In the News
for the Week of 4-22-08
- Public-private partnership aims for quicker pick-up of adverse drug reactions
- Rofecoxib maker misrepresented published research, patient risks, articles conclude
- DASH diet associated with lower cardiovascular risk
- Decline in breast cancer doesn’t reach black women
- Paclitaxel works best given weekly in breast cancer
- Generic bupropion same as Wellbutrin
- CMS grants $50 million to primary care to deter costly ER visits
- Employers, Congress take action to support better pay for primary care
- Expected legislation would avert Medicare payment cuts
- PIER makes dengue fever module freely available
- Free literature available for young physician members
From ACP Hospitalist
- Nominate a colleague to be our top hospitalist
- Latest issue of ACP Hospitalist now online and in your mailbox
Cartoon caption contest
- And the winner is …
From the College
- ACP offers courses for Maintenance of Certification
- Medical college seeks vice president of research
Public-private partnership aims for quicker pick-up of adverse drug reactions.
The FDA is collaborating with major insurers and universities on a way to detect some types of potential adverse drug reactions within months of a drug's release.
The FDA and academics from Harvard, the University of North Carolina and the University of Pennsylvania are developing a post-market real-time drug surveillance system that will track drug interactions and clinical outcomes. Starting in early 2009, insurer WellPoint will scan data on more than half of its 35 million members to look for hidden patterns or spikes in problems that might be linked to certain drugs, said the April 15 Wall Street Journal.
The system will initially investigate any strong suspicion of a serious adverse event based on prior research or sound anecdotal reports associated with a specific product or products, a WellPoint spokesperson told ACP InternistWeekly.
The FDA plans to use the data from WellPoint, UnitedHealth Group and other insurers to follow up on signals of potential problems that emerged before a drug was approved and track potential problems in the first few months of usage. Although certain problems do not show up in the early period of usage, the agency hopes that the new method will enable it to warn patients earlier about potential problems. For example, WellPoint said it could have identified heart-related problems with the painkiller rofecoxib (Vioxx) within four months after it went on the market, according to the Wall Street Journal.
Eventually, the system could continuously monitor clinical data to look for serious adverse events or clinical outcomes. The FDA's current system relies on doctor and patient reports and can take up to five years to confirm adverse events. But the agency has also been planning for years to make a variety of improvements, including increasing its monitoring staff this year and next.
WellPoint's press release is online.
The FDA's five-year plan for improving drug safety monitoring is online.
Wall Street Journal news coverage is online.
Rofecoxib maker misrepresented published research, patient risks, articles conclude.
Two articles in the current issue of the Journal of the American Medical Association (JAMA) conclude that the maker of rofecoxib (Vioxx) ghostwrote articles published in academic journals and misrepresented the risk profile of the painkiller in clinical trials involving Alzheimer's patients.
In the first study, the authors reviewed court documents related to litigation against Merck & Co. after the company pulled the painkiller from the market due to cardiac risks. Their review showed that Merck-sponsored clinical trial and review articles related to rofecoxib had been ghostwritten by for-profit companies, then attributed to academic researchers with minimal involvement in the studies. The second article, based on FDA documents and Merck's own internal analysis, suggests that Merck minimized the mortality risk of rofecoxib in clinical trials involving Alzheimer's patients by using an "as-treated" analysis instead of "intention-to-treat."
In both studies, all authors except one reported having served as paid consultants for plaintiffs in litigation against Merck. The documents used in their studies have been made publicly available on the Internet.
An editorial noted that while the studies focused on Merck and rofecoxib because of the available court documents, the manipulation of study results and authors is likely widespread in the pharmaceutical industry. The study authors said similar authorship patterns were identified using documents related to litigation surrounding gabapentin and sertraline, suggesting that ghostwriting or guest authorship is common practice.
In response to the findings, the JAMA editorial made 11 recommendations, including:
- All clinical trials must be prospectively listed in registries accepted by the International Committee of Medical Journal Editors;
- All individuals named as authors on articles must fulfill authorship criteria, such as reporting his or her specific contributions to the article to the journal;
- For-profit companies that sponsor research should not be primarily or solely involved in collecting and monitoring data, conducting analysis and reporting results; and
- Authors who allow their names to be used for work that they did not perform should be reported to the appropriate oversight body or authority, such as a department chair or medical school dean.
DASH diet associated with lower cardiovascular risk.
Women who ate more fruits, vegetables, whole grains, nuts and legumes and avoided red and processed meats, sweetened beverages and sodium had a lower risk of heart disease and stroke, a new analysis of the Nurses’ Health Study found.
