In the News for the Week of 10-5-04
Clinical news in the headlines
- Arthritis blockbuster Vioxx pulled from market
- Highlights of Annals of Internal Medicine
- ACOG releases new hormone therapy report
- On-call specialists in short supply in nation's ERs
- Medicare proposes expanding coverage for defibrillators
- New NIH online resource helps physicians manage diabetes
- Online discussion group focuses on coding
- ACP urges USP to draft less restrictive drug lists
- Course to help internists diagnose problem drinking
Clinical news in the headlines
Merck and Co. announced last week that it was withdrawing its popular arthritis drug rofecoxib (Vioxx) from the worldwide market after a clinical trial found that patients taking the drug for more than 18 months doubled their risk of heart attack and stroke.
The drug, a COX-2 inhibitor, was the subject of a three-year, 2,600-patient trial to test its effectiveness against placebo in preventing colorectal polyps, according to a Sept. 30 Merck news release. Patients took 25 mg of the drug for more than 18 months.
Those taking rofecoxib had 15 heart attacks or strokes per 1,000 patients, compared to 7.5 events per 1,000 for patients on placebo. Merck halted the trial, and is now urging patients to discontinue using the drug and to discuss alternative therapy with their physician.
The news follows earlier studies that suggested an association between rofecoxib and heart attacks, prompting the FDA in 2000 to require a warning on the drug's label, the Sept. 30 Washington Post reported. Launched in 1999, rofecoxib was sold in 80 countries and had more than 23 million prescriptions written for it in the United States in 2003.
It is not yet known whether the results of the rofecoxib trial have implications for all COX-2 inhibitors, although the FDA announced that it will investigate the long-term effects of the whole class of drugs.
Patients and physicians can get more information from the Merck Web site or by calling (888)368-4699.
The Merck news release is online.
The Washington Post is online.
The following articles appear in this week's Annals of Internal Medicine. Full text is available to College members and subscribers online.
Most malarial deaths among U.S. travelers are preventable. Although indigenous transmission of malaria has been eradicated, about 1,500 cases of malaria occur among Americans every year, with most infections occurring when patients travel abroad. One out of every 100 Americans diagnosed with malaria dies.
Researchers looked at records of those deaths between 1963 and 2001, and found that more than 85% of them were considered preventable. In many of those cases, patients did not take necessary preventive medicines or follow prescribed regimens, and they didn't seek medical attention within two days when symptoms occurred.
Researchers also found that medical errors may have contributed to those preventable deaths if clinicians did not prescribe the correct preventive medicine, make the right diagnosis or begin treatment promptly. More…
Eating unsaturated fats lowers gallstone risk. A new, 14-year study of close to 46,000 men without initial gallstones or gallstone disease has found that those who ate the most unsaturated fats were 18% less likely to develop gallstones than men who ate the least.
Unsaturated fats include both monounsaturated fatty acids—found in olive, peanut and canola oils, avocados and most nuts—and polyunsaturated fatty acids. Polyunsaturated fatty acids are found in safflower, corn and canola vegetable oils, and in fatty fish such as salmon and tuna. The study did not determine the optimal amount of unsaturated fat intake. More…
The American College of Obstetricians and Gynecologists (ACOG) last week released its most comprehensive report to date with evidence-based recommendations on hormone therapy (HT).
The report reaffirmed many findings of the 2002 Women's Health Initiative study, including the fact that HT does not prevent diseases and should be used for the shortest possible time to relieve menopausal symptoms. According to a Sept. 30 ACOG press release, however, the report also tempers some earlier recommendations.
The report points out, for instance, that as many as 10% of menopausal women will have vasomotor symptoms for more than four years, and that it would be appropriate to prescribe HT for those women. The report also found that while selective serotonin reuptake inhibitors can help relieve hot flashes, herbal remedies—such as wild yam extract and black cohosh—do not.
The report was published as a supplement to the October issue of ACOG's Obstetrics & Gynecology.
The ACOG press release is online.
The majority of emergency department directors nationwide report shortages of key on-call specialists, according to survey results released last week. The survey was the largest to focus on the issue of on-call coverage in emergency departments.
Two-thirds of the more than 1,400 medical directors surveyed reported shortages of key on-call specialists, including neurosurgeons, orthopedists, obstetricians and other specialists. The survey was conducted between April and August 2004 by the American College of Emergency Physicians (ACEP).
According to a Sept. 28 ACEP press release, on-call specialist shortages have been exacerbated by last year's relaxation of the federal Emergency Medical Treatment and Labor Act (EMTALA), which allowed doctors to further limit their call time and to simultaneously be on-call at multiple hospitals.
Medical directors surveyed reported that on-call shortages are causing treatment delays and boosting the number of patient transfers. An ACEP official noted that the problem is made worse by medical liability issues that make it less attractive for specialists to be on-call.
