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

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In the News
for the Week of 9-9-08

Highlights

  • ICD shocks prolong life, predict mortality
  • Omega-3s may outperform rosuvastatin for chronic heart failure, study finds

Test yourself

  • MKSAP quiz: diagnostics

Cardiology

  • Vytorin fails to reduce heart events, may increase cancer risk, studies report

Mental health

  • Suicide rates high among teens, tied to gun access

From the Annals of Internal Medicine

  • Intermittent HIV treatment increases risk for related infections, death
  • Medical student burnout linked to suicidal thoughts
  • Study documents a decade of whistleblowers against Medicare fraud

Tools and resources

  • New tool highlights look-alike/sound-alike drug errors

Drug news

  • FDA: TNF blockers must get stronger warnings about infections
  • Class 1 recall of Mobile Oxygen Storage Tank
  • New cases of PML reported in patients taking natalizumab monotherapy

From ACP Internist

  • The latest issue is online and in your mailbox

From ACP Hospitalist

From the blog

From the College

  • College to cosponsor e-prescribing conference with CMS
  • ACP comments on proposed 2009 Medicare Physician Fee Schedule
  • Turn to ACP Web tools for election news
  • New resources for women in medicine

Cartoon caption contest

  • Put words in our mouth …

Highlights

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ICD shocks prolong life, predict mortality

Implantable cardioverter-defibrillators (ICDs) significantly prolong life in patients at increased risk for sudden death from depressed left ventricular function, and the shocks they deliver even help assess mortality, said two separate studies from the New England Journal of Medicine.

While increasing longevity, ICDs may be accompanied by deterioration in the quality of life, said the first study. In an industry-supported trial of 2,521 adult patients enrolled between September 1997 and July 2001 who had New York Heart Association chronic, stable class II-III congestive heart failure and a left ventricular ejection fraction of 35% or less, patients randomly received medical therapy plus amiodarone, placebo, or a conservatively programmed, single-chamber ICD. Patients completed a quality-of-life questionnaire at baseline and months 3, 12 and 30, using as primary outcome measures the Duke Activity Status Index to measure cardiac physical functioning and the Medical Outcomes Study 36-Item Short-Form Mental Health Inventory 5 to measure psychological well-being.

The study found no clinically or statistically significant differences in physical functioning among the study groups. Psychological well-being in the ICD group compared with medical therapy alone significantly improved at 3 months (P= 0.01) and at 12 months (P= 0.003) but not at 30 months.

In the second government- and industry-supported study, researchers implanted for primary prevention an ICD in 811 patients and graded as appropriate shocks that followed the onset of ventricular tachycardia or ventricular fibrillation. All other shocks were called inappropriate. After a median follow-up of 45.5 months, 269 patients (33.2%) received at least one ICD shock, with 128 patients receiving only appropriate shocks, 87 receiving only inappropriate shocks and 54 receiving both.

An appropriate shock was associated with a fivefold increase in the subsequent risk of death from all causes compared with no appropriate shock (hazard ratio [HR], 5.68; 95% confidence interval [CI], 3.97 to 8.12; P<0.001). An inappropriate shock was also associated with a nearly twofold increase in the risk of death compared with no inappropriate shock (HR, 1.98; 95% CI, 1.29 to 3.05; P=0.002).

The risk of death remained elevated (HR, 2.99; 95% CI, 2.04 to 4.37; P<0.001) for patients who survived more than 24 hours after an appropriate shock. The most common cause of death among patients who received any ICD shock was progressive heart failure.

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Omega-3s may outperform rosuvastatin for chronic heart failure, study finds

Parallel studies concluded Omega-3s are slightly better than rosuvastatin (Crestor) for chronic heart failure, based on each compound's efficacy compared to placebo.

In the first study researchers investigated whether Omega-3 polyunsaturated fatty acids could improve morbidity and mortality in patients with symptomatic heart failure of any cause. They conducted a randomized, double-blind, placebo-controlled, industry-supported trial in 326 cardiology and 31 internal medicine centers in Italy and reported their results in The Lancet.

Patients enrolled had chronic heart failure of New York Heart Association class II–IV (ejection fraction of 50% or less), irrespective of cause and left ventricular ejection fraction. Researchers randomly assigned them to Omega-3 pills of 1g daily (n=3,494) or placebo (n=3,481). They followed patients for a median of 3.9 years. Analysis was by intention to treat.

