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

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In the News for the Week of 5-23-06

ACP news

Clinical news in the headlines

FDA update

There will be no 5-30-06 issue of Observer Weekly.


ACP news

Leadership Day 2006 brings ACP members to Capitol Hill

More than 260 ACP members from 42 states and the District of Columbia were in Washington last week to lobby on Capitol Hill for key issues related to internal medicine.

College members visited their senators and representatives to educate them about the dysfunctional payment system, access to care, professional liability reform and the looming collapse of primary care. Summaries of ACP's positions on key health issues are available online.

Attendees also heard remarks from Rep. Nancy Johnson (R-Conn), who observed that 20% of Medicare beneficiaries have five or more chronic illnesses and consume 80% of Medicare's resources. She referenced the advanced medical home and said it was important to get demonstration authority in place, which is consistent with ACP recommendations.

Sen. Ron Wyden (D-Ore.) talked to attendees about the importance of citizen initiatives in developing recommendations to make "health care work for all Americans." And Rep. Kenny Hulshof (D-Mo.) discussed the challenges facing Congress in fashioning a solution to the sustainable growth rate. Attendees were also briefed by staff from Congress, the College and the CMS.

During Leadership Day, ACP presented the "Key Contact of the Year" award to Murli Manohar, FACP, PhD, from Canton, Ohio. During the past year, Dr. Manohar vigorously supported the College's grassroots agenda by maintaining regular contacts with Congressional members and developing longstanding relationships with Sen. George Voinovich (R-Ohio) and Rep. Ralph Regula (D-Ohio) and their staff.

The College also presented the Top Ten Key Contact Special Recognition Awards as well as two Special Advocacy Awards. (More information about the awards and a list of winners are online.

And Mark R. Warner, who just completed his term as Governor of the Commonwealth of Virginia, was selected to receive the 2006 Joseph F. Boyle Award for Distinguished Public Service.

Gov. Warner helped enact long overdue changes in the way the state delivers mental health and veterans care services. He is the founding chair of the Virginia Health Care Foundation, which has provided health care to more than 476,000 underserved Virginians in rural and urban areas.

He also helped expand Medicaid eligibility for pregnant women to include women with incomes up to 150% of the federal poverty level. Because Gov. Warner was not able to attend, the award will be presented to him at a later date.

More information about ACP's Key Contact Program is available online.

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ACP's Annual Session gets name change
Annual Session is now "Internal Medicine 2007."

ACP has changed the name of its national annual meeting to increase the visibility of internal medicine, a key College goal. Registration discounts are now in effect through July 31, 2006.

Internal Medicine 2007, formerly Annual Session, is ACP's premier scientific meeting and will be held in San Diego from April 19-21, 2007. The new name will help link the College's annual scientific meeting to the field of internal medicine.

Members who register for Internal Medicine 2007 by July 31, 2006, will receive $120 savings on registration fees and become eligible to win free airfare to San Diego. Early registrants also get first choice of housing accommodations to ensure the widest hotel selection.

More information and registration are online.

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College urges changes to Medicare Part D

Earlier this month, ACP submitted written testimony to a Congressional subcommittee calling for changes in how the current Medicare Part D plan is implemented.

In a statement submitted to the House Ways and Means Committee, Subcommittee on Health, ACP commended the CMS for dealing with early problems in Part D implementation, including bolstering informational resources for beneficiaries and expanding the transition period to allow physicians to prescribe therapeutically equivalent drugs.

However, several changes still need to be made by Congress and the CMS. According to the testimony, those changes include:

  • Ensuring the use of a standardized exceptions/appeals request form by all participating drug plans.

  • Additional guidelines on the use of drug plan utilization management tools. Such guidelines need to be developed by a panel of stakeholders, including representatives of physician organizations, pharmacists and patient advocates.

The College also asked Congress and the CMS to extend the May 15 enrollment deadline if there were large numbers of beneficiaries who still had to enroll.

The complete testimony is online.

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Clinical news in the headlines

Rheumatoid arthritis drugs increase infection, cancer risks

A recent scientific review found that rheumatoid arthritis patients treated with two anti-tumor necrosis factor (TNF) drugs were more than three times as likely to develop malignancies and twice as likely to suffer serious infections.

The review analyzed nine trials involving almost 4,000 patients who took either infliximab or adalimumab for 12 weeks or more. Overall, the pooled odds ratio was 3.3 for malignancy and 2.0 for serious infection, with malignancies significantly more common in patients who took higher doses. The study appears in the May 17 Journal of the American Medical Association (JAMA).

The review adds to other reports of risks associated with infliximab (Centocor's Remicade) and adalimumab (Abbott Laboratories' Humira), said the May 17 Philadelphia Inquirer. However, in addition to the higher risk of lymphoma found in past studies, this latest study also found that the two drugs were associated with a higher risk of other cancers, including breast, lung, skin and gastrointestinal, and that the risk increased with higher doses.

The researchers stressed that the risk of getting cancer while taking either drug was still small, the article noted.

The researchers emphasized that TNF-inhibition therapy was a welcome development for many rheumatoid arthritis sufferers who did not respond to traditional treatment. The risks highlighted by the review, they said, must be balanced against the effectiveness of these agents, which have slowed joint destruction and improved mobility and quality of life for many rheumatoid arthritis patients.

In addition, they said, anti-TNF agents' ability to reduce disease activity often lessens the risk of cardiovascular events, which is the main cause of death for rheumatoid arthritis patients. Because the study found that risks of adverse events increased with higher dosages, the authors noted, physicians might consider prescribing smaller doses to improve the risk-benefit ratio.

The JAMA abstract is online.

The Philadelphia Inquirer is online.

