American College of Physicians: Internal Medicine — Doctors for Adults ®

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In the News for the Week of 9-25-07

News highlights

  • CDC projects record amount of vaccine for upcoming flu season
  • Americans know little about peripheral arterial disease
  • Health care costs vary from state to state
  • Physicians must file by Oct. 19 to qualify for BCBS settlement payment

Hospital medicine

  • FDA clears rapid test for blood platelet screening

Clinical news

  • ACP Journal Club: Escalating higher-energy regimen better than fixed lower-energy for out-of-hospital defibrillation
  • Osteoporosis shot reduces fractures and mortality
  • Small trial shows possible benefit with nocturnal dialysis

Regulatory news

  • Safety alerts for fentanyl buccal, haloperidol, defibrillators
  • New genetic test to help with warfarin dosage decisions

College news

  • ACP leadership expresses disappointment with SCHIP legislation
  • ABMS selects Kevin B. Weiss, FACP, as president and CEO
  • New issue of IMpact, College’s medical student newsletter

News highlights

CDC projects record amount of vaccine for upcoming flu season

The CDC called on health professionals and the public to step up influenza vaccinations this flu season in light of ample vaccine and new data showing that vaccination rates have been low in recent years.

During the 2005-06 season, only one in five children aged 6-23 months was fully vaccinated, the CDC said. Fewer than one-third of adults up to age 49 with medical conditions, and only about 40% of health care workers, were fully immunized, the Sept. 20 Washington Post reported. About 36,000 people die and more than 200,000 are hospitalized from influenza in the U.S. each year.

A record amount of injectable or spray vaccine is expected to be available for the 2007-08 flu season. By January, an estimated 132 million doses of vaccine—about 12 million more than last season—will have been made available, the Washington Post said. Almost 15% of last year’s supply wasn’t used and had to be thrown away.

People at heightened risk for influenza include children age six months to five years, people with chronic medical conditions and pregnant women. Health care workers, people age 50 and older, and people who are in contact with children younger than six months also should be vaccinated. Vaccination should begin as soon as vaccine is available in a community and can continue well into 2008, the CDC said, since the flu season can run as late as May.

CDC information on influenza and vaccination is online.

The Washington Post is online.

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Americans know little about peripheral arterial disease

Most Americans are unfamiliar with peripheral arterial disease (PAD), and those at highest risk for the disease—older adults, minorities and people with less education and income—are the most likely to have little or no knowledge about the condition, a recent study found.

The telephone survey of 2,051 people age 50 and over found that only 26% expressed familiarity with PAD. Of those who knew about the disease, only one in four knew that PAD is associated with increased risk of heart attack or stroke and only 14% of people were aware that PAD could lead to amputation. Patients who knew about PAD had most frequently learned about it from television (26%) or a family member or friend (17%). Only 14% had obtained PAD information from a physician.

Patients showed much greater knowledge of other cardiovascular risk factors and conditions—about 90% were somewhat or very familiar with high blood pressure, 74% knew about stroke and 67% were familiar with coronary artery disease. The study found less public awareness about PAD than several less common diseases, including multiple sclerosis (42% of people familiar) and amyotrophic lateral sclerosis (36%). The study was published online Sept. 17 by the journal Circulation.

The comparisons to other diseases that have been the focus of nationally coordinated educational programs indicate the potential impact of a national PAD awareness campaign, study authors said. The authors also expressed concern that the current lack of public awareness about the disease likely contributes to under-recognition of symptoms by the public and delay in diagnosis. The survey was conducted by the Peripheral Arterial Disease Coalition, which is funded by grants from pharmaceutical and medical device manufacturers.

Circulation is online.

"Peripheral Arterial Disease," a new title from ACP Press by Emile Mohler III, FACP, and Michael R. Jaff, FACP, both leading experts in the field, is a concise and practical guide to the diagnosing and treatment methods of PAD. You can pre-order a copy of the book online.

Observer Extra: Peripheral Arterial Disease, a Web-based supplement on prevention, diagnostic and treatment strategies, is also online.

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Health care costs vary from state to state

A new report finds that health care spending varies widely in different parts of the U.S., with residents of some northeastern states spending an average of about $2,000 more per year than people who live in the lowest-spending states.

According to the analysis from CMS, residents of Massachusetts, Maine, New York, Alaska, Connecticut, Delaware, Rhode Island, Vermont, West Virginia and Pennsylvania had the highest spending, with an average of $6,345 per capita. The states with the lowest spending—Utah, Arizona, Idaho, New Mexico and Nevada—had an average of only $4,244 per person. Researchers noted that the higher-spending states generally had the highest concentration of physicians, the highest incomes and the smallest percentages of uninsured, while the lower-spending states are less populous and younger.

