In the News for the Week of 9-14-04
Clinical news in the headlines
- Fitness plays different roles in heart disease, diabetes
- Combining erythromycin with other drugs may boost cardiac risk
- Highlights of ACP Journal Club
- Payment cuts for cancer drugs higher than previous estimates
- Rising Medicare premiums may boost HMO rosters
- Journal editors back public clinical trial registry
- Information Rx project gets national media coverage
- College wants to improve CMS' physician enrollment process
- Free patient education videos benefit minority groups
Clinical news in the headlines
Two studies published last week that targeted women offered conflicting findings on how physical activity may mitigate excess weight in preventing heart disease and diabetes. While one study found that fitness levels were a more accurate predictor than body mass index (BMI) for coronary events in women, another found that fitness "only modestly affected the influence of BMI" on diabetes risk.
The first study examined physical fitness and BMI in more than 900 women who had undergone coronary angiography for suspected ischemia. Researchers found that higher fitness scores among overweight or obese women were associated with a significant decrease in risk for a major coronary event.
Investigators in a second study tracked the weight, height and recreational activities of almost 38,000 women initially free of heart disease, cancer and diabetes. They found that while high BMI and physical inactivity were both predictors of diabetes, obese and overweight women were at greater risk than those who were inactive. Both studies appeared in the Sept. 8 Journal of the American Medical Association.
The apparently conflicting results may be rooted in differences in the two diseases and study populations, according to experts interviewed in the Sept. 8 Washington Post. Physical activity may carry a greater benefit for the heart by lowering blood pressure and cholesterol and reducing inflammation.
Experts also pointed out that the findings in the diabetes study should not be used to discourage overweight women from getting more physical activity. They noted that increasing fitness levels is often a more realistic goal for patients than losing weight.
The JAMA articles are online.
The Washington Post is online.
A study released last week found that erythromycin, one of the most commonly used antibiotics, may increase the risk of sudden death from cardiac arrest, especially when combined with certain other drugs.
The study, which appears in the Sept. 9 New England Journal of Medicine (NEJM), found that the risk of heart attack was highest among those who took erythromycin along with certain CYP3A inhibitors, which increase the antibiotic's concentration in the blood.
Investigators examined the records of Tennessee Medicaid patients and found that their rate of sudden death from cardiac causes was twice as high among erythromycin users as among those not taking the drug. In addition, patients' risk of death was five times as great among patients who were also taking CYP3A inhibitors, including nitroimidazole antifungal agents, diltiazem, verapamil and troleandomycin.
Researchers said that although the overall risk associated with erythromycin is small—only 1.2 per 1,000 person-years of follow-up—it was significant enough to advise physicians to avoid combining erythromycin with the CYP3A inhibitors used in the study.
The Sept. 9 Baltimore Sun noted that in 1997, the antihistamine terfenadine (Seldane) was taken off the market after some deaths were associated with combining the drug with erythromycin, causing ventricular arrhythmia.
The NEJM abstract is online.
The Baltimore Sun is online.
A study of hospitalized patients with ventilator-associated pneumonia suggests that doctors could cut the time patients are treated with antibiotics in half without increasing patients' chance of mortality or recurring infection.
Between 10% and 20% of ICU patients who are intubated for more than 24 hours develop ventilator-associated pneumonia, which is typically resistant to first-line antibiotics. Physicians often choose a longer course of different antibiotics to treat the infection, but this practice may contribute to rising rates of antibiotic resistance.
The randomized trial followed more than 400 adult patients who had been on ventilators for more than 48 hours in French intensive care units (ICUs). Researchers concluded that mortality and recurrence outcomes achieved with an eight-day antibiotic regimen did not differ from those with a 15-day regimen. In addition, patients taking antibiotics for eight days benefited from having more antibiotic-free days. The study was abstracted in the Sept.-Oct. ACP Journal Club.
Reviewers said that the study—one of the few to test strategies for minimizing antibiotic exposure—indicates that antibiotic use can be safely limited in hospitals, where patients are most vulnerable.