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New guidelines issued for heart disease prevention

Updated guidelines for preventing coronary artery disease published last week by the American Heart Association (AHA) and the American College of Cardiology call for routine use of statins to lower LDL cholesterol and other medications to reduce blood pressure levels and prevent heart failure.

The 2006 guidelines, published in the May 15 Circulation, recommend goals for six major risk factors, according to a May 15 AHA news release. Those goals include:

  • Stopping smoking and eliminating exposure to tobacco smoke.

  • Reducing blood pressure to less than 140/90 or less than 130/80 for patients with diabetes or chronic kidney disease.

  • Reducing LDL cholesterol to between 70 mg/dL and 100 mg/dL.

  • Engaging in physical activity for 30-60 minutes at least five days per week.

  • Keeping body mass index below 25 and waist circumference less than 40 inches for men, 35 inches for women.

  • For diabetics, keeping HbA1c below 7%.

For patients with established coronary artery disease, the guidelines reaffirm recent recommendations by the National Cholesterol Education Program to aim for LDL-cholesterol below 70 mg/dL, especially in very high-risk patients. To achieve that level, the guidelines recommend routine use of statin therapy.

The guidelines, which were last updated in 2001, also recommend using clopidogrel in patients with acute coronary syndrome after post percutaneous coronary intervention, especially in people undergoing stent replacement. The recommended level of daily aspirin therapy for patients with established coronary or atherosclerotic vascular disease was reduced to between 75 mg and162 mg from the previous guidelines of between 75 mg and 325 mg.

Other medication recommendations include prescribing ACE inhibitors for patients with left ventricular ejection fractions of 40% or less, high blood pressure, diabetes or chronic kidney disease, and routinely administering influenza vaccine because of the increased risk of flu complications among those with chronic cardiovascular problems.

The Circulation article is online.

The AHA news release is online.

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Evidence does not support benefits of multivitamins

A federal panel last week said it found scant evidence that taking a daily multivitamin helps adults stay healthy or ward off disease.

The13-member National Academy of Sciences panel's review of the scientific literature yielded conflicting indications, said the May 18 Washington Post. For example, some studies suggested that a diet rich in fruit and vegetables helps prevent lung cancer but one trial found that beta carotene supplements actually increased the risk of lung cancer in nonsmokers. In addition, while some research found that male smokers can reduce their risk of prostate cancer by taking Vitamin E, the research was unclear on whether the supplements would benefit nonsmokers.

There were three areas where clinical trials pointed to some benefit from supplements, the panel reported: folic acid taken by pregnant women to prevent birth defects; supplements including vitamins C and E, beta carotene, zinc and copper to reduce macular degeneration; and calcium and Vitamin D supplements to reduce bone fractures in post-menopausal women.

The panel advised lawmakers to institute greater oversight of multivitamin manufacturers by requiring them to disclose adverse events and by overseeing production quality, the Washington Post said. The article reported that U.S. consumers spend about $23 billion on multivitamin and multi-mineral supplements annually and that more than half of adults in the country have reported taking multivitamins.

The Washington Post is online.

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Pulmonary artery catheter does not improve outcomes in intensive care

A review of trials involving critically ill patients found that a pulmonary artery catheter (PAC) did not reduce all-cause mortality or length of hospital stay for patients in the intensive care unit. (ICU)

The review included 13 randomized controlled trials conducted between 1985 and 2005 comparing PAC with no PAC for patients in the ICU. The two groups did not differ for all-cause mortality during hospitalization or for number of days in the hospital. The review is abstracted in the May-June ACP Journal Club.

The results of the review are sobering, said reviewer Herbert P. Wiedemann, FACP, of the Cleveland Clinic Foundation. Four of the largest trials included in the review, published within the last three years, concluded that PAC did not benefit patients for whom it is often considered, such as high-risk surgical patients and patients with shock and acute respiratory distress syndrome.

However, noted Dr. Wiedemann, PAC may benefit certain groups of high-risk patients. For example, two of the trials in the review showed a survival benefit in older patients with hip fracture and among patients undergoing peripheral vascular surgery.

It will be interesting to note the results of the Fluids and Catheter Treatment Trial, involving 1,000 patients with acute respiratory distress syndrome, which are due out later this year, he added. That trial compares the use of a PAC or central venous catheter and a liberal or conservative fluid treatment strategy.

Peer ratings for this review: hospitalists 5/7 stars, critical care 6/7 stars.

ACP Journal Club is online.

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FDA update

Cervical cancer vaccine gets panel nod for likely approval

An FDA advisory panel last week recommended approval of a new vaccine that protects against developing cervical cancer.

The drug, to be marketed as Gardasil (quadrivalent human papillomavirus recombinant vaccine) by Merck & Co. pending FDA approval, would be given in three shots over six months to protect against the two types of human papillomavirus (HPV) that cause about 70% of cervical cancers, according to the May 19 New York Times. The FDA's vaccine and related biological products advisory committee unanimously endorsed the vaccine, which is expected to receive final FDA approval by June 8.

While the vaccine has the potential to prevent significant deaths, its high cost ($300-$500) may prevent widespread use, the New York Times reported. The vaccine also protects against two other sexually transmitted viruses that cause most genital wart cases.

Merck officials told the panel that the vaccine is not intended to replace annual Pap smear screenings, said the New York Times. However, the company added that the vaccine could eliminate some of the abnormalities those tests often detect. The article noted that cervical cancer kills about 290,000 women worldwide annually, including 3,500 in the U.S.

In June, the national Advisory Committee on Immunization Practices--which advises HHS and the CDC--will decide whether to recommend routine vaccination, the article said. Merck is seeking approval for routine use in females from ages 9-26 because the vaccine is supposed to work best if given before women become sexually active.

The New York Times is online.

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Copyright 2006 by the American College of Physicians.

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