In the News for the Week of 11-23-04
Clinical news in the headlines
- Rx for quality: public reporting, not lawsuits
- MKSAP now offers money-back guarantee on ABIM exam success
- College weighs in on NIH plan for enhanced journal access
- Course to help internists diagnose problem drinking
Clinical news in the headlines
After a fast-track review, the FDA last week approved the sale of erlotinib tablets to treat non-small cell lung cancer, the country's most common form of lung cancer.
The drug, to be marketed as Tarceva by Genentech and OSI Pharmaceuticals, blocks the tyrosine kinase associated with epidermal growth factor receptor (EFGR), according to a Nov. 19 FDA news release. In one trial of 731 patients, the FDA reported, patients who took erlotinib survived a median of 6.7 months compared with 4.7 months for patients on placebo. Future studies are planned to examine the relationship between high EGFR and survival.
Erlotinib will compete with two other targeted drugs for lung cancer. AstraZeneca's gefitinib (Iressa), approved last year, has been shown to shrink tumors but not to increase survival time, according to the Nov. 19 New York Times. ImClone Systems' colon cancer drug cetuximab (Erbitux) also works by blocking EFGR.
Targeted therapy drugs are often preferred because they have fewer side effects than traditional chemotherapy, the New York Times reported. Erlotinib, which has a wholesale price of $2,000 a month, was approved for patients whose cancer has continued to metastasize despite chemotherapy and other treatments. Its main side effects are rash, diarrhea, nausea and vomiting.
The FDA release is online.
The New York Times is online.
A recent meta-analysis provides new insights into the power of statins to reduce the risk of heart attacks and stokes in patients with type 2 diabetes mellitus.
The analysis looked at 12 randomized controlled trials in which diabetic patients were treated with statins (lovastatin, pravastatin, simvastatin, atorvastatin and fluvastatin) or fibrates (gemfibrozil), some for primary and some for secondary prevention. The authors reported that statins reduced the risk of cardiovascular events in both types of trials, although patients in secondary prevention trials had a much higher absolute risk reduction. The analysis was abstracted in the November-December ACP Journal Club.
The results are in line with recent guidelines recommending lipid-lowering therapy for all diabetics, said the Journal Club reviewer. The results also provide important information about the role of lipid lowering in primary prevention. Patients in the primary prevention trial, who had a lower baseline risk of heart events, had only a 3% absolute risk reduction, highlighting the need to assess each patient's baseline risk before deciding on treatment.
Patients with a very low baseline risk might not benefit from lipid-lowering drugs, the reviewer noted. In addition, the meta-analysis suggests that prescribing a moderate dose of a statin may be more important than aiming for arbitrary LDL targets. Future studies should also examine whether diabetics, especially those with low HDL levels, respond differently to different statins, and whether there is any advantage to combining drugs.
The ACP Journal Club review is online.
Results released last week of a national survey revealed that most adults favor mandatory reporting of medical errors over malpractice claims as the way to improve the quality of health care in the United States.
The survey of 2,000 adults taken by the Kaiser Family Foundation, the Harvard School of Public Health and the Agency for Healthcare Research and Quality found that 55% of respondents were dissatisfied with the quality of U.S. healthcare, up from 44% four years ago, according to a Nov. 17 Kaiser Foundation press release. Among respondents, 40% said the quality of health care has declined in the past five years, while those with chronic diseases were more likely to report having experienced medical errors first-hand.
Workload, inadequate staffing and poor communication were cited as reasons for widespread errors, according to the Kaiser release. Potential solutions endorsed by respondents included giving doctors more time with patients (79%), requiring hospitals to develop systems to avoid errors (72%), better training of health care professionals (72%) and increased use of computerized medical records (51%).
Despite mounting concern about safety, most respondents said they did not view the courts as a satisfactory remedy, according to the Nov. 18 Washington Post. Instead, they said medical errors should be reported to a public agency and published in public reports so that consumers can make informed decisions about where to go for care.
The survey comes five years after the influential Institute of Medicine's "To Err is Human" report estimated that between 44,000 and 98,000 deaths occur every year in hospitals due to preventable errors.
The Kaiser press release is online.
The Washington Post is online.
In related news, a new survey of more than 1,000 hospitals by the nonprofit LeapFrog Group, an employer coalition, found that hospitals have taken some steps to improve safety but that more improvements are needed.
The survey found that eight in 10 hospitals have implemented procedures to avoid wrong-site surgeries while seven in 10 hospitals require pharmacists to review medication orders, according to a Nov. 16 Leapfrog news release. However, seven in 10 hospitals reported not having policies to ensure adequate staffing and a majority said they lack procedures for preventing malnutrition. In addition, 50% had no procedures to prevent bedsores and 40% lacked policies requiring staff to disinfect their hands before and after visiting patients.
The survey also found that only 4% of hospitals had fully implemented computerized physician order entry.
Links to the LeapFrog press release and survey are online.
MKSAP is now extending a money-back guarantee to physicians who complete the latest version of the College's MKSAP self-assessment program and take the ABIM certification or recertification exam.
Internists and residents who subscribe to and complete MKSAP 13 will receive a complete refund of the MKSAP purchase price, no questions asked, if they do not pass their ABIM exam. (A copy of the letter from ABIM confirming exam results is required.)
MKSAP 13 is one of internal medicine's most popular tools for ABIM exam preparation available today. It uses a variety of innovative educational formats to strengthen users' knowledge and reinforce areas that need more study. The course uses summary key points and up-to-the-minute case studies, and has 1,000 Board-like multiple-choice questions with answers, critiques and references.
MKSAP 13 is available in print, on CD-ROM or as a combination package. More information and ordering is available online.
In a recent letter, the College commented on a proposal put forth by the National Institutes of Health (NIH) to enhance public access to research information in scientific journals.
The letter, dated Nov. 16, was signed by ACP's Executive Vice President and Chief Executive Officer John Tooker, FACP, MBA, and sent to the NIH director. It said that the College agrees the public should have free access to studies paid for with federal dollars. However, the concept of enhanced public access will not work, the letter stated, unless the NIH amends its current proposal, which is to locate journal articles in a central repository, such as PubMed.
Such a central repository would create problems controlling corrected versions of an article, which could perhaps "compromise the integrity of the scientific record," the letter said. Maintaining a manuscript repository would also be expensive and perhaps divert funds from research grants.
To resolve those concerns, Dr. Tooker wrote that the College supports having electronic linkage from an online repository to an article's master copy on its publisher's Web site. It would be the publishers' responsibility, the letter added, to ensure that any links from the NIH site function correctly.
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.
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 53-year-old woman is evaluated for a 3-month history of swelling of the face, hands, and feet. She has untreated hepatitis C virus infection. She takes lithium for bipolar disorder. She has no additional symptoms. After a physical exam, lab results and kidney biopsy, what is the most likely cause of this patient's nephrotic syndrome?
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