In the News for the Week of 12-21-04
- Celecoxib trial halted due to cardiovascular risk
- Scientists find flaws in links between oral contraceptives and lower disease risk
- CMS set to launch its "Welcome to Medicare" exam
Clinical news in the headlines
- Study finds infections often precede heart attacks
- Highlights of the Dec. 21 Annals of Internal Medicine
- IHI launches nationwide inpatient safety initiative
- Large employers reduce health care benefits for retirees
- College expands its online resources for recertifying physicians
- ACP Expert Guide series now features new rheumatology book
- Members can reduce dues through "Recruit-a-Colleague" program
Pharmaceutical giant Pfizer Inc. last week announced that a long-term study on its arthritis drug celecoxib (Celebrex) had been halted after participants taking 800 mg and 400 mg doses were found to have higher risk of heart attack and stroke.
According to a Dec. 17 company news release, the findings contradict other studies that have found no increased cardiovascular risk linked to the drug's use. The announcement comes less than three months after Merck & Co. withdrew its COX-2 inhibitor rofecoxib (Vioxx) from the market after a study revealed cardiovascular risks.
In a five-year adenoma prevention trial, participants taking 800 mg of celecoxib were 3.4 times more likely to have a cardiovascular event, while those taking 400 mg had a 2.5-fold increased risk compared to placebo, the Dec. 18 Washington Post reported. The National Cancer Institute, which funded the study, suspended the trial.
The company said that participants in a second long-term cancer prevention study taking 400 mg of celecoxib daily did not experience increased cardiovascular risk. The two studies enrolled a total of 3,600 patients, many of whom completed at least two years of treatment before the one trial was halted.
Pfizer gave no indication that it intends to withdraw the drug from the market, although it announced that it was suspending all consumer advertising for the drug. The Dec. 20 New York Times reported that Pfizer spent $71 million to advertise the drug during the first nine months of 2004.
Although FDA officials announced they had "great concerns" about the drug class, according to the Washington Post, Pfizer said physicians should continue to prescribe the drug, taking the new risk into account just as they would ulcer risks and gastrointestinal bleeding associated with traditional nonsteroidal anti-inflammatory drugs.
Celecoxib is currently approved to treat osteoarthritis at recommended daily doses of up to 200 mg and rheumatoid arthritis at doses up to 400 mg per day. It is also approved to treat familial adenomatous polyposis in doses up to 800 mg per day.
Pfizer's press release is online.
The Washington Post is online.
The New York Times is online.
CORRECTION: Last week's ObserverWeekly erred in its report that the FDA had ordered a black-box warning for packaging of another COX-2 inhibitor manufactured by Pfizer, valdecoxib (Bextra). The black-box warning was ordered only for valdecoxib's risk of a potentially threatening skin reaction. The FDA ordered a bolded contraindication—not a black-box warning—for the drug's use in patients undergoing coronary artery bypass graft surgery.
Federal officials last week disputed recent study findings that oral contraceptive use may lower women's risk of heart disease.
The study, presented in October at a reproductive medicine meeting in Philadelphia, used data from the Women's Health Initiative, which is funded by the National Heart Lung and Blood Institute (NHLBI), according to the Dec. 16 New York Times. A top NHLBI official claimed in a Dec. 15 news release that a new analysis of the findings could not find a link between birth control pill use and reduced heart disease risk, after taking into account age and other factors.
Researchers had found that women using oral contraceptives had a 7% lower risk of developing cancer and an 8% lower risk of developing heart disease, the New York Times reported. However, researchers did not verify the WHI data—which relied on women's memories of whether they ever had heart problems or cancer—with medical records.
NHLBI officials said the findings also cast doubt on the study's conclusions related to lower cancer risk. Previous and more rigorous studies, the NHLBI news release said, have found a small increased risk of cardiovascular disease after pill use, particularly in older women and in smokers, and an increased risk for breast cancer among women who have recently used oral contraceptives.
An NHLBI press release is online.
The New York Times is online.
Medicare next month will begin covering the "Welcome to Medicare" exam, an initial preventive physical exam for beneficiaries enrolled in Medicare Part B. The benefit was created by Medicare reform legislation passed in 2003.
The new benefit will cover several elements, including:
- a comprehensive medical and social history;
- a physical exam;
- a review of potential depression risk;
- an assessment of functional ability and level of safety;
- an electrocardiogram; and
- patient education, counseling and referral.