The survey, funded by the Robert Wood Johnson Foundation, is part of a ongoing effort to track changes in on-call coverage. ACEP has asked Medicare's EMTALA technical advisory group to recommend potential solutions.
An ACEP press release and link to the report are online.
The CMS last week issued a draft proposal to expand the number of Medicare beneficiaries who would be covered for implantable cardioverter defibrillators. According to the proposal, about 500,000 Medicare beneficiaries at risk for sudden cardiac arrest would be covered—one-third more than are currently covered for the device.
The proposal is based on new studies showing that even patients who have never had a heart attack would benefit from the surgically implanted device, according to a Sept. 28 CMS news release.
While the agency may expand coverage to more beneficiaries, the CMS announced it may also reduce its reimbursement from the $25,000 it currently pays for defibrillators implanted in patients with congestive heart failure, the Sept. 28 New York Times reported. To get coverage, beneficiaries would have to enroll in a national registry that would track their progress and provide data for ongoing research.
Medicare will accept public comments on the proposal for 30 days and will publish a final decision 60 days after that.
Comments may be submitted online.
The New York Times is online.
The NIH has launched a new Web site with information to help physicians better manage patients' diabetes.
The practical online resource created by the National Diabetes Education Program (NDEP) provides evidence-based, patient-centered care information. Topics covered include how to develop team care, patient-center and population-based care, and community partnerships.
The site is designed to help physicians and other health care professionals, educators and policy-makers, change their system of chronic care for diabetic patients. The site also offers links to many other resources and references.
According to the NDEP, diabetes affects more than 18 million Americans and accounts for $132 billion in health care costs every year.
More information is online.
This month, ACP's Small Practice Discussion Group is targeting "Coding for Optimum Reimbursement." Participants in the members-only online group will explore the nuances of coding to save time and money, and exchange tips on how to code consults, make their documentation support the level of service they provide and choose the right modifier.
Moderating the group this month is Brett Baker, the College's Senior Associate for Regulatory and Insurer Affairs. Mr. Baker, who has worked for the College for nine years, regularly speaks on coding issues at Annual Session and writes a monthly billing and coding column for ACP Observer. He also works closely with the CMS, the AMA's current procedural terminology editorial panel and the American Hospital Association's international classification of diseases coding clinic editorial advisory board.
According to Mr. Baker, "Coding incorrectly can cost your practice thousands of dollars a year. It is an art to be learned early, done correctly and not delegated."
Maintained by ACP's Practice Management Center, the Small Practice Discussion Group is designed to help physicians in small practices—those with between one and five clinicians—share information about what works in the small practice setting.
A link to the discussion group is online.
In comments sent to the U.S. Pharmacopeia (USP), ACP is urging the standard-setting organization to expand the drug classification list contained in its draft model guidelines.
The USP guidelines are designed to help develop drug categories and classes that will be used by prescription drug plans. Those plans will offer prescription coverage to Medicare beneficiaries under the Medicare drug benefit slated to take effect in 2006.
In a Sept. 17 letter, the College told USP that its proposed list would eliminate numerous therapeutic agents from coverage, including statins, glitazones and selective serotonin reuptake inhibitors.
The College also asked the USP to revise its guidelines to correct other deficiencies. Recommendations included dividing the USP's pharmacologic class of opioid analgesics into long- and short-acting agents and including a pharmacologic class for ondansetron hydrochloride in the antiemetic therapeutic category.
The College pointed out that expanding the list would not be a detriment to controlling costs. The College also asked the USP to clarify how drugs with off-label and multiple uses will be treated in the model guidelines.
The letter is online.
The College has joined with the Boston University School of Medicine to offer an Alcohol Clinical Training (ACT) course immediately prior to next year's Annual Session in San Francisco.
The ACT course, slated for April 13, 2005, is a "train the trainers" session designed for internists who teach medical students, residents and other health providers. The course will demonstrate a new Web-based alcohol screening and brief intervention curriculum aimed at helping physicians recognize and treat patients with alcohol problems.
The course will use slides, case-based videos and skills practice, with an emphasis on cross-cultural communication in the primary care setting. Scholarships and CME credits are provided.
The deadline to register for the afternoon course is Nov. 19. ACP's Annual Session 2005 is being held April 14-16.
More information is online.
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Copyright 2004 by the American College of Physicians.
A 38-year-old woman is evaluated during a follow-up visit. She has a history of well-controlled hypertension and type 1 diabetes mellitus. She is at 16 weeks' gestation with her first pregnancy. Prior to conception she was taking lisinopril, which was discontinued in anticipation of the pregnancy, and labetalol was initiated. Other medications are insulin glargine, insulin lispro, and a prenatal vitamin. Following a physical exam and lab studies, what is the most appropriate step in the management of this patient's hypertension? .
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