In the News for the Week of 6-5-07
- TB traveler spreads concern about disease
- Many avoid rosiglitazone after study finds cardiovascular risks
- Surgery hastens relief of back pain but doesn't change outcomes
- Annals of Internal Medicine:
- Exercise improves low back pain in short term
- Changes in health insurance status result in changes in health care
- ACP Observer Extra: Peripheral Arterial Disease now online
- Study finds new model to predict type 2 diabetes
- New Lyme disease guidelines issued
- FDA targets unapproved cough medicines
- CDC links contact lens solution to rare eye infection
- CMS offers database of NPI information
- Deadline for award and Mastership nominations July 1
- New resources for medical labs available to ACP members
TB traveler spreads concern about disease
The CDC is warning health professionals to be on the lookout for extensively drug-resistant tuberculosis after Andrew Speaker, a 31-year-old Atlanta man with the disease, traveled to and from Europe on commercial airliners.
On May 12 and 13, Mr. Speaker flew from Atlanta to Paris, France for his wedding after having been diagnosed with multidrug resistant TB (MDR TB). According to the CDC, he had been advised not to travel but was not ordered to stay home. Government officials contacted Mr. Speaker in Europe when it was discovered that he had the extensively drug resistant form of the disease (XDR TB).
XDR TB is a subtype of MDR TB which, in addition to being resistant to at least isoniazid and rifampin, is resistant to at least two of the most important second-line antibiotics (i.e., a fluoroquinolone and an injectable agent [amikacin, kanamycin or capreomycin]). XDR TB has about a 30% cure rate and 49 cases have been diagnosed in the U.S. between 1993 and 2006, said the June 1 New York Times.
This is the first investigation of an XDR TB patient involving air travel. Federal officials are particularly concerned about other passengers on Mr. Speaker’s two transatlantic flights (Air France #385 /Delta #8517 on May 12/13 and Czech Air #104 on May 24) because TB is usually transmitted through exposure of at least eight hours. The CDC is asking health care providers to perform TB evaluation and testing on anyone who was on either flight.
Although Mr. Speaker also took several flights within Europe, CDC officials said the risk of transmission during short flights is very low. The low levels of bacteria found in Mr. Speaker’s sputum and the absence of symptoms also reduce the likelihood of transmission, noted the New York Times.
The case has also raised questions about U.S. infection control systems. Although government officials asked Mr. Speaker to go into isolation in Europe and later placed a no-fly order on his passport, he was able to fly into Canada and drive across the border into the U.S. After turning himself in to CDC officials, he was taken from New York City to Atlanta and then Denver, where he is currently undergoing treatment.
Many avoid rosiglitazone after study finds cardiovascular risks
U.S. doctors and patients are avoiding diabetes medication rosiglitazone (Avandia) after a recent study in the New England Journal of Medicine found an association between the drug and cardiovascular problems.
Rosiglitazone’s share of the market for newly prescribed oral antidiabetics dropped from 10% to zero in the two days after the study was published on May 21, the May 30 Wall Street Journal reported. During that time, patients also switched from one drug to another at three times the normal rate and competing drug pioglitazone (brand name Actos) increased market share from 10% of new prescriptions to 22%.
A significant number of patients enrolled in manufacturer GlaxoSmithKline’s clinical trial of rosiglitazone also have dropped the drug because of safety concerns. The company did not reveal how many of the 4,450 enrolled patients had quit the trial, but conceded that it is unclear whether the study will be completed, according to the May 26 New York Times.
The NEJM study, a meta-analysis of 42 trials and almost 28,000 patients, found that rosiglitazone raised diabetic patients’ risk of heart attack by 43% and an accompanying editorial concluded that the rationale for prescribing the drug was unclear. Manufacturer GSK countered that its reviews, which were submitted to the FDA last year, found that the drug increased heart-attack risk by 30%.
After the study’s publication, the FDA issued a public safety alert on rosiglitazone and advised patients who take it to consult their doctors. The agency plans to convene an advisory panel to review safety data on the drug and Congressional hearings on the topic have also been scheduled.
Surgery hastens relief of back pain but doesn't change outcomes
Surgery offers faster relief than conservative treatment for some back problems, but the long-term results are similar and watchful waiting before opting for surgery does not make the surgery less effective, according to findings from two new studies in the May 31 New England Journal of Medicine.
In one study, researchers assigned 283 patients with severe sciatica and who hadn’t improved after 6 to 12 weeks to early surgery or to prolonged conservative treatment with the option of surgery later. Thirty-nine percent of the latter group eventually opted for surgery. One-year outcomes on scores of pain, disability and recovery were similar for the two groups, but pain relief and perceived recovery occurred more quickly for the early surgery group.
The second study of 607 patients with degenerative spondylolisthesis randomized subjects to receive either decompressive laminectomy or usual non-surgical care. Because many in the non-surgical group opted for surgery, however, researchers had to adjust study data because the results were no longer randomized. In the as-treated analysis, those who had surgery showed a significant decrease in pain and improvement in physical function at three months compared with those who didn’t. The advantage increased at one year, and diminished only slightly at two years. The intention-to-treat analysis showed no advantages.
