In the News for the Week of 1-23-07
- Anti-platelet therapy advised for stent patients
- Cancer deaths fall for second year in a row
- Breast density, gene signature predict cancer, survival
- ACP Journal Club: Unfractionated heparin as safe and effective as LMW heparin
- New causes, treatments for pancreatic cancer
- Drug-resistant strain of bird flu found in Egypt
- Delays in generic drug introductions increasing, FTC says
- Many patients fail to tell doctors about use of alternative medicines
- ACP releases new paper supporting patient-centered care
- ACP presents annual State of the Nation’s Health Care address
- Election results for Officers and Regents
Patients with drug-eluting stents (DES) should continue anti-platelet therapy for at least a year after the stent is inserted, according to a new scientific advisory. The advisory was jointly issued by the American Heart Association, American College of Cardiology, Society for Cardiovascular Angiography and Interventions, American College of Surgeons and the American Dental Association.
The groups recommended treatment with thienopyridines, such as clopidogrel and ticlopidine, as well as aspirin. The advisory cites research showing stent thrombosis in up to 29% of patients who discontinued antiplatelet therapy early, including a study of 500 patients who received DES. In that study, the death rate over 11 months was 7.5% for patients who discontinued thienopyridine therapy, compared with 0.7% for those took the medication.
The advisory group made several recommendations to eliminate early discontinuation of dual antiplatelet therapy, including:
- Before implanting a stent, the physician should discuss the need for antiplatelet therapy with the patient. In patients not expected to comply with 12 months of thienopyridine therapy, a bare metal stent should be strongly considered.
- In patients who are likely to require surgery within 12 months of receiving a stent, a bare metal stent or balloon angioplasty with a provisional stent should be considered instead of routinely using a DES.
- Patients should be specifically instructed before hospital discharge to contact their cardiologist before stopping any antiplatelet therapy, even if instructed to do so by another healthcare provider.
- Elective procedures that carry a risk of bleeding should be delayed until a month after the patient has completed an appropriate course of thienopyridine therapy, which, ideally, is 12 months after receiving a DES in patients who are not at high risk of bleeding, and at least one month after a bare metal stent.
- For patients who receive a DES and who must have procedures that mandate stopping thienopyridine therapy, aspirin should be continued if at all possible, and the thienopyridine restarted as soon as possible after the procedure.
The advisory will be published in the journals of the contributing organizations. The American Heart Association news release is online.
Cancer deaths in 2004 fell for the second year in a row, with deaths from colon cancer showing the largest decline, the American Cancer Society reported last week.
Overall, cancer deaths declined by 3,014 from 2003 to 2004, compared with a drop of 369 deaths between 2002 and 2003. While the percentage decreases are small, they mark the first time that the actual number of cancer deaths dropped in the 70 years that records have been kept. Cancer causes 25% of deaths in the U.S., second only to heart disease, the report said.
In addition to colon cancer, there were declines in deaths from breast cancer, prostate cancer and lung cancer in men in 2004. Lung cancer deaths in women rose, however. Breast cancer death rates have been dropping steadily since 1990, the report said, likely due to earlier detection and better treatments.
African-Americans are much more likely than any other group to develop cancer and die from it, while Hispanics, Asian Americans and Pacific Islanders have lower rates of most cancers than whites, the report said.
In 2004, 553,888 people died of cancer. For 2007, the society estimates there will be 1,444,920 new cases of cancer and 559,650 cancer deaths. About 30% of cancer deaths in the U.S. are caused by smoking, the report said.
The report “Cancer Statistics, 2007” is published online in the Jan/Feb issue of the ACS journal CA: A Cancer Journal for Clinicians.
Women with highly dense breasts are nearly five times as likely to develop breast cancer as those with a lot of fatty breast tissue, a study published in the Jan. 18 New England Journal of Medicine found.
Breast density not only indicated increased risk for breast cancer, it also decreased the sensitivity of the mammogram, making tumor detection difficult. Dense breast tissue looks light on mammograms, as do tumors, said the article.
Researchers assembled 1,112 matched case-control pairs from three breast cancer screening studies. The odds ratio of developing breast cancer was 4.7 in women with density in at least 75% of the mammogram (extensive), compared with those with density in less than 10% of the mammogram (minimal).
The odds ratio of cancer detected by screening for the extensive group was 3.5, while detection by methods other than screening within one year of a negative mammogram was 17.8 for women in the extensive versus the minimal group. The latter result is probably due to cancers that were present but not detected at last screening due to masking by dense tissue, the authors said.
Increased risk of breast cancer, whether detected by screening or other means, persisted for at least eight years after study entry and was greater in younger than in older women. This finding indicates that the association between density and cancer may be due to a biologic connection, not just a masking effect, and that more research into how density affects susceptibility is needed, said an accompanying editorial.
The results also suggest annual screening examinations in women with extensive mammographic density aren’t likely to increase the rate of cancer detection, and attention should be directed to developing and evaluating alternative imaging techniques, the authors and editorial said.
