- ITP Incidence Re-evaluated
- Aspartame Linked to ITP in 4 Cases\
- FDA launches Drug Safety Newsletter Including Rituximab Alert
- EC Grants Orphan Drug Status for Sm101
- Amgen Will Request FDA Approval of AMG531 for ITP in Late 2007
- CMS Policy Should Improve Patient Access to IVIG
- Environmental Risks to the Thyroid Under Study
- Gene Therapy May Not Be to Blame for Patient’s Death
- Cranberry Juice May Fight H. pylori Bacteria
- New Jersey Residents Can Compare Pharmacy Prices
- Medical Schools Teaching About Alternative Medicine
- Gentle Touch Therapy Offered to Cancer Patients in Bethesda
- Vitamin D Supplements May Decrease Mortality
- More on Vitamin D
ITP INCIDENCE RE-EVALUATED
According to a review of the recent medical literature, the incidence of ITP is five in 100,000 children per year and two in 100,000 adults. Spontaneous remissions occur more frequently in children than adults. Adult patients with chronic disease may have a better prognosis than previously thought.
[A full-length article will appear in PDSA’s Fall 2007 newsletter, The Platelet News.]
BAXTER LAUNCHING PROGRAM TO ENSURE ACCESS TO ITS IVIG
Starting in 2008, Baxter (Deerfield, OH) will enable patients to enroll in a program that offers continued access to its two intravenous immune globulin products, GAMMAGARD LIQUID and GAMMAGARD S/D, even if the patient’s physician or other provider changes access to another product.
ASPARTAME LINKED TO ITP IN 4 CASES
The author describes four cases (two young girls, one older man, and one adult woman) in which thrombocytopenia seemed to be linked with aspartame consumption. Aspartame is found in diet sodas and other low-sugar foods. With aspartame avoidance, all four improved.
FDA LAUNCHES DRUG SAFETY NEWSLETTER INCLUDING RITUXIMAB ALERT
FDA’s new publication, Drug Safety Newsletter, contains findings on “post-marketing drug safety reviews from FDA's Center for Drug Evaluation and Research (CDER). The newsletter also provides information on important emerging drug safety issues and recently approved new molecular entities.” It is available free online: http://www.fda.gov/cder/dsn/2007_fall/toc.htm
The Fall 2007 issue contains an article on rituximab (Rituxan) and a fatal viral infection of the nervous system called PML or progressive multifocal leukoencephalopathy. As of December 2006, FDA had received 24 reports of PML in patients taking rituximab. PML occurred an average of four months after discontinuation of rituximab therapy. The report states that the infection may occur after a period of immunosuppression, as occurs with rituximab. The FDA encourages physicians to consider evaluating for PML when new neurological signs or symptoms appear in patients taking rituximab.
EC GRANTS ORPHAN DRUG STATUS TO SM101 FOR ITP
The European Commission granted “orphan medicinal product designation” for SM101, a recombinant human soluble Fc-gamma receptor IIb, produced by the German firm SuppreMol, for the treatment of ITP. The immunosuppressive product is in preclinical development and expected to enter phase 1 clinical studies in late 2008. Orphan drug status provides incentives for developing the drug.
AMGEN WILL REQUEST FDA APPROVAL FOR AMG531 FOR ITP
Amgen plans to file for marketing approval of its drug, AMG 531, for treatment of ITP. AMG 531 is a protein being investigated for increasing platelet production by activating the thrombopoietin receptor. Phase 3 clinical studies in patients with ITP are completed. The filing is expected to occur in the fourth quarter of 2007.
CMS POLICY SHOULD IMPROVE PATIENT ACCESS TO IVIG
Effective July 1, 2007, the Centers for Medicare and Medicaid Services (CMS) began reimbursing IVIG by individual brand, to improve patient access. Individual patients have better responses with one brand versus another, therefore, access to all brands appropriately matched to the individual patient is important, according to CMS. “Brand-based reimbursement will eliminate the disincentive to purchase only certain brands within the IVIG class, thus increasing access to all brands of therapy.”