The adjustment of data in the second study calls for caution in interpreting its results, noted an accompanying editorial, and the true effect of the surgical advantage probably lies somewhere between the as-treated and intention-to-treat analyses. The results of both studies indicate that, absent major neurologic deficits, patients with herniated disks, degenerative spondylolisthesis or spinal stenosis don’t necessarily need surgery, but it may still be a valuable option for pain relief, the editorial concluded.
Annals: Exercise improves low back pain in short term
The following articles appear in the June 5, 2007 issue of Annals of Internal Medicine. This issue also includes a trial finding that antipsychotic drugs increase the risk of death in older dementia patients. Two early-release online studies analyze the impact of the resident work-hour cap. The full text is available to College members and subscribers online.
Exercise therapy plus advice improved low back pain at six weeks but not at one yearIn a study of 259 people with subacute low back pain, a combination of exercise and advice directed by physical therapists improved pain and function in the short term. At six weeks, patients who received real exercise and real advice had less pain and more mobility than a group who received sham exercise and sham advice, but at 12 months, these positive effects had almost disappeared.
Changes in health insurance status result in changes in health careA study of national medical expenditure surveys from 2000-04 finds that uninsured people who acquire insurance spend at the same rate as those who have had insurance continuously. Also, insured people who lose their insurance spend at levels similar to those who have been continuously uninsured. The authors suggest that “expenditures associated with gaining insurance will increase in a predictable manner to levels similar to those of persons who are already insured.” An editorial noted that the findings do not show that having health insurance necessarily improves health care but that many other studies in the past quarter century “provide convincing support …that health insurance improves health outcomes.” So, editorial asks, how much longer will uninsured persons have to wait before “we, as a nation, decide to provide health insurance to every person living in the United States.”
ACP Observer Extra: Peripheral Arterial Disease
A complete guide to screening, diagnosing and treating peripheral arterial disease (PAD) is now available free to ACP Members on the ACP Observer Extra Web site.
PAD affects about 8 million Americans, or 12% to 20% of people over age 65, according to the American Heart Association. Many PAD sufferers have limited mobility and an increased risk of heart attack and stroke. Screening for the disease allows early diagnosis and treatment to reduce cardiovascular risk factors and improve functional status.
The supplement can be viewed online or printed out in PDF format. Also, look in the June print edition of ACP Observer for HealthTiPs--4x6 cards with key points on PAD designed for physicians to hand to their patients. The cards, developed by the ACP Foundation, contain clinical content found in PIER, the College's evidence-based clinical support tool.
Study finds new model to predict type 2 diabetes
A simple clinical model can effectively predict the incidence of type 2 diabetes in middle-aged adults, a new study found.
Researchers evaluated the seven-year risk of developing diabetes among participants in the Framingham Offspring Study, 160 of whom developed new cases of the disease during the trial. They compared the predictive value of personal model variables (age, sex, parental history of diabetes, and body-mass index) used alone or considered together with a simple clinical model (hypertension, HDL cholesterol, triglyceride, fasting glucose) with complex clinical models.
The personal model variables, except for sex, were significant predictors of diabetes risk, the study found, but the simple clinical model improved the accuracy of predictions. The complex clinical models performed no better than the simple clinical model, in which the researchers allotted point values to the included risk factors and created an algorithm for evaluating a patient’s risk of developing type 2 diabetes. The study was published in the May 28 Archives of Internal Medicine.
The study was limited by the fact that 99% of participants were white. Study authors recommended that their new algorithm be tested in other population samples to validate the approach. The hope is that the point score could be used in the office setting to predict events and enhance prevention strategies, as has been accomplished with coronary heart disease.
The Archives of Internal Medicine is online.
New Lyme disease guidelines issued
The American Academy of Neurology has issued new evidence-based guidelines on treating Lyme Disease and post-Lyme syndrome.
After reviewing 353 abstracts of studies between 1983 and 2003, an expert panel used 37 articles for its analysis. Recommendations include:
- Parenteral penicillin, ceftriaxone and cefotaxime are probably safe and effective treatments for peripheral nervous system Lyme disease and for CNS Lyme disease with or without parenchymal involvement (Level B recommendation).
- Oral doxycycline is probably safe and effective to treat PNS Lyme disease without parenchymal involvement. Amoxicillin and cefuroxime axetil may provide alternatives, but supporting data are lacking.
- Prolonged antibiotic courses for post-Lyme syndrome aren’t recommended, as they don’t improve the outcome and may be associated with adverse events.
Recommended adult and child doses for the antibiotics are included in the review. The role of corticosteroids in patients with neuroborreliosis remains unclear, the panel determined.
The AAN practice guidelines are online.
FDA targets unapproved cough medicines
The FDA announced plans last week to take action against manufacturers of several unapproved cough and cold medications. The targeted medications are timed-release forms of guaifenesin, a substance that stimulates removal of mucus from the lungs.
According to the FDA, only Adams Respiratory Therapeutics has obtained agency approval for timed-release guaifenesin, in 600 mg and 1200 mg doses, under the brand names Mucinex and Humibid. About 20 other firms currently make unapproved versions of the drug.