In the study, 955 (27%) patients died from any cause in the Omega-3 group and 1,014 (29%) in the placebo group (adjusted hazard ratio [HR], 0.91; 95.5% CI, 0.833 to 0.998; P=0.041). Another 1,981 patients (57%) in the Omega-3 group and 2,053 (59%) in the placebo group died or were admitted to hospital for cardiovascular reasons (HR 0.92; 99% CI, 0.849 to 0.999; P=0.009).

In the rosuvastatin study, which used the same entry criteria, methods and analysis as the Omega-3 trial, researchers randomly assigned patients to rosuvastatin 10 mg daily (n=2,285) or placebo (n=2,289).

Analysis showed 657 (29%) patients died from any cause in the rosuvastatin group and 644 (28%) in the placebo group (HR, 1.00; 95.5% CI, 0.898 to 1.122; P=0.943). In the study, 1,305 (57%) patients in the rosuvastatin group and 1,283 (56%) in the placebo group died or were admitted to hospital for cardiovascular reasons (HR, 1.01; 99% CI, 0.908 to 1.112; P=0.903).

Because patients in the Omega-3 group has a slight benefit compared to placebo and patients in the rosuvastatin group had no benefit compared to placebo, researchers concluded Omega-3s were slightly more effective.

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Test yourself

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MKSAP quiz: diagnostics

A 72-year-old woman is seen for a routine office evaluation to establish care. Past medical history includes only hypertension, hyperlipidemia, and a familial history of coronary artery disease. She does not smoke. She is active and walks daily and denies angina, dyspnea, fatigue and edema.

Physical examination reveals a blood pressure of 128/70 mm Hg. There are no carotid bruits. There is a normal S1 and a physiologically split S2. There is a grade 2/6 midsystolic murmur that does not radiate and is best heard at the second right intercostal space. The rest of the physical examination is unrevealing.

Which of the following diagnostic tests is most appropriate at this time?

A) No further testing at this time
B) Transthoracic echocardiography
C) Electron-beam CT
D) Treadmill stress echocardiogram
E) 24-hour ambulatory electrocardiographic monitoring

Click here or scroll to the bottom for the answer.

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Cardiology

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Vytorin fails to reduce heart events, may increase cancer risk, studies report

Lipid-lowering therapy of simvastatin plus ezetimibe (Vytorin) had no impact on preventing cardiovascular events in patients with aortic stenosis, but the combination therapy may increase the risk of cancer, a recent trial reported.

In the manufacturer-sponsored Simvastatin and Ezetimibe in Aortic Stenosis (SEAS) trial, 1,873 patients with mild-to-moderate, asymptomatic aortic stenosis were given either 40 mg of simvastatin plus 10 mg of ezetimibe or placebo daily. After more than four years, there was no significant difference between the two groups in the incidence of combined aortic valve and ischemic events, despite an average reduction in LDL cholesterol of at least 50% in the therapy group compared with placebo. However, cancer occurred more frequently in the therapy group (105 vs. 70, P=0.01). The findings were published Sept. 2 in the online edition of the New England Journal of Medicine.

In the same issue of the journal, another group of researchers performed a pooled analysis of SEAS and two ongoing studies (SHARP and IMPROVE-IT) that are testing the same lipid-lowering therapy. That analysis found an increased risk for cancer mortality but not cancer incidence.

An accompanying editorial noted that while the observed increased risk of cancer mortality may be due to chance, caution is appropriate. Besides affecting cholesterol, ezetimibe interferes with the gastrointestinal absorption of other molecular entities that could affect the growth of cancer cells, the editorial said.

The FDA has announced that it will investigate the potential cancer hazard of ezetimibe over the next few months. For now, physicians should be aware that uncertainty remains about the effects of the drug on patient outcomes, until the results of large trials become available, said a commentary in Journal Watch Cardiology.

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Mental health

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Suicide rates high among teens, tied to gun access

Two studies give insight into the current trends and possible causes of U.S. suicides, particularly among teens.

The suicide rate among Americans ages 10 to 19 decreased by 5.3% between 2004 and 2005, according to a research letter in the Sept. 3 Journal of the American Medical Association. The decline was an improvement on the 18% spike seen between 2003 and 2004, but still a concerning change from the steady decline seen between 1996 and 2003, researchers said. They calculated that there were 292 excess teen deaths in 2005 compared with projections based on past trends.

