In the News
for the Week of 5-6-08
- ACP issues new guideline on osteoporosis in men
- AAMC recommends against free lunch and speakers’ bureaus
- Sharing antibiotics and painkillers is common
- Hot flushes can reduce quality of life well after menopause
- Report: Many elderly take inappropriate prescription drugs
Annals of Internal Medicine
- Study finds little difference in drugs for preventing fractures
- Frequent cholesterol measurement may be misleading
- Hydroxyurea reduces pain and hospitalizations from sickle cell disease
- Annals audio summary: Checking lipid levels in patients on statins
- New recommendations on Medicare medical home demonstration project
- High chromium levels found in some Total Body Formula products
- Class I recall of all strengths of Digitek
- FDA rejects two new cholesterol drugs
- FDA approves drug for opioid-induced constipation
- Drug for IBS with constipation approved for adult women
From the College
- New MKSAP® Maintenance of Certification Modules
From ACP Internist
ACP issues new guideline on osteoporosis in men.
ACP has released a new clinical practice guideline on screening for osteoporosis in men, an issue affecting 2 million men in the U.S., according to the National Osteoporosis Foundation.
While few men are tested or diagnosed, studies show that osteoporotic fractures result in substantial disease, death and other health costs for men. "Osteoporosis is not just a women’s disease," said ACP’s Clinical Programs and Quality of Care Senior Medical Associate, Amir Qaseem, MD, PhD. "It is significantly underdiagnosed and undertreated in men."
The guideline calls for physicians to periodically perform individual assessment of risk factors in older men and for clinicians to obtain a dual-energy x-ray absorptiometry (DXA) scan for men who are at increased risk for osteoporosis and who may be candidates for drug therapy. ACP also recommends further research to evaluate osteoporosis screening tests.
Although the prevalence of osteoporosis is relatively low in men compared to women—7% in white men, 5% in African American men and 3% in Hispanic American men—the rates of osteoporosis in men are expected to increase by nearly 50% in the next 15 years as the population ages.
The guideline is published in the May 6 issue of Annals of Internal Medicine.
Dr. Qaseem and Charles Cutler, FACP, discuss the guideline in more detail in the latest ACP Internal Medicine Report.
In other osteoporosis-related news last week:
- The osteoporosis drug alendronate was associated with increased risk for atrial fibrillation in older women, concluded a study in the April 28 Archives of Internal Medicine. The population-based case-control study compared 719 older women who had experienced AF with 966 women who had not. In the first group, 6.5% of women had ever used alendronate compared with 4.1% in the second group. Those who used alendronate were found to have a higher risk (odds ratio, 1.86%) of developing AF than women who had never used a bisphosphonate. An accompanying editorial noted that while the benefits of alendronate may outweigh the risks for women at high risk of fracture, physicians should carefully consider the risks in women at lower risk for fracture and in those with other risk factors such as diabetes, coronary disease or heart failure.
- A study published online May 1 by the Lancet, which involved thousands of men and women from the United Kingdom and other parts of Western Europe, reported a link between two genetic variants and the risk of osteoporosis and bone fracture. The study may help with prevention and screening since the two variants—present together in about one in five white people—can be accurately measured years before fractures are likely to occur. The two variants are in a protein governing bone formation (LRP5) and a receptor involved in bone resorption (TNFRSF11B).
- The FDA approved a once-monthly drug, risedronate sodium (Actonel) for treating postmenopausal osteoporosis. Approval was based on a study that found that a monthly dose of 150 mg achieved similar increases in bone mineral density as a 5 mg daily dose.
AAMC recommends against free lunch and speakers’ bureaus.
The Association of American Medical Colleges called for academic physicians to reject industry-funded gifts, lunches and speakers' bureaus in new recommendations released last week.
Such support from the pharmaceutical industry can influence the objectivity and integrity of academic teaching, learning and practice, concluded the AAMC’s Task Force on Industry Funding of Medical Education. The task force, which had been studying the issue since 2006, proposed a number of specific steps which academic medical centers should take to reduce the interaction between their physicians and the pharmaceutical and device industries.