The report also compared trends in spending variations among states over time. Researchers found that geographic differences in health care spending grew in 1991-1998 and decreased in 1998-2004. They attributed this change to managed care plans’ influence on cost and utilization of health care, which was greater in the earlier time period. The study was published in the Sept. 18 Health Affairs.

An accompanying editorial addressed the impact of the data on state plans for health care reform. The authors said that higher spending does not appear to be related to better health care quality, and they suggested that states should concentrate on quality improvement strategies (including medical homes and pay for performance), in addition to expanding coverage. A second editorial noted that the study data revealed significant variations in state Medicaid spending, with higher-spending states spending significantly more on Medicaid programs. The author expressed concern that state-led health care reforms would only widen that gap.

The study and the first and second editorials are online.

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Physicians must file by Oct. 19 to qualify for BCBS settlement payment

Physicians must file a claim form by Oct. 19 to take advantage of a $131 million settlement payment by many Blue Cross Blue Shield (BCBS) plans stemming from a 2003 class action lawsuit concerning physician reimbursement.

In the suit, filed in Miami, physicians claimed that BCBS insurers intentionally and unfairly cut physician reimbursement. The complaint alleges that between 1999 and 2007, BCBS violated the federal Racketeer Influenced and Corrupt Organizations (RICO) Act by engaging in a conspiracy to improperly deny, delay and/or reduce physician payments.

As part of the settlement, these BCBS plans agreed to improve their business practices by, for example, using clinical guidelines that are based on credible scientific evidence when making Medical Necessity determinations. They have also agreed to establish an external review process for resolving billing disputes with physicians.

Physicians who provided covered services to an enrollee in a BCBS settling plan, or enrollees in a non-settling BCBS plan that is a primary licensee, between May 22, 1999 and May 31, 2007 and who have not opted out of this settlement are entitled to a payout. The settlement hearing is scheduled for Nov. 14. After final court approval of the settlement, funds will be dispersed to eligible physicians.

Details about the settlement and information about filing claim forms are online.

Step-by-step instructions on filing from the American Medical Association are online.

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Hospital medicine

FDA clears rapid test for blood platelet screening

The FDA announced this week that the Platelet Pan Genera Detection (PGD) Test System, the first rapid test to screen platelets for bacteremia before transfusion, has been approved for U.S. marketing.

Contaminated platelets are the leading infectious cause of transfusion-related death, according to an FDA press release. With current methods, platelets are tested for bacteria 24 and 48 hours after donation, but infected platelets may not have enough bacteria present at that time for detection. The new testing system, which involves a disposable testing strip, improves the odds of detection because it can be used on stored platelets closer to the time of transfusion, giving bacteria more time to grow, the FDA said.

The FDA also recently licensed 15 blood grouping reagents that previously were not available in the U.S. The tests, which use monoclonal antibodies, will allow more choice for transfusion services and may help increase testing for rare blood types, an FDA official said in a press release.

The FDA press releases on the platelet test and the grouping reagents are online.

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Clinical news

ACP Journal Club: Escalating higher-energy regimen better than fixed lower-energy for out-of-hospital defibrillation

A new study found that when using an automated external defibrillator (AED) for out-of-hospital cardiac arrest, an escalating higher-energy regimen was better than a fixed lower-energy regimen for patients who required multiple shocks.

The randomized, controlled trial compared outcomes in 221 patients in three Canadian cities who had out-of-hospital cardiac arrest and received defibrillation from first responders using a biphasic AED. The AED devices were randomly programmed to deliver either an escalating higher-energy regimen of 200 J, 300 J and 360 J with repeated shocks or a fixed lower-energy regimen of 150 J for all shocks.

The study found that the proportion of patients requiring more than one shock was 51% in the escalating-energy group and 45% in the fixed-energy group. Among patients who received more than one shock, the escalating-energy group had higher rates of conversion and ventricular fibrillation termination. The groups did not differ for other outcomes, including return of spontaneous circulation, 24-hour survival and adverse myocardial outcomes. The study is abstracted in the September/October ACP Journal Club.

The study provides insight into the optimal use of biphasic defibrillators, according to Journal Club reviewer Eddy S. Lang, MDCM, of McGill University in Montreal. However, given the general lack of evidence on the topic and the fact that this study detected limited clinically meaningful differences in outcomes, further research is needed. Until that research is complete, the evidence for decision-makers leans toward escalating energy levels for patients requiring a second shock, Dr. Lang concluded.