The new statistics show that the 2003-2004 rates were not a single-year anomaly and require further attention to determine whether a public health crisis is emerging, the study authors said. They identified several potential causes of the trend, including reduced use of antidepressants because of boxed warnings, Internet social networks, suicides among military personnel, and changes in prevalence of risk factors (such as alcohol use or access to firearms).

Access to firearms is a significant and underappreciated factor in suicide rates, according to a perspective in the Sept. 4 New England Journal of Medicine. The authors surveyed 200,000 people by phone to compare rates of household gun ownership with firearm and overall suicides. Controlling for several factors (including mental illness), they found an association between gun ownership and gun suicide. For example, men in the states with the highest rates of gun ownership were 3.7 times more likely to die from firearm suicide than those in the least-armed states. There was no association between gun ownership and nonfirearm suicides.

Because of the impulsive nature of suicide, a more effective prevention strategy may be to restrict access to lethal means instead of treating mental illness, the authors concluded. They suggested that physicians work with potentially suicidal patients and their families to limit their access to guns and recommended a Web site that can assist with those efforts.

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From the Annals of Internal Medicine

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Intermittent HIV treatment increases risk for related infections, death

Continuous treatment of HIV infection is better than stopping treatment when the patient’s immune status is good and restarting it when immune status deteriorates (interrupted treatment). At the end of this trial, patients assigned to intermittent treatment started continuous treatment and were observed for 18 months. When persons assigned to interrupted treatment resumed continuous treatment, their risk for HIV related infections and death declined but was still slightly higher than those who had been receiving continuous treatment from the beginning.

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Medical student burnout linked to suicidal thoughts

Death by suicide is a major occupational hazard for physicians. Male and female physicians have a 40% and 130% higher suicide rate, respectively, than the general population. A survey of 4,287 students at seven medical schools revealed that many U.S. medical students think about suicide, suggesting that physicians’ increased risk for suicide may begin in medical school.

Burnout is common among medical students, and is associated with a two- to three-fold increased risk of thinking about suicide. In the study, 26% of burned out students recovered within the following year, indicating that burnout is reversible.

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Study documents a decade of whistleblowers against Medicare fraud

In the 1990s, the U.S. Department of Justice (DOJ) increased efforts to combat health care fraud, focusing on false claims made to Medicare and Medicaid programs in particular. The volume of litigation and financial recoveries related to health care grew quickly, especially among qui tam actions, those initiated by whistleblowers who are private citizens with inside knowledge of the alleged fraud.

By 2005, 90% of new health care fraud enforcement actions were initiated by whistleblowers. From 1996 to 2005, the DOJ closed 379 health care fraud cases and recovered $9.3 billion from defendants. Of those cases, the most common targets were provider organizations and billing practices. Although pharmaceutical manufacturers accounted for only 13 of the 379 cases, they accounted for nearly 40% of the total recovery because of the very large awards. Researchers concluded that fraud and abuse may increase during periods of rapid market expansion, but closer government oversight may also be a factor in better detection of fraud and abuse.

These studies are online.

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Tools and resources

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New tool highlights look-alike/sound-alike drug errors

A new online tool enables physicians and consumers to look up drug names that have been identified with a medication error. The USP Drug Error Finder, from U.S. Pharmacopeia, is based on the nonprofit group's annual report on medication errors involving drug nomenclature.

The free Web tool includes more than 1,400 drugs that have been involved in look-alike and/or sound-alike errors. It lists the other drugs involved in the mix-up, as well as designating the severity of the reported error.

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Drug news

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FDA: TNF blockers must get stronger warnings about infections

The FDA ordered the manufacturers of four tumor necrosis factor-α blockers (TNF blockers) to strengthen existing warnings on their prescribing information about the risk of developing opportunistic infections, a news release said.

The drugs, adalimumab (Humira), certolizumab pegol (Cimzia), etanercept (Enbrel) and infliximab (Remicade), can treat conditions ranging from rheumatoid arthritis to plaque psoriasis to Crohn's disease. Their packaging already includes information about infection risk, but reports to the FDA indicate health providers aren't consistently recognizing cases of histoplasmosis and other invasive fungal infections, leading to delays in treatment and sometimes death.

