In the News for the Week of 2-22-05
- FDA panel gives cautious green light to COX-2s
- Studies highlight COX-2 inhibitor risks
- FDA creates new drug safety oversight board
Clinical news in the headlines
- CMS survey seeks practice input on claims attachments
- New toolkit helps hospitals gather racial, ethnic information
- Wanted: young physicians interested in networking at Annual Session
- College calls for Council of Young Physicians nominations
An FDA advisory panel last week voted to recommend allowing rofecoxib to go back on the market and to permit other COX-2 drugs to remain available.
In a three-day hearing, the 32-member panel weighed the cardiovascular risks of COX-2 drugs against their benefits for pain relief and recommended significantly restricting the drugs' use, according to the Feb. 19 Washington Post. Restrictions include banning direct-to-consumer advertising, adding black-box warning labels and having physicians give patients written warnings about cardiovascular risks when they prescribe the drugs.
The panel also said that nonsteroidal anti-inflammatory drugs such as meloxicam and ibuprofen should carry warnings and that any new arthritis drugs should undergo extensive testing, the Washington Post reported. The FDA, which usually follows the panel's advice, will rule on the recommendations in the next few weeks.
The Washington Post is online.
Three new studies published early online in the New England Journal of Medicine (NEJM) provide more evidence that using COX-2 inhibitors increases the risk of heart attack and stroke.
In one study, researchers followed 2,586 patients with a history of colorectal adenomas who took either 25 mg of rofecoxib daily or placebo. The study, which was designed to test the effectiveness of taking rofecoxib on reducing neoplastic polyps of the large bowel over three years, was halted after 18 months when 46 patients in the rofecoxib group had a confirmed thrombotic event, compared with 26 patients in the placebo group. The results prompted Merck to withdraw rofecoxib from the market in September 2004.
In another study, researchers followed 2,035 patients with a history of colorectal neoplasia for up to three years, comparing the use of two doses daily of celecoxib (200 mg or 400 mg) with placebo. After 16 of 685 patients taking the 200 mg dose and 23 of the 671 patients receiving 400 mg died of cardiovascular events—compared to seven out of 679 in the placebo group—the trial was halted.
A third study assessed the safety of valdecoxib and parecoxib after coronary artery bypass grafting. In the trial, which involved 10 days of treatment and 30 days of follow-up, 1,671 patients received either intravenous parecoxib for at least three days, followed by oral valdecoxib; intravenous placebo followed by oral valdecoxib; or placebo. Cardiovascular events were more frequent among the patients given valdecoxib than among those on placebo (2% vs. 0.5%).
Because the three studies reached similar conclusions about three different COX-2 inhibitors, cardiovascular risk appears to be a "class effect," according to an accompanying editorial by Jeffrey M. Drazen, MD. The articles will appear in the March 17 issue but were posted early online.
Links to the NEJM abstracts are online.
The FDA last week announced that it will form an independent board within the FDA to monitor drug safety and promote public disclosure of potential problems with approved drugs.
The Drug Safety Oversight Board will assess whether side effect profiles that emerge after a drug is approved warrant regulatory action, according to the Feb. 16 Washington Post. The formation of the new board will for the first time take responsibility for post-marketing monitoring away from FDA reviewers and medical officers, who may worry about withdrawing a drug they previously approved.
The board will also provide more timely safety information to the public, even if the information is not complete or is potentially damaging to drug companies, the Washington Post reported. The board will be made up of FDA and other federal medical officials and will have the authority to call drug companies to testify about drug safety concerns. The board may also get input from consumer groups.
Some in Congress were critical of the new board, saying it should be separate from the FDA and that it does not adequately sever the close ties between the FDA and drug companies, according to the Washington Post. Others worried that the board could slow down the drug approval process by making reviewers hesitant to approve new therapies.
The Washington Post is online.
See also "Drug safety issues spur debate over monitoring" from the March ACP Observer.
Clinical news in the headlines
A large study led by the National Institutes of Health concluded that giving annual flu shots to elderly patients has had little effect on preventing deaths.
The study, which included flu-season data from 1968 through 2001, noted that while vaccination coverage among the elderly increased from as little as 15% before 1980 to 65% in 2001, there was no corresponding decrease in mortality among elderly patients.
In addition, fewer than 10% of all winter deaths among the elderly were attributable to the flu in any of the years studied. The study, which appeared in the Feb. 14 Archives of Internal Medicine, did not differentiate mortality rates among vaccinated and non-vaccinated patients.
While it is widely believed that immunization reduces flu-related deaths among the elderly by as much as 50%, the authors noted that mortality as an outcome has never been studied in clinical trials. They added that the findings suggest that the current vaccine shortage will have little effect on mortality this season.
In response to the study, the CDC said it will continue to recommend an annual flu shot for patients 65 and older, according to a Feb. 15 CDC statement. The statement pointed out that the study does not imply that seniors should not be vaccinated but that fewer deaths are being prevented. According to the CDC, those results indicate that efforts should be increased to develop more effective vaccines and treatments.