The CMS has also created Healthcare Common Procedure Coding System codes to bill Medicare for the new exam.
More information on what the benefit covers and how to bill for it are online in an early posting of the "How to bill for the new 'Welcome to Medicare' exam" from the January-February 2005 ACP Observer.
Clinical news in the headlines
A large British study found that respiratory and urinary tract infections may increase patients' risk of heart attack and stroke, suggesting the possibility of predicting cardiovascular events in people with stable heart disease.
The study of more than 20,000 patients who had experienced at least one myocardial infarction or stroke found that patients with respiratory tract infections were five times more likely to suffer a heart attack and three times more likely to have a stroke during the first three days of the infection. The risks were similar, although slightly lower, for patients with urinary tract infections.
In contrast, people who received vaccinations for influenza, tetanus or pneumonia did not experience a heightened risk due to being vaccinated. The results were published in the Dec. 16 New England Journal of Medicine (NEJM).
Researchers said the increased risk was likely caused by inflammation, according to the Dec. 16 online edition of BBC News. They added that the findings suggest that heart events may not be random, and that physicians should pay close attention to heart disease patients who are experiencing an inflammatory response, such as during abdominal surgery.
The results lend support to the theory that infections may precede heart attacks, researchers said. Authors stressed, however, that the increased risk is slight, the BBC News reported. Heart disease patients with mild infections, such as bronchitis, should not be unduly concerned unless the illness becomes severe.
The NEJM abstract is online.
BBC News is online.
The following articles appear in the Dec. 21 issue of the Annals of Internal Medicine. Full text is available to College members and subscribers online.
Three studies of acupuncture and manipulation for spine and joints. Three articles and an editorial in this week's issue examine several complementary and alternative medicine treatments for very common medical conditions.
A study of 570 people in a randomized controlled trial comparing acupuncture with sham acupuncture and education to treat osteoarthritis of the knee found that acupuncture, used along with regular arthritis care, is effective. A second study of 138 patients who received either acupuncture or sham acupuncture for chronic neck pain found that acupuncture was no more effective than placebo. A third study found that an existing clinical prediction rule was successful in identifying low back pain patients who are most likely to benefit from spinal manipulation.
An accompanying editorial states that these studies and larger ones are needed, if public and private insurers are going to cover these procedures.
The articles are online.
Veterans' health care scores well on overall quality. A new comprehensive study of health care quality at the Veterans Health Administration (VA) found that VA patients generally received better care than patients elsewhere.
VA care scored best in areas in which the VA routinely monitors quality. In one of the most comprehensive comparisons between the VA and other providers, researchers looked at the quality of acute, chronic and preventive care in 26 medical conditions and compared those scores to a national sample in 12 communities.
Overall, VA care scored higher for adjusted overall quality of care, chronic and preventive care but not for acute care.
The article is online.
The Institute for Healthcare Improvement (IHI) last week announced the launch of an 18-month initiative aimed at saving 100,000 lives by improving patient safety at the nation's hospitals. The IHI—a nonprofit based in Cambridge, Mass.—focuses on innovations to improve health care quality.
Led by Donald Berwick, MD, the IHI wants to enroll thousands of hospitals across the country in adopting some or all of six specific safety measures by July 2006, according to the IHI's web site. The six measures are designed to do the following:
- Deploy rapid response teams at the first sign of patient decline.
- Deliver reliable, evidence-based care for acute myocardial infarction.
- Prevent adverse drug events by implementing medication reconciliation.
- Prevent central line infections by implementing a series of interdependent, scientifically grounded steps called the "central line bundle."
- Prevent surgical site infections by delivering the correct perioperative antibiotics at the proper time.
- Prevent ventilator-associated pneumonia by implementing a series of interdependent, scientifically-grounded steps called the "ventilator bundle."
The program, which will begin in January, already received an $8 million donation from California HMO Kaiser Permanente, according to the Dec. 13 San Francisco Business Times. The money will fund scholarships for health care professionals from Kaiser to attend IHI conferences and training sessions.
Blue Cross Blue Shield of Massachusetts also donated $3 million to the initiative, the Dec. 14 Business Wire reported. Most of that money will be used to help Massachusetts hospitals adopt the IHI safety measures.
More information is available on the IHI's Web site.
The San Francisco Business Times is online.
Business Wire is online.
A new survey has found that retirees are paying sharply higher health care premiums as many large employers reduce health benefits for retirees.