The recommendations for the medical schools include the following:
- Prohibit the acceptance of gifts, food and travel funding from industry by faculty, staff, students and trainees;
- Centrally manage distribution of pharmaceutical samples, if feasible, or look for an alternative way to manage distribution;
- Restrict pharma representatives’ access to physicians to nonpatient, nonpublic areas and require scheduling by appointment or invitation;
- Strongly discourage faculty participation in industry-sponsored speakers’ bureaus;
- Prohibit physicians, trainees and students from making presentations that have been ghostwritten by any party; and
- Prohibit faculty, students and trainees from attending non-ACCME accredited industry-sponsored education events.
The report’s stand on speakers’ bureaus was particularly strong, since many of the medical schools which currently restrict other contacts continue to allow such industry funding, noted the April 28 New York Times. Chief executives of Pfizer and Eli Lilly, who served on the task force, dissented from the report’s recommendations on speakers’ bureaus. A representative of Amgen endorsed the recommendations but disagreed with the report’s wording on the motives of participants in industry-academic interactions, the New York Times said.
According to the report, the AAMC should collaborate with ACCME to create a process for auditing CME offerings for compliance with guidelines. An expert panel of academic and industry representatives should also be convened to identify best practices in information exchange between academia and industry and to highlight those that are transparent, rely on rigorous evaluation of evidence, and are consistent with the standards of professionalism.
The AAMC report is online.
The New York Times is online.
Sharing antibiotics and painkillers is common.
As many as a quarter of American patients may be sharing their prescription medications with friends and family, according to a new survey.
The survey of 700 people in several U.S. cities found that 22.9% reported having loaned their medications to someone else, 26.9% had borrowed prescribed drugs, and 16% had done both. The most commonly shared drugs were allergy medications (25.3%), painkillers (21.9%) and antibiotics (20.6%). Even more people would be willing to share drugs if certain situations arose, the researchers found. Just under 40% of survey participants said that they would share drugs with a family member, in an emergency, or if they had a prescription but ran out or didn’t have the medication with them. The study was released early online and will appear in the June issue of the American Journal of Public Health.
The sharing of antibiotics is particularly concerning, the study’s lead author said in the April 29 Washington Post. When antibiotics are taken properly, patients should not have any leftover medication, he noted. The improper use of the antibiotics—both by the patient for whom they were originally prescribed and those taking the leftover drugs—could encourage the development of antibiotic-resistant infections.
The research was undertaken to determine whether prescription packaging should contain warnings about the sharing of medication. Although the study indicates that sharing is common practice, such a warning would likely be lost among the other information on medication bottles, the study author said.
The study is online.
The Washington Post is online.
Hot flushes can reduce quality of life well after menopause.
Women can still have clinically significant hot flushes five years after menopause, and more than half of older postmenopausal women can have them after three years, researchers concluded.
Hot flushes affect up to 80% of women one year after menopause, disturbing sleep, interfering with work and leisure activities, and exacerbating anxiety and depression, researchers wrote. They assessed prevalence, severity and three-year change in severity by studying 3,167 older postmenopausal women with osteoporosis enrolled in the Multiple Outcomes of Raloxifene Evaluation (MORE) trial.
In that trial, more than 95% of women were five or more years postmenopausal. Participants' mean age was 67 years, and the mean number of years since menopause was 19. Researchers reported their results in the April 28 Archives of Internal Medicine.
At baseline, 375 women (11.8%) reported experiencing clinically significant hot flushes some, most, or all of the time in the previous six months. More than 20% of women reported clinically significant hot flushes five to nine years postmenopause and nearly 10% did 10 or more years after. Furthermore, more than half of women who complained of significant hot flushes at baseline continued to report persistently bothersome symptoms after three years.
Women were more likely to have clinically significant hot flushes if they were less educated, more recently menopausal, had a hysterectomy or had previously used systemic estrogen. Flushes were also associated with higher body mass index, higher serum FSH levels, and lower serum HDL cholesterol levels. The association with lower HDL cholesterol levels remained significant even adjusting for statin use. The only independent predictors of significant hot flushes after three years were fewer years since menopause and trouble sleeping.
