In the News
for the Week of 5-5-09
- MKSAP quiz: Protecting health care workers against communicable diseases
- Ovary removal with hysterectomy associated with increased mortality risk
- PSA testing should be offered at 40, individualized to each patient
- Voice response system helps monitor patients on blood thinners
Annals of Internal Medicine
- News reports often exaggerate the importance of medical research
- Boxed warning ordered for all botulinum toxin products
- OTC pain relievers, fever reducers must revise labels to reflect liver, bleeding risks
- Golimumab approved for three kinds of immune-related arthritis
- Libimax supplement recalled for containing tadalafil
Practice management news
- FTC delays its ‘Red Flags’ Rule requiring doctors to adopt identity theft programs
- AHRQ releases guides on insulin, osteoarthritis
From ACP Internist
- May's ACP Internist is online and coming to your mailbox
From the College
- ACP releases patient resources for managing high blood pressure
From ACP Press
- Annals of Internal Medicine reissues 80 years of landmark papers
- ACP books available on new eBooks Web site
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, ACP Member
Swine flu information from CDC, ACP
ACP Internist has compiled a list of resources to help internists and their patients stay up-to-date about the outbreak of swine-origin (H1N1) influenza A.
According to the CDC, clinicians should suspect swine-origin influenza A (H1N1) in persons with an acute febrile respiratory illness who:
- have had close contact with a person who is a swine-origin influenza confirmed case,
- have traveled to a community domestically or internationally where there are one or more confirmed swine-origin influenza cases, or
- reside in a community where there are one or more confirmed cases.
Patients with uncomplicated disease due to confirmed infection from the virus have experienced fever, headache, upper respiratory tract symptoms (cough, sore throat, rhinorrhea), myalgia, fatigue, vomiting or diarrhea. In suspected cases, clinicians should obtain a nasopharyngeal swab, place it in viral transport medium and refrigerate, and notify the state or local health department to facilitate testing. The virus is treated with either zanamivir (Relenza) or a combination of oseltamivir (Tamiflu) and either amantadine (generic) or rimantadine (Flumadine).
The ACP Foundation, in collaboration with ACP, has developed Swine Flu
HEALTH TiPS. HEALTH TiPS are developed at or below a fifth-grade reading level in English and Spanish. The clinical content is evidence-based and tested with patients. A Spanish version is in development and will be available soon.
PIER has produced a Swine Flu State of Emergency table with up-to-date information on this developing situation..
IOM calls for action on conflicts of interest
Physicians, institutions and physician organizations need to make significant changes to reduce conflicts of interest, according to a new report from the Institute of Medicine.
The report calls on physicians to forgo gifts of any amount from medical companies and to decline to publish or present any material ghostwritten or controlled by industry. Interactions with pharmaceutical reps should be limited and samples should be used only for patients who cannot afford medication, the report said.
The recommendations also call for greater disclosure of industry ties. Physicians should notify medical organizations of their financial connections and Congress should require device and drug manufacturers to publicly disclose payments made to physicians, patient groups, academic health centers and professional societies.
The professional societies and other groups that develop guidelines should not accept direct industry funding for the work, the report said. Anyone with a financial conflict of interest should not participate in guideline development. There's also a need for an overhaul of continuing medical education to make it free of industry influence, according to the IOM. The medical profession should adopt these changes voluntarily, or risk having them implemented by legislation, warned the expert panel which wrote the report.
MKSAP quiz: Protecting health care workers against communicable diseases
A 27-year old nurse is to begin working in a physician's office. The physician sees a broad range of patients, many of whom have chronic illnesses. The nurse received all the required childhood vaccinations and was vaccinated against hepatitis B in nursing school.
In addition to vaccination for seasonal influenza, which of the following vaccinations should the nurse receive to help prevent transmission of communicable diseases between patients and health care workers?
A) Hepatitis A
C) Pneumococcal pneumonia
D) Haemophilus influenzae infection
Click here or scroll to the bottom of the page for the answer and critique.
Ovary removal with hysterectomy associated with increased mortality risk
Women who have their ovaries removed at the time of hysterectomy are more likely to die than those who don't, a new study found.
