In the News
for the Week of 2-19-08
- New trial finds no link between low blood sugar and mortality
- Primary care benefits from IMGs, nonphysician providers
- Baxter halts manufacture of multiple-dose heparin vials
Health care spending
- Back treatment costs rise but patients don't feel better
- Probiotics could be harmful in predicted severe acute pancreatitis, study finds
- Study finds benefits to "open-lung" ventilation strategy in acute lung injury and ARDS
- Fentanyl pain-relief patches recalled
Annals of Internal Medicine
- Audio Summary: Preventing contrast-induced nephropathy
- Muscle and bladder training ameliorate urinary incontinence
- Glucosamine no better than placebo in reducing hip pain
Cartoon caption contest
- Put words in our mouth
From the College
- Regents approve paper on medical marijuana, update procedures for ethical complaints
- New leadership program offers online mentoring and CME instruction
- Employer group endorses principles for health care reform
New trial finds no link between low blood sugar and mortality.
Interim results from a large international diabetes study do not confirm findings that recently halted a large U.S. trial, researchers announced last week. The new findings increased debate about how intensive treatment of blood sugar in high-risk diabetic patients affects mortality.
The ACCORD trial, a large NIH-funded study of diabetes treatment, stopped its intensive treatment arm two weeks ago after researchers found a link between treating patients to low blood sugar goals and increased mortality. Concern about the ACCORD trial’s findings led researchers on the ADVANCE study, an international trial involving 11,140 high-risk patients with diabetes, to evaluate their data for a similar link.
They found no confirmation of the adverse mortality trend reported by the ACCORD trial, according to the chairman of the ADVANCE Data Monitoring and Safety Committee. He also noted that the ADVANCE trial was based on twice as much data and similar glucose targets as the ACCORD trial. Patients in the ADVANCE trial had an A1c goal of less than 6.5% while ACCORD patients in the low-target group had an average A1c of 6.4%.
Full data from the ADVANCE trial are not yet available, because the arm of the study that assessed the effects of intensive blood sugar treatment was only completed in January. The study began in July 2001 and patients were treated and followed for an average of five years. Researchers said that results are more than 99% complete, so the interim findings should be a reliable guide to the final results. The study should be available in the spring, representatives said.
Doctors and patients should be reassured that the mortality trend found in the U.S. study was not confirmed by the international trial, although more definitive analyses are needed, said a representative of the ADVANCE trial. The results of a third trial, expected later this year, should help to clarify the issue, according to the American Diabetes Association. The association also reaffirmed its recommendation that most people with diabetes work toward an A1c of less than 7% and that high-risk individuals consult individually with their health care providers.
The ADVANCE statement is online.
The American Diabetes Association statement is online.
Primary care benefits from IMGs, nonphysician providers.
Although fewer Americans become primary care physicians, primary care providers increased per capita thanks to international medical graduates and the growth in physician assistants and nurse practitioners. And the overall growth in primary care provided more efficient and less expensive health care, according to testimony given to Congress last week.
The Government Accountability Office (GAO), Congress' research arm, provided testimony to the Senate Health, Education, Labor and Pensions Committee. In the past decade, the per capita number of primary care doctors, including internists, pediatricians, family practitioners and general practitioners, rose an average of 1.17% annually. The number of dependent caregivers rose even faster—3.89% per capita annually for physician assistants and 9.44% for nurse practitioners.
The per capita number of primary care physicians grew faster than that of specialty physicians, 12% vs. 5%, respectively. The Associated Press reported from the GAO's testimony that fewer American medical graduates choose primary care, but international medical graduates (IMGs) covered the gap. GAO figures show that in 2006 there were 22,146 American doctors in residency programs in the U.S. specializing in primary care, down from 23,801 the previous year. IMGs made up 1 in 4 new U.S. physicians, according to the AP.
