Chemotherapy and cognitive decline: Chemotherapy patients have long complained that the treatment caused cognitive decline. Imaging studies, presented last month at a scientific meeting in Florida, confirmed these complaints by showing marked differences in breast-cancer patients who had undergone chemotherapy compared to a group who had undergone surgery alone. While two-thirds of women treated with chemotherapy show some level of cognitive problems, most recover within weeks or months of treatment. Tim Ahles, at the Dartmouth Medical School, says 20% to 25% of patients may develop lasting problems. “For patients who need chemo, the problems are not significant enough to turn down treatment. But doctors say patients who are borderline candidates may want to factor the potential cognitive side effects when deciding whether to undergo chemotherapy.”
Wall Street Journal, Tara Parker-Pope, March 6, 2004, p D1. e-mail the author at healthjournal@wsj.com.
Steroid therapy as a risk factor for sigmoid diverticular abscess perforation (SDAP): Reuters Health Information Service reported recently on work done by Dr. S. Mpofu and colleagues that showed steroid therapy was strongly associated with the bowel condition while non-steroidal anti-inflammatory drugs were only weakly associated with SDAP. Corticosteroid is a risk factor for SDAP for patients with our without rheumatic disease.
Ann Rheum Dis 2004;63:588-590.
Immunoglobulin-secreting cells (ISC) persist in the spleen: Work by Julia I. Ellyard and colleagues has demonstrated the persistence of long-lived immunoglobulin-secreting cells (ISC) in lymph tissue and rodent spleens. To date, ISC were thought to reside only in the bone marrow. These findings suggest that the spleen may play an important role in maintaining humoral immunity (immunity conferred by antibodies). Identifying the human counterpart of rodent ISC will be valuable in investigating the long-term immunity of splenectomized patients.
BLOOD, 15 May 2003, Vol 103, Num10, pp3805-3812.
Historically hospitals have told uninsured patients that Medicare requires charging them at the highest rate. The Department of Health and Human Services (HHS) has now notified hospitals that there are no federal rules preventing them from offering discounts to uninsured patients. This is important, good news for the 43 million Americans without health insurance.
NORD, March 2004, p6.
Work by Takashi Satoh and colleagues examined the single nucleotide polymorphisms (SNPs) of inflammatory cytokine genes in 84 adult Japanese patients with ITP. They found that TNF-B (+252) G/G phenotype was significantly higher in ITP patients than in healthy controls. Their findings suggest that the SNP located at TNF-B (+252) contributes to the susceptibility of chronic ITP. “Other genetic and environmental factors are definitely necessary for the development of ITP as well, but the SNP at TNF-B (+252) may play a role in an individual’s susceptibility to this disease by promoting the specific autoantibody response.” The authors did not rule out the possibility that the “observed associations merely reflect linkage disequilibrium with other susceptibility genes.”
British Journal of Haematology, 124, 796-801.
It is well understood that hospitals are great places to pick up infections. Christine Gorman reported in Time last month that hospital infections contribute to nearly 90,000 deaths in the US each year. This in the face of a number of studies that show hospital staffs generally follow hand-washing guidelines less than 40% of the time. Many suggestions have been offered. Some hygiene experts have suggested that patients ask doctors and nurses whether they have washed their hands. But the question becomes how to do this without putting the caregiver on the defensive? Dr. Carolyn Clancy, director of the Agency for Healthcare Research and Quality, suggests one way “might be to say, ‘I’ve read that it’s important for health care professionals to wash their hands frequently and that doctors are so busy they sometimes forget.’” Say it with a smile.
Christine Gorman, TIME, March 29, 2004, p. 81.
A 38 year old male patient experienced a timber rattlesnake bite and went to the emergency room within one hour of the bite. Within three days his platelet count dropped to 590 per cubic millimeter. The patient continued to experience thrombocytopenia despite large quantities of CroFab antivenom. Timber rattlesnake bites commonly cause thrombocytopenia. This case suggests that the established treatment for rattlesnake bite may not be sufficient to correct the venom-induced thrombocytopenia.
Researchers at the Graduate School of Biomedical Sciences, Hiroshima University have demonstrated the development of functional platelets from murine (mouse) embryonic stem cells. They suggest that embryonic stem cell derived platelets could be a substitute for platelet transfusions. They suggest their work “should facilitate functional studies using gene-transferred platelets and be a future approach for treatment of platelet disorders.”
Tetsuro-Takahiro, et. al., Production of Functional Platelets by Differentiated Embryonic Stem (ES) Cells in Vitro, BLOOD, 1 December 2003, volume 102, number 12, pp4044-4051.
Investigators at the Pacific Northwest Research Institute (PNRI) in collaboration with researchers at Johns Hopkins University have developed statistical models that identify patients with MDS, or those at a high risk for the disease. Donald C. Malins, PhD, DSc, director of biochemical oncology at the PNRI, said, “the DNA test for MDS is highly predictive …. and is the first molecular marker capable of distinguishing MDS patients as a group from patients with nonmalignant bone marrow disorders.”
John Watson, Hem/Onc Today, May 2004.
(These new tests are important in the diagnosis of ITP because ITP can be confused with MDS and the treatments for the two diseases are very different. Since ITP is a diagnosis of exclusion, these tests are potentially beneficial for both MDS and ITP patients)
The Platelet Disorder Support Association has printed a wallet-size medical emergency card designed for patients with ITP. It contains a space for personal, emergency contact, treatment, medical history and insurance information. To receive your medical emergency card, send a note and a stamped, self-addressed envelope to PDSA, P.O. Box 61533, Potomac, MD 20859.