The FDA has reviewed 240 reports of histoplasmosis in patients treated with etanercept, adalimumab and infliximab, mostly in the Ohio and Mississippi River Valleys. In at least 21 of the 240 cases, the infections weren't initially recognized and treatment was delayed, and 12 of the patients died. All together, 45 of the 240 patients with histoplasmosis have died, the Washington Post reported.

The FDA has also gotten reports of coccidioidomycosis and blastomycosis in patients treated with TNF blockers, some of whom have died. In addition, there has been one reported case of histoplasmosis in a patient taking certolizumab pegol.

For patients who take TNF blockers and develop fever, malaise, cough, shortness of breath, weight loss or sweats, providers should ascertain if the patient lives in, or has traveled to, areas of endemic mycoses. For patients at risk of histoplasmosis and other invasive fungal infections, providers should consider empiric antifungal treatment until the pathogen/s are identified, the FDA said in a safety alert.

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Class 1 recall of Mobile Oxygen Storage Tank

FDA has issued a Class I recall of Pacific Consolidated Industries' Mobile Oxygen Storage Tank, manufactured and distributed between January and March 2007, because the pressure gauge may rupture and catch fire.

The reaction would occur as a result of hydraulic fluid being present in the pressure gauge tubing, the FDA said last week. Facilities that currently have the Mobile Oxygen Storage Tank should keep it in quarantine until arrangements are made to ship it back to the manufacturer.

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New cases of PML reported in patients taking natalizumab monotherapy

Two new cases of progressive multifocal leukoencephalopathy (PML) have been reported in European patients taking natalizumab (Tysabri) monotherapy for multiple sclerosis (MS) for more than a year, the FDA said in a recent alert.

Previous cases were seen only in patients with MS who took natalizumab as part of combination therapy with immunomodulatory agents. The manufacturer plans to revise prescribing information to reflect the cases that occurred with monotherapy, the FDA said. Natalizumab is available in the U.S. only to patients with relapsing MS or Crohn's disease who are enrolled in a risk minimization plan under which every patient is closely monitored for infections.

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From ACP Internist

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The latest issue is online and in your mailbox

The latest issue of ACP Internist is online and in your mailbox. Check out this month's issue for stories on:

  • Post-traumatic stress disorder. While the military screens soldiers returning from combat, post-traumatic stress disorder can show up months or years after, when the person may have left the military health system and returned to private care.
  • E-prescribing. Congressional mandates pushing internists to use e-prescribing could backfire, say experts who have tried—and sometimes failed—to incorporate the technology into their offices.
  • Mindful Medicine. Don’t let emotion impede the right diagnosis. A case study shows how even subtle emotions can negatively influence thinking. Commentary by Jerome Groopman, FACP, and Pamela Hartzband, FACP.

The September issue of ACP Internist is online.

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From ACP Hospitalist

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The latest issue is online

The latest issue of ACP Hospitalist is online and in your mailbox. Check out this month's issue for stories on:

  • Post-traumatic stress disorder. While the military screens soldiers returning from combat, post-traumatic stress disorder can show up months or years after, when the person may have left the military health system and returned to private care.
  • Ethical Dilemmas. Discontinuing treatment: In hopeless cases, providers have a right to refuse to continue.
  • Career News. Which hospitalist model is right for you? Also, an attorney offers tips on contract negotiation.

The September issue of ACP Hospitalist online.

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From the blog

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DTC advertising may not increase sales

On the blog this week, there's new evidence about the effectiveness of DTC advertising, recent guidelines on an unlikely topic and a special two-part Medical News of the Obvious.

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From the College

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College to cosponsor e-prescribing conference with CMS

CMS will hold a free conference to educate health care providers and professionals about e-prescribing. The National E-Prescribing Conference, to be held in Boston Oct. 6 and 7, comes as CMS is about to roll-out a new e-prescribing initiative designed to encourage the adoption of e-prescribing technology with the use of incentive payments.

Starting Jan. 1, physicians who adopt e-prescribing will be eligible for a 2% bonus in their Medicare payments. This bonus is part of a five-year program under the Medicare Improvements for Patients and Providers Act of 2008 (MIPPA). Under the program physicians who use e-prescribing will receive the bonus payments in 2009 and 2010. In 2011 and 2012 the bonus payment for using e-prescribing will drop to 1%, and in 2013 it will drop to a 0.5% bonus. Those who do not begin using e-prescribing will begin facing payment penalties in 2012. That year providers who have not adopted e-prescribing will have a 1% Medicare payment cut, with a 1.5% cut in 2013 and a 2% cut in 2014.