The growth in primary care benefits U.S. health care, said the GAO, which cited benefits including:
- Patients of primary care physicians are more likely to receive preventive services, to receive better chronic illness management and to be satisfied with their care;
- Areas with more specialists have no advantages in meeting population health needs and may have ill effects when specialist care is unnecessary;
- States with more primary care physicians per capita have better health outcomes—as measured by total and disease-specific mortality rates and life expectancy—than states with fewer primary care physicians;
- States with a higher generalist-to-population ratio have lower per-beneficiary Medicare expenditures and higher scores on 24 common performance measures than states with fewer generalist physicians and more specialists per capita;
- Hospitalization rates for diagnoses that could be addressed in ambulatory care settings are higher in geographic areas with more limited access to primary care physicians.
The GAO report is online.
ACP Internist coverage about international students in the U.S., and the numbers of women vs. men entering primary care, is online.
News coverage of the testimony is online.
Baxter halts manufacture of multiple-dose heparin vials.
Serious allergic reactions in some patients have led Baxter Healthcare Corp. to temporarily stop making multiple-dose vials of heparin, prompting concerns of a heparin shortage.
Some patients who received high bolus doses of the Baxter drug have experienced difficulty breathing, vomiting, nausea, excessive sweating and rapidly falling blood pressure that can lead to shock. Four patients have died, though it’s not clear if the drug caused the deaths, the FDA said.
It isn’t known for how long Baxter, which manufactures half of the multiple-dose vials of heparin sold in the U.S, will suspend production. The FDA is working with other manufacturers to fill the void, and decided not to issue a recall of existing Baxter doses because it would lead to an immediate and severe shortage, an FDA official said in the Feb. 11 Washington Post. The agency is investigating whether adverse events have occurred with other heparin manufacturers.
Baxter also said last week that it is investigating whether the problems have any connection to a Chinese manufacturing facility, according to the Feb. 15 Wall Street Journal. Most of the active ingredient supplied to Baxter by Waunakee, Wis.-based Scientific Protein Laboratories LLC is made at a plant in Changzhou, China, through a joint venture with the Wisconsin company. The FDA did not inspect the Chinese facility, said the Wall Street Journal.
The FDA advises health care providers to use an alternate source of heparin or another blood-thinning drug when possible. When only the Baxter product is available, providers should:
- Administer the heparin as an infusion (not a bolus);
- Use the lowest dose at the slowest infusion rate possible;
- Closely monitor patients for adverse events, especially hypotension and symptoms of hypersensitivity, and make sure resuscitation equipment is available;
- Consider pretreatment with corticosteroids or antihistamines, though it is not known if this will be effective.
Baxter recalled nine lots of heparin in January, but adverse events have occurred since then that extend beyond the recalled lots. About 350 events have been reported since the end of December, compared with fewer than 100 reports in all of 2007. Most have occurred at hemodialysis centers and involved patients receiving a bolus dose, though some have involved patients undergoing cardiac surgery and photopheresis. Reactions have occurred with heparin doses ranging from several thousand units per milliliter to 50,000 units per milliliter, the Washington Post reported.
The FDA release is online.
The Feb. 11 Washington Post is online.
Health care spending
Back treatment costs rise but patients don't feel better.
The cost of treating back and neck pain in the U.S. has risen rapidly over the past decade to almost $86 billion, or 9% of total health care spending, in 2005, but the spending has not resulted in functional improvements for patients, new survey results show.
Using data from the national Medical Expenditure Panel Survey, researchers calculated that total spending among respondents with spine problems rose from a mean per person of $4,695 in 1997 to a mean of $6,096 in 2005, an estimated 65% inflation-adjusted increase in overall national expenditures on adults with spine problems. However, age- and sex-adjusted self-reported measures of mental health; physical functioning; and work, school or social limitations became worse over the same time period. The study appears in the Feb. 13 Journal of the American Medical Association.
While expenditures for outpatient visits accounted for the biggest proportion of total costs (36%), spending on prescription medications saw the highest relative increase, rising 188% over the study period, said the researchers. Much of the spending was on narcotic analgesics after 2003, after two popular COX-2 inhibitors were associated with heart attacks and stroke. The increases in prescription costs and pharmacy events together accounted for an estimated 423% rise in expenditures on spine-related narcotic analgesics from 1997 to 2004.