We thank Nabi Biopharmaceuticals for sponsoring the printing of these cards and Morbus-Werlhof-Selbsthilfegruppe, the German ITP Association, for sharing their emergency card format.
Want to keep your immune system in tip-top disease-fighting shape? If you’re a woman, a new study suggests that immune health is best when your weight is stable but can be compromised by yo-yo dieting (repeatedly losing and regaining weight). Researchers at the Fred Hutchinson Cancer Research Center in Seattle interviewed a group of older women about their weight loss history over the past 20 years and theorized that healthy immune function declines with repeated weight loss (and gain). Women whose weight remained stable or those who had lost excess pounds and then maintained a constant weight had better natural killer-cell activity. (Killer cells are important in destroying viruses, detecting leukemia cells, and performing other cellular defenses.) The women who said they had lost and regained weight more than five times had natural killer-cell function approximately one-third lower than that of women whose weight remained stable. The results suggest that for the sake of your immune system you should get to a healthy weight and maintain it.
The study was published in the June 1, 2004, issue of the Journal of the American Dietetic Association
A new Canadian study links Cox-2 inhibitors (pain-relief drug) to increased risk of stomach bleeding. Last year a study published in the American Heart Journal (October 2003) raised the question of whether the Cox-2 inhibitors were safe to use in patients at risk for cardiovascular events. These drugs were thought to be gentler on the stomach but responsible for making platelets “stickier” and more likely to be responsible for clot formation in blood vessels. Now a retrospective Canadian study of health care data for elderly people suggests that the increase use of Cox-2 inhibitors and gastrointestinal bleeding are directly related. The study published in the British Medical Journal followed the observation that when the Ontario government began paying for the new generation of anti-inflammatory drugs, hospital admissions for stomach bleeding rose. Critics of the study point out that the data does not necessarily link the increased bleeding to patients taking the new drugs and that the new safer medications may have brought higher risk patients to use them. The study is in no way conclusive. More definitive conclusions await a large, prospective randomized trial.
Scott Hensley, Wall Street Journal, June 11, 2004, pB-1
Antibody testing has never proved useful as either a diagnostic tool or a predictor for ITP patients. However research reviewed by Douglas Cines, MD, in a recent issue of Blood raises the “possibility that measuring platelet-specific antibodies may be of use to prognosticate the clinical course in patients with an established diagnosis.” Several recent studies support this position and a large recently published study by McMillan and colleagues showed that “once patients with non-immune causes of thrombocytopenia who responded to ITP-directed therapy are excluded, the specificity of a positive antibody assay for the diagnosis of ITP approached 95%.” And finally, the study by Fabris and colleagues appearing in Blood in June of this year followed fifty consecutive patients and using a solid-phase modified antigen capture ELIAS test for the detection of specific platelet-associated autoantibodies against a number of glycoproteins demonstrated that “ITP patients with platelet autoantibodies ….. have a clinical worsening of thrombocytopenia more frequently and sooner that patients without autoantibodies.
Douglas Cines, “Antibodies Redux” Blood, June 15, 2004, p 4380.
Fabrizio Fabris and colleagues, “Platelet-associated autoantibodies as detected by a solid-phase modified antigen capture ELISA test (MACE) are a useful prognostic factor in idiopathic thrombocytopenic purpura” Blood, June 15, 2004, p 4562.
See: www.bloodjournal.org
“I believe that doctors often make matters worse in the way they manage this condition (ITP in children). They prescribe mostly unpleasant, frequently unnecessary and sometimes dangerous therapy. They also offer self-defensive and over-cautious advice on risk management, creating what amounts to an anxiety state in some patients,” says Dr. John Lilleyman in a note in a recent issue of the British Journal of Haematology. So often it is platelet count that is treated and the author points out that platelet count is a poor predictor of morbidity (life threatening condition). Turning to mortality he points out that, intracranial haemorrhage is effectively the only fatal complication, but even massive cerebral bleeds can be managed successfully with appropriate emergency measures and are by no means always fatal. Dr. Lilleyman concludes, “Outside the context of emergency treatment for life threatening bleeding … the effect of therapy on the mortality of childhood ITP remains to be determined but is probably close to zero. For morbidity, some measures, …. might improve the quality of life for the occasional child with chronic symptomatic thrombocytopenia by relieving disabling menorrhagia or self-consciousness, or by removing the straitjacket of fear. But heroic attempts to raise the
platelet count in otherwise well children seldom justify the risks involved.”
British Journal of Haematology, 2003, 123, 586-589
Complementary and alternative medicine (CAM) use among Americans is on the rise. Seventy-five percent of adults 18 and over have used CAM, 62% during the past 12 months, when prayer specifically for health reasons was included in the definition. The data supporting the report is from the 2002 National Health Interview Survey (NHIS) conducted by the Centers for Disease Control and Prevention’s (CDC) National Center for Health Statistics (NCHS). This level of use when compared with CAM use reported in earlier studies indicates, according to the report released by the U.S. Department of Health and Human Services, a substantial increase in CAM use during the 1990’s. The report attributes the increase to “marketing forces, availability of information on the Internet, the desire of patients to be actively involved with medical decision making, and dissatisfaction with conventional (western) medicine.” This dissatisfaction the report attributes to the inability of conventional medicine to adequately treat many chronic diseases. The report points out several characteristics these therapies have in common; including “the use of complex interventions; often involving the administration of many medications or medical substances at the same time; individualized diagnosis and treatment of patients; an emphasis on maximizing the body’s inherent healing ability; and treatment of the ‘whole’ person by addressing their physical, mental, and spiritual attributes rather that focusing on a specific pathogenic process as emphasized in conventional medicine.” The report also warns that use of these CAM therapies might have unanticipated negative consequences. Other studies have found that many patients do not share with treating physicians their use of CAM therapies; thus raising the possibility of negative consequences.