Researchers compared the diets of 88,000 female nurses with the recommendations of the Dietary Approaches to Stop Hypertension (DASH) diet. The participants’ diets were evaluated by biennial questionnaires collected between 1976 and 2002. All of the nurses were between the ages of 34 and 59 without a history of cardiovascular disease or diabetes in 1980. During the study follow-up, there were 2,129 cases of non-fatal myocardial infarction, 976 coronary heart disease deaths and 3,105 strokes.
After results were adjusted for age, smoking and other cardiovascular risk factors, the study found that women whose eating patterns most closely mirrored the DASH diet had 24% lower risk of coronary heart disease than those who diets were farthest from the DASH model. Higher DASH scores were also significantly associated with lower risk of stroke (18% difference between the groups at the diet extremes). The women with high DASH scores also had lower plasma levels of C-reactive protein and interleukin 6. The study was published in the April 14 Archives of Internal Medicine.
The study authors noted that, because a randomized, controlled trial of the DASH diet on cardiovascular end points may not be feasible, this observational report could be the strongest evidence to date on the long-term cardiovascular benefits of the diet. Although they believe their findings could be generalized to other middle-aged American women, the results need to be replicated in other populations, the authors said. They also noted that the DASH diet should be compared against other diet indexes, such as the Alternate Healthy Eating Index and the Mediterranean Diet, which have previously been associated with lower risk of cardiovascular disease.
The study is online.
Decline in breast cancer doesn’t reach black women.
While overall breast cancer rates have dropped dramatically in recent years, black women have not seen a decline, a new study found.
The new statistics, which researchers gathered from National Cancer Institute databases, were presented at the annual meeting of the American Association for Cancer Research last week. The study looked at rates of various types of breast cancer between 2000 and 2004. Among women between the ages of 50 and 69, reductions in invasive breast cancer with estrogen-receptor positive tumors were 13% for whites, 11% for Hispanics, 4% for Asians, and unchanged for black women, the lead study author told the April 15 Washington Post.
The researchers suggested that a decline in the use of hormone replacement therapy, which had been a more popular treatment among white women, may account for at least some of the difference. They noted that in late 2003, the year in which the FDA warned about a link between hormone therapy and breast cancer, invasive breast cancer among white women decreased 2.41% per quarter. Rates among women of other races saw significantly smaller declines (all less than 0.5%).
Other factors could also be responsible for the disparity, study authors said. They suggested that mammogram screening programs may not be reaching all races equally. They also noted that black women are less likely to have estrogen-receptor positive tumors, so that even among black women who were using hormones, halting the therapy could have had less of an impact on breast cancer rates.
The Washington Post is online.
A press release about the study is online.
Paclitaxel works best given weekly in breast cancer.
In women with breast cancer who have undergone chemotherapy, weekly doses of the drug paclitaxel may be more effective than standard therapy, according to a new trial.
The randomized trial included almost 5,000 women with axillary lymph-node positive or high-risk, lymph node-negative breast cancer. All patients received four cycles of intravenous doxorubicin and cyclophosphamide at three-week intervals. Then the women received either paclitaxel or docetaxel given at either three-week intervals for four cycles or weekly intervals for 12 cycles. Disease-free survival was the primary end point of the study, which was published in the April 17 New England Journal of Medicine.
Overall, the study found no disease-free survival difference between the two drugs, or between the two dosing schedules. However, the patients who received weekly paclitaxel had a 27% higher rate of disease-free survival compared to those who were taking the drug every three weeks. With docetaxel, the less-frequent dose showed greater success. Women who took docetaxel every three weeks were 23% more likely to survive without a recurrence of the disease than those who took paclitaxel at that interval. Weekly paclitaxel was also associated with overall improved survival.
Researchers noted that the lack of benefit shown by weekly docetaxel may be attributable to the greater adverse event rates and poorer adherence found in that group. The study also found no difference in response to the drugs by women with hormone-receptor positive, HER2-negative breast cancer and those with hormone-receptor negative, HER2-positive disease.
The study authors concluded that weekly paclitaxel after standard adjuvant chemotherapy improves disease-free and overall survival. The weekly dosing plan, which many oncologists are already following, should become the new standard for treatment, the study’s lead author told the April 16 Washington Post.
The study is online.
The Washington Post is online.
Generic bupropion same as Wellbutrin.
The generic version of bupropion XL is just as effective as the brand-name version, Wellbutrin XL, a re-evaluation of the drugs by the FDA concluded last week.
The review was motivated by 85 post-marketing reports that the FDA had received about the generic drug, Budeprion XL. Between Jan. 1 and June 30, 2007, 78 patients reported a loss of antidepressant effect following a switch from the branded to the generic product. A number of cases also reported new onset or worsening of side effects, and more than half who were switched back to Wellbutrin reported improvement of depression and/or abatement of side effects.
Based on the reports, the FDA re-examined data on the bioequivalence of the two products and concluded that the generic manufactured by Teva Pharmaceuticals is bioequivalent and therapeutically equivalent to Wellbutrin XL. They found small pharmacokinetic differences in the formulations, but nothing outside the established boundaries for equivalence, the FDA said.