Peer ratings for this review: Emergency medicine, IM, Cardiology: 6/7 stars.

ACP Journal Club is online.

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Osteoporosis shot reduces fractures and mortality

A yearly intravenous dose of zoledronic acid (brand name Reclast) reduces mortality and fractures in patients who have had a previous hip fracture, a new study found.

In the randomized, controlled trial, 2,127 patients (who had a mean age of 74.5 years) were given 5 mg of either the drug or a placebo within 90 days of surgical repair of a hip fracture. The patients who received zoledronic acid had 35% reduced relative risk for fractures compared with controls. They also had a 28% reduction in death from any cause. The drug did not appear to cause any serious adverse events, and fracture union was not delayed. The study was released online by the New England Journal of Medicine on Sept. 17 and will be in the Nov. 1 print issue.

Study authors “never dreamed” that the trial would find such a dramatic reduction in mortality, according to the Sept. 18 Washington Post. It is likely that the positive effects are not unique to zoledronic acid or bisphosphonates in general, concluded an accompanying editorial. Practice guidelines do currently recommend use of bisphosphonates for secondary prevention of fractures, but the majority of elderly patients with hip fractures are either not taking or not receiving the medication, the editorial said.

This study is the first to show that an osteoporosis medication is effective in reducing recurrence of fractures. However, the editorial writer noted that the placebo design of the trial may be criticized and is unlikely to be repeated because of ethical concerns about withholding effective treatment. Study authors explained that they enrolled only patients who were unable or unwilling to take an oral bisphosphonate and allowed concomitant treatment with several other fracture prevention agents.

The study and editorial are online.

The Washington Post is online.

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Small trial shows possible benefit with nocturnal dialysis

Nocturnal dialysis may improve cardiovascular disease and kidney-specific quality-of-life measures compared with conventional dialysis, according to a preliminary study.

Previous cohort and case-control studies had shown clinical improvement with nocturnal dialysis. To determine whether these findings could be reproduced in a randomized, controlled trial, researchers assigned 52 patients at two Canadian medical centers to receive conventional dialysis (three times per week) or nocturnal dialysis (six times per week). The primary end point was change in left ventricular mass on magnetic resonance imaging. Secondary end points included patient-reported quality of life and blood pressure. The study appeared in the Sept. 19 Journal of the American Medical Association.

At six-month follow-up, left ventricular mass increased by a mean (SD) of 1.5 (24.0) g in the conventional dialysis group but decreased by a mean of 13.8 (23.0) g in the nocturnal dialysis group. Although overall quality of life did not improve significantly in the nocturnal dialysis group, statistically significant improvements were seen in two kidney-specific domains, effects of kidney disease and burden of kidney disease. Patients in the nocturnal dialysis group also had improved systolic blood pressure and relied less on antihypertensive medications at six months than those in the conventional group.

The authors acknowledged that they studied a small number of patients for a fairly short time, that study participants may have been highly motivated and thus better able to manage nocturnal hemodialysis than the general population, and that data on dialysis dose were not formally collected in the nocturnal group. However, they noted that a large-scale trial is unlikely due to recruitment difficulties and that clinicians may therefore need to rely on these or similar data when making treatment decisions. The authors plan to perform a cost analysis of the two therapies and recommend that nocturnal hemodialysis should be offered more frequently if its cost-benefit profile proves favorable.

The Journal of the American Medical Association is online.

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Regulatory news

Safety alerts for fentanyl buccal, haloperidol, defibrillators

The FDA recently issued the following MedWatch safety alerts:

  • Fentanyl buccal (Fentora) should only be used to manage breakthrough pain in patients with cancer who are already receiving, and are tolerant to, opioid therapy for persistent cancer pain, according to the drug’s maker. Patients have died because they were given the wrong dose, were treated with the drug although they can’t tolerate opioids, and/or were wrongly given the drug as a substitute for another drug.
  • A recall is in effect for MRL/Welch Allyn AED 20 Automatic External Defibrillators manufactured between October 2003 and January 2005 and with serial numbers 205787 through 207509. These devices may display an error message that makes it impossible to analyze the patient's ECG or deliver treatment. Owners should contact their local Welch Allyn representative to obtain a loaner AED 20 at no cost while theirs is being fixed.
  • At least 28 patients have had QT prolongation and torsades de pointes (TdP), and some have died, due to off-label use of intravenous haloperidol (Haldol). The FDA has added a new cardiovascular subsection to the drug’s prescribing information to warn that these effects are possible, especially when the drug is given intravenously or at doses higher than recommended. Injectable haloperidol is only approved for intramuscular injection.
  • A recall is in effect for B. Braun Medical Inc.’s Normal Saline Flush syringes with lot numbers ending in “SFR”. Customers have complained about an increase in particulate matter in the saline, which can damage vital organs and cause phlebitis. No patient injuries have yet been reported.