“Complementary and Alternative Medicine Use Among Adults: United States, 2002”, Patrick M. Barnes, et. al. The full report is available at www.nccam.nih.gov
(For more information on the use of CAM for ITP see the results of our PDSA 2001 survey of non-traditional therapies see www.pdsa.org/surveyres/ and www.itppeople.com/treatments.htm)
A significant increase in bruising or other minor bleeding has been reported in patients treated with the ketogenic diet; a high fat low carbohydrate diet used to control epilepsy. Dr. Berry-Kravis and colleagues used chart review and prospective screening of 51 past and current diet treated patients for symptoms of bruising and bleeding. They report 16 of the 51 patients experienced bruising or minor bleeding symptoms. The researchers suggest that “Patients on the diet undergoing anticoagulation or surgery be evaluated carefully for symptoms of bleeding tendency.”
“Bruising and the ketogenic diet: evidence for diet-induced changes in platelet function” Berry-Kravis E et al. Ann Neurol. 2001 Jan;49 (1)98-103
PMID: 11198302 [PubMed – indexed for MEDLINE]
(The Atkins diet and other very low carbohydrate diets produce a ketogenic state in the body. PDSA does not recommend these diets. See diet results from our survey at http://www.itppeople.com/surveyres/. You can view our diet suggestions at http://www.pdsa.org/articles.htm)
A group of 34 patients diagnosed with ITP at age 6 months to 15 years were seen over a period of almost 8 years by Dr Kenneth Charles and colleagues at Eric Williams’ Medical Sciences Complex on the island of Trinidad. Sixteen patients (47%) were managed by observation alone. Five of these patients (14.7%) were discharged from the emergency room and followed as out patients the others were admitted to hospital. All patients managed by observation alone recovered fully. They report “that non-intervention was safe, cost-effective, and acceptable to both children and parents in the <10 years of age group. However, adolescents were more likely to require treatment.” One patient experienced an intracranial haemorrhage and was treated with IVIg. Three of four adolescent girls tested positive for antinuclear antibodies and developed chronic ITP. Dr Lilleyman of the NHS National Patient Safety Agency in London, UK, responded to the correspondence from Trinidad by saying, “the message from this small cohort study is clear; doing more of nothing produces little difference in outcome apart from less time in hospital and less invasive investigations.”
“Medical nemesis and childhood idiopathic thrombocytopenic purpura” British Journal of Haematology, 126: 282-283, 2004.
The call for more comprehensive disclosure of the start and outcome of clinical trials is growing. The New York Times reported last month that the leading medical journals are considering a proposal that would require drug companies to disclose trials that shed unfavorable light on their products. Editors at a number of journals declined to discuss the matter but confirmed that the Times report was accurate.
The Washington Post reported earlier this month that the World Health Organization (WHO) wants to start an international registry of clinical trials or drug trials. Full disclosure has been gaining momentum following a recent report that drug companies had not published the results of tests of antidepressant drugs that showed they were ineffective in treating children.
The underreporting is significant. In 2002 the FDA found that only 48% of trials for cancer drugs were registered. The Washington Post reports that a review now indicates that the listing rate for drugs for some other serious diseases may be in the single digits. A 1997 federal law requires drug manufacturers to register clinical trials with the FDA. But the law is not enforced because the statute did not spell out penalties or explicitly give the FDA authority to crack down on violators. Senator Kennedy, who helped create the registry in 1997, plans to seek enforcement provisions.
There are a number of important issues. The drug companies are concerned that more fully complying with registering trials could endanger trade secrets. Critics, on the other hand, hold that the drug manufacturers want to prevent all the evidence from emerging because it could have a negative impact on sales and profits. These issues become all the more important with the turn to evidence based practice and evidence based reimbursement. The evidence based approach will be difficult to justify in an environment where the evidence is so selectively made available by those with an important financial stake in the process.
Shankar Vedantam, “Drugmakers Prefer Silence on Test Data”, Washington Post, July 6, 2004, p A1
S. Vedantam, “WHO Wants to Start Drug Trial Registry” Washington Post July 8, 2004, p A3
“Medical Journals May Force Disclosure of Bad Trials” Reuters Health Information as reported on Medscape, June 23, 2004.
Evidence is accumulating that some herbs and food additives when taken along with certain prescription drugs may weaken the effects of the prescription drugs or increase the risk of undesirable side effects. Some examples are garlic intensifying the effects of blood-thinning drugs and echinacea increasing the risk of side effects with some medications. The FDA is funding a study of the effects of Echinacea on birth control regimens. Calcium fortified orange juice and Total cereal may weaken the effects of antibiotics such as Cipro, Noroxin, and tetracycline. Some drug companies are listing herbal interactions on their labels and some herbal companies are printing potential drug interactions on their labels. The available evidence would call for patients to list all herbs and food additives with their physicians when providing medical histories or medications they are using.