The review suggested that the reported effects could simply be due to the natural history of major depression, which has been shown to intermittently recur despite continued treatment. They noted that it would not be surprising that some patients, among the large number who switched to the generic when it was approved in 2006, would have a recurrence of depression that coincided with the drug change.
The FDA report is online.
CMS grants $50 million to primary care to deter costly ER visits.
CMS will grant $50 million to 20 states over four years to fund local and rural initiatives in primary medical care so that Medicaid beneficiaries can avoid improper use of costly hospital emergency rooms.
Grantees will use the funds to:
- establish new community health centers;
- extend the hours of operation at existing clinics;
- educate beneficiaries about new services; and
- provide for electronic health information exchange between facilities for better care coordination.
More information and a list of emergency room diversion grant recipients are online.
Employers, Congress take action to support better pay for primary care.
The Patient Centered Primary Care Collaborative (PCPCC) released a new framework to help educate employers about the advantages of buying health care for employees that is coordinated by a primary care physician in a patient centered medical home (PCMH). The guide suggests specific actions employers can take to use their influence and purchasing dollars to support the PCMH.
The PCPCC is a coalition of physicians, business leaders and policymakers working to encourage the adoption of patient-centered primary care. ACP is a founding member of the Collaborative.
The guidelines are a chapter of the PCPCC’s Employer Purchaser Guide, which is expected to be completed in mid-May. The guide will introduce employers to the concept of the PCMH, make a case for the employer’s support of the medical home, and describe how employers can support the concept. The guidelines illustrate six ways that purchasers can use the PCMH model, including:
- participating in regional pilot programs sponsored by the PCPCC;
- incorporating PCMH into insurer procurement and performance assessment activity;
- aligning payment strategy with PCPCC guiding principles;
- building coalitions in support of the PCMH;
- engaging consumers; and
- integrating the PCMH into other corporate health strategies.
The Purchasers Guide is available online [PDF].
Expected legislation would avert Medicare payment cuts.
Legislation to avert pending Medicare cuts to physician payments is expected to be introduced by Sen. Max Baucus (D-MT), chair of the Senate Finance Committee, by mid-May. The cuts of 10.6% scheduled on July 1, 2008 and another 5% on Jan. 1, 2009 stem from the sustainable growth rate formula, which ties physician payments to growth in the overall economy rather than to the cost of providing care.
Sen. Baucus has indicated that he is developing a bill that will include positive updates to physician payments under Medicare for 18 months in lieu of the expected cuts. Additionally, he has expressed interest in including provisions that would require targeted increases in Medicare payments for primary care services and promote the concept of the patient-centered medical home.
ACP President David C. Dale, FACP, said in a joint letter with the chair of the American Academy of Family Physicians and the president of the American Osteopathic Association, that the College strongly supported his efforts to increase payments for primary care and implement a national pilot of the PCMH. Although any initial increase in payment for primary care services would likely require "budget neutral" offsets in payments for other physician services, the letter stated that new ways are needed to fund primary care that take into account the evidence that primary care is associated with better outcomes and lower utilization of services covered under other parts of Medicare.
Legislation was introduced last month by Sen. Debbie Stabenow (D-MI) that would also avert the payment cuts. Sen. Stabenow’s bill, the “Save Medicare Act of 2008,” would provide a 0.5% update for the second half of 2008, and a 1.8% increase in payments for 2009.
ACP’s letter in support of Sen. Baucus’s efforts to introduce new legislation is online.
A joint letter signed by ACP urges other senators to cosponsor the “Save Medicare Act of 2008.”
A CQ Politics article about Sen. Baucus’s plan is online.
PIER makes dengue fever module freely available.
A dengue fever outbreak in Brazil has led ACP to offer for free its module on the prevention, diagnosis and management of dengue fever, dengue hemorrhagic fever and dengue shock syndrome. The module may prove helpful to physicians and other health professionals involved in the care of patients with this deadly mosquito-borne disease. Given the gravity of the situation, the College is making this module freely available to everyone online.
In Brazil, there have been 28,233 reported cases of dengue fever in 2008 that have resulted in 54 confirmed deaths, and an additional 60 are suspected. According to the State Secretariat of Health in Rio de Janeiro, these numbers would rival the last significant outbreak in 2002, when 288,245 cases of dengue were reported that resulted in 91 deaths.
The U.S. Embassy in Brazil issued a warning to travelers.
News about the outbreak is online.
PIER offers Web-based evidence-based clinical guidance in a unique layered and telegraphic format designed for rapid access to clinical information at the point of care by physicians and other health care providers. In its 480 modules, PIER covers not only individual diseases but also topics in legal medicine and ethics, complementary and alternative medicine, and common procedures, as well as screening and prevention.