The authors attributed some of the increased spending to more widespread use of expensive new drugs, such as gabapentin, fentanyl and time-release oxycodone. Other possible reasons for the higher spending, they said, include medical imaging and diagnostic testing; spinal injections; lower threshold for providing treatment; higher patient expectations; and increased use of spinal fusion surgery and instrumentation.
The data suggest that the higher cost of treating spine problems is not resulting in better health outcomes, said the authors. Treatment of back and neck problems, therefore, may represent an opportunity to reduce health costs without worsening clinical outcomes.
The JAMA abstract is online.
Probiotics could be harmful in predicted severe acute pancreatitis, study finds.
Probiotics used prophylactically could have adverse effects in patients with predicted severe acute pancreatitis, according to a new study.
Because infectious complications are fairly common in patients with acute pancreatitis and do not usually respond to antibiotics, probiotics have begun to be used along with enteral nutrition as a possible prophylactic measure. However, existing trials showing a benefit with this strategy have been small and of lower methodologic quality. Dutch researchers therefore conducted a multicenter, randomized, double-blind, placebo-controlled trial to better determine the usefulness of probiotics in patients predicted to have severe acute pancreatitis. The results were published in the Feb. 14 online edition of Lancet.
Researchers randomly assigned 153 patients with predicted severe acute pancreatitis to receive a multispecies probiotic preparation, while 145 patients were randomly assigned to placebo. Randomization was done within 72 hours of symptom onset. The primary end point was infectious complications during admission and 90-day follow-up, including infected pancreatic necrosis, bacteremia, pneumonia, urosepsis or infected ascites. Because one patient in each group was incorrectly diagnosed with acute pancreatitis, 152 patients receiving probiotics and 144 receiving placebo were analyzed.
Patient characteristics and disease severity were similar in both groups at baseline. Probiotics did not appear to affect rates of infectious complications (30% in the probiotics group and 28% in the placebo group), but mortality rates were higher in those who received probiotics (16% vs. 6%; relative risk, 2.53 [95% CI, 1.22 to 5.25]). In addition, nine cases of bowel ischemia were seen in the probiotics group compared with zero in the placebo group, and eight of the nine patients with bowel ischemia died.
Probiotic preparations "can no longer be considered to be harmless adjuncts to enteral nutrition, especially in critically ill patients or patients at risk for non-occlusive mesenteric ischaemia," the authors wrote. Their findings may have differed from those of earlier trials because the study sample was larger and included more critically ill patients, they said. Until more is known about the mechanism of action, the authors recommended against routinely administering probiotics, particularly the formulation used in their study, to patients with predicted severe acute pancreatitis.
The Lancet is online.
Study finds benefits to "open-lung" ventilation strategy in acute lung injury and ARDS.
Patients with acute lung injury and the acute respiratory distress syndrome (ARDS) may benefit from a ventilation strategy based on the "open-lung approach," a new study reports.
The established treatment method for patients with acute lung injury and ARDS involves ventilation with low tidal volumes, which has been shown to improve survival. However, it has been suggested that adding measures to open collapsed lung tissue would lead to increased benefit. Canadian researchers performed a randomized, controlled trial at 30 hospitals to determine whether a "lung open ventilation" (LOV) strategy that combined lung recruitment maneuvers, high levels of positive end-expiratory pressure and low tidal volumes would improve mortality rates in patients with acute lung injury. The study appears in the Feb. 13 Journal of the American Medical Association.
Researchers randomly assigned patients to receive LOV or control ventilation (509 patients). The main outcome measure was all-cause hospital mortality. Of the 983 study patients, 85% were considered to have ARDS at enrollment. Rates of all-cause hospital mortality were 36.4% in the LOV group and 40.4% in the control group (relative risk, 0.90 [95% CI, 0.77 to 1.05]; P= 0.19), while barotrauma rates were 11.2% and 9.1%, respectively (relative risk, 1.21 [95% CI, 0.83 to 1.75]; P= 0.33]). Rates of refractory hypoxemia, death with refractory hypoxemia and use of rescue therapies were all lower in the LOV group (4.6% vs. 10.2%, 4.2% vs. 8.9% and 5.1% vs. 9.3%, respectively).