Jane Spencer, “The Risks of Mixing Drugs and Herbs, Wall Street Journal, June 22, 2004
The U.S. Supreme Court ruled unanimously last month that patients can not sue their health insurance carrier in state court; federal courts are their only recourse. The cases ruled on were brought under the 1997 Texas Health Care Liability Act alleging that decisions to deny care were medical, not administrative, and covered by the 1997 Texas law. The court held otherwise. This ruling weakens the Texas law as well as similar laws in other states that have been enacted to give patients the option to sue (in state courts) insurance company decision makers for malpractice damages instead of being limited by the federal law of suing for the cost of the denied treatment.
Health Assistance Partnership, Weekly Email, June 21, 2004.
A report this month on the findings from a population-based study of more than 20,000 initially arthritis-free subjects suggests foods high in vitamin C may protect against inflammatory polyarthritis (IP) a rheumatoid arthritis involving two or more joints. Dr. Dorothy Pattison and colleagues found that those reporting low intake of fruits, vegetables, and vitamin C, less than 55.7 mg/day, were 3.3 times more likely to develop IP than the control group who consumed vitamin C at a rate of more than 94.9 mg/day. The findings from this study at the University of Manchester, UK contrast with a recent report based on work using a guinea pig model of osteoarthritis that linked high doses of vitamin C with increased severity of the disease. The researchers pointed out that comparing the results from observational studies with those conducted in a laboratory setting is difficult. Also these contrasting results may suggest different disease mechanisms.
“Vitamin C Rich Diet May Cut Rheumatoid Arthritis Risk”, Annals of the Rheumatic Diseases, 2004; 63:843-847, WebMD Medscape, Reuters Health Information.
A recent randomized clinical trial found that yoga or exercise “produced improvement in secondary measures of fatigue, including the Energy and Fatigue (Vitality) score on the Short Form (SF)-36 health related quality of life, and general fatigue on the Multi-Dimensional Fatigue Inventory (MFI).” Dr Barry Oken and colleagues at the University of Portland randomly assigned 69 subjects with clinically definite MS to one of three groups. One group attended a weekly yoga class and supplemented this with home practice. The second group did weekly exercise class using a stationary bicycle along with home exercise and the third group was a wait-listed control. While there were no clear changes in mood related to yoga or exercise, there is a possibility that mood improvements contributed to the observed improvements in quality of life and fatigue.
Laura Barclay, MD, “Yoga, Exercise Improve Fatigue Associated with Multiple Sclerosis”, Neurology, June 8, 2004, vol 62, pp2058-2064; and Medscape Medical News.
The availability of the SOS Philips In-Touch Address Recorder was reported recently in Time magazine. The device is available for $20.00 and records up to a 20 second message. The message can include medical information and attaches to a child’s clothing. The recording button is recessed and reasonably tamper proof. Details can be found at www.philipsusa.com, search on In-Touch Address Rercorder.
“A Recording to Help Keep Your Kid Safe”, Time magazine.
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Two recent articles in the journal “Blood” address several long term aspects of splenectomy outcome for ITP. The first article examines the outcome for ITP patients refractory to splenectomy. The second addresses three questions: How durable are the responses to splenectomy? Is it possible to predict who will respond to splenectomy? What is the frequency of surgical complications with splenectomy as a treatment for ITP?
The first article by Robert McMillan and Carol Durette reports on long-term follow-up of 105 patients who failed splenectomy and required additional therapy. Seventy-five of these patients attained a stable partial (platelet count 30,000/mm3) or complete (normal platelet count) remission. Of these 75 patients, 51 maintained their remission after stopping therapy while 24 required continued treatment. Thirty of the 105 patients in the study remained unresponsive to treatment. Thirty-one of the 105 patients died 17 due to ITP (11 – bleeding, 6 – therapy complications) and 14 of unrelated causes. Five of these deaths were from the group of 51 who maintained remission after stopping therapy, 8 from the group of 24 who achieved remission but required continued treatment, and 18 from the 30 patients who remained unresponsive to treatments. The authors conclude “that most refractory ITP patients attain a stable remission although, on average, this occurs slowly. However, a subpopulation with severe, resistant disease has significant morbidity and mortality.”
McMillan, Robert and Durette, Carol, “The Long Term Outcome of Adult Chronic ITP Patients Who Fail Splenectomy,” Blood, August 2004, 104:956-960.
The second article by James George and colleagues poses three very important questions regarding the durability, predictability, and complications associated with splenectomy. The study reviewed 135 case series reporting over 6,000 splenectomized ITP patients. They report a complete response in 1731 of 2623 (66%) patients with a median follow-up of 29 months (2.4 years). This series included adults and children. In another set of case series that included only adults 456 of 707 (64%) patients were reported to have had complete remission with a median follow-up of 87 months (7.25 years). Among the variables available prior to splenectomy, age at the time of splenectomy most often correlated with response. Six case series studies used different radioisotope techniques to determine the site of platelet destruction and found that patients who had predominately splenic destruction had a better response than patients who had predominately non-splenic destruction. However 10 other case series did not support the site of platelet destruction as a good predictor of response. The authors caution that “the decision for splenectomy must be carefully balanced by consideration of the potential risks, since the rate of complications following splenectomy is relatively great. Mortality rates of 0.2% and 1.0%, with laparoscopy and open laparotomy, respectively.” The authors go on to warn that “the risks of splenectomy may be greater than described in this systematic review, since we did not evaluate long-term risks of sepsis and thrombosis.”
Kojouri, K., Vesely, S.K., Terrell, D.R., George, J.N., “Splenectomy for Adult Patients with ITP: A Systematic Review to Assess Long Term Platelet Count Responses, Prediction of Responses, and Surgical Complications,” Blood (prepublished online), June 24, 2004, DOI 10.1182/blood-2004-03-1168.
