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

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In the News
for the Week of 4-15-08

Highlights

  • AHA offers recommendations for resistant hypertension
  • Estrogen therapy increases risk of benign breast disease
  • ARBs as effective as ACE inhibitors in preventing heart events in high-risk patients

Oncology

  • Cancer drug trials halted early for benefit and approval

Infectious disease

  • Study of ’06 mumps outbreak prompts questions about vaccine, policy

Annals of Internal Medicine

  • Testosterone spray works for premenopausal women but so does placebo
  • Risks and benefits of prescription drugs from foreign countries
  • Comprehensive strategy needed to control gonorrhea epidemic
  • Annals audio summary: Testosterone and women's sexual satisfaction

Patient communication

  • Video training program for treatment of alcohol problems
  • Screening for postpartum depression advised in first year after giving birth

Regulatory actions

  • Estimate of heparin-linked deaths rises to 62
  • Rotigotine skin patch for Parkinson’s recalled
  • Exubera prescribing info to reflect lung cancer reports
  • New test detects MRSA within 24 hours
  • Federal judge delays CMS demonstration project

Cartoon caption contest

From the College

  • Web CME courses address geriatrics
  • ACP offers Maintenance of Certification program
  • ACP launches online version of the popular ACP Doctor's Dilemma™ competition
  • ACP Closing the Gap diabetes program plans online launch in the fall
  • Submit your 2008 ACP Job Placement Center physician profile
  • Election Web tool offers analysis of candidates' health care platforms

Highlights

AHA offers recommendations for resistant hypertension
.

An American Heart Association committee has issued new recommendations on how to diagnose, evaluate and treat resistant hypertension. The recommendations were published early online by the journal Hypertension.

The report includes a helpful flow chart outlining specific diagnostic and treatment recommendations, including the following:

  • Confirm treatment resistance: for example, the patient's office blood pressure is at goal but they require four or more hypertensive medications.
  • Exclude the "white coat effect"
  • Identify contributing lifestyle factors such as obesity and physical inactivity.
  • Discontinue or minimize interfering substances, such as NSAIDs, stimulants and oral contraceptives.
  • Screen for secondary causes of hypertension, such as obstructive sleep apnea, primary aldosteronism, chronic kidney disease, renal artery stenosis, pheochromocytoma, Cushing's syndrome, and aortic coarctation.
  • Pharmacologic treatment: maximize diuretic therapy, combine agents with different mechanisms of action, use of loop diuretics in patients with chronic kidney disease and/or patients receiving potent vasodilators
  • Refer to specialist if, for example, blood pressure remains uncontrolled after six months of treatment.

The full text of the recommendations is online.

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Estrogen therapy increases risk of benign breast disease
.

Women who take conjugated equine estrogen have an increased risk of developing benign proliferative breast disease, according to a new analysis of data from the Women’s Health Initiative (WHI).

Of the 10,739 postmenopausal women with hysterectomies who were included in the WHI, the authors of this study found 232 incident cases of benign proliferative breast disease. Of those cases, 155 occurred in women who had been randomly assigned to receive 0.625 mg per day of conjugated equine estrogen (CEE). Only 77 cases were found among women in the placebo group.

Researchers calculated that use of CEE was associated with a more than two-fold increase in risk of the disease. The risk for benign proliferative breast disease without atypia was 234% higher in the intervention group, while the risk for atypical hyperplasia was 12% higher.

These findings are reason for concern, study authors said, because researchers believe that benign proliferative breast disease without atypia, proliferative disease with atypia and in situ cancer are successive steps preceding development of invasive breast cancer. Therefore, the women with benign proliferative disease would be at increased risk for breast cancer.

Data from the WHI has yet to show any significant association between CEE and breast cancer, although researchers speculated that the increased risk may appear later in the ongoing followup of study participants. The study was published online on April 8 in the Journal of the National Cancer Institute.

The study and a press release are online.

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ARBs as effective as ACE inhibitors in preventing heart events in high-risk patients
.

The angiotensin-receptor blocker (ARBs) telmisartan was as effective as the angiotensin-converting-enzyme (ACE) inhibitor ramipril at reducing cardiovascular events in a recent trial involving patients with vascular disease or high-risk diabetes without heart failure.