The authors concluded that the two strategies resulted in similar mortality rates, but that the LOV strategy led to less frequent use of rescue therapies and fewer deaths related to refractory hypoxemia. The trial was limited by an inability to determine the specific effects of each component of the LOV intervention and by small differences between the study groups in age and presence of sepsis at baseline (the control group was 2.4 years older on average than the LOV group and had a rate of sepsis that was 3.7% higher). However, the authors wrote that their results, in conjunction with those from two earlier major trials, justify the use of higher positive end-expiratory pressure in patients with acute lung injury and ARDS.
The Journal of the American Medical Association is online.
Hypertension increasing among American women.
Uncontrolled hypertension became more common among American women during the 1990s, while rates for men continued to decline but at a slower rate than in the past, a new study found.
Researchers used data from the National Health and Nutrition Examination Survey and a mobile examination clinic to evaluate rates of hypertension (defined as more than 140 mm Hg systolic) in each state. They found that between the early 1990s and the early 2000s the prevalence of uncontrolled hypertension in adult women increased from 17% to more than 22%. During the same period, male hypertension decreased from 19% prevalence to 17%. The study was published online in the journal Circulation on Feb. 11.
Southern states had the highest rates of hypertension, according to the researchers. In the District of Columbia, Mississippi, Alabama, Louisiana, Texas, Georgia and South Carolina, 18% to 21% of men had uncontrolled hypertension and 24% to 26% of women did. The states with the lowest rates were Vermont, Minnesota, Connecticut, New Hampshire, Iowa and Colorado.
The researchers also evaluated which states had seen the greatest change. For women, the ranks of the hypertensive grew the most in Idaho and Oregon and shrunk in Washington, D.C., and Mississippi. For men, the best states were Vermont and Indiana and the worst New Mexico and Louisiana. Researchers noted that it was impossible to tell whether these variations between states were due to better public health efforts in some areas or populations having hit a peak in the possible rates of hypertension.
It is alarming that U.S. states are experiencing worsening rates in a risk factor that is easily controllable by lifestyle, diet and medication, said a study author. States with the highest prevalence, in particular, need to focus on interventions to reverse the trends seen in the past decade, he concluded.
The study is online.
A press release from the American Heart Association is online.
Autopsies indicate increase in coronary artery disease.
Rates of coronary artery disease have stopped declining and may be on the rise, according to a new analysis of autopsy data.
In the population-based study, researchers reviewed the pathology reports of 425 residents of Olmsted County, Minn. who died between 1981 and 2004 and had their coronary anatomy graded. The individuals were between the ages of 16 and 64 and died due to accident, suicide, homicide, or in a manner that could not be determined. Over the 23-year period, 8.2% of the individuals studied had high-grade coronary disease and 83% had some evidence of disease.
Using age- and sex-regression analysis, the researchers determined that overall rates of coronary disease declined over the entire study period, although declines in the grade of disease ended after 1995. They also found suggestive, but not statistically significant, evidence that the trend of declining disease reversed after 2000. This study provides some of the first data to support concerns that past declines in heart disease mortality may not continue, study authors said. Further research is needed to determine the extent to which this reversal is due to the epidemics of obesity and diabetes, the authors concluded.
The findings underscore the importance of making a continued effort to encourage younger patients to quit smoking, eat healthy and exercise, said an accompanying editorial. The editorialist noted that the study was limited by its narrow sampling of a single county, but suggested that the results are alarming enough to alert public health officials to better monitor younger cohorts for early signs of coronary artery disease. The study was published in the Feb. 11 Archives of Internal Medicine.
Fentanyl pain-relief patches recalled.
