In the News for the Week of 4-17-07
Internal Medicine 2007
- Look for ACP Observer's daily coverage of Internal Medicine 2007 in San Diego starting Thursday, April 19, including highlights of each day's sessions and previews of upcoming events. A special section for hospitalists will highlight the course track for this growing specialty.
- FDA panel rejects new arthritis drug
- Most U.S. states plan to have P4P program in next five years
- Copayments decrease statin use
- Annals of Internal Medicine:
- Chondroitin, popular supplement for joint pain, shows no benefit
- Sequential therapy beats standard therapy for Helicobacter pylori
- Review finds no definitive diagnostic test for ventilator-associated pneumonia
News from the CDC
- Rise in drug-resistant gonorrhea narrows treatment options
- Physicians advised to watch for potentially fatal MRSA pneumonia
- Report: Some cancer prevention and detection measures stall, others improve
- Renew your ACP membership online
- Key information from Internal Medicine 2007 available online
- CMS announces new online tool to encourage health IT
- College member elected to physician consortium
A government advisory panel last week voted overwhelmingly against approval of etoricoxib (brand name Arcoxia), a new Cox-2 inhibitor. Manufacturer Merck & Co., Inc. had submitted the drug for FDA approval to treat symptoms of osteoarthritis.
The panelists voted 20 to 1 against approval after testimony by FDA officials and other experts. An FDA drug safety expert told the panel that etoricoxib would substantially increase patients' risk of stroke and heart attack and represented "a potential public health disaster," according to the April 12 Washington Post.
Merck representatives presented studies showing that the cardiovascular risk of the new drug was comparable to that of the currently approved drug diclofenac. However, opponents of the drug argued that it would be more appropriate to compare the drug to other NSAIDs, including naproxen, which studies have shown to be less dangerous for the heart, the April 12 New York Times reported.
Etoricoxib is currently sold by Merck in 63 countries. The drug is the first Cox-2 inhibitor submitted for U.S. government approval since rofecoxib (Vioxx) was removed from the market in 2004. An FDA memo released earlier in the week stated that in reviewing proposed NSAIDs, the agency would focus on risks to the cardiovascular system and approve new drugs only if they fill a need for patients that is not met by safer options. The FDA usually, but not always, follows the recommendations of the advisory panel. The agency is expected to announce a decision on etoricoxib by April 27.
The Washington Post is online.
The New York Times is online.
More than half of U.S. states operate one or more pay-for-performance programs and about 85% expect to do so within the next five years, a new report by the Commonwealth Fund said.
The results of a survey of 50 state Medicaid directors suggest states are moving faster than the federal government to adopt P4P measures, the April 12 New York Times said. It came a week after Medicare officials unveiled a program that lets doctors earn bonus payments for recording quality measures in patient care, the article noted.
Conducted from mid-May through mid-October 2006, survey results included:
- 28 states had a total of 35 P4P programs. In five years, that is expected to increase to 82 programs in 43 states,
- Almost half of all existing state programs are more than five years old, while more than 70% of new programs are expected to start within two years,
- Bonuses and differential reimbursement are the most effective incentives, while penalties are least effective,
- The most common assessment methodologies are attainment of a specified level of performance and degree of improvement,
- The most commonly used measures are HEDIS and HEDIS-like measures, followed by structural measures. Few programs use measures based on medical records,
- Many programs use non-financial incentives, like public reporting of performance, and
- Medicaid directors generally believe quality of care is improving under P4P, but have mixed opinions about cost savings.
The Commonwealth Fund report is online.
The New York Times is online.
Patients are more likely to discontinue statin use when they are required to make a copayment or share the drug's cost, a new study found. The study also confirmed previous findings that overall adherence to statin therapy among older patients is low.
Researchers collected data on 51,651 residents of British Columbia who were age 66 or older. When the Canadian government switched patients from a full drug-coverage plan to one with $10 to $25 copays, there was a 5% drop in statin use nine months after the policy change. Adherence dropped by the same amount when patients were later moved to a plan with a 25% coinsurance requirement. Even for patients with full coverage, the study found that only 55.8% took the medication more than 80% of the time.
The study also found that patients who had to pay the full cost of their drugs discontinued therapy at twice the rate of those who had full coverage. Lower-income patients were most likely overall to discontinue treatment, and were more affected by the copayment plan, possibly because the coinsurance program had an income-based deductible. The study was published online on April 9 and will appear in the April 24 issue of Circulation.
