In the News
for the Week of 12-8-09
- HPV vaccine effective for at least 6 years
- ACP supports the importance of scientific evidence in medical decision making
- MKSAP Quiz: tuberculin skin test induces induration
- Sulfonylureas associated with higher CVD, mortality than other diabetes meds
- Simple tool effective in predicting mortality for dialysis patients
- ADT for prostate cancer associated with higher risk of diabetes, heart disease
- Government issues reminder about H1N1 tools, resources
- Depression drug gets cardiac warning
- CMS announces delay to new enrollment policy
From the College
Cartoon caption contest
- Put words in our mouth
Physician editor: Darren Taichman, FACP
HPV vaccine effective for at least 6 years
A vaccine against human papillomavirus (HPV) has sustained efficacy and immunogenicity for more than six years after administration, according to a new study.
The study, conducted by GlaxoSmithKline, included more than 1,000 women, aged 15 to 25, who received either the Cervarix vaccine or a placebo. After 6.4 years of follow-up, the vaccine’s efficacy against incident infection with HPV strains 16 and 18 was 95.3%, and efficacy against persistent (12-month) infection was 100%. The intervention group also had no cases of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) associated with HPV 16/18. In addition, the researchers recorded some cross protection against HPV-31 and HPV-45 and an overall effectiveness of 71.9% against CIN2+ lesions.
The trial also analyzed antibody concentrations and found no evidence of decline between three and six years after vaccination. Safety outcomes were similar between the vaccine and placebo groups and no serious adverse events were found to be associated with the vaccine. The results were published online by The Lancet on Dec. 3.
An accompanying editorial warned that the study was not sufficiently powered to capture any small waning of efficacy, but concluded that the antibody data suggest that the vaccine could be effective for more than 20 years. These findings could answer questions about the appropriate age for vaccination, since a longer duration of efficacy would increase the value of earlier vaccination, the editorialist said..
ACP supports the importance of scientific evidence in medical decision making
In response to criticism and attacks directed at the U.S. Preventive Services Task Force (USPSTF) following the Nov. 17 publication of its breast cancer screening recommendations for women ages 40 to 49, ACP has publicly defended the role of the USPSTF to Congress, the Obama Administration and the public at large. In 2007, ACP released similar breast cancer screening guidelines for women ages 40 to 49, developed by the College’s Clinical Efficacy Assessment Subcommittee (CEAS).
In a Nov. 24 statement, ACP urged Congress, the administration, and patient and physician groups to support the protection of evidence-based research by respected scientists and clinicians from being used to score political points that do not serve the public’s interest. The College also signed a joint letter with other medical associations sent to the House Energy and Commerce Committee addressing misstatements about the task force and highlighting its vital role in determining which clinical preventive services are effective in improving health.
On Dec. 2, former ACP Board of Regents Chair and current member of the College’s Clinical Efficacy Assessment Subcommittee, Donna Sweet, MACP,
testified on behalf of the College and in support of the task force at a hearing on breast cancer screening recommendations. Dr. Sweet told the House Energy and Commerce Committee’s Subcommittee on Health that the controversy over the task force’s breast cancer screening guidelines offers an opportunity to engage individual patients in an informed discussion of the importance of evidence-based clinical efficacy assessments in contributing to better care decisions.
Read more from the College about the nuances of cancer screening from Steven Weinberger, FACP, ACP deputy executive vice president and senior vice president of medical education and publishing, in his column on KevinMD.com, and about the politicization of breast cancer screening from Bob Doherty, ACP’s senior vice president of Government Affairs and Public Policy, in his advocacy blog. Additionally, Annals of Internal Medicine is conducting an online survey about how the new breast cancer screening recommendations will impact practice.
ACP Internist will address practical ways physicians can discuss the new guidelines with their patients in its February issue.
MKSAP Quiz: tuberculin skin test induces induration
A 25-year-old man has a pre-employment physical examination before beginning a medical residency program at an urban teaching hospital. He is from India, where he completed his medical training. He is in good health and takes no medications.
Physical examination is normal. A tuberculin skin test induces 22 mm of induration. The patient subsequently remembers having received bacille Calmette–Guérin vaccine as a child and has a scar on his right shoulder compatible with such a vaccination. A follow-up chest radiograph is normal.
Which of the following is most appropriate at this time?
A) Repeat the chest radiograph in 6 months
B) Obtain an induced sputum sample for Mycobacterium tuberculosis stain and culture
C) Treat with isoniazid for 9 months
D) Treat with isoniazid, pyrazinamide, and ethambutol for 1 month
Click here or scroll to the bottom of the page for the answer and critique
Sulfonylureas associated with higher CVD, mortality than other diabetes meds
Sulfonylureas were associated with higher rates of cardiovascular disease and mortality than other oral antidiabetes medications, according to a new retrospective cohort study.
