In the News for the Week of 3-20-07
- FDA: Strengthen warnings for sleep aids
- Anemia drugs targeted for Medicare review
- CDC recommends HPV vaccination
- Match Day 2007 shows only slight rise in internal medicine matches
- Annals of Internal Medicine:
- Rheumatoid arthritis responds to flexible drug regimen
- Osteoporosis drug strengthens bones in men with prostate cancer
- Patients’ treatment expectations are usually met
- Weekend heart attacks more likely to result in death
Warning labels should be strengthened for 13 sedative-hypnotic sleep aids to highlight risks like anaphylaxis and driving while not fully awake, the FDA told drug manufacturers last week.
Other possible side effects, which can occur even the first time a product is taken, include angioedema and complex sleep-related behaviors like making phone calls, having sex and preparing and eating food while asleep, the FDA said. Manufacturers are sending letters to providers about the new warnings, and have been asked to develop Patient Medication Guides to inform consumers about risks and advise them of precautions, the FDA said. It also asked the drug makers to conduct clinical studies on how often the sleep-related behaviors occur.
The label revisions apply to the following drugs:
Zolpidem (Ambien/Ambien CR)
Butabarbital (Butisol Sodium)
Flurazepam Hydrochloride (Dalmane)
The FDA has uncovered more than a dozen reports of “sleep driving”-- driving while not fully awake and without subsequent memory, said Dr. Russell Katz, the FDA’s director of neuropharmacological drug products, in the March 14 Washington Post.
The FDA release is online.
The Washington Post is online.
CMS has announced it will review the use of anemia drugs darbepoetin alfa (Aranesp) and epoetin alfa (Epogen and Procrit) in response to a recent FDA-issued public health advisory and black box warning. The drugs, known as erythropoiesis-stimulating agents (ESAs), are widely used in patients with chronic kidney failure and in patients with anemia caused by chemotherapy.
The FDA strengthened safety labeling on the drugs on March 9, based on recent studies finding an increased risk of death, blood clots, stroke and heart attacks in kidney failure patients given higher than recommended doses of the drugs. Additional studies found that recommended doses resulted in an increased risk of death in cancer patients not receiving chemotherapy and more blood clots in patients after orthopedic surgery, the FDA said.
Based on the findings, the new black box warning advises physicians to monitor hemoglobin and adjust ESA doses to maintain the lowest hemoglobin level needed to avoid the need for blood transfusions. On March 14, CMS officials announced plans to review the appropriate use of ESAs, particularly for conditions other than end-stage renal disease. Epogen is Medicare’s single biggest drug expense, noted the March 15 New York Times.
The Renal Physicians Association has also responded to the FDA action, issuing a statement that cautions physicians about changing anemia management regimens. The FDA advisory may be misleading and could lead to unacceptably low hemoglobin levels in patients with chronic kidney disease and end stage renal disease, the statement said. The RPA recommends that risks and benefits for ESA use be considered on an individual patient basis by physicians.
The FDA advisory is online.
The CMS press release is online.
The Renal Physicians Association statement is online.
The CDC last week officially recommended HPV vaccination of females aged 11-26, in a statement published in Morbidity and Mortality Weekly Report.
The new report includes the findings of the CDC’s Advisory Committee on Immunization Practices, which last October proposed routine vaccination of 11 and 12 year old girls and catch-up vaccinations for females age 13-26. The ACIP’s recommendations become CDC policy after publication in the MMWR.
The March 12 report noted that the vaccine (Gardasil) is FDA-approved for females 9-26 years, but recommended routine vaccination of 11 and 12-year-olds based on clinical trials which found high antibody titers after vaccination in girls of that age, as well as data on HPV epidemiology and average age of sexual debut in the U.S.
The CDC also suggested catch-up vaccinations of 13-26 year-olds, noting that ideally the vaccine should be administered before sexual contact, although sexually active females can also benefit from vaccination. The vaccine offers an opportunity to decrease the burden of HPV infection, cervical cancer and its precursors, anogenital cancers and genital warts, the CDC concluded.
State legislatures around the country continue to debate mandatory HPV vaccination. Texas is the only state to require vaccination currently, by governor’s order; however, the state House voted last week to halt any mandatory vaccination programs. State legislatures in New Mexico and Virginia passed mandatory vaccination laws last week, both of which are expected to be signed by the state’s respective governors, the March 12 Boston Globe reported.
The MMWR is online.
The Boston Globe is online.
The March ACP Observer has more information about the HPV vaccine.
