Platelet E-News – August 11, 2008

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

Contents:

ITP Research and Treatments

General Health and Medicine

Hospitals, Insurance and Medical Care

Nutrition, Fitness, and Lifestyle

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ITP Research and Treatments

Romiplostim Shows Sustained Effects, but FDA Approval Postponed
Long-term results of a treatment study of romiplostim (Amgen’s Nplate), showed sustained platelet count increases in adult patients with ITP, along with reduced need for concurrent and rescue ITP medications. After average treatment of 65 weeks, 83% of patients achieved a platelet response above 50,000 platelets per microliter. Results were presented at the June meeting of the European Hematology Association. Romiplostim stimulates the thrombopoietin receptor for platelet production. In related news, the FDA has postponed its decision, which was expected in late July, on approval of the sale of Nplate for patients with ITP whose disease has not responded to other treatments.

Romiplostim Data Show Potential Long-Term Efficacy and Safety in Adults with Chronic Immune Thrombocytopenic Purpura (ITP). Medical News Today, June 17, 2008; www.medicalnewstoday.com
Ed., Zimmerman, D. Amgen Says US FDA Decision on Clot Drug Delayed. Reuters, UK, July 23, 2008.; www.amgen.com

ITP Treatment, Sym001, Moves to Phase 2 Testing
Sym001 has moved into phase 2 testing for treatment of ITP. The drug is a recombinant, polyclonal anti-Rhesus D antibody product, in development by Symphogen and Biovitrum. Up to 55 nonsplenectomized, RhD-positive patients with ITP will be enrolled in the phase 2 study at 23 sites in Europe. The study will determine appropriate dosages to use for Phase III trials by assessing increases in platelet levels and exploring the mechanism of action of Sym001.

Symphogen and Biovitrum Recruit First Patient for Phase II ITP Study, Pharmaceutical Business Review, July 17, 2008. For more details, visit www.symphogen.com

Are Better Anticoagulants in Development?
In an editorial, Nigel Key of University of North Carolina, expresses concerns that new anticoagulant drugs in development may be no better than warfarin, and may hold the same bleeding risks that the older drug does. Effective and safe anticoagulation therapy will be a major health care priority, with the aging U.S. population.

Key NS. Anticoagulant-related Bleeding: Into the Unknown? HemOnc Today, June 25, 2008

Antidepressants Can Boost GI Bleeding; Acid-Reducing Drugs May Help
Two types of anti-depressants, SSRIs and SNRIs (specifically venlafaxine), may increase risk for upper gastrointestinal bleeding. A Spanish study indicates that acid-suppressing drugs appear to reduce that risk for bleeding. This population-based study compared 1,300 adults with upper GI bleeding to 10,000 controls without bleeding. Selective serotonin reuptake inhibitors( SSRI) and selective serotonin and norepinephrine reuptake inhibitors (SNRI) users had double or more risk of bleeding, even more so if the patient was also taking nonsteroidal anti-inflammatory drugs (NSAIDs), such as ibuprofen and naproxen, or corticosteroids. Acid-suppressing drugs reduced the risk.

De Abajo FJ. Garcia-Rodriguez LA. Risk of Upper Gastrointestinal Bleeding Associated with Selective Serotonin Reuptake Inhibitors and Venlafaxine Therapy. Archives of General Psychiatry. 2008;65(7):795-803

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General Health and Medicine

Comparing the Presidential Candidates’ Health Proposals
The National Hemophilia Foundation has published a guide on where the presidential candidates stand on key health-care issues, with special attention to issues that might affect individuals with bleeding and clotting disorders. The guide is available through the Foundation at 800-42-HANDI or www.hemophilia.org.

Ragni M. Patients and Politics: Interpreting the Footprints of Donkeys and Elephants for Patients. The Hematologist. July/August 2008, Pg. 14.

Some Governments Getting Serious About Chemical Exposures
Governments are beginning to examine the dangers posed to human health by chemicals in our air, water, food, and products we use. Many cancers and autoimmune diseases might result from chemical pollution. The European Union is requiring industry to prove the safety of chemicals and consumer products before they reach the market, according to a story in the Montreal Gazette. Currently Health Canada is testing 5,000 Canadians for chemical contamination and preliminary results should be available in November. Early results from Europe and the U.S. indicate we are all contaminated with some chemical toxins.

Marsden W. We’re on Chemical Overload. The Montreal Gazette, June 20, 2008, http://www.canada.com/montrealgazette

Antibiotic-Resistant Bacteria Found in Pork
Scientists are beginning to detect bacteria that are resistant to antibiotics in pigs and pork products. University of Iowa public-health doctors found the antibiotic-resistant strain in 147 of 299 pigs tested. These bugs have not yet sickened people in North America, though they’ve been found in 10% of ground pork collected in some Canadian provinces, and caused problems in Scotland and the Netherlands.