Although it was conducted in Canada, the study's findings have application to the U.S. health care system, the study's lead author told the April 10 Washington Post. He compared the cohort of patients who discontinued statins because they were paying full cost for their medications to Americans who fall into the Medicare Part D doughnut hole. The author also noted that all insurers should be motivated to provide more extensive drug coverage because it is less expensive to prevent a heart attack with statins than to treat one.
Circulation is online.
The Washington Post is online.
The following articles appear in the April 17, 2007 issue of Annals of Internal Medicine. In another article released online today, medical ethicists discuss the ethics of quality improvement practices. The full text is available to College members and subscribers online.
Chondroitin, popular supplement for joint pain, shows no benefit. Chondroitin, a dietary supplement used to treat osteoarthritis, is ineffective, a new meta-analysis found. The authors selected 20 trials comparing chondroitin to placebo or no treatment and found that chondroitin had little effect on knee or hip pain caused by arthritis. Although few adverse side effects were reported, the authors concluded that chondroitin use should "be discouraged." An accompanying editorial noted that the U.S. market for chondroitin and glucosamine (usually sold together) tops $1 billion/year, and that despite these findings, "chondroitin sulfate should not be considered dangerous. If patients say that they benefit from chondroitin, I see no harm in encouraging them to continue taking it as long as they perceive a benefit."
Sequential therapy beats standard therapy for Helicobacter pylori. In a clinical trial testing two different ways to treat Helicobacter pylori infection (a common cause of stomach ulcers), researchers found that four antibiotics given sequentially cured the infection more often than standard treatment with three antibiotics taken together for 10 days. The cure rate for the sequential treatment was 91% compared with 71% for the standard treatment. The sequential regimen was also more effective than conventional therapy for patients with certain antibiotic-resistant H. pylori bacteria.
Accurate diagnosis of ventilator-associated pneumonia (VAP) is difficult and often requires multiple tests in addition to a bedside clinical examination, a new review found.
Researchers reviewed 14 studies of 655 patients who received mechanical ventilation and subsequently underwent pulmonary biopsy or autopsy. They used clinical findings from these patients to determine which factors were most often associated with VAP. The review was published in the April 11 Journal of the American Medical Association.
According to the results, presence or absence of fever, abnormal white blood cell count or purulent pulmonary secretions do not substantively alter the probability of VAP. However, the combination of at least two of those three factors and a new radiographic infiltrate increases the likelihood of VAP to 23%. The absence of a new infiltrate on a plain chest radiograph or fewer than 50% neutrophils on cell count analysis of lower pulmonary secretions both lower the probability of VAP.
The review's findings support current consensus opinions and guidelines that acknowledge the lack of a definitive gold standard to diagnose VAP. Clinical examination can be used to alert physicians to the possibility of VAP, but examination alone is insufficient to establish a definitive diagnosis, study authors said. They suggested that clinicians caring for patients with possible VAP should consider additional diagnoses and further investigations, particularly when a trial of antibiotics does not lead to improvement within 48 to 72 hours.
The Journal of the American Medical Association is online.
News from the CDC
The CDC said last week that fluoroquinolone antibiotics should no longer be used to treat gonorrhea in the U.S., limiting physicians' options for treating the disease to a single class of antibiotics.
The decision was based on new data showing widespread resistance to fluoroquinolones, which include ciprofloxacin, ofloxacin and levofloxacin, among those diagnosed with gonorrhea, said an April 12 CDC news release. The agency had already recommended that fluoroquinolones no longer be used to treat gonorrhea in men who have sex with men because the proportion of drug-resistant cases had risen above the 5% threshold for changing treatments. The new data show that the proportion of drug-resistant cases among heterosexuals has also surpassed that threshold, rising from 0.6% in 2001 to 6.7% in the first half of 2006.
The new data, published in the April 12 Morbidity and Mortality Weekly Report, is based on the CDC's Gonococcal Isolate Surveillance Project in 26 cities. Increases in drug-resistant gonorrhea cases were seen across the nation, with sharpest increases between 2004 and 2006 in Philadelphia (from 1.2% to 26.6%) and Miami (from 2.1% to 15.3%).
