Focus on Scleroderma
June is National Scleroderma Awareness Month. Scleroderma, or systemic sclerosis, is a chronic connective tissue disease generally classified as one of the autoimmune rheumatic diseases. Since scleroderma presents with symptoms similar to other autoimmune diseases, diagnosis is difficult. The exact cause or causes of scleroderma are still unknown, but it is known that scleroderma involves overproduction of collagen. To learn more, visit www.scleroderma.org.

WHO declares H1N1 pandemic
The World Health Organization (WHO) raised the H1N1 (swine flu) alert Thursday, June 11, to its highest level, saying H1N1 has spread to enough countries to be considered a global pandemic — the first flu pandemic in 41 years. As of June 10, the virus had spread to 72 countries, according to WHO data. There were 25,288 confirmed cases and 139 deaths. The United States had 13,217 cases and 27 deaths, according to the Centers for Disease Control and Prevention (CDC).

CDC: H1N1 flu shots may be ready by October
The CDC says an H1N1 (often called swine flu) vaccine could be available as early as October — if vaccine production and testing run smoothly this summer. The government will review the safety and effectiveness of what is produced, and decide if a vaccination campaign is warranted. U.S. Department of Health & Human Services (HHS) says the department will take the steps necessary to prepare for potential commercial-scale production of a vaccine for the novel Influenza A (H1N1). HHS is directing approximately $1 billion in existing funds that will be used for clinical studies that will take place over the summer and for commercial-scale production of two potential vaccine ingredients for the pre-pandemic influenza stockpile.

White House wants $3 billion for flu preparedness
The Wall Street Journal reports that the White House has asked for new funding for flu preparedness, and the administration is also seeking the power to take an additional money from unspent stimulus funds in the event of a pandemic emergency. The president requested $2 billion to prepare for a possible resurgence of the H1N1 swine flu this fall, and he also asked for the authority to take a 1% across-the-board cut to stimulus programs allocated at Congress’s discretion, or $3.1 billion out of the $311 billion in discretionary stimulus funds. A White House budget official said the president is merely seeking flexibility in the event of a true national emergency. Funds to respond to a swine-flu outbreak would be taken from the stimulus program only in a worst-case scenario.

Relaxing patient ID requirements being considered
The Joint Commission is considering removing a crucial requirement prior to identifying patients when collecting specimens, including blood samples for crossmatching donor blood. The agency’s proposed 2010 National Patient Safety Goals (NPSGs) for laboratories recommends deleting the step requiring specimen collection personnel to use active patient involvement prior to collecting laboratory samples. Also at risk is the requirement to label laboratory specimens at the patient’s side, according to a Joint Commission spokesperson. The requirement to actively engage patients by asking them to state their name prior to sample collection became a Joint Commission requirement in the 2009 NPSGs.

The Center for Phlebotomy Education submitted a letter urging the agency not to weaken its requirements for labeling in the presence of the patient and requiring patients to be asked to state their name prior to blood collection procedures. The letter cites 14 studies, articles and publications that underscore the importance of maintaining the patient and specimen identification steps currently under reconsideration. The Center has posted its letter to the Joint Commission on its website. Readers are urged to submit their comments on the proposed revisions to the Joint Commission by mail, e-mail or through their website here. Comments must be received by June 16.

Health experts anticipate noninvasive test for bladder cancer
Researchers are fine-tuning a test that would allow pathologists to examine a urine sample for specific genes and genetic activity related to bladder cancer, rather than require the patient to undergo an invasive procedure like biopsy.

An advanced urine test to both diagnose and monitor bladder cancer has the potential not just to make testing for the disease easier, but also to save thousands of lives, says a New York genetics expert. The current urine screening tool for bladder cancer is used in conjunction with other diagnostic procedures, but the new test could potentially replace other procedures, experts say.

Current diagnostic testing includes laboratory urine tests; imaging like PET or CT scans; a procedure called cystoscopy, which requires a slender tube to be inserted into the bladder; and surgical biopsy. Health experts are hopeful that the new urine test will help patients avoid the more invasive diagnostic tests. The ease of the test could also help reduce healthcare costs.

