- New Policy For Publishing Clinical Trial Results Goes Into Effect
- Helicobacter Pylori Eradication Leads To Increased Platelet Count
- European Studies Link Cell Phone Radiation to Increased Cancer, Alzheimer's Risks
- Can Antioxidants Slow Aging and Extend Life?
- Americans Look Increasingly to Internet for Health Information
- Hepatitis C Expected to Sicken Thousands who were Unknowingly Infected
- Adenovirus an Emerging Threat to Immunocompromised Patients
- Active Ingredient in Tylenol May Exacerbate Asthma, Lung Function
- E-mails improves Doctor-patient Communication
NEW POLICY FOR PUBLISHING CLINICAL TRIAL RESULTS GOES INTO EFFECT
Clinical trials that begin enrolling patients July 1, 2005 and thereafter must be fully registered prior to enrolling the first patient for the results of the trial to be published in some leading medical journals in the United States, Canada, Europe, New Zealand, and Australia. The changes follow recommendations from the International Committee of Medical Journal Editors (ICMJE), the World Health Organization, and even the U.S. Congress through its proposed Fair Access to Clinical Trials (FACT) Act. The aim of the changes is to provide as comprehensive and accurate information about the results of clinical trials to the public as possible. Ongoing clinical trials will have until September 13, 2005 to comply with registration requirements in order to be considered for publication. The minimum requirements for registration were set out at a meeting convened by the WHO in April 2004. These can be found at: www.nejm.org. The new policy will be applied primarily to phase 3 trials that seek to determine clinical effectiveness and not to phase 1 trials that assess among other things toxicity. But because these distinctions are sometimes hard to make – in fact, all trials in some way, test for drug safety and effectiveness – the Journal is leaving many publication decisions up to individual editors.
Editorial, The New England Journal of Medicine, June 9, 2005, pg. 2436
HELICOBACTER PYLORI ERADICATION LEADS TO INCREASED PLATELET COUNT IN ITP PATIENTS
A number of recent studies in several countries have reported that eradicating an H. Pylori infection in ITP patients resulted in an increase in platelet count. These studies so far have not been long term or conducted with large patient pools. However, scientists have known that H. pylori plays a role in other diseases involving autoimmune mechanisms, including acne rosacea, idiopathic chronic urticaria, and atherosclerosis. Scientists studying H. pylori's correlation with ITP have discovered a method for testing the progress made in ITP patients following H. pylori eradication. The ELISA titers of anti-CagA antibody were “significantly higher in the responders than the non-responders, suggesting that an ELISA serum titer of serum anti-CAGA antibody may be a good predictor of platelet recovery.”
Franchini, M, et al; Recenti Prog. Med.; March 2005, pg. 151
Suzuki T., et al; Am. J. Gastroenterol.; June 2005, pg. 1265
Gasbarrini A., et al; Am. J. Gastroenterol.; June 2005, pg. 1271
EUROPEAN STUDIES LINK CELL PHONE RADIATION TO INCREASED CANCER, ALZHEIMER'S RISKS
On the whole, there are far more studies done in Europe than in the United States that look at the relationship between cell phone use and potential health risks. Most studies are small and aren't conclusive in whether or not exposure to electromagnetic waves, a form of radiation emitted from cell phones, are dangerous or could cause cancer or Alzheimer's disease. A December 2004 study involving scientists from seven European countries found DNA damage to human and animal cells when exposed to cell phone radiation in a laboratory setting; DNA damage often leads to cancers. In fact, Swedish researchers found that people who used analog-style phones for more than ten years had greater risk of developing acoustic neuroma, a non-cancerous tumor on the auditory nerve linking the brain and the inner year. It's unclear if newer digital phones are similarly risky. The Swedes have also found that cell phone radiation damaged brain cells in rats, and this poses questions about cell phone use and the development of Alzheimer's disease. Nothing is conclusive, however, if you must use your cell phone, it doesn't hurt to pull the antenna all the way out if your phone has a retractable antenna; your phone emits more radiation if it has to work harder to find a signal. Or use hands-free set to limit exposure to radiation signals.
Dr. Andrew Weil’s Self Healing, May 2005, pg. 6
CAN ANTIOXIDANTS SLOW AGING AND EXTEND LIFE?
Experts have long touted the benefits of eating foods high in antioxidants as a way of maintaining good health, especially as we age. This is because lifelong exposure to particles called free radicals that come at us both externally (from sun exposure) and internally (from metabolic processes) inevitably lead to a natural breakdown of the body's defenses. Scientists at the University of Washington in Seattle have engineered a variety of mice to produce a specific antioxidant, catalase, and direct it to different parts of the mice's cells in an effort to actually document how antioxidants work to combat aging and the onset of disease. Catalase, when made by the mice naturally, goes to a cell's peroxisomes. These scientists altered the mice to produce extra catalase that would either go into the cell's nucleus or the cell's mitochondria. In mice as well as humans, the mitochondria are where cells convert food to energy, and as a side effect, free radicals are released. The scientists found that in mice where the catalase was directed to the mitochondria – where it doesn't normally occur – the mice live significantly longer than normal mice (about an additional five months to a normal 3-year lifespan) possibly because the catalase neutralized the free radicals before they did any internal damage.