The number of medical students choosing internal medicine residencies stayed about the same this year compared with 2006, according to results from the 2007 residency match. The results underscore the need to redesign internal medicine training and fundamentally change the way that primary care is organized, delivered, financed and valued, said College leaders.
In the National Resident Matching Program (NRMP) held on March 15, 2,680 American medical students matched with categorical internal medicine training programs, slightly higher than the 2,668 matches last year. Overall, more than 98% of internal medicine positions matched and 56% of those were filled by U.S. medical school graduates.
ACP has cautioned that unless there is an increase in the number of medical students choosing internal medicine careers, there will not be enough internists to care for an aging population, which will result in lower-quality care, diminished access to care, higher costs, and decreased patient satisfaction. The college also calls for a redesign of training in internal medicine to ensure that tomorrow's internists meet the challenges of both an expanding body of medical knowledge and a rapidly evolving system of health care delivery.
According to Steven E. Weinberger, FACP, ACP's senior vice president for medical education and publishing, "If trends continue, there will not be enough general internists to take care of an aging population with growing incidences of chronic diseases. The health care system will become increasingly fragmented, over-specialized and inefficient - leading to poorer quality care at higher costs."
The NRMP is online.
An ACP press release is online.
The following articles appear in the March 20, 2007 issue of Annals of Internal Medicine. This issue also includes an article about conducting timely and effective discussions about hospice with dying patients. The full text is available to College members and subscribers online.
Flexible use of drugs with close patient follow-up can successfully control rheumatoid arthritis. In the second year of a study of treatments for early rheumatoid arthritis, 508 patients were assigned to one of four treatment groups using standard arthritis drugs. The disease status of all groups was evaluated every three months and medications were adjusted according to a protocol. All groups improved and maintained improvement during the second year. The two groups that began with combinations of drugs improved the fastest and had less damage to the arthritic joints. An editorial writer said the study shows that most patients with early rheumatoid arthritis will preserve a high quality of life if clinicians have the flexibility to change therapy, maintain close contact with patients, and adjust therapy in a timely fashion until patients have achieved low levels of disease activity or are in remission.
Osteoporosis drug strengthens bones in men with prostate cancer A small trial of 112 men with prostate cancer who were receiving androgen deprivation therapy found that men assigned to take an oral dose of alendronate had less bone loss or bone turnover and increased bone mineral density of the spine and hip at the end of one year than men assigned to a placebo. Androgen deprivation therapy involves reducing hormones such as testosterone that encourage cancer growth. Alendronate, a bisphosphonate, is best known as an anti-osteoporosis drug. The groups did not differ significantly in adverse side effects. The study was not designed to show whether alendronate reduces fractures.
The varicella vaccine loses effectiveness against the chickenpox virus five years after vaccination, a new study found. The findings support current recommendations that all children receive a vaccine booster.
Researchers looked at 10 years of surveillance data (from 1995 to 2004) among 350,000 subjects to determine whether the severity and incidence of breakthrough varicella increased with time since vaccination. They found that the vaccine reduced the number of varicella cases by 85% over the time period, but that 9.5% of infections occurred in vaccinated subjects. The annual rate of breakthrough cases significantly increased with time from vaccination, from 1.6 cases per 1000 person-years within 1 year of vaccination to 58.2 cases after 9 years.
The study also found that children who had been vaccinated more than 5 years before infection had more severe cases. Children between 8 and 12 with more than 5 years since vaccination were twice as likely to have moderate-to-severe breakthrough disease as those less than 5 years past vaccination. The study was published in the March 15 New England Journal of Medicine.
Preliminary findings from this study led the CDC’s Advisory Committee on Immunization Practices to recommend last year that children between 4 and 6 years old receive a second dose of the varicella vaccine. The panel also recommended that catch-up doses be given to children, adolescents and adults who previously received one dose. No long-term data are available on the duration of immunity afforded by the second dose of the vaccine, study authors noted.
The New England Journal of Medicine is online.
Lapatinib, a new targeted anti-cancer drug, has been approved by the FDA for treatment of advanced HER2 positive breast cancer. The drug (brand name Tykerb) is to be used in combination with capectabine (Xeloda) in women who have received prior therapy with other drugs, including anthracycline, taxane and trastuzumab.
The approval is based on a randomized clinical trial in 400 women with advanced or metastatic HER2 positive breast cancer. Patients receiving lapatinib with capectabine had statistically significant improvement in time to tumor progression compared with capectabine alone, the FDA said. Women on combination therapy had a delay of about seven months compared with about five months with just capectabine, the March 15 Washington Post said. Survival data from the study is not yet available.