The survey found that retirees receiving health benefits from former employers paid a 25% average increase in premiums this year, according to the Dec. 14 release from Kaiser Family Foundation and Hewitt Associates, which conducted the survey. While most large private employers are continuing benefits for current retirees, 8% took steps last year to end coverage for future retirees and 11% plan to follow suit next year.
Companies tried to cut costs on current retiree benefits by increasing prescription copays, requiring prior approval for certain drugs or mandating use of mail-order pharmacies, the Dec. 15 New York Times reported. The survey looked at 333 companies that had at least 1,000 employees, which together provide health coverage for a combined 4.9 million retirees and their spouses.
Most employers surveyed said, however, that they would continue to offer drug benefits to retirees 65 and older because of subsidies by Medicare, which plans to spend $71 billion on subsidies from 2006-2013, the New York Times reported. Eighty-five percent of companies surveyed claimed they were likely to maintain current levels of prescription benefits, which are typically more comprehensive than drug benefits provided by Medicare. A Kaiser Foundation press release is online.
The New York Times is online.
ACP members preparing for recertification now have more tools in their arsenal of educational aids.
The College is now offering free online support to physicians completing the ABIM's new "Recent Advances in Internal Medicine" self-evaluation process (SEP) module. Online resources for the module—which include MKSAP sections, Annals articles and ACP Books material, as well as material from PIER, the College's Physicians' Information and Education Resource—expand College resources already posted to help physicians complete other SEP modules, including outpatient and inpatient medicine modules, and those on general internal medicine and women's health.
The College has also updated its resources to help physicians complete the ABIM's Practice Improvement Module (PIM) on diabetes. This 17-chapter module—13 of which are devoted to disease-specific issues—was designed to be used as a resource after physicians have received comments from the ABIM on office system and patient audits. ACP has added new content and tools to resources posted earlier this year for the diabetes PIM.
Free online support to all ACP members for the new "Recent Advances" module is online.
ACP online support for the diabetes PIM module is also online.
"Rheumatology," the newest addition to ACP's Expert Guide series, provides an accessible reference to state-of-the-art rheumatology practice for practicing internists and subspecialists. The book highlights clinical aspects of rheumatology and gives special emphasis to current concepts of etiology and pathogenesis pertinent to practical patient management.
The book provides a discussion of the general clinical approach to inflammation and groups major disorders into several categories: erosive inflammatory arthropathies, collagen vascular disease, vasculitides, infections and degenerative disease. Two final sections consider common symptoms and comorbidities and summarize the latest findings in the pharmacological treatment of inflammatory rheumatic disease.
Practical approaches to diagnosis and management are emphasized throughout, with tables and figures to illustrate the text. Case studies give the busy practitioner examples of patient encounters frequently seen in the office setting.
The 494-page softcover book is available to College members for $45. You can order online or call ACP Customer Service at 800-523-1546, ext. 2600, and refer to product #330300440.
ACP members can now earn dues credits by recruiting non-member colleagues to become full ACP members.
Members will receive a $100 credit for recruiting one member and an additional $100 credit for two. If they recruit three or more colleagues, they will have their next year's dues payment waived. (Total credits cannot exceed member dues.)
The current "Recruit-a-Colleague" program runs until March 1, 2005. For every colleague they recruit within this promotional period, members will receive a chance to win a trip to Annual Session 2006, including registration, airfare and four days of hotel accommodations.
To be considered a "recruited" member, your colleague must meet the following:
Be a nonmember (or former member) eligible for full ACP membership, so Associate or medical student members do not qualify.
Submit a membership application, along with his or her national annual dues payment, between now and March 1, 2005.
Include your name in the recruiter box at the top of the membership application.
Complete details of the program are online. You can use the same site to send a personalized recruitment e-mail to a colleague, or to download and print a membership application to personally deliver.
Membership inquiry kits are also available from ACP Customer Service at 800-523-1546, ext. 2600 (9 a.m.-5 p.m. ET).
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Copyright 2004 by the American College of Physicians.
A 50-year-old man is evaluated in follow-up after hospitalization 6 months ago for a large bleeding gastric ulcer. Tests performed for Helicobacter pylori infection at that time were negative. However, for the 3 months before hospitalization he had been taking ibuprofen for chronic back pain. He was discharged from the hospital on omeprazole, and his ibuprofen was discontinued. Following a physical exam and upper endoscopy, what is the most appropriate management?.
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