C Brownlee, Science News, May 7, 2005, pg. 292
AMERICANS LOOK INCREASINGLY TO INTERNET FOR HEALTH INFORMATION
The non-profit Pew Internet and American Life Project recently released a survey as part of a Pew Research Center initiative that showed an increasing number of health care consumers are researching doctors and hospitals, diet and nutrition, vitamins, experimental treatments, insurance, and prescription drug information online. This has implications on how employers, health plans and patient advocates will go about providing health care in the future because this information is so readily available to consumers. The study acknowledged, however, there a discrepancy between more affluent consumers with high-speed Internet access and poorer consumers who rely on dial-up, in how far they will go in their online research of health information; broadband users will likely hit the Internet first before consulting any health care professional, and some might actually find a doctor through the Internet than through traditional referrals. Experts agree that the Internet provides just a fraction of the information that could be available to consumers but currently isn't, such as detailed descriptions of a particular doctor's care beyond typical credentials and training information. But the Internet is becoming a useful tool for both consumers and health care providers to communicate with each other about certain diseases with an ease that the traditional health care structure didn't allow.
Laura Landro, The Wall Street Journal, May 18, 2005, pg. D7
HEPATITIS C EXPECTED TO SICKEN THOUSANDS WHO WERE UNKNOWINGLY INFECTED DECADES BEFORE
Though the number of new hepatitis C infections has decreased 90% since 1989, experts at the Centers for Disease Control expect that the number of deaths related to hepatitis C will triple in the next decade. Symptoms lie dormant for years after infection, so many people getting sick today actually contracted the virus in the 1960s through the 1980s and didn't know it. Experts say these patients are mainly baby boomers – white, male and who live above the poverty line – who caught the virus in their youth while engaging in some kind of risky behavior. Hepatitis C is the leading cause of chronic liver disease and liver transplants that is spread through contact with contaminated blood, usually from dirty needles or, less often, unprotected sex. Symptoms can include jaundice, abdominal pain and nausea. In its later states, cirrhosis, a buildup of scar tissue that blocks blood flow through the liver, can occur.
Paul Davies, The Wall Street Journal, May 31, 2005, pg. D1
(Note: People with hepatitis C can have low platelets. Some are misdiagnosed as having ITP)
ADENOVIRUS AN EMERGING THREAT TO IMMUNOCOMPROMISED PATIENTS
There are 51 varieties of adenoviruses that threaten humans to different degrees, depending on the virulence strength of the virus as well as the strength of immune defense in a particular human being. Consequently, in the sick, where immunity is weakened, many adenoviruses cause infections that can lead to more illnesses and even death. Immune-compromised children are at great risk for developing adenovirus infections, as are patients who receive transplants, including those for hematopoietic stem cells. Diseases are likely to develop after infection if the adenovirus has multiple sites on and in the human system to reproduce. Current anti-viral therapies prove to be only partially effective, but researchers are looking into engineering T cells, a cell type that is vital to the immune system in fighting bacterial and viral infections, in the laboratory that are specific for a given adenovirus in order to facilitate its eradication.
Ann M. Leen, et al, at the Center for Cell and Gene Therapy, Baylor College of Medicine, Houston, TX; British Journal of Haematology, 2004, v. 128, pg. 135
ACTIVE INGREDIENT IN TYLENOL MAY EXACERBATE ASTHMA, LUNG FUNCTION
Acetaminophen, the active ingredient in the pain killer Tylenol, has been linked to asthma, asthma progression, chronic obstructive pulmonary disease (COPD) and general decreased lung function, according to a study published in the May issue of American Journal of Respiratory and Critical Care Medicine. But the study failed to consider other factors including long-term effects in patients who take acetaminophen for a variety of other diseases. It also lacks quantitative data on dose and duration of use in those patients in which lung function was shown to deteriorate. Further research conducted in a more scientifically organized way, is necessary.
Lauri Barclay, Medscape Medical News, May 3, 2005; http://www.medscape.com/viewarticle/504187
E-MAIL COMMUNICATE IMPROVES DOCTOR-PATIENT COMMUNICATION
Researchers at Penn State College of Medicine have found that both patients and physicians increasingly look to e-mail as a quick, inexpensive, simple, and convenient way of communicating with each other. The American Medical Association has even released “Guidelines for Patient-Physician Electronic Mail” to better instruct doctors on what is appropriate for e-mail communication. Patients typically e-mail their physicians for prescription refills, non-urgent consultations, and for laboratory results. Though doctors' responses to patient e-mails range from ignoring them to providing detailed information, many physicians find that responding well to patient e-mails cuts down on the number of non-urgent phone calls to the doctors' offices and encourages the patients' learning and participation in making decisions about treatments. There are lingering concerns over privacy, security, and the amount of time physicians will need to devote to answering e-mails rather than actually treating patients. And there is the risk that someone with a serious, acute illness will wrongly resort to e-mail when they should be headed to the emergency room; medical and legal liability are also issues as patients worry about their doctors' response times. But it looks like e-mail communication is poised to reconfigure the traditional doctor-patient relationship and function.
Shou Ling Leong, et al; J. Am. Board Fam. Practice, 2005; v. 18(3) pg. 180; reprinted in Medscape