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

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In the News for the Week of 6-13-06

Clinical news in the headlines

  • ACE inhibitors found unsafe in early pregnancy
  • Young black women at higher risk for deadliest type of breast cancer tumor
  • ACP Journal Club: WHI study finds low-fat diet does not reduce risk for cancer, heart disease

FDA update

Health care access

The business of medicine


Clinical news in the headlines

ACE inhibitors found unsafe in early pregnancy

Research published last week reported that women planning to become pregnant or who are in their first trimester of pregnancy should avoid taking ACE inhibitors for hypertension.

The study looked at the records of 29,507 infants born between 1985 and 2000. The 209 infants who were exposed to ACE inhibitors in the first trimester were found to have an increased risk (risk ratio 2.71) of major congenital malformations of the cardiovascular system and central nervous system compared with infants who had no exposure or who were exposed to other hypertensive medications. The study was published in the June 8 New England Journal of Medicine (NEJM).

The FDA is studying the data to determine whether it should require changes to the drug’s prescribing information. The findings point to the dearth of safety data for drugs taken during pregnancy, according to the June 8 New York Times.

An accompanying editorial noted that eight other hypertension drugs have not been associated with birth defects: chlorothiazide, chlorthalidone, hydrochlorothiazide, atenolol, acebutolol, pindolol, nifedipine and reserpine. However, these drugs can have side effects for women, the editorial said, and there is inadequate research on their safety.

The NEJM abstract is online.

The New York Times is online.

For more information, see "Medically managing your pregnant patient" in the November 2005 ACP Observer.

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Young black women at higher risk for deadliest type of breast cancer tumor

Scientists reported last week that premenopausal black women with breast cancer are more likely than older black women or whites to develop basal-like tumors, the hardest to treat and most lethal of the breast cancer subtypes.

In the study, researchers analyzed 496 cases of invasive breast cancer and found that the basal-like subtype was present in 39% of premenopausal African American women compared with 14% of postmenopausal African American women and 16% of non-black women of any age. The study appears in the June 7 Journal of the American Medical Association (JAMA).

The results could help explain why the death rate from breast cancer is higher among younger black women than other women, even though breast cancer is generally less common in blacks than in whites, said the June 7 New York Times. The authors noted that U.S. mortality from breast cancer in white women is 28.3 deaths per 100,000 compared with 36.4 per 100,000 among black women.

The findings could help boost the development of drugs that target basal-like tumors, which have no specific treatment, said the New York Times. Women with these tumors often benefit from chemotherapy but are still more likely to die than women with other types of tumors, the article said. Basal-like tumors do not respond to drugs used to treat estrogen-receptor positive tumors, such as tamoxifen or raloxifene, or to trastuzumab, used to treat HER2 overexpressed protein tumors.

Further research is needed to confirm the study’s findings and to determine the role of socioeconomic and environmental factors, said the authors. In addition, they said, because none of the African American patients in the study carried the BRCA2 mutation—typically associated with basal-like tumors—other mutations may predispose black women to these tumors.

The JAMA abstract is online.

The New York Times is online.

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ACP Journal Club: WHI study finds that low-fat diet does not reduce cancer, heart disease risk

Results from the Women’s Health Initiative found that postmenopausal women who followed a low-fat diet did not reduce their risk for breast cancer, colorectal cancer or cardiovascular disease.

About one-third of the 48,835 women age 50-79 included in the study followed a low-fat diet with the goal of reducing total fat to 20% of calories and increasing their intake of fruits, vegetables and whole grains. After eight years, women in the low-fat group had no greater reduction in breast cancer, colorectal cancer or heart disease than women in a control group that were not asked to make dietary changes. The study is abstracted in the July-August ACP Journal Club.

The results suggest that the dietary interventions in the study may have been too little, too late, said Journal Club reviewer Holly L. Thacker, FACP, of the Women’s Health Center in Cleveland. Most participants were already overweight or obese with an associated high risk for diabetes, heart disease and breast cancer, she noted, and the study did not result in significant weight loss.

In addition, unlike current recommendations, the study did not distinguish between trans or saturated fats and unsaturated fats, she said. Secondary analyses of the data revealed a non-significant trend suggesting a reduced risk for breast cancer among women on the low-fat diet. It would be interesting in the future to look at targeted and more intensive dietary changes, said Dr. Thacker, with the goal of lowering body mass index to a normal range.