Pain-relief patches containing fentanyl (brand name: Duragesic) were recalled last week due to a packaging defect that may bring patients or caregivers in direct contact with the potent opioid gel.
The recall includes 25-microgram-per-hour fentanyl patches that expire on or before December 2009. The patches may have a cut along one side of the internal reservoirs that house the drug gel, which could cause the gel to leak and expose patients or caregivers to it, potentially causing respiratory depression or overdose.
Anyone exposed to the gel should wash his or her hands with water and no soap, and any patches affected by the recall should be flushed down the toilet, advised PriCara, the unit of Ortho-McNeil-Janssen Pharmaceuticals, Inc. that makes the product. PriCara estimates that two patches out of every million included in the recall have the flaw that causes the leak, the Feb. 13 Washington Post reported.
Information on Duragesic patches sold by PriCara is available at 800-547-6446; for generic fentanyl patches sold by Sandoz, Inc, the number is 800-901-7236.
The PriCara release is online.
The Washington Post is online.
Annals of Internal Medicine
Audio Summary: Preventing contrast-induced nephropathy.
In this week's Annals audio summary, Aine Kelly, MD, discusses her meta-analysis of drugs used to prevent contrast-induced nephropathy, and Faith Fitzgerald, MACP, reads her essay, entitled "I Can't Be Bothered." The podcast, which also includes a summary of the articles in the current issue, is available at www.annals.org or on iTunes.
Muscle and bladder training ameliorate urinary incontinence.
A new systematic review of published studies on nonsurgical management of urinary incontinence (UI) in women found that pelvic floor muscle training plus bladder training resolved urinary incontinence. Pelvic floor muscle training alone resolved or improved urinary incontinence compared with regular or ordinary care, although the effect was inconsistent across studies. The anticholinergic drugs oxybutynin and tolterodine resolved UI compared with placebo. Other management techniques, from drugs to mechanical devices, showed little positive to actual negative effects.
The review was published online last week and will appear in the March 18, 2008, print edition of the journal.
Glucosamine no better than placebo in reducing hip pain.
The Feb. 19 print issue includes a trial of glucosamine for hip pain as well as a study of universal health insurance in Taiwan.
A new two-year, randomized, placebo-controlled trial found that glucosamine sulfate was no better than placebo in controlling hip pain, the ability to do normal activities and the progression of hip osteoarthritis. Editorial writers caution that the 222 adults in the study had early arthritis, which might differ from more advanced and severe arthritis.
A study of Taiwan’s 10-year experience with universal health insurance found that life expectancy increased most among the least healthy. Utilization and health care expenditures increased, although percentage of GDP spent on health care remained at 5% to 6%. Editorial writers note that the life expectancy figures are mitigated by that fact that in Taiwan about 57% of the population had health insurance before the universal plan took effect in 1995. They offer suggestions about what the Taiwanese experience can teach the U.S.
Annals of Internal Medicine is online.
Cartoon caption contest
Put words in our mouth.
ACP InternistWeekly's cartoon caption contest continues. ACP staff has selected three finalists for the latest contest and is now asking readers to vote for their favorite caption to determine the winner.
Go online to view the cartoon and then pick the winner, who receives a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history. The winning caption will appear in the next issue.
From the College
Regents approve paper on medical marijuana, update ethical complaints procedures.
At its January meeting, the Board of Regents approved a policy monograph, “Supporting Research into the Therapeutic Role of Marijuana.” The College supports rigorous scientific evaluation, and publication, of potential therapeutic benefits of medical marijuana; increased research to determine optimal dosage and delivery route for conditions where marijuana efficacy has been established; review of marijuana as a schedule I controlled substance, and reclassification; and exemption from criminal or other penalties for doctors and patients who use medical marijuana as allowed by state laws.
The board also approved updated procedures for addressing ethical complaints against College Members. Approved changes to procedures, last updated in 2005, include new provisions regarding disclosure and confidentiality and language specifying that the procedures apply to all physician members of the College, including affiliates and students.