More than 70,000 people in the United States will be diagnosed with new cases of bladder cancer in 2009, says the National Cancer Institute. It is the fourth most common type of cancer in men and the eighth most common in women, leading to roughly 14,000 deaths a year. Experts have not yet been able to pinpoint what causes bladder cancer but believe that both genetic and environmental factors come into play.

IBD patients more susceptible to MRSA
Digestive Disease Week reports that patients hospitalized with inflammatory bowel disease (IBD) were 39% more likely to become infected with methicillin-resistant Staphylococcus aureus (MRSA) than those admitted with other gastrointestinal conditions, a retrospective study showed. MRSA infection quadrupled their risk of death, according to a doctor at Mount Sinai Hospital in Toronto.

In patients with other gastrointestinal (GI) conditions, MRSA infection resulted in only about half that mortality risk. Compared with patients hospitalized with other GI conditions, those with inflammatory bowel disease were more likely to acquire MRSA, after adjusting for several risk factors. Patients with Crohn's disease were particularly susceptible, possibly because of frequent treatment with ciprofloxacin. The risk of acquiring MRSA was increased in older patients and those undergoing bowel surgery, those who required IV nutritional supplementation, and those with public health insurance. In addition, infection with Clostridium difficile almost doubled the risk of acquiring MRSA. An important next step, researchers say, is to find out whether the MRSA was acquired in the hospital or in the community.

Hospitals brace for shortage of medical isotopes
Reuters reports that makers of medical isotopes used in diagnostic imaging tests are scrambling to find new suppliers after Canadian health officials temporarily closed a nuclear reactor that produces a third of the world’s supply. Atomic Energy of Canada shut down its reactor at Chalk River, Ontario, on May 14 after a leak of heavy water, used as part of the nuclear reaction.

The reactor is expected to remain out of operation for at least three months. Only five nuclear reactors in the world produce molybdenum-99 or Mo-99, which is used in diagnostic tests for cancer, heart disease, and other illnesses. For patients in North America, the shutdown will have a dramatic impact, because that reactor supplies about half of the clinics and hospitals in the United States says the president of the Society of Nuclear Medicine.

Study finds half of men arrested test positive for drugs
As reported in USA Today, half of the men arrested in 10 U.S. cities test positive for some type of illegal drug, a federal study found.

In 2008, researchers interviewed and obtained urine samples from 3,924 men arrested in 10 metropolitan areas: Atlanta, Charlotte, Chicago, Denver, Indianapolis, Minneapolis, New York, Portland, OR, Sacramento and Washington, DC. In Chicago, 87% tested positive for drug use and in Sacramento, 78% tested positive. Many of the men — 40% in Chicago and 29% in Sacramento — tested positive for more than one drug.

Marijuana is the most common drug in every city where testing was done except Atlanta, where cocaine is most prevalent, the study found. Methamphetamine use is concentrated on the West Coast where 35% of the men arrested in Sacramento and 15% of the men arrested in Portland tested positive for the drug. Heroin use is highest, at 29%, among men arrested in Chicago.

Stool screening test for GI cancers being tested
It may be feasible to screen for all cancers of the GI tract with a stool DNA test, Mayo Clinic researchers say. Digestive Disease Week reports that a stool DNA test detected mutations from the tumors of 68% of patients who had known GI cancers, located from the oropharynx to the colon, according to doctors at the Mayo Clinic in Rochester, MN. There were no false-positives in a control group of patients who were free from GI symptoms and had a normal colonoscopy.

The technology already exists to screen for colon cancer with a stool DNA test, but other GI cancers account for twice as many deaths and are not currently screened for, according to researchers. To assess the feasibility of a stool DNA test for all GI cancers, researchers collected samples from 70 patients with proven GI cancers and 70 healthy controls matched by age and sex (median age 65; 65% male). Broken down by type, the test identified 40% of oropharyngeal, 65% of esophageal, 62% of pancreatic, 75% of biliary/gall bladder, and 100% of stomach and colorectal cancers. The test also identified 61% of the patients with precancers; 100% of pancreatic intraductular papillary mucinous neoplasia and 56% of colorectal advanced adenoma.

