivity of nerve cells in the wall of the heart that sense changes in blood pressure and initiate changes in heart function to maintain normal pressure. The study included 46 subjects; 20 patients with essential hypertension and 26 healthy controls. Slow breathing increased baroreflex sensitivity in the hypertensive patients and the control subjects. The authors conclude, "slow breathing had the effect of acutely normalizing the baroreflex sensitivity in these patients," Dr. Bernardi and his group conclude, "It seems that slow breathing induces a generalize decrease in the excitatory pathways regulating respiratory and cardiovascular systems."
Bernardi, L., et.al., Hypertension 2005;46:714-718, http://www.medscape.com/viewarticle/514756
The Institute of Medicine (IOM) notes that “a chasm exists between the kind of care that patients receive and the kind of care they should have, and calls for fundamental change in the system of care. It further argues that these changes would both be better for patients and make the provision of care more satisfying for clinicians.” Dr. Davis proposes seven attributes of patient centered care;
1. Access to care
2. Patient engagement in care
3. Information systems
4. Care coordination
5. Integrated and comprehensive team care
6. Patient-centered care surveys
7. Publicly available information
It has been reported that 25% of primary care physicians currently incorporate these attributes in their practices. Marked improvement will require major changes including a new system of primary care payment. One proposed structural change would ensure that everyone had a “medical home”; everyone regardless of whether insured by public programs or private insurance would have a place to enter the health care system. The task is monumental with rewards to match.
Davis, K., et.al., Journal of General Internal Medicine, 2005;20(10):953-957, http://www.medscape.com/viewarticle/514194.
It is estimated by the World Health Organization (WHO) that 17 million people die prematurely each year from chronic diseases and that international action to prevent chronic disease could save 36 million people world wide over the next decade. The three most important causes of chronic diseases are unhealthy diet, physical inactivity, and tobacco use. The personal, social, and economic impact of these diseases is significant. Families are fractured and the economic losses amount to billions of dollars. It is estimated that in the period 2005 – 2015, China, India, and the Russian Federation will each forgo billions of dollars of national income to premature death due to chronic disease. The WHO report includes inexpensive and cost-effective measures that could produce rapid health gains. These include: salt reduction in processed foods, improved school meals, and taxation of tobacco products. The latter approach is not only cost-effective but would increase revenue as well.
http://www.who.int/mediacentre/news/releases/2005/pr47/en/
Researchers in Toronto report that children treated with steroids for acute ITP are 26% less likely to have a platelet count greater that 20,000 48 hours after therapy than children treated with IVIG. This finding resulted from a meta analysis of data from randomized, controlled trials and was reported originally in the Journal of Pediatrics in October 2005.
Beck, C., Nathan, P., Parkin, P., Blanchette, V., Macarthur, C., “Corticosteroids Versus Intravenous Immune Globulin for the Treatment of Acute Immune Thrombocytopenic Purpura in Children: A Systematic Review and Meta-Analysis of Randomized Controlled Trials” The Journal of Pediatrics, October 2005 (Vol. 147, Issue 4, Pages 521-527) see also IgG Today, Newsletter of IgG America, November 2005. http://www.jpeds.com/article/PIIS0022347605003422/abstract
The American Society of Hematology (ASH) has made available full-text, searchable PDF versions of all articles dating back to 1946. Access is free to all. Only articles from the last 12 months are under access control. However, even articles published during the last 12 months can be obtained by patients at no cost by emailing a request to the journal. For an explanation of the procedure to obtain articles published during the last 12 months, go to:
http://www.bloodjournal.org/misc/Patient_Request.shtml.
To use the Blood archive, go to: www.bloodjournal.org.
ASH Newslink, November 2005.
Researchers at Boston University reported on data from a nationwide survey examining the teeth and gums of 6,700 nonsmokers. They found that bleeding gums were 20% less likely in those with the highest levels of Vitamin D. The authors suggest that Vitamin D may keep gums healthy by fighting inflammation.
Nutrition Action Healthletter, November 2005, p 10.
The National Institutes of Health (NIH) announced that a 230 page volume, Thrombosis Research, will be available December 10, 2005. This publication represents the work of the NIH Conference on Dietary Supplements, Coagulation, and Antithrombotic Therapies. The volume examines the effects of dietary supplements and various therapies on coagulation.