The July 2004 Bulletin of The National Organization for Rare Disorders (NORD) brought attention to the difficulty in updating drug labels to reflect the results of clinical trials completed after a drug has been approved by the FDA. Even if a company submits clinical trial data showing that a drug is not effective after a drug has received FDA approval, the information cannot be added to a drug’s label unless the manufacturer agrees. Triggered by recent disclosure of the ineffectiveness of some and the adverse effect of other medications, “medical societies, and especially pediatricians, are telling FDA it is unethical not to add information to drug labels if the FDA knows about it, even if the manufacturers object.”
NORD On-Line Bulletin, “Keeping Negative Clinical Trial Results Secret,” July 2004, pp2,3. http://www.rarediseases.org
NovoSeven, a drug used to prevent hemophilia patients from bleeding to death, shows promise of lowering the risk of disability and death for victims of bleeding stroke. The drug is a clotting agent called factor VIIa, a protein that causes blood clots to form. It was administered to bleeding stroke patients at Columbia Medical Center in New York. The study was designed to test the drug’s safety and potential for reducing bleeding. The patients in the study received an intravenous infusion of the drug, in one of three doses, or a placebo. Twenty-four hour follow-up revealed that any of the three doses reduced bleeding in the brain by about half. At three month follow-up those receiving the drug were approximately 30% less likely to die or be left severely disabled (paralyzed or in a coma). Close to 70% of those receiving the placebo either died or were severely disabled. On the downside, those receiving the drug were about 6% more likely to suffer heart attacks or blood clot caused strokes. The study was funded by the manufacturer and most comments suggested more testing to determine the relative risks and benefits of the treatment.
Stein, R, “Possible Therapy for Bleeding Strokes,” The Washington Post, June 27, 2004, p. A14.
(NovoSeven has also been used off-label to help stop internal bleeding in patients with ITP)
The spleen is important in protecting humans from babesiosis, a rare tick-transmitted disease. In the United States it is found mainly in New England (especially the coastal islands) and the Great Lakes Region. It takes from one to six weeks (in some cases up to three months) for symptoms of this disease to appear. Symptoms vary widely from a mild case without visible symptoms, to more severe cases where the flu-like symptoms include tiredness, loss of appetite, fever, drenching sweats, and muscle pain that may be accompanied by nausea, anemia, and weight loss. Humans who have had a splenectomy, the elderly, and those who have had a serious disease, such as cancer or AIDS, are at a higher risk of infection. Stained blood smears are the most common diagnostic tool in conjunction with patient history. In more serious cases clindamycin and quinine are the standard treatment. Best prevention is to stay away from the New England and the Great Lakes Region between May and September. In these areas wear protective clothing and use tick repellant.
Talsky, J, “Babesiosis in Humans,” Science Education, July 30, 2003, http://www.bact.wisc.edu:8080/scienceed/stories/storyReader$115
Note: Babesiosis is a life threatening infection for splenectomized patients and for all patients when treatment is delayed. Splenectomized patients have an additional hurdle in that an important part of treatment is quinine which has been associated with (some suggest causes) low platelet counts.
Some promise for treating inflammatory diseases comes from an unlikely source. Treating glaucoma, a buildup of fluid that causes pressure in the eye, involves surgically implanting an artificial tube to drain the fluid. In one-third of all patients the treatment is not effective due to the formation of scar tissue that blocks the surgically implanted tube. To prevent the formation of this scar tissue, researchers turned to protein-sized polymers called dendrimers. Sugar molecules were added to the outer tips of the polymer chains. These sugar molecules were known to bind to the immune cells involved in the inflammation and the scaring. Injecting a solution containing these dendrimers into the eyes of rabbits that had undergone glaucoma surgery reduced the scaring significantly. The success rate of the surgery increased from 30% to 80%. Donald Tomalia, of Dendritic Nano Technologies, suspects that this strategy could be important in developing therapies for inflammatory diseases like rheumatoid arthritis.
Goho, A, “Velcro Therapy,” Science News, July 31, 2004, vol 166, p70.
Gone are the days of going to the hospital and relinquishing full control of your care to the hospital staff of nurses, physicians and administrators. For example, in 2002 approximately 500 hospitals and health care facilities across the country reported nearly 200,000 mistakes in prescribing and dispensing medicine. In February new FDA regulations required bar codes on commonly used prescription drugs. About 2% of hospitals have such a system in place today. (The FDA has given institutions 2 years to implement this change.) In the mean time we suggest you know the purpose and appearance of all medications and monitor your care closely.
Another alarming statistic is the fact that 2 million patients acquire an infection while in the hospital each year. The best that you can do in this area is to be sure you as the patient as well as your caregivers and guests wash their hands at the start and the end of their visit.
Also avoid hospitals from mid-December through the end of the first week of January. In teaching hospitals avoid the period mid-June through the middle of July when new residents begin training.
Simon, N., “Good Medicine,” Time Bonus Section, September 2004.
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The International Committee of Medical Journal Editors (ICMJE) has proposed comprehensive clinical trial registration as a solution to the problem of the selective announcing of the initiation, progress, and results of clinical trials. The proposal was made in an editorial published simultaneously in all member journals. It was signed by 12 editors of medical journals and the editor of Medline, a service of the National Library of Medicine. The editorial calls for a registry that is accessible to the public at no charge, open to all prospective registrants, and managed by a not-for-profit organization. It must have a mechanism to insure the validity of registration data and be electronically searchable. The editorial also specifies the minimum data elements that must be included and makes registration of a clinical trial at or before patient registration a necessary condition for publication in the journals that make up the ICMJE.