Free literature available for young physician members.
Free copies of ACP’s Pocket Guide to Selected Preventive Services for Adults and the Young Physician Practice Management Survival Handbook are available to members. Developed by the 2006-2007 Council of Young Physicians, the Pocket Guide is a proactive way to encourage preventive care in your daily practice, while the Survival Handbook offers helpful tips and resources for starting your own practice.
Electronic copies of the Pocket Guide to Selected Preventive Services for Adults and the Young Physician Practice Management Survival Handbook are available on ACP Online. You will need your ACP username and password to access these sites. If you do not know this information, please visit the registration Web site.
If your chapter is holding an event for Young Physicians and you would like to make copies of the Pocket Guide and Survival Handbook available, please contact Jodi Todd, Programs and Services Coordinator, at firstname.lastname@example.org or by calling 800-523-1546, ext. 2611. A limited supply is available, so requests will be filled on a first-come, first-serve basis while supplies last.
From ACP Hospitalist
Nominate a colleague to be our top hospitalist.
ACP Hospitalist is accepting nominations for our 2008 top hospitalist. We’re looking for the hospitalist who made the most notable contributions to the field, whether through cost savings, improved work flow, patient safety, leadership, mentorship or quality improvement.
Do you know a colleague who might qualify? Fill out our form and tell us who and why. All nominations must be received by July 14, 2008, when our editorial advisory board will pick the winner. The top hospitalist and the runners-up will be profiled in our November 2008 issue.
Latest issue of ACP Hospitalist now online and in your mailbox.
The April issue of ACP Hospitalist is now available on the Web and in your mailbox. Go online to www.acphospitalist.org for the latest stories on:
- Integrative medicine. Although most integrative therapies are provided on an outpatient basis, they're becoming more common within hospitals: In a 2005 survey by the American Hospital Association, 27% of reporting hospitals said they offered at least one type of alternative medicine to patients, up from 8% in 1998.
- Patient safety. An effort led by ACP's New York Chapter allows residents throughout the state to anonymously track "near-misses," or mistakes they almost made that were caught in time, through a centralized Web site.
- Hyperbaric oxygen therapy. Hospitals are discovering new indications for this treatment.
Cartoon caption contest
And the winner is ....
ACP InternistWeekly has compiled the results from its latest cartoon contest, where readers are invited to match wits against their peers to provide the most original and amusing caption.
This issue's winning cartoon caption was submitted by Robert Bailey, ACP Member, an internist with Providence Medical Group in Gresham, Ore. He receives a copy of "Medicine in Quotations," ACP's comprehensive collection of famous sayings relating to sickness and health, disease and treatment and a portrait of medicine throughout recorded history.
ACP readers cast 227 ballots online to choose the winning entry. Thanks to all who voted!
The winning entry:
"I don't care which one you use, just get it over with."
The winning caption received 71.8% of the votes cast. The two runners up were:
"But doc, I thought my insurance allows for at least a five-minute appointment." (24.7%)
"It's either a turkey or a bunny rabbit. I wouldn't quit my day job if I were you, doc." (3.5%)
From the College
ACP offers courses for Maintenance of Certification.
Registration is now open for the College's new suite of courses covering all aspects of Maintenance of Certification (MOC), which will be offered in Boston from June 27-30. The program includes a two-day recertification exam prep course (14.75 CME credits), two half-day Self-Evaluation Process (SEP) module learning sessions, each covering two 25-question modules (10 self-evaluation points each), and a one-day course to help you design and implement a practice improvement module (PIM) for MOC (7 CME credits).
Take advantage of one or more of these courses to assist in your efforts to maintain your certification. The MOC exam prep emphasizes key advances in internal medicine over the past decade. The PIM course, which helps you complete the American Board of Internal Medicine’s requirement for self-evaluation of practice, focuses on applying quality measurement to patient care. This year marks the first time that ACP is offering half-day SEP module courses, which will include an audience response system to encourage discussion and participation. To register or get more information, go online.
Medical college seeks vice president of research.
Meharry Medical College in Nashville, Tenn., the nation's largest, private independent historically black academic health center, is inviting nominations and applications for vice president of research (VPR).
The VPR will be responsible for administrating sponsored research and working with three academic deans to support scholarship. The VPR also will develop and implement strategies to secure external funding for all research and provide leadership nationally promoting the college's research agenda.
Qualifications include a PhD, MD or MD/PhD and a record of research published in peer-reviewed publications. For more information, go to Meharry's Web site.
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 54-year-old woman is evaluated for shortness of breath of 3 months' duration and a 4.5-kg (10-lb) weight loss over the preceding 2 months. She has a 35-pack-year smoking history. Following a physical exam and further testing, what is the most appropriate treatment?
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