Clinical Trial News
ITP and Platelet Research
- Insurers Trying to Defuse Anger over Policy Cancellations
- Are Health Insurers Making Consumers Shoulder Too Many Costs?
General Health Research Findings
- Exercise Slows Aging at the DNA
- Do Changes in Adult Stem Cells Contribute to Aging?
- Why Are Allergies on the Rise?
- Fatigue May Occur with Body Clock Failure During Sickness
Nutrition and Food
Clinical Trial News
FDA PANEL VOTES ‘YES’ FOR NPLATE
All 10 members of an FDA advisory panel agreed that the benefits of NPlate (romiplostim, AMG531) outweighed the risks at a meeting on March 12. If approved, NPlate, which helps to raise the platelet count of people with ITP by stimulating platelet production in the bone marrow, will be available in conjunction with a risk reduction program that will closely monitor the benefits and risks of this new treatment paradigm.
LIGAND’S DRUG, LGD-4665, PASSES PHASE 1 TESTING
Ligand has announced that LGD-4665, an oral, small molecule drug that mimics the activity of thrombopoietin, a growth factor that promotes growth and production of blood platelets, has passed phase 1 testing. The drug was safe and well tolerated and platelet levels increased. The company plans to initiate clinical studies in patients with ITP in first quarter 2008.
NEW STUDY OF PRTX-100 FOR ITP
Protalex Inc. has begun a phase 1b treatment trial of PRTX-100, a “highly purified native bacterial protein called staphylococcal protein A.” The protein is thought to dampen the body’s autoimmune response to platelets. Two phase 1 studies in healthy volunteers found the drug was well tolerated. The new trial will evaluate safety as well as effects on platelet counts and fatigue in patients with chronic ITP who have not responded to at least one standard treatment. The study, recruiting patients in Australia and New Zealand, is listed on www.clinicaltrials.gov.
ITP and Platelet Research
SIMPLE TEST CAN FIND CAUSE OF DRUG-INDUCED THROMBOCYTOPENIA
When drug-induced thrombocytopenia occurs, it is important to determine which drug caused the problem to avoid re-exposure. Researchers from Italy found that flow cytometry, a readily available technique, can identify the causative drug. In the two cases described, the antibiotic rifampicin and the anti-clotting drug abciximab caused late-onset thrombocytopenia.
Scognamiglio F, Corso C, Madeo D, et al. Flow cytometry in the diagnosis of drug-induced thrombocytopenia: Two illustrative cases. American Journal of Hematology, published online Nov. 20, 2007.
SHEDDING LIGHT ON PLATELET PRODUCTION
Harvard researchers used multiphoton intravital microscopy to visualize platelet generation within the bone marrow of live mice—and settle debates about how platelets are formed. They found that megakaryocytes within bone marrow extend arm-like pseudopodia into the bone marrow blood vessels. Sheer stress from blood flow fragments these protrusions, generating platelets.
Junt T, Schulze H, Chen Z. et al. Dynamic visualization of thrombopoiesis within bone marrow. Science. 2007;317:1767-70.
Flaumenhaft R. Caught in the Act: Megakaryocytes delivering platelets into the circulation. The Hematologist, March/April 2007, pg. 13-14.
NHLBI OFFERS PODCASTS
The National Heart, Lung, and Blood Institute’s Diseases and Conditions Index offers podcasts and animations to enhance learning. The DCI is a web-based information index about heart, lung and blood diseases and sleep disorders. Podcasts allow you to listen to the information on your MP3 player or computer. As of March, podcasts are available on heart attack, insomnia, and overweight/obesity. www.nhlbi.nih.gov/health/dci/pods/podcasts.html
INSURERS TRYING TO DEFUSE ANGER OVER POLICY CANCELLATIONS
After patients get sick, insurers will investigate a patient’s medical history to look for nondisclosure of pre-existing medical conditions that would have disqualified them from coverage. But public outrage in several stages against insurers that voided policies after beneficiaries started “racking up large claims for cancer or other serious illnesses,” has insurers pushing a proposal that would give consumers the right to appeal policy cancellations, known as rescissions, to an external panel. Some insurers are preparing to roll out their own independent review programs. The article notes that, after coming under attack, Blue Cross reversed a practice of enlisting doctors to report patients’ pre-existing conditions.
Rundle RL. Health insurers address issue of nixed policies.
The Wall Street Journal, February 27, 2008, Pg. D1, D3.
ARE HEALTH INSURERS MAKING CONSUMERS SHOULDER TOO MANY COSTS?
The New York attorney general is going after health insurers that pay out of network providers a going rate, which is lower than their actual fee. Consumers have to pay the difference. There are 16 insurers who are being investigated, but at the core of the investigation is UnitedHealth, which owns the database that the rest of industry uses to set usual and customary charges. Insurers contend the problem is high doctor fees, not low reimbursement rates.
Fuhrmans V, Frances T. Probe targets health insurers on payments.
The Wall Street Journal, February 14, 2008, Pg. D1, D3.