The companies producing the unapproved drugs are asked to stop manufacturing them within 90 days and cease shipments within 180 days, the FDA said. The agency had previously warned manufacturers and distributors of extended-release guaifenesin in 2002 and 2003 that the products required FDA approval, reported the May 26 Washington Post.
The government action does not apply to immediate-release forms of the drug. Timed-release medications require approval to ensure that the active ingredients are released safely and effectively, sustaining the intended effect over the entire time in which the product is intended to work, the FDA said. The agency has not identified any safety issues with guaifenesin, which has been used in medications for decades, noted the Washington Post.
CDC links contact lens solution to rare eye infection
The CDC and FDA are warning consumers to throw out a contact lens solution that may be linked to a rare but serious eye infection.
A CDC investigation found a potential link between the product, AMO Complete Moisture Plus Multi-Purpose Solution, and Acanthamoeba keratitis, an infection that is caused by a parasite and can lead to vision loss or blindness. Symptoms may include eye pain or redness, blurred vision, discharge, light sensitivity, sensation of something in the eye or excessive tearing.
Clinicians should consider referring patients with these symptoms to an ophthalmologist, as early diagnosis greatly improves treatment success, the CDC said. Patients should not only stop using the suspected contact lens solution, but discard all partially used or unopened bottles and replace their lenses and storage container, the FDA said.
The CDC and FDA are investigating 138 confirmed cases of Acanthamoeba keratitis since 2005, the May 25 Washington Post reported. The CDC drew its conclusion because 58% of the people with confirmed cases who wore soft contact lenses had used AMO’s product in the previous month, and 39% had used only that solution, the Washington Post reported.
However, the doctors who initially discovered the outbreak believe that a reduced use of chlorine in public water supplies may be the culprit, rather than the contact lens solution, the Wall Street Journal reported.
Database of NPI information going online
CMS announced that it will post a database of all National Provider Identifiers (NPI) on its Web site starting June 28. This database can be used when an NPI is needed for a claim, referral, lab test or other reason.
NPIs replace all other numbers used to identify physicians by Medicare and private payers, including the Unique Physician Identification Number (UPIN). Physicians were mandated to begin using NPIs in most of their payment transactions on May 23, 2007.
The data initially will be available as a downloadable file, but CMS envisions creating a free, searchable online database that would include provider name, address and phone number. The database will not include personal information such as social security number, date of birth or tax identification number. Since all provider NPIs will be obtainable through the publicly available database, CMS recommends that the number should not be used to verify the identity of a physician in any instance.
More information is online.
Deadline for award and Mastership nominations July 1
Each year, ACP bestows 18 awards and a number of Masterships during Convocation at the Internal Medicine meeting. These honors recognize outstanding contributions in the practice of medicine, teaching, research, public service, leadership and medical volunteerism. The deadline for this year’s nominations is July 1, 2007.
The Awards Committee particularly welcomes recognition of accomplished women, international physicians, and ethnically diverse candidates. Nominations are especially encouraged for the Edward R. Loveland Award to a lay person or lay organization, the William C. Menninger Awards for contributions to mental health, the Richard and Hinda Rosenthal Awards, the Ralph O. Claypoole Sr. Award for devotion to the care of patients, the Outstanding Volunteer Clinical Teacher Award and the Joseph E. Johnson Leadership Award.
Five detailed supporting letters and a curriculum vitae (or equivalent) with full biography are required for nominations to be considered. Individuals may not self-nominate. The Awards and Mastership Booklet contains complete criteria for ACP awards and Masterships as well as detailed instructions for writing nominating and supporting letters. The booklet is available online.
For questions and information about the status of previously submitted nominations, contact Martha Cornog, staff liaison to the Awards Committee, at email@example.com, 800-523-1546 ext. 2696, or Meghann Williams, Coordinator, Awards–Convocation and Diversity, at firstname.lastname@example.org, 800-523-1546 ext. 2714.
New resources for medical labs available to ACP members
Several new and innovative tools are now available from ACP’s proficiency testing (PT) provider, Medical Laboratory Evaluation (MLE). These new tools are available exclusively to ACP members or other MLE participants and include free shipping and handling.
The new tools include:
- A patient education tool for placement in phlebotomy areas called The Adventure of the Lab Explorers: Sometimes When You Feel Bad, which aims to help patients understand the role of the clinical laboratory professional.
- The Performance Standards for Antimicrobial Susceptibility Testing comes with updated tables for testing standards. This is a new resource from MLE in conjunction with the Clinical Laboratory Standards Institute (CLSI)
- New OSHA-related resources, including the Basic OSHA Compliance Program, the OSHA Safety Program Manual, both with OSHA Watch Newsletter Updates, and Dr. Dunn Live! OSHA Annual Retraining DVD Program.
The MLE program, which began in 1973 to offer PT services to physician office labs, seeks to enhance the quality and safety of patient care. The program is now offered throughout the U.S., Canada, Latin America, Southeast Asia, New Zealand, Portugal and the Caribbean.
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Copyright 2007 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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