Ceftriaxone, an injectable drug that is part of the cephalosporin class of drugs, is currently the only treatment option for all three types of gonorrhea, said the CDC release, indicating the need for accelerated research into new drugs. Some alternative oral cephalosporin treatments are available for genital and anal gonorrhea, but there are no other recommended alternatives for pharyngeal infection.
Gonorrhea is the second most commonly reported infectious disease in the U.S. after chlamydia, the CDC said, with almost 340,000 cases reported in 2005.
The CDC news release is online.
More information about gonorrhea treatments is online.
The CDC last week reported 10 severe cases of community-acquired pneumonia (CAP) caused by methicillin-resistant Staphylococcus aureus (MRSA), four of which resulted in death.
The 10 cases occurred in previously healthy children and adults in Louisiana and Georgia, said the CDC's April 12 Morbidity and Mortality Weekly Report. Several victims had a history of MRSA skin infection or had close contact with an infected person before developing pneumonia.
The CDC advised physicians to suspect MRSA pneumonia in anyone who has a history of MRSA skin infection or if influenza presents with severe respiratory symptoms. While rare, MRSA is a potentially fatal cause of CAP especially during the influenza season, the CDC said. When MRSA CAP is suspected, current guidelines recommend treatment with vancomycin or linezolid.
The MMWR summary is online.
About 73,000 Guidant defibrillators are being recalled because they contain a faulty capacitor that could cause rapid battery depletion, the FDA said last week.
Affected are Implantable Cardiac Defibrillators and Cardiac Resynchronization Therapy Defibrillators in the Contak Renewal 3 & 4, Vitality, and Vitality 2 series. The defect may reduce the time between the device's elective replacement indicator and the end of the battery's life to less than three months. There have been 19 reports of premature battery depletion, the FDA said.
In most cases, routine follow-up is the only requirement for those patients implanted with recalled devices. The device will need to be removed prematurely only in rare cases, the FDA said. In a letter to physicians, Boston Scientific Corp. recommended that physicians:
- Review patient records to assess battery voltage
- If voltage is above 2.65 volts (MOL2), follow the patient every three months per device labeling
- If voltage is at or below 2.65 volts, determine the time between implant and the current observation
- If the time from implant is greater than 27 months, this advisory doesn't apply
- If the time from implant is less than 27 months, the patient should be followed monthly until elective replacement indicator (ERI) is displayed. The device should be replaced within 30 days after ERI is displayed.
To check if a device has been recalled, an interactive tool is online.
The FDA alert is online.
Boston Scientific's letter to physicians is online.
The FDA last week announced new warnings and contraindications for tizanidine (brand name Zanaflex), a drug used to treat spasticity. According to the FDA, studies have found that the coadministration of tizanidine with either fluvoxamine or ciprofloxacin increased the hypotensive and sedative effects of the drug.
Manufacturer Acorda Therapeutics has issued a letter to health care professionals, advising them not to prescribe the drugs together. Fluvoxamine and ciprofloxacin are both potent CYP1A2 inhibitors, noted the letter. The effect of tizanidine on patients taking other CYP1A2 inhibitors has not been studied, but physicians are advised to avoid such combinations. Other CYP1A2 inhibitors include zileuton, other fluoroquinolones, antiarrhythmics (amiodarone, mexiletine, propafenone and verapamil), cimetidine, famotidine, oral contraceptives, acyclovir and ticlopidine.
The FDA also warned physicians and pharmacists last week about an apparently isolated instance of tampering with an HIV medication. At a pharmacy in California, two 60-count bottles of lamivudine and zidovudine (Combivir) were found to contain 300 mg tablets of abacavir sulfate (Ziagen). The bottles had counterfeit labels, identified as Lot No. 6ZP9760. Pharmacists have been asked to immediately examine the contents of all bottles of Combivir and report any problems to the manufacturer, GlaxoSmithKline.
The FDA warnings are online.
The percentage of people taking action to help prevent and detect cancer has stalled in recent years in some areas, though in other areas such actions have increased, a new report by the American Cancer Society said.
The report, "Cancer Prevention and Early Detection Facts & Figures 2007" found that the nation's steady decline in smoking rates has stalled, as has the steady increase in the percentage of women getting mammograms at age 40 or older. News about other kinds of screenings was more positive, however. Findings include:
- After declining each year after 1997, the 23% smoking rate for high school students has stayed stagnant between 2003 and 2005.
- Adult smoking rates, which declined between 1997-2004, were essentially unchanged between 2004 and 2005, with 24% of men smoking vs. 18% of women.