In a prospective, observational study, researchers evaluated 29,380 women from the Nurses' Health Study, 56% of whom had hysterectomy with bilateral oophorectomy, and 44% of whom had hysterectomy with ovarian conservation. Researchers evaluated incident death or events from coronary heart disease (CHD), stroke, breast cancer, ovarian cancer, lung cancer, colorectal cancer, total cancers, hip fractures, pulmonary embolus and all-cause mortality. The study is in the May 2009 Obstetrics & Gynecology.
Bilateral oophorectomy patients were 12% more likely to die during 24-year follow up. They also had a 17% higher risk of CHD, a 14% higher risk of stroke, a 26% higher risk of lung cancer and a 17% higher risk of total cancer. Their risk of breast cancer, however, was 25% lower, and their risk of ovarian cancer was 96% lower. The risk of death, stroke and CHD was higher for those who had their ovaries removed before age 50 and never used estrogen therapy. A subset analysis which excluded women with a family history of ovarian cancer yielded similar results.
Prophylactic oophorectomy, with the goal of improving survival by reducing ovarian cancer, is not supported by the study, the authors noted. About 300,000 U.S. women per year undergo elective oophorectomy, they said. While it appears the procedure shouldn't be standard, women who are at higher risk of ovarian or breast cancer due to family history should still be given the option, said Isaac Schiff, MD, chief of OB/GYN at Massachusetts General Hospital and a Harvard professor, in an April 28 New York Times article.
PSA testing should be offered at 40, individualized to each patient
The American Urological Association (AUA) updated its prostate screening
statement to include men beginning at age 40 and to base the decisions on individual patient factors.
The statement, "Prostate-Specific Antigen Best Practice Statement: 2009 Update," refreshes two aspects of the organization's policy. It sets the earliest age for getting a baseline PSA at 40 years old, and does not set any threshold value for biopsy. While the decision to biopsy should continue to be based on PSA and digital rectal exam results, a doctor and patient should also factor in age, family history, comorbidities and life expectancy.
Also, the statement recommends discussing with men the risks and benefits of testing, as well as the risks of overdetection and overtreatment and all treatment options, including active surveillance. The updated statement is based on a literature review, clinical experience and expert opinion of a multispecialty panel.
PIER's module on prostate cancer screening is available online to ACP members.
Voice response system helps monitor patients on blood thinners
Using an interactive voice response system cuts down on the time it takes medical staff to monitor patients on oral anticoagulants, a new study found.
Researchers recruited 226 patients whose anticoagulation control was stable after at least three months of warfarin therapy. The intervention, which lasted a minimum of three months per patient, involved an interactive voice response system that told patients the results of their international normalized ratio (INR) testing and dosage schedules for anticoagulation therapy. It also reminded patients of upcoming and missed appointments for blood tests. Researchers collected data for each patient for the three months before enrollment, as well. The study is in the April 28 Canadian Medical Association Journal.
Anti-coagulation control among patients in the period before and after the intervention didn't differ. The system did, however, reduce staff workload for monitoring anticoagulation therapy by 33%, or 48 minutes per week, from a baseline of 2.4 hours per week. The voice response system delivered 78% of scheduled dosage messages. The most common reason for staff having to deliver the remaining messages was an INR that was excessively high or low (.5 or more outside therapeutic range). About 77% of patients chose to continue with the voice response system after the study ended.
One study limitation is that most patients had stable anticoagulation control, which is not representative of community-based patients, the authors said. Also, there was no control group. A future randomized trial is needed for more definitive evidence that the technology is effective for monitoring this and other high-risk medication therapies, they concluded.
Annals of Internal Medicine.
News reports often exaggerate the importance of medical research
The news media is often criticized for exaggerating science stories and deliberately sensationalizing the news. However, researchers argue that sensationalism may begin with the journalists’ sources. The researchers reviewed 200 press releases from 20 academic medical centers. They concluded that academic press releases often promote research with uncertain relevance to human health without acknowledging important cautions or limitations. However, since the researchers did not analyze news coverage stemming from the press releases, they could not directly link problems with press releases with exaggerated or sensational reporting. Authors suggest that academic centers issue fewer releases about preliminary research, especially unpublished scientific meeting presentations, to reduce the chance that journalists and the public are misled about the importance or implications of medical research.