In the trial, researchers randomly assigned patients to receive daily either 10 mg of ramipril (8,576 patients), 80 mg of telmisartan (8,542 patients), or combination therapy (8,502 patients). After follow-up of almost five years, there was no significant difference in the primary composite outcomes (cardiovascular death, myocardial infarction, stroke, or hospitalization due to heart failure) in the ramipril and the telmisartan groups. Telmisartan preserved 94% (95% confidence interval [CI], 83 to 105) of the benefit of ramipril and was less likely to cause angioedema.

The combination therapy group had more adverse events that the other two groups, (including hypotension and renal dysfunction) without an increase in benefit. The authors concluded that there is no advantage, and some potential harm, in using combination therapy in full doses compared with ramipril alone in this population. The study, which was funded, in part, by telmisartan manufacturer Boehinger Ingelheim, appears in the April 10 New England Journal of Medicine.

An accompanying editorial noted that this study and earlier studies indicate that telmisartan and valsartan provide similar benefit in patients with vascular disease or high-risk diabetes, but without heart failure. Since ARBs are more expensive than ACE inhibitors and are associated with more side effects, the editorial continued, they should be considered primarily as an alternative for patients who cannot tolerate ACE inhibitors due to cough.

The NEJM abstract and editorial are online.

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Oncology

Cancer drug trials halted early for benefit and approval
.

More trials of cancer drugs are being halted early due to benefit, and those truncated results are often being used to support regulatory approvals of the medications, a new study found.

Researchers looked at 93 papers which were halted after an interim analysis and found that 28 were stopped for benefit, 28 for futility and 4 for harm. Of the 25 randomized, controlled trials which were stopped for benefit and included in this analysis, 56% were published between 2005 and 2007, while the rest came out in the first eight years of the study (1997-2004). The results of 79% of the more-recent trials were then used to support an application for marketing approval to either U.S. or European regulatory agencies.

The researchers did find that about 3,300 fewer patients were involved in trials because of the early halts, which may have spared some negative events. However, they expressed concern that stopping trials early for apparent benefit will systematically overstate treatment effects.

The study authors were also particularly concerned that the trend toward more halted trials and the use of data for regulatory approval indicated that commercial, rather than ethical, concerns may be driving research decisions. They noted that although the majority of trials had a data and safety monitoring committee, that group was not always reported to be independent from the study.

The early halting of the studies did not necessarily mean that patients would receive the beneficial treatments soon after the research was completed, the authors noted. They found about two years delay on average between study termination and published reports. They concluded that only untruncated trials can provide a full level of evidence which can be translated into clinical practice without further research.

The study is online.

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Infectious disease

Study of ’06 mumps outbreak prompts questions about vaccine, policy
.

A new mumps vaccine, or another booster shot, may be needed in light of a 2006 U.S. mumps outbreak among people who had largely received the recommended vaccine coverage, a new study suggests.

In 2006, 6,584 mumps cases were reported-the largest outbreak in 20 years-and sent 85 people to the hospital. Cases were most common in eight contiguous Midwestern states and among people age 18 to 24 years old, most of whom attended college. The states were Illinois, Iowa, Kansas, Minnesota, Missouri, Nebraska, South Dakota and Wisconsin, according to the April 10 New England Journal of Medicine article.

Current recommendations are to get a mumps shot at age 12-15 months and another at age four to six years. Among those who knew their vaccination status, 84% of the 18-24 year-old patients said they had received the recommended two doses of mumps vaccination. In the general patient group, 63% said they had received two doses. Records show that in the 12 years before the outbreak, 89% of preschoolers had gotten one dose of mumps vaccination, while in 2006 the national two-dose coverage rate was 87%.

The virus in the 2006 outbreak was a fairly new strain in the U.S. and differs from the one targeted by the vaccine, but it has generally worked in other places, like the U.K. Possible factors that may have contributed to the outbreak include declining immunity, high population density in colleges, and incomplete vaccine immunity to wild virus. Future studies should help evaluate national vaccine policy, including whether a second dose of MMR vaccine at a later age, or the administration of a third dose, might provide better immunity, the study’s authors said.

The New England Journal of Medicine is online.

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Annals of Internal Medicine

Testosterone spray works for premenopausal women but so does placebo
.

A study that randomized 261 women aged 35 to 46 with self-reported low libido and low serum free testosterone levels to a group that received one of three different doses of a testosterone spray or placebo daily for 16 weeks found that all groups—including those taking placebo—reported increased frequency of sexually satisfying events. The difference between testosterone spray and placebo was statistically significant only for the middle dose of testosterone.