The two-day conference is being sponsored by CMS along with industry partners, including ACP. The conference is designed to help health care professionals figure out how to incorporate e-prescribing into their businesses. Featured speakers include: Mike Leavitt, secretary of the Department of Health and Human Services; Kerry Weams, acting administrator for CMS; and David J. Brailer, MD, PhD, former National Coordinator for Health Information Technology. Topics covered will include:

  • What the Law Means—Implementing e-prescribing: The Basics;
  • Privacy, Security & Risk Management;
  • The Office Environment & Change Management;
  • A panel on Learning from Experience—from Prescribers;
  • The Business Case for Providers—the Economics of Adoption; and,
  • E-Prescribing and Medicare Part D—Focus on Standards and Certification.

Registration information for the conference is online.

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ACP comments on proposed 2009 Medicare Physician Fee Schedule

The College last week sent comments to CMS about the 2009 proposed Physician Fee Schedule which was released at the end of June.

The fee schedule, as originally released, had included a payment cut for physicians in 2009. However, due to legislation that was passed in mid-July, physicians will not be subject to the cut originally scheduled for next year. The “Medicare Improvements for Patients and Providers Act of 2008” will instead provide physicians will a 1.1% increase in payments for 2009.

The letter from the chair of ACP’s Medical Service Committee, Yul Ejnes, FACP, addresses several other issues with the proposed rule, including a proposal—which the College opposes—that would require physician offices that provide diagnostic services to register as independent diagnostic testing facilities and comply with the standards for stand-alone testing facilities.

ACP also noted that CMS proposed changes to the provider enrollment process based on an Internet-based enrollment system that has yet to be introduced. ACP recommended that CMS wait to make these changes until after the Internet-based system has been introduced and tested by physicians.

The final Physician Fee Schedule for the year is typically released in November. That Fee Schedule should include the 1.1% payment update. At that time, ACP will inform members of any other changes to the Medicare program you may need to know about for 2009.

The College’s complete comments can be found online[PDF].

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Turn to ACP's Web tools for election news

The presidential election campaigns are in full swing, and the candidates continue to release details about their proposed health care reforms. However, these proposals can often be difficult to sort through. ACP has developed several tools to help internists take a critical eye to these plans and find ways to get involved.

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New resources for women in medicine

In honor of "Women in Medicine" month this September, ACP has developed a Web page that includes information on women leaders of ACP, as well as a special podcast panel interview of women physicians at various career stages. The resources are online.

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Cartoon caption contest

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Put words in our mouth …

ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Craft your caption “Mad Libs” style by filling in the blanks to the caption we’ve started.

Cartoon caption contest

“It’s _______ [noun]. They’re ____ [adjective] about their _____ [noun].”

E-mail all entries to acpinternist@acponline.org by Sept. 19. ACP staff will choose three finalists and post them in the Sept. 23 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the Sept. 30 issue.

Pen the winning caption and win a $50 gift certificate good for any ACP product, program or service.

As a further distraction, more official Mad Libs are online.

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MKSAP Answer

A) No further testing at this time

The complete MKSAP critique on this topic is available to subscribers in Cardiovascular Medicine: Item 18.

ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:

  • Update your knowledge in all areas of internal medicine
  • Prepare for ABIM certification or recertification
  • Support your clinical decisions in practice
  • Assess your medical knowledge with 1,200 multiple-choice questions

To order the latest edition of MKSAP, go online to http://mksap.acponline.org.

Return to the rest of ACP InternistWeekly.

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About ACP InternistWeekly

ACP InternistWeekly is a weekly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.

To add your e-mail address to your member record and to begin receiving ACP InternistWeekly, please click here.

Copyright 2008 by the American College of Physicians.

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Test yourself

A 76-year-old woman is evaluated for a 3-month history of left knee pain of moderate intensity that worsens with ambulation. She reports minimal pain at rest and no nocturnal pain. There are no clicking or locking symptoms. She has tried naproxen and ibuprofen but developed dyspepsia; acetaminophen provides mild to moderate relief. The patient has hypertension, hypercholesterolemia, and chronic stable angina. Medications are lisinopril, metoprolol, simvastatin, low-dose aspirin, and nitroglycerin as needed. Following a physical exam, lab results and radiograph, what is the next best step in management?

Find the answer

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