The changes also call for a new public page on the ACP Web site to list members with adverse actions in cases where there is a suspension of membership or expulsion. All recommendations for sanctions are reviewed by the ACP Ethics, Professionalism and Human Rights Committee.
Cases that were already under review before the adoption of the revised procedures will be governed by the 2005 rules. New cases will be reviewed under the revised procedures.
Full details on the procedures are available on the Center for Ethics and Professionalism's Web page.
New leadership program offers online mentoring and CME instruction.
LEAD (Leadership Enhancement and Development Program), a highly accessible and multifaceted program for members looking to develop their leadership skills was launched last week on ACP's Web site. LEAD offers an online discussion group for members to discuss a variety of challenges with experienced ACP leaders. The first “leadership challenge”—a scenario or problem requiring solid leadership skills to solve—is now online.
Entitled “A Physician on Your Faculty Is Rude and Disrespectful,” the challenge focuses on how to effectively deal with difficult faculty members. Senior online mentors are Ernest Yoder, FACP, and Norman J. Wilder, MACP. Bios of all mentors, requirements for a leadership Certificate of Completion, related IM courses and other resources are online. Ongoing challenges will be announced every two weeks in ACP InternistWeekly. Members are encouraged to join the discussion to share questions, solutions, and their own challenges.
The CME portion of the LEAD program officially debuts at Internal Medicine 2008 with the pre-course “Essential Competencies for the Emerging Leader” on May 14. The pre-course will be led by course director Erik Wallace, FACP, and will concentrate on developing the communication, team-building, and negotiation skills needed to build the core competencies of leadership. Faculty for the pre-course are Clarence H. Braddock III, MD, F. Daniel Duffy, MACP, Donna E. Sweet, MACP, and Steven E. Weinberger, FACP. Small group discussions facilitated by College leaders will be an integral part of the day. In addition to the pre-course, other courses offered at IM 2008 will count toward the LEAD Certificate of Completion. The list of courses is online.
Registration for the LEAD pre-course is offered with other IM 2008 courses online. Registration is also available by calling 800-532-1546 ext. 2600, or by mailing in the Early Bird or Advance Program registration form (icon in the lower right for member pricing). Related IM courses are included in the standard registration fee and do not require pre-registration. More information about LEAD will be available at a mentoring breakfast held Friday, May 16 at IM 2008 by the Council of Young Physicians, as well as the Women’s Networking Luncheon held that afternoon.
Interested members can get involved at the Chapter level as well. Contact your Governor or attend your chapter’s next meeting for more information.
Employer group endorses principles for health care reform.
The National Business Group on Health (NBGH) recently announced principles for health care reform that promote primary care as the foundation of a high-quality health care system, and call for policies that recognize the value of primary care.
Key principles highlighted by the NBGH include:
- Primary care as foundational to a high-quality, efficient and effective health care delivery system.
- Payment policies that recognize the value of primary care and primary care–like services.
- Support the concept of the “advanced medical home” as appropriate.
- Growth in health information technology to support and enable efficiency, quality and safety in practices of all sizes.
- Educational and loan programs that encourage physicians and other health professionals to work in primary care.
"With health costs continuing to rise, a weak economy and the number of uninsured Americans growing at an alarming pace, the need to reform our health care system is at an all-time high," said Helen Darling, president of the NBGH.
The principles endorsed by the NBGH closely follow what ACP has been advocating regarding primary care. In particular, they support the concept of the patient-centered medical home (PCMH). The PCMH is a model of care that allows patients to partner with their primary care physician to receive continuous and comprehensive care.
ACP and the NBGH are both members of the Patient Centered Primary Care Collaborative (PCPCC), a coalition of major employers, consumer groups, organizations representing primary care physicians, and other stakeholders who have joined to advance the patient-centered medical home. Other major employer members include General Motors, IBM, and Xerox.
NBGH’s complete principles for reform can be found online.
About ACP InternistWeekly
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Copyright 2008 by the American College of Physicians.
A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?
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