Researchers cautioned that MORE studied mostly white women with preexisting osteoporosis. Results may not be generalizable to different races or to women with preserved bone density who may have different hormone profiles or responses. As well, one of the exclusion criteria for the MORE trial was severe postmenopausal symptoms that required hormone therapy. The study lacked data on how many women were excluded for this reason and may underestimate prevalence.
The study abstract is online.
Report: Many elderly take inappropriate prescription drugs.
A substantial number of Americans age 65 and older say they use at least one prescription drug that is inappropriate for their age, the Agency for Healthcare Research and Quality reported last week.
About a quarter of older Americans with disabilities, and 13% of elderly people without disabilities, use inappropriate drugs, according to an analysis of 2004 data. Thirty-three drugs are deemed inappropriate for people 65 and older, either because they carry a high risk of side effects, are ineffective, or because a safer alternative is available. Examples include alprazolam (Xanax), propoxyphene (Darvon) and meperidine (Demerol).
The analysis also found that use of the drugs was more common among older adults with complex disabilities (27%) than basic disabilities (23%), and that those with a high school education or less were more likely to use inappropriate drugs than those who went to college. The analysis is based on data in the AHRQ’s National Healthcare Disparities Report, which shows disparities in health care access and quality according to race, ethnicity, income and education.
The AHRQ news release is online.
The AHRQ National Healthcare Disparities Report is online.
Annals of Internal Medicine
Study finds little difference in drugs for preventing fractures.
A study of pharmacy records of 43,135 people who began to take osteoporosis drugs between 2000 and 2005 found 1,051 nonvertebral fractures within 12 months and no large differences in fracture risk between those who took risedronate, raloxifene, and alendronate. Those who took nasal calcitonin had more nonvertebral fractures than those who took alendronate.
A study like this one, which uses existing administrative data to compare drugs directly, has important shortcomings: the researchers did not know if patients actually took the medications, could not measure side effects, and did not know why physicians prescribed one medication over another.
An editorial writer says that this study is an attempt to solve a problem in the U.S. drug approval process, which specifies that a new drug be tested against placebo but not against existing drugs. Currently there are several drugs for osteoporosis but no head-to-head trials to guide use. "I propose that we devise an ethical way to prospectively randomly assign patients to different (and apparently equivalent) drug regimens and measure the outcomes of treatment, potential adverse events, drug interactions and costs," the editorialist said.
The current issue of Annals is online.
Frequent cholesterol measurement may be misleading.
Although cholesterol-lowering drugs have become some of the most widely used and expensive pharmaceuticals, guidelines on how often to monitor cholesterol levels while on treatment vary widely, from every four months to annually or as necessary.
Changes in a person’s cholesterol level could be due to random fluctuations or a long-term effect of the drug. A new study involved more than 9,000 people with past heart disease whose cholesterol levels were measured at regular intervals for five years. Researchers found that for the first four years of treatment, fluctuations were greater than the effect, making it difficult to accurately identify someone who needed a change in dose.
The results suggest that frequent testing of cholesterol levels while on treatment will often be misleading. "Current guidelines that recommend annual or more frequent monitoring (of cholesterol levels) should be reconsidered," the authors said.
The current issue of Annals is online.
Hydroxyurea reduces pain and hospitalizations from sickle cell disease.
A review for a consensus conference on hydroxyurea for treatment of adults with sickle cell disease found the drug increases fetal hemoglobin, reduces frequency of extreme pain crises, reduces frequency and/or length of hospital admissions, and reduces the need for transfusions. Hydroxyurea is a chemotherapy agent that affects the bone marrow. Approved by the FDA in 1998 for treatment of adults with sickle cell disease, hydroxyurea remains the only approved disease-modifying therapy. This article is posted online and will appear in the June 17, 2008, print edition of the journal.