A second study in the Jan. 18 New England Journal of Medicine found that a 186-gene signature was associated with survival of breast, lung and prostate cancer, as well as medulloblastoma. The study compared the gene expression profile of breast cancer stem cells with that of normal breast cells, then created an "invasiveness" gene signature to see how it related to overall survival and metastasis-free survival in patients. The signature was strongly correlated with both survivals.
The researchers combined the gene signature with prognostic criteria from the National Institutes of Health to classify patients as having a "good" or "poor" prognosis. Those with a good prognosis had a 10-year metastasis-free survival rate of 81%; those with a poor prognosis had a 57% rate. The study’s authors hope the results will eventually help doctors decide how aggressively to treat patients based on their gene signatures, the Jan. 18 San Jose Mercury News reported.
The San Jose Mercury News is online.
A new trial found that fixed-dose, weight-adjusted unfractionated heparin was as effective and safe as low-molecular weight heparin in patients with venous thromboembolism (VTE).
In a randomized, controlled, noninferiority trial, researchers studied 708 patients with symptomatic or asymptomatic deep venous thrombosis of the legs or symptomatic pulmonary embolism. The patients received either unfractionated heparin or LMW heparin subcutaneously, twice daily in doses determined by patient weight. The study is abstracted in the January/February ACP Journal Club.
The two groups did not differ for recurrent VTE, major bleeding or death. The results in this landmark study provide solid evidence that regular heparin, administered subcutaneously, is as safe and effective as LMW heparin in the initial treatment of VTE, said Journal Club reviewer Richard H. White, FACP, of the University of California, Davis. He noted that several factors may prevent the widespread adoption of subcutaneous regular heparin, including the dosing, which may be somewhat alarming to physicians. Regular heparin also requires twice daily injections and regular monitoring of platelet counts, and it has not been studied in overweight persons or patients with renal insufficiency.
The major benefit of regular heparin is its low cost, said Dr. White. Given the increasing number of patients without drug coverage, regular heparin is an option for those who have to pay out-of-pocket, he said.
Peer ratings for this review: Primary Care, IM/Referred Care/Hospitalists, Hematologists/Thrombosis: 6/7 stars.
ACP Journal Club is online.
Two recently published studies offer possible causes and treatments for pancreatic cancer. According to the research, gum disease may increase risk for the cancer while a common chemotherapy drug may lengthen survival.
Researchers in the Health Professional Follow-up Study, which tracked 51,529 men (216 of whom developed pancreatic cancer), found that men who reported periodontal disease had 64% higher risk of pancreatic cancer than those without periodontal disease. Although previous studies had found a link between tooth loss or gum inflammation and pancreatic cancer, this study was the first to control for the effects for smoking, the Jan. 16 Washington Post said.
Although it’s still undetermined whether the link is a cause-and-effect relationship, one possible explanation for the study’s findings is that inflammation from gum disease (indicated by higher blood levels of C-reactive protein) could promote cancer cells, researchers said. The study was published in the Jan. 17 issue of the Journal of the National Cancer Institute.
In the other study, a randomized controlled trial of 368 patients with pancreatic cancer, researchers found that chemotherapy after surgery increased the amount of time before the cancer returned. Patients who received six cycles of gemcitabine (brand name: Gemzar) every four weeks had an average of 13.4 months of disease-free survival compared with 6.9 months for patients who received no chemotherapy.
The study was supported in part by a grant from Eli Lilly and Co., the drug’s manufacturer. The study was published in the Jan. 17 issue of the Journal of the American Medical Association.
The Journal of the National Cancer Institute is online.
The Journal of the American Medical Association is online.
The Washington Post is online.
A strain of avian flu that is resistant to the antiviral drug oseltamivir (Tamiflu) was isolated from two family members in Egypt, the World Health Organization reported last week.
Although WHO experts said the new strain does not currently have broad public health implications, the development is potentially dangerous because oseltamivir is a chief weapon against the H5N1 flu virus, the Jan. 18 New York Times reported. It has not yet been determined whether the drug-resistant strain developed independently in the two patients or whether they had caught it from birds or each other. This mutation had previously been identified in Vietnam in one case in 2005.
The mutated strain was found to be susceptible to zanamir (Relenza), a more expensive, powdered medication and amantadine, an older drug which is not normally used because many avian flu strains are resistant to it, the New York Times said. Both patients died but the resistant strain did not spread to anyone else, including another family member who had avian flu.
In an effort to help increase the supply of avian flu vaccine, the U.S. Department of Health and Human Services awarded contracts last week for the development of an adjuvant vaccine. Under the five-year contracts, GlaxoSmithKline and Novartis AG will work to develop vaccines that protect against the virus with less active ingredient per dose. Iomai Corp. also received funding to complete preliminary trials of its candidate vaccine, the Jan. 17 Washington Post reported.
The World Health Organization release is online.
The New York Times is online.
The Washington Post is online.
Delays in introducing generic medications have increased since 2005 due to the rise in a certain type of legal settlement between drug companies and their generic competitors, a report issued last week by the Federal Trade Commission said.