Clinicians say sepsis monitoring is urgently needed
New technologies and/or methods to solve complexities surrounding the diagnosis and treatment of bacterial sepsis are needed, according to three surveys conducted by bioMérieux. More than 90% of the physicians surveyed report that they need a tool that would help them monitor the progression of sepsis over a 24-hour period because the condition can rapidly turn fatal.

Patients with suspected sepsis are typically treated with antibiotics, but there is no reliable way to know if that treatment is effective. Frequently, a physician learns that treatment is insufficient only when the patient progresses into full septic shock. “Due to the lack of advancement in sepsis diagnosis and because we know the importance of timely treatment of sepsis, physicians have been forced to continue diagnosing and treating patients with suspected sepsis based on little more than clinical clues,” says the medical director of Critical Care Services at Morton Plant Hospital in Clearwater, FL.

Radiometer updates its website
Radiometer has just relaunched its knowledge site bloodgas.org under a new name: acutecaretesting.org.

Quebec pathologists fear 20% of breast cancer hormone tests wrong
Hundreds of women in Quebec with breast cancer may have been prescribed the wrong treatment because of faulty pathology tests, a CBC News investigation has found. In Newfoundland and Labrador, the issue surfaced recently, as Eastern Health's pathology lab turned over inaccurate hormone receptor tests to almost 400 patients over an eight-year period. More than 100 women died.

Worried that the same problem could occur in Quebec, the province's pathology association took 15 breast cancer tissue samples, had them tested by a reliable lab, and then sent the samples to labs across the province asking them to retest for hormone receptors. The results showed 15% to 20% of the hormone receptor tests got the wrong result, and 30% of tests looking for the HER2 protein were wrong. Chronic underfunding in the province led to a drastic lack of pathologists, training, and poor equipment, according to the president of Quebec Federation of Medical Specialists, adding Quebec is one step away from what happened in Newfoundland and Labrador.

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Researchers devising new blood test to diagnose organ rejection
Researchers, funded by Genome B.C., have discovered that blood from heart and kidney transplant patients has genetic indicators that can diagnose and predict acute organ rejection. Biomarkers in Transplantation, a research initiative that will allow doctors to identify patients rejecting transplanted organs with a simple blood test, is making use of advanced genomic, proteomic, and computational tools to develop the test, which will diagnose organ rejection before and when it happens by allowing doctors to intervene much earlier and to personalize patients’ immunosuppressant therapy.

Newborn screening rates rise
Most states have expanded the required screening of newborns for life-threatening genetic and functional disorders, according to an annual report card issued by the March of Dimes. In 2000, most states screened for only four conditions. In 2005, the American College of Medical Genetics recommended that screening for 29 disorders be mandated for every newborn in the United States. According to the most recent March of Dimes report card, all 50 states and the District of Columbia will now require that every newborn baby be screened for at least 21 of the 29 serious disorders. Forty-six states and the District of Columbia screen for 26 or more, and 24 states and the District of Columbia require screening for all 29 disorders, with more states expected to join them this year. Although all states now have required screening, only two states — Pennsylvania and West Virginia — have yet to implement expanded programs as of December 31, 2008, according to the report card.

CAP joins lawsuit challenging legality of gene patents
The College of American Pathologists (CAP) has joined a lawsuit against the U.S. Patent and Trademark Office and Myriad Genetics, challenging the legality of Myriad’s patents for the genes known as BRCA1 and BRCA2, which are indicators for hereditary predisposition to breast and ovarian cancer.

According to CAP, as a result of these patents, patients have been adversely affected because Myriad restricts most laboratories from providing full gene testing, requiring patients and their physicians to rely solely on Myriad to provide the test.

The complaint cites specific cases where patients were directly impacted because the diagnostic test services were not readily and affordably accessible. The College has long opposed the issuance of human health-related gene patents because doing so violates the principle restricting patents on laws of nature. Patenting human health-related gene patents limits access to medical care, jeopardizes the ability to practice medicine in the best interest of patients, and raises the cost of care.

The lawsuit was filed by the American Civil Liberties Union and the Public Patent Foundation in the United States District Court for the Southern District of New York on May 12, 2009. The College is joined by 19 other plaintiffs in the lawsuit including patient advocates, cancer patients, individual clinicians, and other medical societies.