New England Journal of Medicine, September 9, 2004, pp1250-1251
http://content.nejm.org/cgi/content/full/NEJMe048225
Some years ago, Italian researchers reported the recovery from ITP in a large percentage of patients treated to eradicate H pylori infection. Other researchers, in the United States and elsewhere, have had difficulty duplicating these results. A recent communication reported in “Blood” (The journal of the American Society of Hematology) suggests that this discrepancy in the clinical response to eradication therapy might be due to differences in the bacterial strains. In the patients who responded to the eradication therapy, the level of an antibody associated with H pylori declined. The level of H pylori antibody did not decline in the patients who did not respond. The H pylori antibody is specific to different strains of H pylori. The authors of the “Blood” correspondence suggest “that molecular mimicry between the H pylori antibody and a platelet antigen might mediate the autoimmunity in some chronic ITP patients (the ones who respond to the eradication therapy).”
Blood, July 15, 2004, p 594
The National Institutes of Health (NIH) has launched an expanded health information Web site http://health.nih.gov/. It includes three new sections. The Healthy Lifestyles section addresses nutrition and weight loss; the Research in Action section provides information on stem cells and genetics; and the Now Online section deals with current topics of interest. The new site provides links to popular health databases and information for people of all ages, including children and teens.
Orphan Disease Update, Summer 2004, p 16.
In 1978 it was shown that a Guinea pig megakaryocyte (cell in the bone marrow that gives rise to platelets) when stimulated with an electric current fired exactly as a neuron (brain cell) would under the same conditions. We now recognize that blood cells, like neurons, generate and store electric potential energy. It is also accepted in the scientific community that when a blood cell like a platelet performs any of its functions, electric energy is spent through many of the same chemical steps or pathways that exist in brain and muscle cells. Current research published in the journal “Blood” reports that human stem cells (primary human CD34+ hematopoietic stem and progenitor cells) “express not only genes encoding many of the ion channels (chemical pathways) found in the brain, but also a variety of other proteins whose roles have been primarily defined in the nervous system.” Sullivan goes on to say that “in their paper, Steidl et al go to great lengths to show that many neurobiologic genes are not only expressed at both the mRNA (messenger RNA) and protein level in CD34+ cells, some of them exhibit their predicted functions in these cells. …The blood-brain barrier is weakening”
Richard Sullivan, “Blood Cells: Excitable at Last”, Blood, July 2004, vol 104, n 1, p 5.
Recent research shows that the brain and body both respond to the same family of stimulating peptides. Tachykinins, stimulating peptides, are widely expressed in central and peripheral nervous systems and participate in neurotransmission. Recent research has addressed the possibility that platelets respond to tachykinins. This possibility was raised because a high concentration of a tachykinin, neurokinin B, by the placenta has been linked to pre-eclampsia, a hypertensive (high blood pressure) disorder occurring during pregnancy. Since platelet dysfunction is associated with pre-eclampsia, Graham and colleagues addressed the possibility that platelets respond to tachykinins. Their work forms strong evidence that tachykinins influence platelet function. Robert Flaumenhaft of the Harvard Medical School in commenting on the work of Graham and colleagues says, “It is conceivable that under certain physiologic conditions tachykinins mediate cross talk between these 2 cell types (platelets and neurons).
Robert Flaumenhaft, “Platelets Feel Your Pain”, Blood, August 2004, vol 104, n 4, p 913.
Additional warnings have been added to the labeling of infliximab (Remicade). According to the notification letter, postmarketing cases of lekopenia, neutropenia, thrombocytopenia, and pancytopenia, some with fatal outcome, have been reported in patients treated with infliximab for rheumatoid arthritis and Crohn’s disease. Infliximab was approved in the US on August 24, 1998 and since that time 508 cases of hematologic and neurologic problems have been reported by the approximately 509,000 patients who have used the drug. Infliximab is an anti-TNF drug that works by blocking the tumor necrosis factor (TNF), a protein involved in causing inflammation. Other ant-TNF drugs on the market, Enbrel and Humira, carry similar label warnings regarding blood disorders.
http://www.medscape.com/viewarticle/488100
A drug that presently carries the name CP-690,550, shows promise as a therapy for quieting the overactive immune system in patients with autoimmune disease. Dr. Borie, who is studying the drug, said it holds promise of suppressing the immune system without major side effects. This drug inhibits the enzyme Jak3 that is found only in immune cells. Studies show that inhibiting this enzyme suppresses the immune system while not affecting other systems of the body. Much work remains.
NIH News, October 30, 2003 http://www.niams.nih.gov/ne/press/2003/10_30.htm
“Preventing Transplant Rejection ---Research Summary” July 9, 2004 www.ivanhoe.com/newsalert/
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Strokes were the third leading cause of death in the United States in 2001 behind heart disease and all cancers. Many who are stricken are seemingly in good health. Much of this mortality and disability associated with strokes could be avoided with two simple, relatively inexpensive tests. One is the carotid ultrasound test that spots fatty plaque buildup in the carotid arteries. This buildup curtails blood flow to the brain and can be the cause of a stroke. Experts estimate that carotid strokes account for one-third to one-half of all strokes. The other test is the ankle-brachial test that provides an indication of plaque buildup throughout arteries in the entire body. The tests can cost several hundred dollars but many facilities charge much less. Neither Medicare nor private health insurance companies pay for these tests for screening purposes. Screening information is available at www.lifelinescreening.com .