In the year that ended Sept. 30, 2006, half of the 28 final patent litigation settlements between brand-name and generic drug makers included an agreement whereby the former would pay the latter, and the latter would agree to postpone the entry of generic drugs, the report said. In the two years prior, there were only three such settlements.
The settlements address attempts by the generic firms to put drugs on the market before a brand-name patent expires. The legality of this kind of settlement was upheld by two appellate court decisions in 2005.
The FTC report was issued at the same time as a U.S. Senate Judiciary Committee hearing on the matter. Sen. Herb Kohl, D-Wis., reintroduced legislation last week to ban this type of settlement, the Washington Post reported.
The Washington Post is online.
Many older Americans use alternative medicine but do not talk to their physicians about it, a new NIH study found. According to the poll, 69% of patients who use complementary and alternative medicine (CAM) have not discussed the therapies with their physicians.
CAM is defined as medical and health care systems, practices and products that are not considered part of conventional medicine, including herbal supplements, meditation, homeopathy and acupuncture. The most frequently cited reason for not discussing CAM use (42% of respondents) was that physicians never asked. Patients also said that they did not know they should (30%) or that there was not enough time during the office visit (19%).
Nearly three-fourths of survey participants have one or more prescription medications and more than half said they take one or more over-the-counter medications. The number of other medications used by respondents highlights the importance of patients discussing with physicians all therapies and treatments, study leaders said.
The findings are based on a telephone survey of 1,559 people age 50 or older, conducted by the AARP and the National Center for Complementary and Alternative Medicine at the National Institutes of Health.
The NIH news release is online.
On Jan. 22 ACP released a new policy paper, “A System in Need of Change: Restructuring Payment Policies to Support Patient-Centered Care.” The paper offers a series of nine recommendations to address inadequacies in the current Medicare physician payment and delivery system.
The guiding philosophy of these recommendations is that patient needs are best met through the delivery of patient-centered, longitudinal, coordinated care. ACP believes that these proposals have the potential to improve the quality and effectiveness of care provided in this country.
Internists and other physicians who provide primary and principal care are trained and well-suited to deliver this type of care yet that fact historically has been unrecognized or under-recognized by the payment system, said ACP President Lynne M. Kirk, FACP.
The full text of the paper is online.
ACP’s annual State of the Nation’s Health Care address, issued on Jan. 22, includes sweeping policy proposals to advance patient-centered primary care.
In the 2006 address, ACP reported that the U.S. health care system is facing a collapse of primary care medicine. Very few new physicians are going into primary care and many of those currently in practice are leaving the field or are planning to retire in the near future. The result of this collapse of primary care will be higher costs, lower quality, diminished access and decreased patient satisfaction.
The 2007 address proposed a solution to this looming collapse: a patient-centered health care system. Patient-centered health care builds upon the relationship between patients and their primary and principal care physicians and supports the systems needed to achieve better results.
Many U.S. physicians already are providing some of the characteristics of patient-centered care, but few provide all of them, said ACP President Lynne M. Kirk, FACP. In comparison, many other industrialized countries have made a deliberate policy decision to build their health care systems around patient-centered care, and physicians in those countries are far more likely to report that they have all or most of the characteristics associated with patient-centered care.
Dr. Kirk went on to address the need for patient-centered care to be available to all Americans, not just all insured Americans. She emphasized ACP’s belief that immediate steps must be taken to expand health insurance coverage, with the goal of providing coverage to all Americans.
The recommendations include paying physicians on a risk-adjusted, bundled and prospective basis for providing patient-centered care through a qualified medical home, instead of paying doctors solely on the volume of services billed. ACP also released a legislative roadmap for implementing the College’s recommendations, which will be the basis for discussions on Capitol Hill.
The complete recommendations are online.
The election of Officers and Regents has been completed, and the following members were elected. Phone and e-mail addresses are provided for your convenience; please feel free to contact them with congratulations. Terms become effective at the conclusion of the Annual Business Meeting at Internal Medicine 2007 on April 21.
Jeffrey P. Harris, MD, FACP
W. James Stackhouse, MD, MACP
The following Regents were elected for a second term to expire in 2010:
Virginia U. Collier, MD, FACP
Robert G. Luke, MD, MACP
Lawrence G. Smith, MD, FACP
Great Neck, NY
J. Fred Ralston, MD, FACP
The following new Regents were elected for a term to expire in 2010:
Jose A. Rodriguez-Portales, MD, FACP
Non Governor Pool
Barbara J. Turner, MD, FACP
If you have any questions regarding the election, please contact Florence Moore at firstname.lastname@example.org.
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Copyright 2007 by the American College of Physicians.
A 67-year-old man is evaluated for a recent diagnosis of primary hyperparathyroidism after an elevated serum calcium level was incidentally detected on laboratory testing. Medical history is significant only for hypertension, and his only medication is ramipril. Following a physical exam and lab studies, what is the most appropriate management of this patient?
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