Also included in Annals of Internal Medicine
- Molecular markers may help predict prostate cancer mortality. Researchers reviewed health records for 1,313 U.S. veterans with prostate cancer who were at least 50 years old to determine whether certain molecular factors are associated independently with death from the disease. The researchers found that BCL2, p53, or high microvessel density in prostate cancer biopsies is associated with increased risk for death.
- USPSTF reaffirms folic acid recommendations to prevent neural tube defects. In 1996, the U.S. Preventive Services Task Force (USPSTF) recommended that all women who could become pregnant should take a multivitamin supplement containing folic acid. The USPSTF recently reviewed literature published since its last recommendation and concluded that folic acid supplementation clearly reduces neural tube defects. While many foods are now fortified with folic acid, it is not known whether women can get enough folic acid through their diet to prevent defects.
Boxed warning ordered for all botulinum toxin products
All botulinum toxin products must get a boxed warning on their labels and a Risk Evaluation and Mitigation Strategy (REMS) due to reports of serious adverse events, the FDA said last week.
Specifically, reports indicate the effects of the botulinum toxin may spread from the area of injection to other areas of the body, causing symptoms similar to botulism like unexpected loss of strength or muscle weakness, hoarseness or trouble talking, trouble saying words clearly, loss of bladder control, trouble breathing, trouble swallowing, double vision, blurred vision and drooping eyelids. Effects have been reported as early as several hours and as late as several weeks after treatment. Physicians should tell patients to seek immediate medical attention if any of these symptoms develop, the FDA said.
The products affected by the FDA action include Botox and Botox Cosmetic (botulinum toxin type A), marketed by Allergan; Myobloc (botulinum toxin type B), marketed by Solstice Neurosciences; and a new FDA-approved product, Dysport (abobotulinumtoxinA), marketed by Ipsen Biopharm Ltd.
Adverse symptoms have mostly been reported in children with cerebral palsy being treated for muscle spasticity, an unapproved use, although symptoms have also been reported in adults treated for both approved and unapproved uses. Botox, Myobloc, and Dysport are approved to treat cervical dystonia, while Botox Cosmetic and Dysport are approved to treat glabellar lines (frown lines). Botox is also approved to treat primary axillary hyperhidrosis, strabismus and blepharospasm..
OTC pain relievers, fever reducers must revise labels to reflect liver, bleeding risks
All over-the-counter (OTC) pain relievers and fever reducers must revise their labels to include warnings about potential safety risks like internal bleeding and liver damage, the FDA said last week.
Affected products include acetaminophen and NSAIDs, as well as cold medicines that contain fever reducers or pain relievers. The active ingredients of these drugs must also be prominently displayed on the drug labels. The revisions must occur by April 28, 2010.
Taking too much acetaminophen can increase the risk for severe liver damage, as can alcohol use. Stomach bleeding risks may also increase in people who combine NSAIDs with anticoagulants or steroids, take multiple NSAIDs at once, use alcohol, or take NSAIDs longer than directed, the FDA said..
Golimumab approved for three kinds of immune-related arthritis
The FDA last week approved golimumab (Simponi) as a monthly injectable for adults with moderate-to-severe rheumatoid arthritis, active psoriatic arthritis, and active ankylosing spondylitis.
The drug, a TNF-α blocker, is meant for use in combination with methotrexate in patients with rheumatoid arthritis. It may also be used with or without methotrexate for psoriatic arthritis, and alone in patients with ankylosing spondylitis. The most common adverse reactions are upper respiratory tract infection, sore throat and nasal congestion.
Like other TNF-α blockers, golimumab has a boxed warning about the risk of tuberculosis and invasive fungal infections. The drug also has a risk evaluation mitigation strategy (REMS) which includes a Medication Guide for patients and a communication plan to help prescribers understand the drug’s risks..