Overall, 81% to 86% of women in the active treatment groups and 70% of the women in the placebo group reported adverse events. The most common event in the treatment group was hair growth on the abdomen, where the testosterone was sprayed.

An editorial writer said that just because testosterone levels and women’s libidos may decline as women age does not mean that lack of testosterone explains sexual dissatisfaction. “We do not have a fully satisfactory rationale for testosterone therapy,” the writer says, and there is also a “lack of long-term safety data.” Rather than prescribe testosterone, the writer advises primary physicians to address women’s mental health and relationship issues, sexual dysfunction in the partner and treat problems by conventional therapy, such as cognitive behavioral therapy, sex therapy, and psychotherapy.

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Risks and benefits of prescription drugs from foreign countries
.

Buying imported prescription drugs is legal in some cases, but even when the drug is cheaper than a U.S. brand-name drug, it may not be a wise purchase, say authors of a paper on the international pharmaceutical market as a source of low-cost prescription drugs for U.S. patients.

They posit four guidelines for patients, physicians and policymakers for importation of prescription drugs. “However, the safest way to control U.S. drug prices is by promoting consumer demand for and appropriate prescription of domestic generic drugs,” they say.

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Comprehensive strategy needed to control gonorrhea epidemic
.

Incidence of Neisseria gonorrhoeae in the U.S. declined markedly from 1975 to 1997 and has remained relatively stable over the past decade at about 120.9 cases per 100,000 population. However, rates of gonorrhea remain high in the South and among African Americans, adolescents, young adults, and men who have sex with men, and infection rates are rising. Further, the disease has serous implications for reproductive health and health costs; and treatment options have narrowed as gonorrhea has become resistant to many drugs. Currently, gonorrhea treatment options come from a single class of antimicrobials-cephalosporins.

Authors say that in addition to developing and providing effective antimicrobial drugs, a comprehensive program to control gonorrhea must include screening people at risk for infection, surveillance for resistance, secondary screening and treatment of sex partners, and stimulating investment into research for new antimicrobials.

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Annals audio summary: Testosterone and women's sexual satisfaction
.

In this week's Annals audio summary, Rosemary Basson, MD, of the University of British Columbia in Vancouver, discusses the use of drugs and behavioral treatments to improve women's sexual satisfaction. The podcast, which also includes a summary of all the articles in the current issue, is available at www.annals.org or on iTunes.

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Patient communication

Video training program for treatment of alcohol problems
.

Physicians can learn effective strategies to screen patients for alcohol abuse and help those with problems through a free new video training program, the National Institute on Alcohol Abuse and Alcoholism (NIAAA) announced last week.

The videos are based on the NIAAA Clinician’s Guide and include four 10-minute case scenarios led by an expert clinician. The scenarios include patients with different levels of alcohol involvement at varying stages of readiness to change, and represent evidence-based techniques for assessing and managing at-risk drinking and alcohol use disorders, NIAAA experts said.

The online program also includes a brief tutorial which teaches clinicians how to:

  • Ask patients about alcohol use,
  • Assess heavy drinkers for alcohol use disorders,
  • Help at-risk drinkers cut back to safer drinking levels, and
  • Help patients with alcohol use disorders to quit, including treatment with medications when indicated.

The tutorial and case studies require about an hour to complete, and continuing education credit is available for physicians and nurses who complete the program through Medscape.com.

“Video Case Studies: Helping Patients Who Drink Too Much” is online.

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Screening for postpartum depression advised in first year after giving birth
.

Providers should screen women for postpartum depression (PDS) through the first year after delivery of a child, particularly those at heightened risk, the CDC said in new report.

Almost 52,000 women in 17 states who had delivered a baby in the previous 2-6 months were asked about their mood during 2004-2005.The prevalence of self-reported PDS symptoms ranged from 11.7% (in Maine) to 20.4% (in New Mexico). Women who were physically abused before or during pregnancy had PDS rates ranging from 31% to 53%, depending on the state. Also more likely to report PDS were younger women, less-educated women, and women who received Medicaid benefits for their delivery.

In 13 of 16 states, non-Hispanic white women had a lower prevalence of PDS compared with women of other racial/ethnic groups. Risk factors for PDS in most states were: use of tobacco during the last 3 months of pregnancy; partner-related stress during pregnancy; and traumatic and/or financial stress during pregnancy.

Research has shown that women who report depressive symptoms are less likely to engage in practices to promote child development, such as playing with their infant, and may also be more likely to discontinue breastfeeding, the report noted. Women should be screened for PDS either at their postpartum visit or at well-child visits, the report recommended.