GOOGLE JUMPING IN TO ELECTRONIC HEALTH RECORDS
Google is pilot testing a personal health record with a group of patients at Cleveland Clinic. On Google Health, consumers will be able to enter their basic medical data and ask their doctors to electronically send information to be stored by Google. Microsoft and Revolution Health Group have also launched personal health record sites. These websites raise patient privacy issues. Patients’ online records may not be protected under federal privacy rules of HIPA (Health Insurance Portability and Accountability Act). Plus Google and the other providers face the challenge of receiving medical records from various institutions that store electronic records in different ways.
Lawton C, Worthen B. Good to Offer Health Records on the Web. The Wall Street Journal. February 28, 2008, pp. D1, D4.
General Health Research Findings
EXERCISE SLOWS AGING AT THE DNA
Telomeres guard the ends of chromosomes—like the plastic tips on shoelaces—to fend off aging and cell death. London researchers measured the effect of exercise on telomere length and found that those who reported more than 3 hours per week of moderate-to-vigorous exercise had markedly longer telomeres than the least active individuals.
Live Long and Perspire. Science News, February 2, 2008, Pg. 69.
DO CHANGES IN ADULT STEM CELLS CONTRIBUTE TO AGING?
We all have small reservoirs of so-called adult stem cells in some of our tissues, such as the bone marrow and skin, to generate new cells when existing tissues are worn out or damaged. Even the brain has stem cells that make new nerve cells throughout life. And those adult stem cells produce more copies of themselves, “maintaining a seemingly indefinite pool of cells capable of churning out a stream of replacement cells.” Scientists are beginning to look into whether the declines of old age may be caused by the decline of adult stem cells. The answers, so far, are more complex than expected.
Barry P. Faulty Fountains of Youth. Science News, February 9, 2008, Pg. 88-89.
WHY ARE ALLERGIES ON THE RISE?
Experts estimate that many allergies and immune system diseases have doubled, tripled, or quadrupled in the last few decades. But why? It may be that modern, clean living leaves the immune system untested and more likely to overreact to allergens. As one researcher put it, “Our immune systems are much less busy, and so have much more strong responses to much weaker stimuli, triggering allergies and autoimmune diseases.” Some question the theory, but others are testing giving small amounts of allergenic foods, for example, to try to train the immune systems of people with allergies. Others are using parasitic worms to improve autoimmune diseases such as Crohn’s disease.
Immune Systems Increasingly on Attack. The Washington Post, March 4, 2008, A1, A4.
FATIGUE MAY OCCUR WITH BODY CLOCK FAILURE DURING SICKNESS
A jump in TNF-alpha activity is found in many infectious diseases as well as autoimmune diseases, such as rheumatoid arthritis and Crohn’s disease. This immune system inflammatory protein may be the cause of daytime tiredness during illness. TNF-alpha spurs immune-fighting cells to seek out and destroy the agent causing the illness. But it may also interfere with the body’s clock, which guides the daily cycles of alertness and fatigue. This may be good for stimulating rest during short-term illness, to spur extra rest. But in long-term illness, fatigue may not be useful. The scientists suggest exercise to alleviate fatigue symptoms.
Cavadini G, Petrzilka S, Kohler P, et al. TNF- alpha suppresses the expression of clock genes by interfering with E-box-mediated transcription. Proceedings of the National Academy of Sciences U.S.A. July 31, 2007;104(31):12843-8.
Nutrition and Food
GENETICALLY MODIFIED CROPS ARE PERVASIVE
Seven out of every 10 items in the grocery store has genetically modified ingredients, according to Dr. Joseph Mercola, who suggests ways to reduce your chances of eating GM foods, such as buying organic, avoiding processed foods, and checking the stickers on fruits and vegetables. The Price-Look Up Code (PLC) stickers on fruits and vegetables offer clues to whether the produce is conventionally grown, organically grown, or genetically engineered. Conventionally grown food has a PLU of four digits, such as 1022. Organically grown food has a five-digit PLU that begins with 9, such as 91022. Genetically modified food has a five-digit code that begins with 8, such as 81022. The Mercola website has several articles on genetically modified crops. www.mercola.com
For further info, see The Future of Food, an in-depth look into the controversy of genetically modified foods in a documentary by Deborah Koons Garcia. http://www.thefutureoffood.com/
FOLIC ACID WITH CAVEATS
Some studies have linked high doses of folic acid with increased risk of certain cancers.
Folic acid comes from vitamin supplements and fortified foods, while folate is found naturally in foods. Both are a form of the B vitamin folacin. Getting some folacin —especially folate—may shield normal cells from becoming cancerous, but getting too much folic acid may stimulate cancer growth. Folic acid may deter cognitive decline, but people with low blood levels of vitamin B12 with high folate levels may experience cognitive impairment. Bottom line: Get most of your folate from foods. Good sources are beans, green leafy vegetables, and citrus fruits. Multivitamins are still a good idea, but don’t buy one that exceeds 100% the daily value for folic acid. And avoid heavily fortified cereals and energy bars.
Folic Acid: Too much of a good thing? Food folate to the rescue Environmental Nutrition Newsletter, March 2008, Pg. 1, 6.
The Future of Food, an in-depth look into the controversy of genetically modified foods, is a documentary by Deborah Koons Garcia. http://www.thefutureoffood.com/