T. M. Burton, “Two Simple Tests Can Prevent Stroke, But Few Get Them”, Wall Street Journal, Sept 24, 2004, pA1.
(Note: people with ITP, even those with low platelets, are not protected from strokes)
Last month the National Institutes of Health dedicated the 238-bed Mark O. Hatfield Clinical Research Center on the NIH Bethesda, Maryland campus. Dr. Elias A. Zerhouni, director of NIH said “there is nothing out there like it.” The new NIH center is unique in that it combines a large size and research labs. There are 80,000 patients on the NIH’s active rolls. Last year 8,600 new patients were admitted to the current clinical center with the average length of stay 8.5 days. Care at the new hospital is entirely free to the patient. Except for unusual circumstances, no insurance companies are billed either. The taxpayer foots the whole bill. The building is flooded with natural light and flexibility is built in everywhere. The building has been designed to last 50 years at a cost of over $600 million with another $30 million for furnishings. Scientists will be moving labs during the next several months. All patients will move during a single day, December 4, 2004. One patient called it “the house of hope”
D. Brown, “NIH Dedicates New Research Hospital”, Washington Post, Sept 23, 2004, p.A27.
See: http://videocast.nih.gov/PastEvents.asp?c=4 to view a videocast of the ribbon cutting ceremonies and other NIH meetings.
The link goes like this. High levels of a substance called C-reactive protein (CRP) in the blood have been associated with a variety of health problems including heart disease. Edward Suarez and colleagues at Duke University had 121 healthy men and women take a personality test that assessed levels of anger, hostility, and depression. Then this group was tested to determine the level of CRP in their blood. The study found that the subjects that scored high on the tests for anger, hostility, and depression had CRP levels in their blood two to three times higher than those who scored low on the personality test. Heart disease has been associated with high blood pressure, smoking, and an inactive life style. Now we can add psychological factors that activate the inflammatory process.
R. Stein, “Emotions, Heart Disease Linked”, Washington Post, Sept 27, 2004, pA27.
(Note: Inflammation as measured by CRP has been associated with some autoimmune diseases. See: http://www.itppeople.com/enews/enews012802.htm)
An important policy shift at the National Institutes of Health will ban all its scientists from any new collaborating arrangements with pharmaceuticals or biotechnology firms for at least one year and require all existing collaborations to be discontinued. The need for such a ban became apparent after the agencies own conflict-of-interest investigation turned up more problems and more serious ones than had been anticipated. The examples of ethics violations have been alarming to many. As many as 100 NIH scientists are involved in collaborations that will have to be discontinued. Many others, it is thought, have recently dropped their collaborating arrangements in light of all the recent attention.
R. Weiss, “NIH Bans Collaboration With Outside Companies”, Washington Post, Sept 24, 2004, pA23.
A healthy gut includes a population of “friendly” bacteria (probiotics) that help digest food and just as important produce certain vitamins, like vitamin K. Dr. Andrew Weil points out certain foods like yogurt, the best-known probiotic food, and miso, which is fermented soybean paste, as excellent foods to help maintain a healthy gut. Other helpful probiotic foods include kefir, which is similar to liquid yogurt, and sauerkraut. Dr Weil prefers probiotic supplements to probiotic foods to assure an adequate supply of the friendly backteria. He recommends Culturelle but cautions the use of the supplements by people “with compromised immune function as they could theoretically develop an infection from the probiotic organisms.”
Dr. A. Weil, “Probiotics: Beneficial Bacteria”, Self Healing, October 2004, p1. http://www.drweil.com
(Note: Vitamin K is needed for your blood to clot)
The state of Illinois has initiated, with the strong support of Governor Blagojevich, the I-SaveRX program to save state residents from 25% to 50% on their prescription refill costs. There will be direct savings to the states for the drug benefit programs it offers state employees. While not all drugs are available, the list is extensive. The medications are available from 45 licensed, inspected pharmacies in Canada, Ireland, and Great Britain. The I-SaveRX program is presently available only to residents of Illinois and Wisconsin but other states are considering adopting the program. The program requires your physician’s approval and signature on your application. Also you qualify only for medications that were first filled at a pharmacy in the U.S. and which you have been taking for 30 days without adverse side effects. There is a one page application that with your physician’s signature can be mailed or faxed to CanaRx Services Inc. The Illinois form and available medications are available at www.isaverx.net/materials/enrollment.pdf.
Weekly Email, HealthAssistance Partnership, October 4, 2004, p.3.
http://healthassistancepartnership.org
If your immune system is weakened, take note. Infectious diseases have been on the increase for a decade or more. Researchers have been searching ever more diligently for any overlooked sources of germs. Recently a most unlikely hideout was discovered by scientists at the University of Colorado at Boulder. The soap scum from vinyl shower curtains yielded a host of pathogens including the Sphingomonas bacteria which can cause urinary tract infections, pneumonia, and skin ulcers. Another critter discovered in the same hideout was Methlobacterium which also can cause pneumonia, skin ulcers, and inflammation of the cornea. These pathogens are especially a risk for those with a weakened or troubled immune system. The researchers recommend a 10 % bleach solution to keep them in check.
Alternative Medicine Newsletter, News, October 2004.
(Note: Those with certain diseases and conditions, especially ITP, take warning; the bleach solution could be as bad as or worse than the problem. Bleach is a strong chemical and great care is required in using it. If you have ITP consider using a less potentially harmful method of control, maybe washing with a detergent in hot water.