Annals audio summary: Checking lipid levels in patients on statins.
In this week's audio summary, Paul P. Glasziou, PhD, of University of Oxford, U.K., discusses optimal lipid monitoring intervals, and introduces the idea of evidence-based medical monitoring. The podcast, which also includes a summary of all the articles in the current issue, is available online or on iTunes.
New recommendations on Medicare medical home demonstration project.
The American Medical Association/Specialty Society Relative Value Scale Update Committee (RUC), last week issued recommendations on the Medicare medical home demonstration project. This project is designed to test the medical home model of patient care; it would provide targeted, accessible, continuous, and coordinated family-centered care to Medicare beneficiaries with at least one chronic disease.
The medical home demonstration project was mandated by Congress in the Tax Relief and Health Care Act of 2006. This is the same legislation that provided an update to Medicare payments to physicians in 2007. The legislation directed CMS to conduct a three-year project in a limited geographic area that includes a care management fee to physicians that participate in the program. The project is set to begin in 2009. The legislation that created the demonstration project required CMS to ask the RUC to provide recommendations on a value for care management fees associated with participation in the program.
To determine the value for the fee the RUC said that CMS would need to take into account:
- the number of Medicare patients who would agree to participate in the demonstration per participating physician;
- the amount of time per patient, per month that a physician would spend on care coordination activities related to the medical home project; and,
- direct practice expenses such as staff time, medical supplies, and health information technology.
J. Leonard Lichtenfeld, MACP, served as a representative for ACP to the RUC workgroup that developed the recommendations that were presented to the full RUC and eventually to CMS.
The RUC recommendations indicate that substantial physician and nurse time will be required for a practice to serve as a medical home and that time should be recognized in the eventual fee which is set for the service by CMS. The RUC, which is composed of members representing many different medical and surgical specialties, unanimously supported this recommendation.
The complete recommendations from the RUC can be found on the AMA website.
High chromium levels found in some Total Body Formula products.
Harmful levels of chromium have been detected in certain flavors of "Total Body Formula" and "Total Body Mega Formula," supplements that are already being recalled due to hazardous selenium levels.
The affected products are the Tropical Orange and Peach Nectar flavors of Total Body Formula, and Orange/Tangerine flavor of Total Body Mega Formula. In analyzing samples, the FDA found up to 17 times the recommended chromium intake of 35-45 micrograms per day.
Excess chromium consumption can cause fatigue, muscle cramps, hyperactivity, hypoglycemia, renal failure and liver toxicity. It can also interfere with some medications. At least 195 people have had adverse reactions to the supplements, including hair loss, deformed fingernails and diarrhea. The FDA is still investigating how the excess chromium and selenium got into the supplements.
The FDA release is online.
Class I recall of all strengths of Digitek.
Actavis Totowa LLC issued a Class I recall of all strengths of digoxin (brand name: Digitek) due to the potential that some tablets may contain double their approved strength.
Specifically, tablets with double the appropriate thickness may contain twice the approved level of active ingredient. Double strength tablets pose a risk of digitalis toxicity in patents with renal failure; digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. There have been several reports of illnesses and injuries associated with the drug, the FDA said.
The FDA safety alert is online.
FDA rejects two new cholesterol drugs.
The FDA rejected two new cholesterol drugs, ER niacin/laropiprant (brand name: Cordaptive) and mipomersen, saying they needed more information on them.
The agency said the application for ER niacin/laropiprant, which lowers LDL and raises HDL, needed more information, the April 29 Washington Post reported. The agency also rejected the brand name "Cordaptive," so the makers plan to resubmit an application with the new name "Tredaptive," the Washington Post said.
One business day earlier, the agency told the makers of mipomersen that they must conduct a large-scale study to see if patients taking the drug not only have lower cholesterol levels, but also live longer or have fewer heart problems. The research will delay the drugs’ launch by several years, according to the Washington Post.
