In the News for the Week of 10-17-06
- Manufacturer to cap price of costly cancer drug
- Study reports slow adoption of EHRs
- More veterans seeking mental health treatment
- Annals of Internal Medicine:
- Antibiotic improves symptoms of IBS.
- High risk of reinfection with sexually transmitted infections
- Atypical antipsychotics have little effect on Alzheimer’s
- Drug-eluting stents raise concerns
- NCHS fellowships for health service researchers
- ACP’s Center for Practice Innovation completes site visits
- ACP urges CMS to continue support for preventive health benefits
- ACP joins coalition for Peripheral Artery Disease awareness
Genentech announced last week that it will begin capping the cost of its cancer drug, bevacizumab, for patients below a certain income level. The drug treats colorectal cancer and was recently approved to treat advanced non-small-cell lung cancer.
The drug will be capped at $55,000 a year for patients, said the Oct. 12 New York Times. Eligibility criteria have not yet been set, but the cap would likely apply to patients with annual incomes of $75,000 per year, or higher.
Bevacizumab costs about $4,400 a month for colorectal cancer patients but double that amount to treat non-small-cell lung cancer, which requires higher dosages. The cap will cover spending by all payers, including Medicare and private insurers, not just patients' out-of-pocket costs.
Currently many patients taking bevacizumab do not live long enough to meet the spending cap—in clinical trials, lung cancer patients had a median survival of 12.3 months, said the New York Times. However, the drug is also expected to be approved for breast cancer and earlier stages of lung and colon cancer.
Genentech officials said they had been working on the plan for the past year, before the drug’s price became a target of criticism from physicians, politicians and patient advocates. In a similar move, Amgen recently announced that the out-of-pocket cost of panitumumab, its newly approved colorectal cancer treatment, will be capped at 5% of patients’ adjusted gross income.
The New York Times is online.
A new study found that about one in four U.S. physicians use some form of electronic health records (EHRs), but that fewer than one in 10 have fully operational systems.
The study, funded by the Robert Wood Johnson Foundation, also found that:
- Solo practitioners or two-physician practices were much less likely to use EHRs than larger practices
- Doctors based in urban areas were more likely to use EHRs than those in rural communities
- Physicians in the West were more likely to have EHRs than those in the South, Midwest or Northeast
- EHR use was greater among physicians with who treat fewer Medicaid patients
Researchers defined fully operational systems as those that collect patient information, display test results, help with treatment decisions and allow documentation of prescriptions and medical orders, said the Oct. 12 Washington Post. The study, conducted by researchers at Massachusetts General Hospital and George Washington University, based its findings on an analysis of dozens of surveys of EHR use conducted since 1995.
Reasons for the slow adoption rate included the cost of purchasing systems as well as workflow disruptions caused by implementation, said the Washington Post. The report was commissioned as a benchmark to track EHR adoption in the U.S. healthcare system.
The full study report is online.
The Washington Post is online.
The number of Iraq and Afghanistan veterans seeking mental health treatment increased tenfold between January 2005 and June 2006, according to a recently released report from the Veterans Health Administration.
Of the approximately 184,000 veterans of the two wars who have received VA health care, nearly 64,000 of them exhibited symptoms of post-traumatic stress disorder (PTSD), drug abuse or other mental issues. Almost half of those had possible PTSD, the Oct. 13 Washington Post said.
VA and Defense Department officials attributed the increase in part to efforts to destigmatize mental health issues and train commanders and medical personnel to recognize symptoms. Officials also said the statistics overestimate the number of troops suffering from mental health disorders and that most veterans are suffering normal reactions to war, such as flashbacks and trouble sleeping.
The VA has increased mental health funding by hiring 100 new counselors, designating $300 million for PTSD treatment in 2005-06, and requesting another $300 million for 2007.
The Washington Post is online.
For more information on treating veterans with PTSD, see the July/August 2006 ACP Observer online.
The following articles appear in the Oct. 17 issue of Annals of Internal Medicine. This issue includes a study about the effect of rifaximin on irritable bowel syndrome. The Full text is available to College members and subscribers online.