ENVIRONMENTAL RISKS TO THE THYROID UNDER STUDY
A form of hyperthyroidism called Graves’ disease is associated with ITP in 14% of ITP patients. Both are autoimmune diseases. Sometimes mild thrombocytopenia disappears with treatment of the thyroid problem. Environmental studies are beginning to tie environmental chemical exposures to thyroid problems. To date, those chemicals include: polychlorinated biphenyls (PCBs); triclosan, an antibacterial common in soaps and other products; phthalates, added to plastics to make them soft and to fragrances; perfluorooctanoic acid (PFOA) used in non-stick cookware, stain-resistant clothing, and microwave popcorn bags; polybrominated idphenyl ethers (PBDEs), a chemical flame retardant; perchlorate, a component of rocket fuel found as a groundwater contaminant; and bisphenol A (BPA), found in plastics and canned-food liners. A simple blood test can tell if the thyroid is working properly.
GENE THERAPY MAY NOT BE TO BLAME FOR PATIENT’S DEATH
It may be that a 36-year-old woman with arthritis who died during a gene-therapy trial succumbed to an infection she had before the study began, according to a preliminary analysis by an advisory panel to NIH. The woman died in July, raising alarms about the safety of gene-therapy studies. She died 22 days after receiving an injection in her knee of a virus vector that carried a gene for an anti-inflammatory protein, called TNFR:Fc, which inhibits tumor-necrosis factor-alpha. She was overwhelmingly infected with histoplasmosis, an environmental fungus that causes serious infections in people with compromised immune systems. TNFR:Fc (marketed as etanercept or ENBREL) suppresses the immune system.
Nature vol. 449:20 September 2007
(Note: etanercept has been given to some people with ITP to improve their platelet count)
CRANBERRY JUICE MAY FIGHT H.PYLORI BACTERIA
Cranberries are used to treat urinary tract infections. A study from China suggests it can fight an ulcer-causing bacteria called H. pylori. The bacteria were eradicated in 14% of patients who drank two eight-ounce boxes of cranberry juice daily, compared with 5% who drank a placebo drink. A second study, however, suggests that for patients on antibiotics to treat the H. pylori, cranberry juice does not make a difference. Ocean Spray Cranberries, Inc., funded both studies.
(Note: Treating H. pylori is particularly important for ITP patients because when eradicated, platelet counts can improve in some patients.)
NEW JERSEY RESIDENTS CAN COMPARE PHARMACY PRICES
New Jersey residents can now go online or call a toll-free number to compare prescription drug prices. The Prescription Drug Retail Price Registry lists prices at area pharmacies for 150 of the most commonly prescribed drugs. New York and Maryland have similar registries.
Go to http://www.njconsumeraffairs.gov/njpdr or call 1-800-242-5846 (English or Spanish).
MEDICAL SCHOOLS TEACHING ABOUT ALTERNATIVE MEDICINE
A growing number of U.S. medical schools are teaching medical students about alternative therapies. The aim is to expose students to a wide range of practices so they can better communicate with their patients. Roughly one third of accredited North American medical schools are part of the Consortium of Academic Health Centers for Integrative Medicine. Studies indicate that alternative therapies are used by more than a third of Americans, but more than half of those people are not comfortable talking with their doctors about it.
GENTLE TOUCH THERAPY OFFERED TO CANCER PATIENTS IN BETHESDA
Suburban Hospital, in Bethesda, MD, is offering its cancer patients access to Healing Touch, an alternative therapy based on the energy field that extends outward from the body. The therapy is said to reduce anxiety and fatigue, and may decrease pain in some patients.
VITAMIN D SUPPLEMENTS MAY DECREASE MORTALITY RATES
An analysis of 18 randomized controlled trials published up to November 2006 indicated that taking vitamin D supplements is associated with a decrease in total mortality. The authors call for the confirmation of this review through new, randomized, placebo-controlled trials.
MORE ON VITAMIN D
Along with its role of supporting the bones, evidence suggests that vitamin D helps maintain a healthy immune system. The recommended daily intake of vitamin D for children and young adults is 200 IU, but requirements increase with age. Adults over age 50 should consume 400 IU daily, and adults over 70 could have 600 IU per day. Although milk is fortified with vitamin D (1 cup of milk contains about 100 IU of vitamin D), other dairy products generally are not. Ten to fifteen minutes of sun exposure at least two times per week to the face, arms, hands, or back without sunscreen is usually sufficient to provide adequate vitamin D. It is very important for individuals with limited sun exposure to include in their diets other good sources of vitamin D such as salmon, mackerel, tuna, and egg yolks.