The value of newer cholesterol drugs is under debate following a January study that showed Vytorin—which combines ezetimibe (Zetia) and simvastatin (Zocor)—doesn’t reduce plaque any more than simvastatin alone, though it does produce lower cholesterol levels. Some observers say the FDA appears to be setting a higher standard for determining a cholesterol drug’s effectiveness in the wake of those results, said the Washington Post.
FDA approves drug for opioid-induced constipation.
The FDA approved methylnaltrexone bromide (Relistor) to restore bowel function in patients with late-stage, advanced illness who are continuously receiving opioids.
Opioids can relax the intestinal smooth muscles and prevent them from contracting and pushing out waste products. Methylnaltrexone bromide blocks opioid entrance into the cells, allowing normal function.
Methylnaltrexone bromide is a once-daily injectable medication, with a starting schedule of one dose every other day as needed for patients with late-stage advanced illness. It is not recommended for patients with known or suspected intestinal obstructions. Common side effects include abdominal pain, gas, nausea, dizziness and diarrhea.
Drug for IBS with constipation approved for adult women.
The FDA approved lubiprostone (Amitiza) for irritable bowel syndrome with constipation for adult women. A higher dose had been approved in 2006 for chronic idiopathic constipation in adult women and men. It's efficacy for the latest indication wasn't proven for men.
The new approval involves an 8-microgram dose twice daily with food and water. Common side effects include nausea, diarrhea, and abdominal pain. Less frequent effects include urinary tract infections, syncope, peripheral edema, dyspnea and heart palpitations. It should not be used in patients with severe diarrhea or bowel obstruction. Its safety and efficacy has not been established in patients with renal or hepatic impairment or in pregnant or nursing mothers.
The FDA press release is online.
From the College
New MKSAP® Maintenance of Certification Modules.
Eight new Maintenance of Certification Modules (MOC II) for the 14th edition of MKSAP (Medical Knowledge Self-Assessment Program), are now available to subscribers.
The new MKSAP MOC II Modules test knowledge of multidisciplinary office-based and inpatient care, evidence-based critiques providing immediate feedback, and explanations for correct and incorrect options. They also provide an alternative option for earning Self-Evaluation of Medical Knowledge points toward completion of the ABIM Maintenance of Certification program, as well as evidence-based rationales for the correct answers upon successful completion of the ABIM Module.
The new option for earning points allows users to earn 10 Self-Evaluation of Medical Knowledge points for up to 80 points, or to combine the modules with ABIM Medical Knowledge points, including the new ABIM Annual Update Modules. Each module offers fewer points than each of the original MKSAP MOC Modules (10 instead of 20) but involves fewer questions (25 instead of 60), as the MKSAP MOC II Modules are modeled after the ABIM Update Modules, each of which also involves 25 questions and 10 Self-Evaluation of Medical Knowledge points.
The original MKSAP MOC Modules will remain available until July 1, 2008 if you are a MKSAP 13 or MKSAP 14 subscriber. If you are not currently a MKSAP subscriber and would like subscribe, you can register online.
From ACP Internist
The latest issue of ACP Internist is online.
The latest issue of ACP Internist is online and in your mailbox. Check out this month's issue for stories on:
- Behavioral Economics. Why do patients choose short-term indulgences instead of long-term health? An economic theory explains how doctors can suggest small and easy changes for healthier lifestyles.
- Stroke management. Education about symptoms should target office staff with patient contact, as well as patients and relatives of those at risk. And, conference coverage focuses on studies about abdominal obesity, symptoms and the importance of dialing 911 first.
- Mindful Medicine. Experts in the art of diagnosis tackle "search satisfaction," one of the ways that radiologists can overlook a second detail after finding the first one, and suggest ways that internists can better present material for a consult.
ACP Internist is online.
Cartoon 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 to email@example.com by May 8. ACP staff will choose three finalists and post them in the May 13 issue of ACP InternistWeekly for an online vote by readers. The winner will appear in the May 20 issue.
Pen the winning caption and win a $50 gift certificate good for any ACP product, program or service.
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.
To add your e-mail address to your member record and to begin receiving ACP InternistWeekly, please click here.
Copyright 2008 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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