Medical records for more than 90,000 British people with type 2 diabetes were included in the study, and 3,588 myocardial infarctions, 6,900 cases of congestive heart failure and more than 18,000 deaths were recorded. After controlling for potential confounders, the researchers found that monotherapy with first- or second-generation sulfonylureas was associated with a 24% to 61% excess risk for all-cause mortality compared to metformin, and second-generation sulfonylureas carried an increased risk of congestive heart failure of 18% to 30%.
The study also looked at thiazolidinediones and found no overall association with myocardial infarction. In fact, pioglitazone showed a lower (31% to 39%) risk of mortality than metformin. However, rosiglitazone was associated with a 34% to 41% higher risk of mortality than pioglitazone. The study was published online by BMJ on Dec. 4.
The study authors concluded that sulfonylureas have an unfavorable risk profile compared to metformin, a finding that provides support for existing guidelines favoring metformin as the initial treatment for type 2 diabetes. The difference in risk between pioglitazone and rosiglitazone could also have implications for prescribing, but requires confirmation by other studies, the authors said. Although the analysis was corrected for a large number of potential confounders, the authors noted that residual confounding or confounding by indication cannot be completely excluded.
Simple tool effective in predicting mortality for dialysis patients
A simple five-point prognostic tool was effective in predicting six-month survival of patients with end-stage renal disease, a recent study reported.
Researchers monitored survival for up to 24 months of 512 patients at five dialysis clinics and then tested the prognostic model with a validation cohort of 514 patients at eight clinics. Five variables were independently associated with early mortality: older age, dementia, peripheral vascular disease, decreased albumin and a response of "no" to a “surprise question” (nephrologists were asked "Would I be surprised if this patient died within the next six months?"). The results were published online Dec. 3 in the Clinical Journal of the American Society of Nephrology.
Nephrologists are often hesitant to give a prognosis for dialysis patients due to the questionable accuracy of existing prediction tools, the authors noted. The new predictive model, which showed a relatively high level of accuracy, represents a potentially valuable tool for physicians to identify patients with a poor prognosis who could benefit from palliative care and support services, the authors said.
The surprise question is an innovative aspect of the new model and played a key role in the accurate risk stratification of patients, researchers said. At the end of the study, almost 55% of patients nephrologists classified into the “No” group had died compared with 17% in the “Yes” group.
The new prognostic model is more specific and sensitive than any one of its components and is a significant improvement over existing methods at predicting survival of patients on dialysis, researchers concluded. They noted that future research should focus on other instruments that combine actuarial and clinical estimates of survival.
ADT for prostate cancer associated with higher risk of diabetes, heart disease
Androgen deprivation therapy (ADT) may lead to an increased risk of diabetes and cardiovascular disease in men diagnosed with prostate cancer, a recent study found.
Researchers used Veterans Health Administration data to track outcomes of more than 37,000 men of all ages diagnosed with local or regional prostate cancer between 2001 and 2004. Men treated with androgen deprivation therapy had a significantly increased risk of developing diabetes (159.4 events per 1,000 person-years vs. 87.5 events for no ADT), incident coronary heart disease (adjusted hazard ratio=1.19), myocardial infarction (12.8 events per 1,000 person-years for ADT vs. 7.3 for no ADT), sudden cardiac death (AHR=1.35), and stroke (AHR=1.22). The results were published online Dec. 7 by the Journal of the National Cancer Institute and will appear in the Jan. 6 issue.
While further study is needed, the authors said, the findings suggest that the potential risks of ADT should be weighed against its benefits. So far, the data show that ADT is effective only as secondary treatment in men with locally advanced disease but evidence is lacking on whether it should be used as primary therapy or to treat asymptomatic recurrences based on increasing levels of prostate-specific antigen (PSA). Physicians should use caution in using ADT until these risks and benefits are better defined, the authors suggested.
The study shows how prevalent ADT has become, as almost one-quarter of men younger than 55 and more than half of those older than 75 years received ADT, said an accompanying editorial. It is not known whether the treatment prolonged survival, but the current findings show that ADT has potentially serious negative side effects that should be tested in randomized trials, the editorial said.
With the advent of PSA screening, physicians increasingly are using ADT primarily to treat prostate cancer patients with rising PSA levels rather than to relieve symptoms of advanced disease, the editorial noted. In light of these findings, careful consideration should be given to initiating ADT, the editorial concluded, especially in older men with low-grade disease who may not live long enough to benefit from treatment.
Government issues reminder about H1N1 tools, resources
The Department of Health and Human Services (HHS) has issued a reminder to clinicians, asking them to direct patients to FLU.gov for accurate information about the H1N1 influenza outbreak.