Representatives from 10 patient care organizations participated including Joan Young, President of PDSA. In addition to the representatives from patient care organizations, more than 35 speakers presented.
http://www.sciencedirect.com/science/journal/00493848
Contents:
This month encouraging reports were presented at the American Society of Hematology (ASH) Conference in Atlanta, Georgia on the new ITP treatments in development that stimulate platelet production. Reports from clinical trials of both Amgen’s AMG 531 and GlaxoSmithKline’s Eltrombopag indicate treatments that increase platelet counts to safe levels at doses that are well tolerated.
One group of researchers at ASH reported that “AMG 531 has been generally well tolerated and able to stimulate platelet production in a dose-response manner in healthy volunteers and ITP patients. Results suggest that both unit dosing and weight based dosing provide a predictable platelet response. AMG 531 may represent a new treatment option for thrombocytopenic patients with ITP.” Another group of researchers reporting results from a clinical trial involving 21 patients state that “AMG 531 was well tolerated and both doses (two dose levels were tested) were able to increase platelet counts within the targeted range.”
Results of clinical trials were announced for GSK’s Eltrombopag. Researchers reported that a phase 1 study resulted in a dose-dependent increase in platelet count without safety or tolerability issues. They reported no effects on other blood cell lineages or priming of platelets for activation or aggregation. The report from a phase 2 study demonstrated that patients with ITP for at least 6 months and having failed at least one prior therapy with a platelet count less that 30,000 achieved platelet counts greater that 50,000 after 6 weeks without safety or tolerability issues.
Clinical trials for both compounds are on-going. See http://www.itppeople.com/clinical.htm for information on these and other clinical trials for ITP.
See http://www.hematology.org/meetings/2005/abstracts.cfm to view the abstracts. The next issue of our newsletter, The Platelet News, sent to our members (see http://www.pdsa.org/joinus.htm) will contain a synopsis of all the relevant ITP abstracts as well as summaries of the special ITP sessions.
Stepan, D.E., et. al., “Safety Profile of AMG 531 in Healthy Volunteers and in Thrombocytopenic Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
Kuter, D., et. al., “A Placebo Controlled tudy Evaluating the Platelet Response and Safety of Weekly Dosing with a Novel Thrombopoietic Protein (AMG 531) in Thrombocytopenic Adult Patients with Immune Thrombocytopenic Purpura (ITP)”, abstract 1240, Blood, Volume 106, issue 11, November,2005.
The Food and Drug Administration (FDA) has issued a safety alert indicating that some IgG products may cause false elevated blood glucose measurements. These false measurements have resulted in inappropriate administration of insulin, resulting in life-threatening hypoglycemia according to the FDA. The products involved are Octagam 5%, Gamimune N 5%, and WinRho SDF Liquid (No interference expected at labeled doses).
See: http://www.fda.gov/ohrms/dockets/ac/05/slides/1 for more information.
IgG Today: News and Information for Clinicians, IgG America, December 2005.
Adverse drug and device events affect hundreds of thousands of patients annually. Many are or become life-threatening. New medications and devices are tested very carefully before being approved for use by the medical community to treat patients. However, these trials are conducted with relatively small numbers of patients. This means that adverse events that will affect a small percentage of patients are less likely to be detected. It is important that post approval adverse events be reported and evaluated. The FDA has established an on-line system that enables patients to report adverse events directly. You can report an adverse event at the MedWatch section of the FDA website. The form is available at: http://www.fda.gov/medwatch/SAFETY/3500.pdf. Instructions to complete the form can be found at: http://www.fda.gov/medwatch/REPORT/CONSUMER/INSTRUCT.HTM.
ITP is one of the most common bleeding disorders in children. However, there have been relatively few clinical trials with ITP children leaving diagnosis and treatment to expert opinion not clinical trial evidence. As a result, treatment varies widely. Drs. A.T. Shad, C.E. Gonzalez and S.G. Sandler (a member of the PDSA Board of Medical Advisors) all at Georgetown University Medical Center have reviewed the diagnosis and treatment of ITP in children in the current issue of Pediatric Drugs. The abstract is available at:http://pt.wkhealth.com/pt/re/pdd/currenttoc.htm;jsessionid=DnLAOpOPaJ8l05yMxI1AzP3PH7BuZQc56t5SQnDfJ2Mwo32cJl16!-85436088!-949856145!9001!-1 and a sample issue of the journal is available at the same site after registration.