The ACP Journal Club abstract and commentary are online.
A professional oncology society last week released findings showing that government reimbursement for community cancer care could fall by more than 50% under approved Medicare reforms that begin next year. At the same time, Medicare reimbursements for office-based infusion cancer drugs could drop by an average of 15%—almost double Medicare's previous projections.
The new figures come from an analysis by the American Society of Clinical Oncology (ASCO), which also found that up to 25% of the office-based drugs used in cancer treatments will cost physicians more than what Medicare will pay, according to a Sept. 8 ASCO news release. For instance, the majority of practices that ASCO surveyed claimed that Medicare reimbursement would not meet their costs for epoetin, pamidronate, irinotecan or gemcitabine.
In the past, Medicare's reimbursement system overpaid oncologists for chemotherapy drugs and underpaid them for associated services, such as drug administration and counseling. The Medicare Modernization Act of 2003 attempted to correct that imbalance by establishing new pricing mechanisms for infusion drugs and new reimbursement levels for administrative services.
ASCO claims, however, that the new rates fall short of allowing physicians to recoup their costs for providing office-based cancer services, and that some practices may have to close offices or limit services.
Based on its analysis, ASCO recommended that net Medicare reimbursement levels for cancer care stay the same until 2006, when the government is expected to complete its own series of impact studies on the payment changes.
In related news, ACP last week joined ASCO and 15 other medical societies to send a letter to the CMS, asking the agency to provide a complete list of estimated 2005 drug payments. The group is "deeply concerned," the letter said, about the lack of information on Medicare drug payments that are slated to take effect in 2005.
The ASCO press release is online.
See also, "Medicare's new office-drug payment policy has oncologists concerned about access," in the April issue of the ACP Observer online.
The College's letter to the CMS on 2005 drug payments is online.
In the wake of recently announced premium hikes for Medicare beneficiaries, analysts say more Medicare patients may opt to join private HMOs.
Earlier this month, the CMS announced that premiums for office visits for Medicare beneficiaries next year would rise $11.60 a month for a total of more than $78 a month. According to the Sept. 9 New York Times, the 17.4% increase is the biggest one-step hike since the Medicare program was launched in 1965.
Medicare patients in both the fee-for-service and HMO programs will pay the same monthly premium. However, HMOs may offer partial premium refunds, lower copays or drug coverage to attract enrollees, the New York Times noted. The Medicare prescription drug benefit act, approved last year, authorized government subsidies for private plans to encourage them to enter the Medicare HMO market. About $1.75 of the monthly premium increase is designed to cover those subsidies.
The CMS also announced an increase in Medicare patients' annual hospital deductible.
The New York Times article is online.
In related news, a national survey revealed that the cost of health care benefits for patients in private plans rose by 11.2% in 2004, the fourth consecutive year of double-digit increases.
The Kaiser Family Foundation survey of 3,000 showed that the increase in health care coverage costs—while down from a 2003 peak of 13.9%—was still more than five times the national 2.2% increase in wages between 2003 and 2004. The Sept. 10 New York Times reported that coverage for the average family in preferred provider networks rose to $10,217 a year, prompting many small businesses to stop covering employees' families.
A Kaiser Family Foundation press release is online.
The New York Times is online.
In an effort to boost access to comprehensive clinical trial data, the editors of many of the most prestigious medical journals jointly announced last week that they will no longer publish findings of clinical trials that have not been registered in a public trial database. Trial registry, the editors said, must begin next year.
In a statement published in each of the 12 journals, the editors—members of the International Committee of Medical Journal Editors—said the move was designed to halt the selective reporting of trial data that suppresses negative or inconclusive results and skews clinical evidence. According to the statement, trial results that may have a negative impact on a sponsor's financial interests are "particularly likely to remain unpublished."
Harold C. Sox, MACP, Editor of Annals of Internal Medicine, signed the statement, as did the editors of the New England Journal of Medicine, the Journal of the American Medical Association and The Lancet, among others.