Antibiotic improves symptoms of IBS. A study of 87 patients with irritable bowel syndrome found greater global improvements in symptoms and less bloating using rifaximin compared with placebo. The randomized, double-blind study is the first to demonstrate a sustained benefit of antibiotics for IBS symptoms after treatment is stopped. In the study, patients took the antibiotic or placebo for 10 days and reported their symptoms for the next 10 weeks. More than 50% improvement in symptoms was reported by more patients who took rifaximin (37.2%) than by those who took placebo (15%). However, the researchers did not detect a difference in symptoms of diarrhea or constipation.
High risk of reinfection with sexually transmitted infections. A study of 2,419 people treated for chlamydia, gonorrhea, or vaginosis (women only) at three urban STD clinics found that 25.8% of women and 14.7% of men became reinfected with one or more of the sexually transmitted infections within a year. Approximately 66% of reinfections were asymptomatic. New infection was more common among participants who had a new partner or had more than one partner. The researchers recommend that patients diagnosed with chlamydia, gonorrhea, or vaginosis should return in three months for rescreening because they are at high risk for new asymptomatic sexually transmitted infections.
A new study of 421 Alzheimer’s patients found that adverse effects offset the advantages of atypical antipsychotics for the treatment of psychosis, aggression and agitation, except in a small subgroup of patients. The study found that olanzapine, quetiapine and risperidone were no more effective than placebo for most patients.
The main outcome of this double-blind study, published in the Oct. 12 New England Journal of Medicine, was the time from initial treatment to the discontinuation of treatment for any reason. Overall, no significant differences were noted among the groups with regard to improvement on the Clinical Global Impression of Change (CGIC) scale at 12 weeks.
Although about 80% of all patients discontinued treatment within the 12 weeks, those who took the drugs instead of placebo were significantly more likely to discontinue due to adverse events or intolerability, reported the Oct. 12 New York Times.
The researchers reported that the drugs were effective for a subgroup of patients who either tolerated or did not have side effects, such as parkinsonism or sedation. Among those patients, olanzapine and risperidone were equally effective and superior to placebo and quetiapine. The study’s findings suggest that the drugs have a limited, but necessary, role in the treatment of Alzheimer’s disease, and are best used in systems of care that can provide the expertise to ensure that the drugs’ risks are justified by the benefits, said an accompanying editorial.
In April 2005, the FDA issued a public health advisory requiring that all atypical antipsychotics, none of which are approved for treatment of dementia, carry a warning about the drugs’ cardiovascular risk.
The full study is online.
The New York Times is online.
For more information on the topic, see the July/August 2005 ACP Observer online.
The authors of a new editorial argue that drug-eluting stents (DES) are not worth the risk for most patients. The editorial, published on the Web site of the American College of Cardiology, finds that the increased risk of stent thrombosis in DES patients outweighs the benefits of reduced restenosis.
As evidence, the authors cite a recent study, which tracked stent thrombosis rates over three years in 8,000-plus patients enrolled in studies in Holland and Switzerland. That study found that while initial thrombosis rates are similar in patients receiving DES and bare-metal stents (BMS), over time the use of DES increases patients’ risk of getting a clot by 0.6% annually. Based on use of DES in the U.S. and the fatality rates of thrombosis, the authors projected that approximately 2,160 deaths per year in the U.S. are attributable to stent thrombosis.
DES is the proper treatment for many patients, but is too frequently used in cases where BMS or drug therapy would be safer, the editorial authors told the Oct. 12 New York Times. The widespread off-label use of DES—which they put at nearly 80%--concerns them, as well as the tendency of patients not to adhere to antiplatelet therapy.
In conclusion, the editorial advocates initial DES use in selective patients at high risk for restenosis, provisional or bailout use in those who present with restenosis following BMS, and strict avoidance of DES in patients unable or unlikely to comply with long-term dual antiplatelet therapy. This December, the FDA plans to convene a panel to review data on DES and determine whether changes in labeling and use are needed.
The editorial is online.
The New York Times is online.