This study makes it clear that reducing an older woman’s total fat intake without reducing her body weight has no impact on her risk for cancer and cardiovascular disease. Dr. Thacker indicated, however, that interventions targeting obesity may have more success in reducing these risks. In Dr. Thacker’s view, physicians should continue to stress the importance of achieving a normal body weight and a diet low in trans and saturated fats.

Peer ratings for this review: endocrinologists: 6/7 stars; general internists and subspecialists, family practitioners, oncologists: 5/7 stars.

ACP Journal Club is online.

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FDA update

FDA okays cervical cancer vaccine

The FDA last week gave final approval to the first vaccine that protects women against cervical cancer.

The vaccine, Merck & Co.’s Gardasil, is approved for use in females age 9-26, according to a June 8 FDA news release. The vaccine protects against human papillomavirus (HPV) types 16 and 18, which cause about 70% of cervical cancers, said the FDA, as well as types 6 and 11, which cause most genital wart cases. Cervical cancer is blamed for about 3,700 deaths in the U.S. each year.

The vaccine, which is expected to be available by the end of this month, is given in three shots over six months, said the June 8 Washington Post. Widespread use may be hindered by its cost—$360, said the article, as well as opposition to mandatory immunizations of younger females by some conservative groups.

The vaccine is most effective when given to girls before they become sexually active, said the Washington Post. It may not protect women who have already contracted an HPV infection and may increase the risk of lesions that lead to cervical cancer. In addition, noted the article, the vaccine does not eliminate the need for women to be screened with regular Pap smears to detect precancerous lesions.

It is not yet known how long the vaccine’s protection will last or if women will need booster shots, the Washington Post said. The national Advisory Committee on Immunization Practices—which advises the CDC and the HHS—will decide later this month whether to recommend routine vaccination, said the article. Individual states will then have to decide whether the vaccine should be a standard requirement for attending public schools.

The FDA news release is online.

The Washington Post is online.

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Health care access

Citizens' panel calls for universal coverage

A federally appointed citizens group recommended last week that all Americans have access to affordable health care by 2012.

The Citizens’ Health Care Working Group, a 14-member committee created as part of the Medicare prescription drug benefit legislation in 2003, also recommended that Americans have guaranteed protection against catastrophic health care costs, according to a June 1 working group news release.

The group made other interim recommendations, including:

  • All Americans should have a “core” benefits package that would include physical, mental and dental health benefits and be based on evidence-based science and expert consensus. An independent, public-private group would identify and update the specific benefits covered.
  • Integrated community health networks should be developed to ensure access to quality care for low-income and uninsured Americans, and those living in underserved areas.
  • More intensive efforts should be made to improve the quality and efficiency of care, such as support for health information technology and evidence-based practices.
  • New strategies for financing palliative care and hospice should be developed.

The interim recommendations are meant as a framework and do not include specific cost mechanisms or estimates, according to the June 7 Seattle Post-Intelligencer. The group visited 50 communities and heard from 23,000 people before issuing its report. ACP Governors and chapters were encouraged to participate in those meetings.

Advocates of free-market approaches to health insurance criticized the report, saying that it would require new funding sources and laws, the article said. The idea for the committee was spearheaded by Sens. Ron Wyden (D-Ore.) and Orrin Hatch (R-Utah).

The public can comment on the interim recommendations until Aug. 31. Final recommendations will be sent to the president and Congressional committees will hold hearings on those recommendations.

In 2002, the College released its "Achieving Affordable Health Care Coverage for All Within Seven Years" paper, which recommended several mechanisms to increase access, including expanded public programs and tax credits for business.

To see the full report or make comments on the interim recommendations, visit the group’s Web site.

The work group news release is online.

The Seattle Post-Intelligencer is online.

The ACP access position paper can be linked to online.

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The business of medicine

Aetna announces new 'Modifier 25' payment policy

Following an agreement with several state medical societies, Aetna Inc. last week announced that it is changing its payment policy regarding E/M codes appended with a Modifier 25. That modifier is used to designate an office visit billed under an E/M code that occurred on the same day as a procedure.

Under the agreement, Aetna will pay physicians separately for specific procedures billed with an E/M code appended with Modifier 25. According to its online notice, Aetna will reprocess previously denied claims dating back to July 1, 2004, and physicians do not need to resubmit claims for them to be reprocessed.

As a permanent solution, Aetna is updating its computer systems so that when a specific procedure code is billed with an E/M code appended with Modifier 25, both codes will be paid.

More information and a list of the specific procedures is online.

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Copyright 2006 by the American College of Physicians.

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