Libimax supplement recalled for containing tadalafil
Libimax, a libido supplement, is being voluntarily recalled by its manufacturer because it contains tadalafil, the FDA said.
Tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), may interact with the nitrates in some prescription drugs (like nitroglycerin), and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates, and ED is a common problem in men with these conditions, who may seek products like Libimax to enhance sexual performance, the FDA said.
The recalled Libimax is sold as a 1 capsule individual pack, or in 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas and Ohio.
Practice management news.
FTC delays its ‘Red Flags’ Rule requiring doctors to adopt identity theft programs
The Federal Trade Commission will delay enforcement of the new “Red Flags Rule” until Aug. 1, to give physicians more time to develop and implement written identity theft prevention programs. The rule was to have taken effect May 1.
The Fair and Accurate Credit Transactions Act of 2003 (FACTA) directed financial regulatory agencies, including the FTC, to create rules requiring “creditors” and “financial institutions” to identify, detect and respond to patterns, practices, or specific activities that could indicate identity theft. The FTC defined the rule to cover doctors and other professionals who defer payment or bill later for goods or services.
The proposed rule initially went unnoticed by the medical community for several reasons. The rule came from federal agencies that are unlikely sources of health care-oriented regulations, and there was no mention of physicians, medical practices, or health care in the proposed rule. As a result, it went to final publication without comment from the medical societies. The language of the final rule added references to "medical identity theft" and "health care field," garnering the attention of ACP and others who have been negotiating with the FTC on the scope of its impact.
During outreach efforts last year, the FTC staff learned that some industries and entities within the agency’s jurisdiction were uncertain about their coverage under the Red Flags Rule. During this time, FTC staff developed and published materials to help explain what types of entities are covered, and how they might develop their identity theft prevention programs. Among these materials were an alert on the Rule’s requirements, and a Web site with more resources to help covered entities design and implement identity theft prevention programs.
For entities that have a low risk of identity theft, such as businesses that know their customers personally, the Commission will soon release a template to help them comply with the law..
AHRQ releases guides on insulin, osteoarthritis
The Agency for Healthcare Research and Quality (AHRQ) recently released new summary guides for the treatment of diabetes and osteoarthritis. The summary guides are condensed synopses of the available research on a specific condition. The guides are meant to aid both physicians and their patients, and each guide comes in two different versions tailored to each audience. The diabetes guides, Premixed Insulin Analogues: a Comparison with Other Treatments for Type 2 Diabetes for clinicians and Premixed Insulin for Type 2 Diabetes: a Guide for Adults for patients, and the osteoarthritis guides, Three Treatments for Osteoarthritis of the Knee: Evidence Shows Lack of Benefit for clinicians and Osteoarthritis of the Knee: a Guide for Adults for consumers, are all available on the AHRQ Web site.
For more information about the summary guides, and to see other guides produced by AHRQ, please visit online.
From ACP Internist.
May's ACP Internist is online and coming to your mailbox
The May issue of ACP Internist is online. www.acpinternist.org Highlights include:
- Internist follow-up key for breast cancer survivors. Breast cancer survivors may recover from their illness only to face the same diseases as their "well" peers, such as hypertension and diabetes. Experts suggest a shared care model to keep breast cancer survivors healthy.
- It's just old age—or is it? Would you make the same diagnosis in a 50-year-old patient that you would in an 80-year-old? This and a vague history led one internist to press for a better answer to a patient's anemia and sedimentation rate.
- Practice hassles have more docs going locum. Economic factors and bureaucratization are prompting more internists to adopt locum tenens employment as a career path. Read the stories of doctors who have made the switch successfully.
From the College.
ACP releases patient resources for managing high blood pressure
ACP released "Know Your Numbers: A Guide to Managing High Blood Pressure" available for free to ACP member physicians to distribute to patients and their families. The guidebook and accompanying DVD will help patients learn about high blood pressure, what steps to take to control it, and how to lower the risk of heart and blood vessel problems. The guide is sponsored by Daiichi Sankyo, Inc. ACP members can order the guidebook and DVD for free by calling ACP Customer Service at 800-523-1546, extension 2600, or through ACP's
From ACP Press.