The National Center for Health Statistics is now accepting applications for its 2007 fellowship. The program, sponsored by NCHS and AcademyHealth, brings visiting scholars in health services research-related disciplines to the NCHS to collaborate on studies of interest to policymakers and the health services research community using NCHS data systems. Fellows can access the data resources provided by the CDC and participate in developmental and health policy activities related to the design and content of future NCHS surveys.
Applicants must have training or experience in health services research. They can be at any stage in their careers from doctoral students to senior investigators; however doctoral students must have completed course work and be at the dissertation phase. All applicants must be U.S. citizens, permanent residents, or able to acquire a valid work authorization.
Fellows will reside in Hyattsville, Md., for a duration of 13-24 months beginning September 2007. The application deadline for the program is Jan. 8, 2007.
More information and applications are online.
ACP’s Center for Practice Innovation (CPI) has completed the first round of site visits to 34 practices participating in a pilot project to test practice redesign strategies.
The CPI was funded with a grant from the Physicians’ Foundation for Health System Excellence in January 2006. The center is an effort by ACP to address some of the many needs of small and medium-sized internal medicine practices. The goal of the pilot project is improve clinical quality while addressing the impact of redesign strategies on patient satisfaction, safety, the economics of practice and the adoption of health information technology.
The purpose of the initial visits was to observe how the practices are currently operating. CPI staff asked the practices to select two significant workflow or practice efficiency projects to focus on during the course of their participation in the project.
Initial observations about the practices revealed that 41% of the practices are family-run businesses. That means that in addition to the key physician, at least one of the other major members of the team is a family member. Also, approximately 50% of the practices had at least one non-family staff member who had worked with them for more than eight years.
Within these practices, technology implementation has been difficult. While 30% of the participating practices have electronic medical records, there is a wide range in the usefulness of the systems. Additionally the CPI staff has seen considerable anxiety about software upgrades from vendors, a potentially large cost.
More information about the CPI is online.
In an Oct. 9 letter to Mark McClellan, MD, PhD, administrator of the Centers for Medicare and Medicaid Services, ACP provided comments on the proposed 2007 Physician Fee Schedule and pointed to two specific changes that could negatively impact the intended improvement in screening services.
Joseph W. Stubbs, FACP, chair of ACP’s Medical Services Committee, specifically pointed to concerns ACP had with two different proposals legislatively mandated by the Deficit Reduction Act (DRA) of 2005. The proposals introduce an abdominal aortic aneurysm screening benefit and eliminate the patient deductible for colorectal screening.
In the letter, Dr. Stubbs also supported increased access to abdominal aortic aneurysm screening and colorectal screening. He noted that it was important to ensure that patients receive the full benefits to which they are entitled by recognizing the work of physicians in coordinating and encouraging these services.
If physicians are reimbursed for the important work that they do in coordinating these important preventive health services, they will be more likely to spend the time to encourage patients to receive these services, said Dr. Stubbs.
The full text of the letter is online.
Peripheral artery disease (PAD) affects one in every 20 Americans over the age of 50, yet it is often mistaken for the natural signs of aging or arthritis. September marked the launch of “Stay in Circulation: Take Steps to Learn about PAD,” the first ever PAD national awareness campaign sponsored by the National Heart, Lung, and Blood Institute (NHLBI) in partnership with the PAD coalition of over 40 national organizations and professional societies, including ACP.
Historically, PAD has not garnered much of the spotlight despite its prevalence—up to 12 million Americans suffer from it. The disease’s expansive nature also detracts from awareness. Because PAD spans so much of the body (all of the arteries below the heart), diagnosis and treatment are often split among a multitude of medical specialties.
The ACP is a national collaborator in the campaign to increase public and health care provider awareness of PAD and its association with increased risk for cardiovascular disease. The “Stay in Circulation” campaign includes resources for physicians, patient education materials, public service announcements and a community action tool kit. ACP offers its own patient education material on PAD in a special report, “Learning About PAD.” The reports come in bundles of 100 and are free to members.
More information about the campaign is online.
The campaign’s resources for physicians are online.
ACP’s patient education material can be ordered online.
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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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