The Morbidity and Mortality Weekly Report is online. The Edinburgh Postnatal Depression Scale is available online.

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Regulatory actions

Estimate of heparin-linked deaths rises to 62
.

The FDA upped its estimate of the number of deaths that included allergic reaction or hypotension after taking contaminated heparin to 62 from 19.

Most of the deaths occurred between last December and February, and none have been reported since late February, when Baxter International recalled the heparin it made with ingredients from a Chinese supplier. It is believed that a heparin mimic got mixed with the drug in China before it was imported to the U.S.

A total of 103 deaths in patients receiving heparin were reported to the FDA between January 2007 and March 2008, 62 of which involved allergic/hypotensive reactions. In 2006, three of the 55 deaths in patients taking heparin involved such reactions.

The contaminated heparin has been taken off the market, but reports of death are still being investigated. “The fact that allergic symptoms or hypotension was reported does not mean that these were the cause of death in all cases,” the FDA said on its Web site.

The FDA report is online

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Rotigotine skin patch for Parkinson’s recalled
.

Schwarz Pharma is recalling its early-stage Parkinson’s transdermal patch with rotigotine (Neupro) because crystals form on the patch and make the medicine less effective.

Physicians should avoid starting new patients on the patch, and begin to gradually down-titrate current patients per the product label. The company strongly advises against abrupt withdrawal of the drug, which will not be available in the U.S. after April. Information is available at 1-800-477-7877.

The company letter to healthcare providers is online.

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Exubera prescribing info to reflect lung cancer reports
.

Pfizer updated its prescribing information for Exubera (insulin human rDNA origin) to reflect new reports of lung cancer in patients who used the inhaled insulin product.

Six of 4,740 Exubera patients in clinical trials were diagnosed with lung cancer, compared to one of 4,292 patients treated with a comparator drug. There has also been one post-marketing report of lung cancer in an Exubera patient. All patients had a prior history of cigarette smoking, and there are too few cases to determine if the cancer is related to Exubera, the FDA said in an alert.

In October, Pfizer said it would stop marketing Exubera due to slow sales. Providers should seek other means of maintaining patients’ glycemic control, the FDA said.

The FDA safety alert is online. Pfizer’s press release is online.

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New test detects MRSA within 24 hours
.

The FDA approved a new test that detects nasal colonization of methicillin-resistant Staphylococcus aureus (MRSA) within 24 hours.

The Spectra MRSA test has a positive predictive value of 98.1%, and shows MRSA as dark blue colonies against a white background, the manufacturer said.

Thermo Fisher Scientific’s press release and test information are online.

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Federal judge delays CMS demonstration project
.

A federal judge in San Diego ordered a preliminary injunction against the Medicare Demonstration Project for Competitive Bidding of Clinical Laboratory Services last week. The demonstration project from CMS is designed to evaluate whether competitive bidding will lower the rates for independent lab services.

San Diego was set to be the first site for this project. The suit was filed by a clinical laboratory and two health care systems in the San Diego area earlier this year. Internist Laboratory of Oceanside, Calif., Sharp HealthCare and Scripps Health argued that only labs who submitted winning bids would be reimbursed for Medicare Part B services and not being selected would mean they would have to close their lab entirely.

CMS was expected to announce the winning bids on April 11, but the ruling means that they are prohibited from doing so, subject to an appeal from the Department of Health and Human Services.

CMS is required to perform the demonstration project by the Medicare Modernization Act of 2003. Under current Medicare policy labs are paid using the Part B lab fee schedule. This fee schedule is set prior to the start of the year and labs are paid according to the rate in their geographic area for each service that cannot exceed a national limit.

Further information about the Medicare Demonstration Project for Competitive Bidding of Clinical Laboratory Services can be found on the CMS Web site. The ruling from Judge Thomas J. Whelan is also available online.

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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.

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From the College

Web CME courses address geriatrics
.

The Society of General Internal Medicine, with funding from the Merck Institute on Aging and Health, has launched three highly interactive Web modules for CME on geriatric medicine topics for practicing physicians.

These modules take about one hour to do online, for one CME credit per module: Falls, Memory Assessment and Urinary Incontinence. The modules are entertaining and include sections on clinical decision making, strategies for practice improvement, assessment tools, patient and family education materials, billing tips, and useful Web links.