Annals of Internal Medicine reissues 80 years of landmark papers
"Landmark Papers in Internal Medicine: The First 80 Years of Annals of Internal Medicine" presents a selection of 33 groundbreaking papers chosen by experts from among the pioneering, influential and most-cited articles published in Annals. Each article is introduced by commentary from a distinguished expert who discusses the article’s importance at the time it was published, how it shaped patient treatment or influenced medical practice, and how the knowledge continues to be significant today. Landmark Papers can be ordered online or by phone at 800-523-1546, ext 2600 (weekdays, 9 a.m. - 5 p.m. ET).
Also, ACP Press' book "Breaking the Cycle: How to Turn Conflict into Collaboration When You and Your Patients Disagree" recently received praise from the Wall Street Journal's blog, "How to Help Patients be Good.".
ACP books available on new eBooks Web site
More than 40 books published by ACP Press are now available for purchase in digital format. Visitors can search the full text of an entire book, view sample pages online before making a purchase, and purchase digital copies of books at reduced prices. A personalized electronic bookshelf allows readers to store, read and manage eBooks, and Flash technology creates an electronic version of each page identical to the equivalent page in print. Users can bookmark pages, add notes, email a selected page to a friend, and place a link to an eBook on their personal blogs or Web sites. The abilities to purchase individual chapters of a book and download an eBook for offline reading are coming soon.
Print versions of books are available through ACP's print product catalog.
Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner.
E-mail all entries by May 21. ACP staff will choose three finalists and post them in the May 26 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the June 2 edition of ACP InternistWeekly. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service..
MKSAP answer and critique
The correct answer is B) Varicella. This item is available to MKSAP subscribers in Infectious Disease section: Item 133.
ACP's Medical Knowledge Self-Assessment Program (MKSAP) allows you to:
- Update your knowledge in all areas of internal medicine
- Prepare for ABIM certification or recertification
- Support your clinical decisions in practice
- Assess your medical knowledge with 1,200 multiple-choice questions
To order the latest edition of MKSAP, go online.
Health care workers should have received up-to-date vaccinations for 1) tetanus and diphtheria; 2) measles, mumps, and rubella; 3) hepatitis B; and 4) seasonal influenza. In addition, even if this person had been given varicella vaccine in childhood, the vaccine should be administered again because a single dose prevents mild disease in only 70% to 80% of persons, and individuals with mild disease are likely to transmit pathogens to susceptible persons via contact or airborne spread. A second dose of vaccine results in 99% seroconversion when given to persons over 13 years of age, and this is presumed to be protective. In the health care setting, the goals of vaccination are to prevent the acquisition of infection in health care workers and to prevent transmission of communicable diseases to patients. Exposures to varicella (chickenpox) can result in morbidity for both patients and health care workers. Health care workers without evidence of immunity (by history or serologic studies) should therefore receive varicella vaccine.
Both pneumococcal and Haemophilus influenza vaccines protect patients from acquiring disease but do not prevent transmission of the infection. Hepatitis A vaccine is reserved for travelers and for persons at high risk of acquiring hepatitis A. It has not been advocated for use in health care workers.
- In the health care setting, the goals of vaccination are to prevent the acquisition of infection in health care workers and to prevent transmission of communicable diseases or increased morbidity in patients.
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About ACP InternistWeekly
ACP InternistWeekly is a weekly newsletter produced by the staff of ACP Internist. It is automatically sent to all College members who have an e-mail address on file with ACP.
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Copyright 2009 by the American College of Physicians.
A 50-year-old man is evaluated in follow-up for a recent diagnosis of cirrhosis secondary to nonalcoholic steatohepatitis. He has a history of asthma, type 2 diabetes mellitus, hyperlipidemia, and obesity. His current medications are inhaled fluticasone, montelukast, insulin glargine, insulin lispro, simvastatin, and lisinopril. Following a physical exam, lab studies, and upper endoscopy, what is the most appropriate treatment?
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