- Between 1999-2004, obesity in men rose from 28% to 32%, while in women obesity changed only from 34% to 34.6%.
- Between 1987-2000, the percentage of women aged 40 and older who had a mammogram in the past two years rose from 29% to 70%, but the percentage remained stable from 2000-2003.
- Among women 18 years and older, those who had a Pap test in the last three years rose from 74% in 1987 to 79% in 2003.
- Between 2000 and 2003, colorectal screenings among adults age 50 and older rose from 39.4% to 42.2%
- Prevalence of PSA screening in the past year in men aged 50 and older rose from 41% in 2000 to 57.6% in 2003.
The report comes a few months after another ACS study found that cancer deaths had declined for the second straight year in 2004.
The prevention and detection report is online.
Writing checks and walking back and forth to your mailbox eats up precious time you could spend doing something else. Save yourself the hassle this year by renewing your ACP membership online using ACP's secure Web site or the phone. Those who pay online or by phone before May 2, 2007 will not receive a print bill.
Your membership keeps you up to date on the latest medical information, offers you substantial discounts on numerous educational tools and activities, and supports ACP's public policy efforts to improve the health care environment for you and your patients. Soon you will be receiving an email inviting you to renew your membership for the next fiscal year. The email will direct you to pay online via a "Pay Dues Now" link on a secure, encrypted ACP Web site. Or you may go to the ACP home page and look for the Pay Dues Now link, starting on April 18. If you'd rather pay by phone, call ACP Customer Service at 800-523-1546, ext. 2600 or direct at 215-351-2600 (Monday-Friday, 9 a.m. - 5 p.m. ET).
If your membership renewal payment is not received by May 2, a print renewal form will be sent to you in mid-May. Please note than the online and print dues forms have changed this year and require you to specifically indicate whether you wish to pay chapter dues and/or make a charitable contribution to ACP and the ACP Foundation. If you have any questions, contact Customer Service at the number above.
More information about ACP activities and member benefits is online.
For those who are not able to attend Internal Medicine 2007, the College will offer key take-home messages from the meeting on acponline.org beginning on April 23. The information will be taken directly from the slides from the annual meeting wrap-up session, "Internal Medicine 2007 Highlights: Key Messages You'll Want to Take Home." At this session, three expert clinician-educators will summarize what they found to be the meeting's most important take-home messages for practicing internists.
This year will be the first that the information is available to those who did not attend the meeting. The downloadable format will help disseminate this valuable information as broadly as possible. Slides are useful for members to share with colleagues, use at grand rounds or present at chapter meetings.
Beginning April 23, the files will be available via a link on the IM 2007 homepage.
The Centers for Medicare and Medicaid Services last week launched a new online tool to encourage the use of health information technology (HIT).
The Doctor's Office Quality Information Technology University (DOQ-IT U) is a free, interactive, web-based tool designed to help physicians in small practices to successfully adopt HIT. The first lessons are available now and focus on physician office workflow redesign, culture change, communication necessary for successful electronic health record adoption, implementation of care management, and the incorporation of patient self-management to clinical care.
DOQ-IT U is being developed and managed by the Quality Improvement Organization Program, under contract to CMS. QIOs work with consumers as well as physicians, hospitals and other caregivers to refine care delivery systems to make sure patients, particularly those from underserved populations, get the right care at the right time.
CMS's DOQ-IT U Web site and more information are online. http://elearning.qualitynet.org Free registration is required. The announcement from CMS is online.
ACP Member Eric C. Schneider was recently elected to the executive committee of the Physicians Consortium for Performance Improvement. Dr. Schneider, who is an associate professor in the Department of Health Policy and Management at the Harvard School of Public Health and the Division of General Medicine and Primary Care at Brigham and Women's Hospital, will hold the methodologist seat on the committee.
Dr. Schneider's research focuses on quality of health care, including measurement methods in quality and safety, the impact on health care delivery of measurement and public reporting of health care performance, and the impact of race and other patient characteristics. He currently serves on the College's Performance Measures Subcommittee.
The Consortium is comprised of over 100 national medical specialty and state medical societies committed to enhancing quality of care and patient safety by taking the lead in the development, testing and maintenance of evidence-based clinical performance measures and measurement resources for physicians.
Information about the Consortium is online.
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Copyright 2007 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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