The project goals are to assist physicians in implementing practice changes that enhance the management of common geriatric conditions, as well as determine if Web-based CME is attractive and effective.

All of the materials can be downloaded, copyright-free, for immediate use in one's practice. Go online to access the modules at any time. For questions or problems, contact Anya Solotskaya at solotsayaa@sgim.org.

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ACP offers Maintenance of Certification program
.

Registration is now open for the College's new Maintenance of Certification (MOC) courses to be held in Boston from June 27-30.

The program includes a two-day recertification exam prep course (14.75 CME credits), two half-day Self-Evaluation Process module learning sessions each covering one 25-question module (10 self-evaluation points per module), and a one-day course to help you design and implement a practice improvement module (PIM) for maintenance of certification (7 CME credits).

Take advantage of one or more of these courses to assist in your efforts to maintain your certification. The MOC exam prep emphasizes key advances in internal medicine over the past decade. The PIM course, now required by the American Board of Internal Medicine, focuses on applying quality measurement to patient care. And this year marks the first time that ACP is offering half-day SEP module courses, which will include an audience response system to encourage discussion and participation.

Go online to register or to get more details about the courses and cost information.

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ACP launches online version of popular ACP Doctor's Dilemma™ competition
.

Test your knowledge in a variety of disciplines with a new online game based on the popular ACP Doctor's Dilemma™ competition from the College's annual Internal Medicine meetings. The game is free and simple to play. All you'll need is a Web browser.

Because this product was designed using standards for mobile Web content, all devices equipped with a Web browser are supported, including mobile smartphones and PDAs like Windows Mobile devices and Palm OS devices. An active internet connection is required to play, but there is nothing to download or install.

Learn more online.

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ACP Closing the Gap diabetes program plans online launch in fall
.

ACP’s Closing the Gap Quality Improvement Program: Diabetes Care offers physicians and their staffs strategies to create systems change in their practices so they can improve the care they provide to patients with diabetes. ACP is currently recruiting practices interested in participating in the new online program which will launch in September 2008.

The new online version will offer the same rigorous coursework, educational tools, and interaction with faculty as the live training sessions of the traditional program, but will allow physicians to participate at their own pace without having to leave their practice. Previous participants of Closing the Gap programs report statistically significant improvements in the care they delivered after completing the course. For example, one practice reported a decrease in number of days between office visits from 115 to 58.

Participants will have access to online modules covering the Standard of Care for Diabetes, Systems Change and the Chronic Care Model and faculty-led conferences calls will provide coaching on quality improvement plan development as well as diabetes-specific discussions. Traditional CME can be earned, as well as practice-based CME for their quality improvement efforts. In addition, Closing the Gap has been accepted by the American board of Internal Medicine for Part 4 Maintenance of Certification, and participants are also eligible for National Commission for Quality Assurance recognition.

Information about the fundamentals of the program and registration is available online.

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Submit your 2008 ACP Job Placement Center physician profile
.

Get your career on the right track by submitting your profile for the 2008 ACP Job Placement Center.

The ACP Job Placement Center is a service available at Internal Medicine 2008 that provides tools to assist you in your job search and the opportunity to meet with potential employers.

By submitting a physician profile, you increase the odds of finding your dream position. Before the meeting, your profile will be sent to hospital and physician group recruiters only. After reviewing the profiles, a recruiter may contact you to set up an interview in one of the private interview booths in the center. Only hospital and physician recruiters may use the ACP Job Placement Center for interviews.

Don’t miss out on getting your profile seen by numerous recruiters attending Internal Medicine 2008. Submit your profile today.

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Election Web tool offers analysis of candidates' health care platforms
.

As the next presidential primary draws near ACP is offering updated information to help internists sort through the presidential candidates’ health care platforms. In anticipation of the Pennsylvania primary to be held on April 22, ACP has revised its Election 2008 Web tool to include more details about the leading candidates’ proposals.

The non-partisan web tool analyzes the health care reform proposals of the presidential candidates, drawing on proposals ACP made at their State of the Nation’s Health Care briefing in January. Building on the Candidates’ Pledge to Make the U.S. Health Care System Second to None ACP has analyzed the candidates’ health care platforms based on their work toward enactment of reform legislation.

The tool is designed to help internists conduct a personal analysis of the candidates' platforms. It will be updated continually throughout the 2008 election cycle. Watch for updates as candidates release additional information.

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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.

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Copyright 2008 by the American College of Physicians.

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