FLU.gov is a one-stop resource with the latest updates on the H1N1 flu. On this site, patients can find information on how to prevent and treat the flu, flu essentials and vaccine safety, and can look up where to get vaccinated in their state by visiting the vaccine locator. The site also allows patients to dispel myths about H1N1 flu and vaccination. In addition, patients can call the 24-7 CDC hotline, 800-CDC-INFO (800-232-4636), available in English or Spanish.
Depression drug gets cardiac warning
A warning has been added to the label for depression medication desipramine hydrochloride (Norpramin), the FDA announced last week.
According to the new safety information, extreme caution should be used when this drug is given to patients who have a family history of sudden death, cardiac dysrhythmias, and cardiac conduction disturbances. The warning also notes that seizures precede cardiac dysrhythmias and death in some patients.
CMS announces delay to new enrollment policy
CMS delayed a new enrollment policy that would have rejected claims submitted by providers whose enrollment records are not current. ACP had previously signed a letter with the AMA and other organizations to let CMS know that implementing the new rule would have impeded patient access to care, bogged down the enrollment system, and presented significant workflow challenges to physicians and other health care practitioners.
In order for an enrollment record to be current, it must be entered in the Medicare Provider Enrollment, Chain and Ownership System (PECOS) and it must also contain provider’s National Provider Identifier (NPI) number. It is estimated that up to 200,000 physicians and other providers have not yet enrolled through PECOS. To check whether your enrollment record is up-to-date, please visit the Internet-based PECOS system on the CMS Web site. Clinicians now have until April 5, 2010 to ensure their records are current.
From the College.
Nominate candidates for upcoming ACP Council Elections
The Council of Young Physicians (CYP), the Council of Associates (COA), and the Council of Student Members (CSM) are currently seeking candidates to fill all vacant seats for 2010-2011.
Each Council meets once a year in Philadelphia and several times via conference call and Webinars and is responsible for contributing to the development of programming and products, creating internal medicine workshops, and advocating for their respective constituencies on Capitol Hill. CYP candidates must be Members or Fellows of the College who are within 16 years of graduating from medical school as of May 1, 2010; COA candidates must be Associate Members of the College; and CSM candidates must be current Medical Student Members..
ACP partner to hold e-health conference
Join national, state and local leaders and policymakers as they debate the current state of health information technology. The eHealth Initiative’s Sixth Annual Conference, of which ACP is a strategic partner, will be held Jan. 25-26 in Washington, D.C.
The conference will highlight examples of e-health programs and will address challenging questions about the country's ability to move toward universal, meaningful use of health information technology.
Registration is online.
Cartoon caption contest.
Put words in our mouth
ACP InternistWeekly wants readers to create captions for this cartoon and help choose the winner. Pen the winning caption and win a $50 gift certificate good toward any ACP product, program or service.
E-mail all entries to email@example.com. ACP staff will choose three finalists and post them online for a vote by readers. The winner will appear in an upcoming edition..
MKSAP answer and critique
The correct answer is C) Treat with isoniazid for 9 months. This item is available online to MKSAP 14 subscribers in the Infectious Disease section, Item 28.
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.
This patient requires treatment for latent tuberculosis with a 9-month course of isoniazid despite his previous inoculation with bacille Calmette–Guérin (BCG) vaccine. Persons who received BCG vaccine usually have a negative tuberculin skin test (as defined by standard criteria) unless they are infected with Mycobacterium tuberculosis or are given a second tuberculin skin test shortly after the first. Occasional persons who have received BCG vaccine may have positive skin test results without having latent tuberculosis. However, no currently available test or prediction rule can distinguish true-positive from false-positive skin test reactivity.
Because a 22-mm test reaction is most likely related to infection rather than to BCG vaccine, this patient should receive a 9-month course of isoniazid. Observing him for 6 months and then repeating the chest radiograph jeopardizes his health as well as the health of his patients. His normal physical examination and chest radiograph help rule out active tuberculosis, and patients with a normal chest radiograph do not require sputum examination. Alternative treatments for latent tuberculosis include rifampin and pyrazinamide for 2 months or rifampin alone for 4 months. Treatment with isoniazid, pyrazinamide, and ethambutol for 1 month is not an acceptable alternative regimen.
Although not listed as an option, blood tests for tuberculosis based on interferon-γ production after exposure to M. tuberculosis are available and have a sensitivity and specificity comparable to tuberculin skin testing. However, these tests have not been as widely used as the tuberculin skin test and are not yet part of algorithms used for prevention and treatment of health care workers with a positive tuberculin skin test.
- No currently available test can differentiate true-positive from false-positive tuberculin skin test reactions in a person who previously received bacille Calmette–Guérin vaccine.
- The recommended treatment for latent tuberculosis is isoniazid for 9 months.
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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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