Blood bank collection displayed via virtual museum
As reported in the Tampa Tribune, a World War II Army medic, former president of Southwest Florida Blood Bank (now part of Florida Blood Services), and historian for the AABB (formerly the American Association of Blood Banks), plans to showcase his collection of antique blood equipment, which includes bloodletting cups and leech jars, in a virtual museum.

Organizers are now in the process of documenting the collection and raising funds to support the museum. The collection also features antique blood storage equipment, bloodletting tools, cupping devices and transfusion equipment, including a 1942 German transfusion pump for direct soldier-to-soldier transfusions. See photos of the collection at www2.tbo.com/content/2009/may/22/former-blood-bank-president-relishes-relics-trade/life.

Kidney disease patients reap rewards of prevention
Medical Research News reports that chronic kidney disease (CKD) patients who have tests run on a regular basis are more likely to avoid serious complications. According to a study appearing in an upcoming issue of the Journal of the American Society Nephrology, patients who follow preventive measures are more likely to stay healthy. Researchers at the United States Renal Data System, Minneapolis, MN, found that increasing preventive measures correlated with lower rates of heart disease. CKD patients who received influenza vaccines and had their lipids, calcium-phosphorus levels, and parathyroid hormone levels (and blood glucose levels if they were diabetic) monitored had lower rates of heart disease and heart-related deaths during the following year.

Genetic tests offer new approach to warfarin dosing
Researchers from the Stanford, California-based International Warfarin Pharmacogenetics Consortium reported in the Feb. 19 New England Journal of Medicine a new way to estimate a starting dose of warfarin that is based on a patient’s genetic information. About 2 million people begin warfarin therapy each year to prevent or treat blood clots and other conditions such as deep vein thrombosis (DVT) and cardiovascular problems. There is a high risk of bleeding for patients on warfarin, so the dose is carefully monitored. Currently, physicians start most of their patients on a low dose of warfarin and ramp up gradually or start with a standard dose and adjust it up or down until blood tests indicate the dose is correct — a trial and error process that can take weeks.

In this study, the researchers determined if the patients had variants of two genes that are known to affect the metabolism of warfarin. The first, CYP2C9, affects how the liver processes warfarin. The second, VKORC1, activates vitamin K.

The study showed incorporating genetic information into prescribing patterns may help doctors adjust warfarin doses for these patients. Incorporating this kind of genetic information in a standard office visit, however, will be a challenge for many clinicians, and the time lag between obtaining a DNA sample and getting a useful result can now vary from days to weeks.

Pioneer in genetic disease dies
Alexander G. Bearn, 86, a physician and scientist whose research on a rare liver disease in the 1950s helped lay the groundwork for the field of human biochemical genetics, died May 15, 2009. Dr. Bearn was one of the first scientists to unravel the intricacies of Wilson’s disease, a potentially fatal buildup of copper in the body.

Wilson’s disease is caused by a toxic accumulation of dietary copper in the liver, brain, and other organs, leading to progressive neurological and behavioral problems and, if untreated, death. The symptoms, which include erratic behavior, slurred speech and tremors, can be misinterpreted as schizophrenia or Parkinson’s disease. Wilson’s disease affects about 1 in 40,000 people.

Dr. Bearn’s research showed that the disease is inherited as a recessive trait, meaning that a patient would have received the same abnormal gene from both parents; transmission of the abnormal gene from just one parent would not cause the disease.

The diagnosis of Wilson's disease is made by relatively simple tests. The tests can diagnose the disease in both symptomatic patients and people who show no signs of the disease. These tests can include: opthalmalogic slit lamp examination for Kayser-Fleischer rings; serum ceruloplasmin test; 24-hour urine copper test; Liver biopsy for histology and histochemistry, and copper quantification; and genetic testing.

The treatment of Wilson's disease involves avoidance of foods rich in copper and any supplements containing copper and drug treatment with chelating agents that remove the excess copper from the body.

The 2009 MLO Media Handbook is now online at www.mlo-online.com. Click on the media kit button.

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