An Archives of Internal Medicine abstract is online.
The CDC's statement is online.
Age may play a role in determining the risk of death in postmenopausal women taking hormone replacement therapy (HRT), according to a recent review abstracted in the January-February ACP Journal Club. Journal Club reviewers called the findings into question, however, saying the mortality data were suspect.
Researchers looked at 30 randomized controlled trials in which women age 36-87 were given transdermal or oral estrogens alone or in combination with a progestin, or placebo. Overall, total mortality figures did not differ between the group taking some form of HRT and the control group. However, HRT was associated with fewer deaths in trials where the mean age was less than 60.
The Journal Club reviewers pointed out, however, that a critical look at the review throws those results into question. First, researchers based age classifications on a "mean" age rather than actual individual ages, which clouded the definition of "young." In addition, they did not separate the effects of age from other entry criteria, such as having ovarian cancer.
The mortality data were also suspect, the reviewers said. For example, researchers did not provide a plausible explanation or evidence why there would be a "global" effect on cardiovascular, cancer and other deaths. As a result, the findings should not influence current guidelines that recommend using HRT for symptomatic relief only, at the lowest effective dose for the shortest possible time.
ACP Journal Club is online.
The CMS is now conducting an online survey designed to gauge how physicians and other providers use claims attachments in claims processing.
The CMS is asking physicians across all specialties and care settings to provide input on their use of claims attachments. Physicians will be asked to provide de-identified information on the size of their practice, the number of specialties represented, the number of claims filed with the CMS and the types of claims attachments used.
The CMS is also surveying public and private insurers, software vendors, claims clearing houses and technology service firms. The survey can be taken online only, with all responses due March 7.
The CMS survey is online.
Additional information is also online.
In related survey news, the CMS is urging the 8,200 fee-for-service Medicare providers chosen to take the pilot Medicare contractor provider satisfaction survey to complete the survey and send their responses to the CMS.
Respondents can rate Medicare contractors on seven administrative functions, including provider communications, enrollment, reimbursement and inquiries, claims processing, appeals, and medical review.
The pilot project represents the first time the CMS will use provider satisfaction in assessing fee-for-service contractors. Respondents can either answer questions online or request a paper copy that can be sent in by fax or mail. Responses from individual providers will not be identified.
More information about the pilot survey is online.
Citing the need to improve health care for patients of all racial and ethnic backgrounds, a nonprofit organization affiliated with the American Hospital Association is offering a free Web-based toolkit to help hospitals gather data on patients' racial and ethnic origins.
The kit, which was released by the Health Research and Educational Trust (HRET) in conjunction with the Commonwealth Fund, is designed to help hospitals collect accurate information from patients to meet regulatory and local community needs. According to a Feb. 15 HRET news release, use of the toolkit can help hospitals ensure accurate data collection through the following:
Standardizing who provides the information, with patients or caretakers more likely to provide accurate information than hospital staff.
Establishing a protocol for collecting information on admission or patient registration.
Standardizing racial and ethnic categories.
Ensuring that data collection is compatible across hospitals and health systems.
Keeping information in a standard format that can be merged with clinical data files.
According to the news release, hospitals can use gathered data to track outcomes and quality improvements. The toolkit also covers staff training, collecting and using the data, and legal and privacy concerns.
More information is online.
The HRET press release is online.
The College's Young Physicians Subcommittee invites young internists attending this year's Annual Session to network and get advice from experienced colleagues during a breakfast meeting on Friday, April 15, in San Francisco.
Mentors at the breakfast meeting will offer personal guidance on topics such as balancing career and family, changing careers, women physicians' issues, academic medicine, and starting a new practice. Mentors will be seated at round tables designated for small group discussions on different topics. Signs on tables will announce the topics, with attendees selecting topics that interest them.
There is no charge for the breakfast, but interested attendees are asked to pre-register online by March 31.
ACP's newly established Council of Young Physicians is now taking nominations for physicians to fill the council's 11 seats. Nominations (or renominations of existing Subcommittee members) are limited to physicians who are under age 40 or who have been out of training for less than five years.
Physicians who want to serve should supply a current copy of their CV with a cover letter to their Chapter Governor. Each governor can submit up to two names to the College.
Two nominees will be selected from each region in the United States (North Eastern, Southern, Midwestern and Western) and Canada, as well as two at-large representatives. The council will then elect a chair who will serve for one year.
The Board of Regents approved the formation of the new council—which will replace and expand the College's Young Physicians Subcommittee—at its January meeting, giving the new Council representation on the Boards of Governors and Regents. The Regents believe the expanded Council will allow young physicians to provide more input on College leadership, products and services.
More information, including requirements for nominees' cover letters, is online.
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Copyright 2005 by the American College of Physicians.
A 24-year-old woman undergoes routine evaluation. She is pregnant at 12 weeks' gestation. Medical history is notable for homozygous sickle cell anemia (Hb SS). She has had multiple uncomplicated painful crises treated at home with hydration, nonopioid analgesia, and incentive spirometry. Following a physical exam and lab studies, what is the most appropriate management?
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