Burton TM. Bacteria in Pork Showing Resistance to Antibiotics. The Wall Street Journal, June 16, 2008. Reprinted at:
www.organicconsumers.org/articles/article_13009.cfm

Immune System May Spark Depression
During sickness or infection, the body’s immune system releases proteins called cytokines that trigger inflammation to fight the disease, and in some cases, may cause depression in those who are susceptible. Previous studies have linked cytokines to depression and fatigue. Researchers are attempting to treat depression by blocking the action of cytokines. Depression caused by inflammation is most prevalent in patients with autoimmune diseases, cancer, and infectious diseases.

Maxmen A. Sick and Down. Science News, July 19, 2008, Pg. 26-29.

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Hospitals, Insurance and Medical Care

Tier 4 Drugs and the Cost Conundrum
Many of the newer biological drugs come with high price tags, for example, $50,000 to $100,000 per year--and insurers are putting them into their tier 4 category, requiring patients to pay up to 20% to 33% of the overall cost of these medications, which can easily exceed what their budgets can bear. A health system president and an NIH bioethicist express concern that the tier 4 system as a cost-containment tactic is growing and they make suggestions for getting smarter about which interventions are covered and who gets them based on what really works.

Lee TH, Emanuel EJ. Tier 4 Drugs and the Fraying of the Social Impact. New England Journal of Medicine, July 24, 2008, 359(4):333-335.

Companies Filling Patient Advocate Needs
More companies are offering advocacy services to consumers—either directly or through employers. The services aim to help users “find the right doctor, haggle over insurance coverage and manage other medical system headaches,” according to The Washington Post. Companies like Health Advocate charge $365/year, some charge more and offer telephone or Web-based support. Flagship Global Health, Care Counsel, and Enhanced Care Solutions offer similar services. One non-profit option is the Patient Advocate Foundation, a free service that helps people with chronic, debilitating and life-threatening conditions.

Stobbe M. Patients Turn to Advocates to Navigate Health-Care System. The Washington Post. July 29, 2008. Pg. F6.

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Nutrition, Fitness, and Lifestyle

 Relaxation Techniques Alter Gene Activity
Harvard’s Herbert Benson, a long-time advocate of meditation to reduce stress, has shown that gene expression changes with meditation, yoga and other relaxation techniques that reduce cellular damage from chronic stress.  Gene expression changed with stress reduction activity, not only in long-term practitioners, but also in people new to relaxation techniques.  They compared gene expression in 19 long-term relaxation practitioners, 19 healthy controls, and 20 newcomers who took up 8 weeks of relaxation-response training.

Dusek JA, Otu HH, Wohlhueter AL, Bhasin M, Zerbini LF, et al. (2008) Genomic Counter-Stress Changes Induced by the Relaxation Response. PLoS ONE 3(7): e2576.

Meditation Can Change the Brain
Herbert Benson and others were interviewed for a recent program on British television (Alternative Therapies, BBC Two, Monday, March 17, at 9pm), exploring the evidence that meditation can make people healthier and happier, altering brain structure.  In research by Dr. Sarah Lazar, MRI scans of brains of long-term meditators showed differences in areas of the brain’s cortex, in areas that process emotion.  Research also indicated greater activity in brain circuits involved in paying attention.  The idea that meditation could improve the wellbeing of patients, even those struggling with mental illness, is exciting for researchers and patients.

http://news.bbc.co.uk/1/hi/health/7319043.stm

Even Cooked Vegetables Carry Risks For Travelers
Most travelers know to avoid the water, unpeeled fruit and raw vegetables, but a new study indicates that even cooked vegetables eaten abroad can carry more risk of contamination.  A comparison of cooked vegetables at restaurants in Guadalajara, Mexico, versus Houston, Texas found higher levels of dangerous bacteria in the Mexican restaurants than in the Texas establishments.

Zuger A. Is Any Vegetable a Safe Vegetable? Journal Watch General Medicine, July 24, 2008.

Book Reviews the Dangers of Milk Containing Growth Hormones
A 2006 book calls itself an exposé of the dangers of milk containing rBGH (recombinant Bovine Growth Hormone), used to boost milk production “and Monsanto’s longstanding attempt to suppress this information.”  The book presents a comprehensive summary of the scientific literature since 1985.  This is another topic related to the future of food and its effects on health.

Got (Genetically Engineered) Milk? By Samuel Epstein.  Trafford Publishing, 2006.

EPA Bans Carbofuran Residue on Food
The Environmental Protection Agency (EPA) stated that the chemical residue of the toxic pesticide carbofuran poses an unacceptable risk to small children. The agency’s ban applies to domestic and imported food.  Carbofuran, one of the most widely used pesticides in the world, is a neurotoxin that threatens animals as well as humans.  In the past it caused the deaths of millions of birds.  Some of the crops it is used on include rice, bananas, grapes, coffee, potatoes, soybeans, corn, and sugar cane.

Eilperin J. In Surprise Move, EPA Bans Carbofuran Residue on Food. The Washington Post, July 25, 2008. A2.
http://www.epa.gov/OGWDW/contaminants/dw_contamfs/carbofur.html

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This e-newsletter is published by the Platelet Disorder Support Association, 133 Rollins Avenue, Suite 5, Rockville, MD 20852, phone 1-87-Platelet, fax: 301-770-6638, web: http://www.pdsa.org, e-mail: pdsa@pdsa.org

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