More information on fentanyl buccal, AED 20 defibrillators, B. Braun syringes and haloperidol is online.

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New genetic test to help with warfarin dosage decisions

The FDA cleared for marketing a new genetic test that helps assess whether patients may be sensitive to warfarin (Coumadin), which could help doctors with dosage decisions.

The Nanosphere Verigene Warfarin Metabolism Nucleic Acid Test detects some variants of the genes CYP2C9 and VKORC1. Studies have linked patients with these genetic variants to a greater risk of bleeding from warfarin; in August, the FDA updated warfarin’s label to reflect this risk. Doctors should use the Nanosphere test along with clinical evaluation and other tools in making treatment decisions, the FDA said.

Separately, the agency approved raloxifene hydrochloride (Evista) for reducing the risk of invasive breast cancer in postmenopausal women who have osteoporosis and/or are at high risk for breast cancer. Because the drug can cause serious side effects, such as blood clots in the legs and lungs and death from stroke, the benefits and risks should be carefully weighed for each woman, the FDA urged. Women with current or prior blood clots in the legs, lungs or eyes shouldn’t take the drug.

The FDA releases on warfarin and raloxifene hydrochloride are online.

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College news

ACP leadership expresses disappointment with SCHIP legislation

In a letter to congressional leadership, ACP President David C. Dale, FACP, expressed “deep concern and disappointment" about reports that the pending State Children’s Health Insurance Program (SCHIP) reauthorization will go forward without addressing several critical issues relating to access to care for Medicare beneficiaries.

Before leaving for their August recess, the House and the Senate both passed differing versions of legislation to reauthorize SCHIP. The House version of the bill would expand the SCHIP budget by $47.4 billion and included provisions to reverse cuts to physician payments under Medicare. The Senate version of the bill would expand the SCHIP budget by $35 billion, and did not include any Medicare provisions. Congressional negotiators agreed to a compromise version of the legislation to move forward that will not include any Medicare revisions.

In his letters sent on Sept. 20, Dr. Dale expressed deep concern about the absence of Medicare provisions in the compromise legislation and urged the House and the Senate to work together “to reach prompt agreement on Medicare legislation to preserve and improve access to care for America’s seniors.”

The ACP letter urged congressional leaders to work for enactment of a separate Medicare bill that incorporates important improvements from the original House version of the SCHIP legislation. Dr. Dale stated that Congress needs to replace physician payment cuts in 2008 and 2009 with positive annual updates of at least 0.5%.

Dr. Dale concluded by noting that “America’s children and seniors both deserve the best health care possible.”

More information about Dr. Dale’s letters is online.

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ABMS selects Kevin B. Weiss, FACP, as president and CEO

ACP Regent Kevin B. Weiss, FACP, has been appointed president and CEO of the American Board of Medical Specialties (ABMS), the group announced last week. On Dec. 17, Dr. Weiss will succeed retiring president and CEO Stephen H. Miller, MD, and take over leadership of ABMS, which oversees the certification of physician specialists in the U.S.

Dr. Weiss described several goals for his new role at the helm of ABMS, including implementation of maintenance of certification ahead of schedule, opening ABMS to more input from public members, and establishment of a new evaluation program for physicians based on demonstration of high proficiency standards.

Dr. Weiss has devoted more than 20 years of his medical career to quality and access issues in primary care, conducting epidemiological and health services research projects related to guideline implementation, chronic care management, outcomes measurement and quality improvement, with a specific emphasis on asthma. He is a professor of medicine and director of the Institute for Healthcare Studies at Northwestern University’s Feinberg School of Medicine in Chicago. He also directs the Midwest Center for Health Services and Policy Research located at Hines and Chicago Veterans Administration Medical Centers.

In addition to serving as a Regent, Dr. Weiss represents ACP at the National Quality Forum and the American Medical Association’s Physicians Consortium for Performance Improvement.

An ABMS news release is online.

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New issue of IMpact, College’s medical student newsletter

The September issue of IMpact includes an interview with ACP member Bill J. Johnson, a Texas internist who has been unusually successful at keeping his patients out of the hospital. Another article offers a Canadian medical student’s perspective on health care coverage. IMpact is a monthly online newsletter produced by ACP for medical students.

The September IMpact is online.

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