Many medications used to treat ITP weaken the immune system making people more susceptible to opportune infections. People who have had a splenetomy are particularly vulnerable to pneumonia)
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At the recent American Society of Hematology meeting two companies reported studies of new treatments for ITP. Both promote thrombopoietin levels, stimulating platelet production; one is administered by injection, the other orally.
Amgen announced the results of a study involving an agent (AMG531) that stimulates thrombopoietin levels. The phase 2 study was multi-center, randomized, double blind, and placebo controlled. Study subjects had to have a platelet count less than 30,000 or less that 50,000 if on corticosteroids, between 18 and 65 years of age, diagnosed with ITP at least three months, and no history of thrombosis. The study objective of maintaining platelet count between 50,000 and 450,000 for these ITP patients was met at both dosage levels of 1ug/kg and 3ug/kg. The treatment was well tolerated by the patients overall. However several patients experienced adverse events. A large clinical trial is being planned.
GlaxoSmithKline announced results of a study testing an orally administered small molecule (SB497115) that stimulates platelet production. This phase 1 study was randomized, single blind, placebo controlled and involved 72 healthy male subjects. The study observed a dose dependent response of platelets in these subjects. The treatment was reported well-tolerated; no serious adverse events were reported, and there was no observed relationship between the incidence or severity of adverse events and dose. SB 497115 will be studied in phase 2 trials involving thrombocytopenic patients.
Note: Thrombopoietin is a substance in your blood that stimulates platelet production. You would expect it to be higher in people who have low platelets, but that is not the case for people with ITP. Also, about 30% of people with ITP have platelet production problems in addition to platelet destruction problems. As the results of the studies noted above show, encouraging additional platelet production in people with ITP can raise platelet counts. We will send an e-mail about the new clinical trials as soon as the information is available to us.
Kuter, D., et al, “A Phase 2 Placebo Controlled Study Evaluating the Platelet Response and Safety of Weekly Dosing with a Novel Thrombopoietic Protein (AMG531) in Thrombocytopenic Adult Patients (pts) with Immune Thrombocytopenic Purpura (ITP)”, Blood: Journal of the American Society of Hematology, November 16, 2004, vol. 104, no. 11, Part 1, p 148a.
Jenkins, J., et al, “An Oral, Non-Peptide, Small Molecule Thrombopoietin Receptor Agonist Increases Platelet Counts in Healthy Subjects”, Blood: Journal of the American Society of Hematology, November 16, 2004, vol. 104, no. 11, Part 1, p 797a.
A new study of 68,781 patients on long-term steroid use of more than 7.5 mg/day were found to be 2.5 times more likely to develop heart disease than people who did not use steroids. The study compared the steroid using patients with 82,202 people who did not use these drugs. The researchers found that patients on doses below 7.5 mg/day did not face an increased risk of heart disease. The study did not isolate the role of steroids as a cause of the increased cardiovascular events from the role of the underlying disease. And factors such as diet, smoking, and exercise were not considered.
Wei, L., et al, “Taking Glucocorticoids by Prescription is Associated with Subsequent Cardiovascular Disease”, Annals of Internal Medicine, November 16, 2004, vol. 141, Issue 10, pp 764 – 770.
In this study eleven volunteers inhaled a saltwater spray and then researchers measured the number of germ-spreading particles given off when they coughed. Those prone to producing the most droplets when coughing saw up to a 70 % reduction in germ-spreading particles or droplets. Researchers said that this type of spray could prove effective in controlling the spread of tuberculosis and flu. The study was conducted by Gerhard Scheuch of Harvard University and colleagues at Pulmatrix and Inamed, two biotechnology firms.
Washington Post, November 30, 2004, p.A3.
In a glycmic index diet, the dieter consumes carbohydrates that do not cause a sharp rise in blood sugar. These ‘good’ carbohydrates include whole grains such as oatmeal. C-reactive protein (CRP) is a special type of protein produced in the liver that has been thought to be present only during episodes of acute inflammation; recent studies indicate CRP may also be elevated in heart attacks. One of the findings in a recent study of the glycemic index diet (GID) at Boston’s Children’s Hospital led by David Ludwig, was that people on the GID experienced a reduction in the levels of CRP.
Note: This is potentially important information for those managing an auto-immune disease. Lowering the level of C-reactive protein could play a role in delaying onset or flare-ups of auto-immune reactions. For a list of PDSA’s diet recommendations see http://www.pdsa.org/diet.htm
Washington Post, November 24, 2004, p.A11.
A new feature of the website of the American Society of Hematology (ASH), “Find a Hematologist”, is open to the public and may prove very useful to patients. This new feature is an online directory of ASH members (physicians) who added their name to this list. The service is designed for both patients looking for hematologists in their community and medical professionals who want to make referrals. ASH is encouraging members to sign up.
See http://www.findahematologist.org
E-Newsletter, American Society of Hematology, November 22, 2004.
Vitamin D’s role in protecting bone strength is well established and widely understood. What is less well understood but equally clear to researchers is that vitamin D is important in regulating cell growth, immunity, and energy metabolism as well as providing some protection against multiple sclerosis, diabetes, and cancer. Recently, Margherita T. Cantorna and colleagues reported new findings describing how the presence of vitamin D during T cell development affects how the mature cells operate. They found that vitamin D deficiency during development “leads the cells to produce agents that are more reactive to other cells than those produced when the killer T cells grow up with abundant vitamin D.” Unfortunately Cantorna suspects that once full-blown autoimmune disease appears, “you’ve already lost your window of opportunity to change the kind of T cells that develop.”
Raloff, J., “Vitamin Boost”, Science News, October 9, 2004, vol. 166, p. 232-233.
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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.
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