Shad, A.T., et. al., “Treatment of Immune Thrombocytopenic Purpura in Children”, Pediatric Drugs, 2005: 7 (5):325-336.
The good news is more Americans are eating vegetables. The bad news is illnesses traced to fresh vegetables are on the rise. Government and the produce industry have identified five products that are particularly problematic: tomatoes, melons, lettuce, sprouts, and green onions. The FDA is pushing to extend food-safety practices to include those who harvest, store, and distribute raw agricultural products. The industry is also developing detailed guidelines covering each step of the journey to market. The Partnership for Food Safety Education recommends a six step approach to handling fruits and vegetables. One, check for bruises and reject bruised fruits and vegetables; two, clean hands and utensils with hot soapy water before washing fruits and vegetables; three, separate fresh fruits and vegetables from household cleaning chemicals as well as meat, poultry, and sea food from shopping cart to table; four, cook or throw away fresh items that touch meat, poultry, or sea food; five; chill by refrigerating all cut, peeled, or cooked fresh fruits and vegetables within 2 hours; six, throw away all fresh fruits and vegetables not refrigerated within two hours. To get the details on the six step procedure go to: http://portal.fightbac.org/pfse/toolsyoucanuse/phec.
Zhang, J, “When Eating Your Vegetables Makes You Sick”, The Wall Street Journal, November 30, 2005, p D1.
A study conducted by Kenneth Mukamal and colleagues at Beth Israel Deaconess Medical Center in Boston suggests that moderate drinking may lower the risk of heart attacks. They studied the blood of 3,789 men and women over several decades investigating risk factors for cardiovascular disease. They found that “the blood of people who consume 3 to 6 [alcoholic] drinks weekly was less likely to clot in a test tube than was blood from nondrinkers, Platelets from the moderate drinkers were also less likely than those from nondrinkers to display a surface protein that makes them sticky.” The study seems to confirm other work showing that people who drink regularly have a lower risk of heart attacks but a higher risk of bleeding strokes than do teetotalers.
Science News, November 12, 2005, vol 168, p 317
Health insurance companies are using graphic videos to educate patients about their health and help them go into surgery with realistic expectations. Some of the videos available show very graphic detail of surgical procedures such as a needle being inserted into the eye as part of cataract surgery or blood dripping from a foot from which skin is being peeled away as part of a surgical procedure. This objective for the videos of building realistic expectations for patients is claimed by the companies that create them and the insurers and employers who are making them available to workers. Surgery videos join preventive-care guides and online drug cost software that insurers and health-plan administrators are using to educate patients as part of a movement that is referred to as consumer driven health care. Some claim that watching these videos can empower patients to question their physicians instead of just accepting their recommendations as if no alternative is available or worthy of consideration. Others see these tools as discouraging procedures that patients can benefit from. The Ottawa Health Research Institute recently chaired an international group to develop standards for effective standards for effective “decision aids” for patients.
Rubenstein, S, “Health Insurers Show Employees Graphic Surgery Videos”, The Wall Street Journal, November 30, 2005, p B1.
Food marketers want to use terms such as “good source” and “excellent source” of whole gains to promote the sale of a wide range of grain-based food products. According to the Wall Street Journal 432 whole grain products have been launched this year. The FDA has entered the fray by rejecting General Mills Inc.’s request for permission to label cereal, bread and other products as “good source” or “excellent source” of whole gains. Presently it is difficult for shoppers to know how much whole grain is in a product. While some manufacturers are using the phrase “all our products are made with whole grain” the FDA has not ordered them to pull this wording. The FDA has not decided what “whole grains” includes or whether it should be considered a food category, ingredient, nutrient, or something else. It will be some time before this is resolved. In the mean time buyer beware.
Zhang, J., Adamy, J., “FDA Limits Claims About Whole Grains”, The Wall Street Journal, December 6, 2005, p D1.