The drug works differently from current treatments by entering the tumor cell to block function of the HER2 protein, making it effective in some cancers that have been treated with trastuzumab and are no longer responding. Manufacturer GlaxoSmithKline said that the drug will be available in about two weeks and will cost $2,900 a month, the Washington Post reported.
The FDA release is online.
The Washington Post is online.
Patients’ expectations for specific tests, medications or referrals during a primary care visit are met two-thirds of the time, according to a study published in the March 12 Archives of Internal Medicine.
Researchers interviewed patients in waiting rooms before their visits about expectations, and the visits were then recorded on audiotape. Out of 200 clinical encounters, 256 expectations were expressed by direct patient request 41% of the time, by mentioning symptoms 30% of the time, and by doctor initiation 27% of the time. Expectations for medication were met 76% of the time and for tests 71% of the time, compared with 41% of the time for referrals.
Physicians said they wouldn’t have fulfilled 45% of the requests had patients not asked directly, and they were uncomfortable with agreeing to 12.9% of requests, but did it anyway. Patients who voiced requests directly got what they wanted 78% of the time, compared with 50% of those who expressed requests indirectly by mentioning symptoms. Patients were more prone to directly ask for medications and tests than referrals. Those whose expectations weren’t met said their physicians gave them a reason 73% of the time, and 95% of the time that reason was satisfactory.
The study came on the heels of an advertising campaign launched by the federal Agency for Healthcare Research and Quality this month to encourage adults to be more proactive in their health care. Aimed at helping prevent the medical mistakes that kill at least 120 people per day, the campaign advises patients to bring a list of questions to each medical appointment, take notes in the exam room, make sure they receive test results and make sure they understand doctors’ instructions upon leaving the hospital. Patients can create a customized list of questions for appointments at www.ahrq.gov/questionsaretheanswer.
On a related note, a Wall Street Journal/Harris Interactive poll found that 44% of Americans say they or an immediate family member have ignored a physician’s treatment or sought a second opinion because they felt the doctor’s orders were unnecessary. Twenty-seven percent have left a prescription unfilled; 20% have sought a second opinion about a diagnostic test; 7% have opted against a surgical procedure; and 7% have changed doctors because a recommended treatment seemed too aggressive, according to the March 15 Wall Street Journal.
The Archives of Internal Medicine is online.
The AHRQ release is online.
The Wall Street Journal is online (subscription required).
Heart attack patients admitted to the hospital on weekends are more likely to die and less likely to undergo invasive cardiac procedures, a new study in the March 15 New England Journal of Medicine found.
Researchers studied 231,164 patients admitted to New Jersey hospitals between 1987-2002 for first-time acute MI. They looked at trends over four-year periods, in part to account for advances in treatment over time. In the most recent four-year interval, patients seen on weekends were 7.5% more likely to die within 30 days than those admitted on weekdays. The difference became significant the day after admission, and remained so after one year.
Adjusted for age, medical problems and site of MI, the rate was still 5% higher if admitted on a weekend, but the difference became non-significant after adjusting for invasive cardiac procedures. Death rates for most other four-year time spans yielded similar results. Weekend patients were less likely to undergo invasive cardiac procedures, especially in the first two days of hospitalization, with weekend patients one-third less likely to get percutaneous coronary intervention (PCI) on admission, for example. The number of days between admission and performance of catheterization, PCI or CABG was also higher for weekend patients than for weekday patients.
The study’s main limitation was that unmeasured factors, such as medications administered or time from the onset of symptoms, may have contributed to mortality differences between weekend and weekday patients, the authors said. Strengths include a large sample and the absence of patient selection.
“Our study suggests that a hospital workweek of Monday through Friday is not optimal for the care of patients with acute myocardial infarction,” the authors said, adding that better staffing or regionalization of care may prevent deaths.
The New England Journal of Medicine is online.
The Washington Post is online.
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Copyright 2007 by the American College of Physicians.
A 69-year-old woman is evaluated for a lump under her arm found on self-examination. She is otherwise healthy and has no other symptoms. Medical and family histories are unremarkable, and she takes no medications. A needle aspirate of the right axillary mass reveals adenocarcinoma. Bilateral mammography and breast MRI are normal. CT scan of the chest, abdomen, and pelvis demonstrates the enlarged axillary lymph node and no other abnormalities. What is the most appropriate initial treatment?
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