Any trial that begins enrolling patients after July 1, 2005,must be registered in a public database for the results to be considered for publication in one of these journals, the statement read.Trials already under way before that date must be registered by Sept. 13, 2005. While the editors did not advocate any particular registry, they noted that the registry must be free, public and electronically searchable.
The Sept. 9 New York Times pointed out that suppression of negative trial data has become a major issue in federal investigations into the use of antidepressants in adolescents and children. The New York Times also noted that three drug companies—Merck, Eli Lilly and GlaxoSmithKline—have already announced that they will register their clinical trials.
The Annals statement is online.
The New York Times is online.
The Information Rx project, a joint program sponsored by the ACP Foundation and the National Library of Medicine, will be the focus of a feature article in this Sunday's Parade magazine. Parade is distributed to more than 35 million households nationwide.
Information Rx gives physicians free tools—including presciption pads, office posters and bookmarks—to help them refer patients to MedlinePlus.gov, a Web site maintained by the National Library of Medicine that provides health care information that is evidence-based and free of advertising.
The ACP Foundation rolled out the pilot phase of Information Rx last year to College chapter members in Iowa, Georgia and Virginia. Since Annual Session 2004, the program has been available free to College members, with more than 2,000 ACP members now participating.
You can get more information about the program or enroll online.
Also see "Medlineplus project: premium information for patients" in the December 2003 ACP Observer online.
In an effort to streamline physicians' interactions with the CMS, the College recently submitted testimony to a Medicare advisory committee on a broad range of issues, including ways to improve physician enrollment, the process used to establish billing privileges and call center information.
The College pointed out, for instance, that the CMS does not provide timely processing of physician enrollment information. To address those delays, ACP recommended that the CMS implement the following:
Adopt a contingency plan for processing new enrollment applications or changes.
Assign temporary unique provider indentification numbers to physicians.
Wait to finalize new requirements for establishing and maintaining Medicare billing privileges until physician enrollment problems are resolved.
The College also recommended that the CMS work with physician organizations to ensure that new requirements to establish billing privileges do not impose further regulatory burdens on physicians.
ACP also outlined several steps to improve the accuracy of information physicians receive from Medicare call centers. Recommendations included soliciting input from physicians who interact with call center personnel, and implementing a process that physicians can follow to resolve questions that call center personnel aren't able to answer.
The College submitted its recommendations to the CMS' Practicing Physicians Advisory Council.
ACP's recommendations are online.
ACP has released four free patient education videos to help patients understand and deal with a wide range of health issues. The 30-minute videos and accompanying guidebooks, which target Hispanic Americans and African Americans, can be used in an office setting or given to patients to take home.
The newest video in the series, "Celebrating Life: A Guide to Depression for African Americans," explains the warning signs and types of depression as well as treatment options. The video also offers suggestions on how to help a friend or relative who may show signs of depression.
"Awareness is Power: Cancer and the African American" discusses the risks and treatment options for prostate, breast and lung cancers, which are the three most common cancers among black Americans.
"Diabetes Prevention and Control: A Guide for Hispanic-Americans" provides information and advice about the prevention and treatment of diabetes. The video and guidebook are available in both Spanish and English editions.
And "Living with Diabetes: A Guide for African Americans," helps patients deal with the serious health problem facing African Americans with diabetes. The video provides tips on preventing serious complications and offers suggestions for healthy eating, exercise and weight management.
The videos and guidebooks are free for ACP members. Shipping costs $5 for one to five items and $10 for six to 10 items.
More information, including product order numbers, is online.
To order videos, call ACP Customer Service at 800-523-1546, ext. 2600 or 215-351-2600.
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Copyright 2004 by the American College of Physicians.
A 30-year-old woman is evaluated for difficult-to-treat migraine. She has had severe headaches, usually on the first day of menses, since menarche. The pain is hemicranial, pulsatile, and associated with severe nausea and vomiting but no aura. She frequently awakens with the attack already in progress. A series of drug regimens have become ineffective in controlling pain. Following physical and neurological exams, what is the most appropriate next step in treatment?
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