In the News for the Week of 4-3-07
- ACP issues new screening mammography guideline for women age 40 to 49
- High-risk women should get breast MRI annually
- Adjuvant antidepressants have little effect on bipolar depression
Cardiology conference highlights
- Succinobucol doesn’t lower composite CV event risk
- Nesiritide neither helps nor harms heart failure outpatients
- Annals of Internal Medicine:
- Long-term effects of false-positive mammography unclear
- New injected drug added to traditional drug may help type 2 diabetes
- Web site warns consumers against buying isotretinoin online
- Parkinson’s disease drugs pulled off the market
- Marketing of irritable bowel syndrome drug suspended for CV risk
- AMA and ACP to conduct physician practice information survey
- New details and guidance on Physicians Quality Reporting Initiative
- ACP President testifies before Congress on importance of health IT
- Professionalism charter project seeks research participants
The College last week released a new clinical practice guideline for screening mammography for women age 40 to 49. The guideline, a background article, an editorial, and a patient summary appear in the April 3 issue of Annals of Internal Medicine.
The guideline states that, according to the evidence studied, breast cancer risk is not evenly distributed among women age 40 to 49 and the benefits of screening mammography are not uniformly applicable. Therefore, women in this age group need to take into account their level of risk and the possible benefits and harms of screening mammography.
The main benefit of screening mammography is a decrease in breast cancer mortality. However, the risks associated with screening mammography include false-positive results, possible treatment for lesions that would not have become clinically significant, and radiation exposure.
“It is important to tailor the decision of screening mammography by discussing the benefits and risks with a woman, addressing her concerns, and making it a joint decision between her and her physician,” said lead author Amir Qaseem, PhD, MHA, Senior Medical Associate in the Clinical Programs and Quality of Care Department of the College's Medical Education and Publishing Division at ACP.
The guideline makes four recommendations for women between the ages of 40 and 49:
- Clinicians should periodically perform individualized assessment of risk for breast cancer to help guide decisions about screening mammography.
- Clinicians should inform women in this age group about the potential benefits and harms of screening mammography.
- Clinicians should base screening mammography decisions on benefits and harms of screening as well as a woman’s preferences and breast cancer risk profile.
- ACP recommends further research on the net benefits and harms of breast cancer screening modalities for women in this age group.
In addition to publications from the original mammography trials, ACP reviewed 117 studies to evaluate the evidence about the risks and benefits of mammography screening for women age 40 to 49. ACP’s clinical guidelines are developed in an explicit, rigorous process based on extensive review of available scientific evidence. They are considered “evidence-based” rather than “expert-opinion” or consensus guidelines.
The guidelines are online.
New guidelines on breast cancer screening from the American Cancer Society (ACS) recommend that all women at high risk for the disease receive annual MRI screening. Confirming the society’s support for MRIs, a study released last week also found that MRIs are effective at detecting cancer in the contralateral breast of recently diagnosed women.
The ACS guidelines specifically recommend annual screening for women who have:
- BRCA mutations
- First degree relatives who are BRCA carriers
- 20% or greater lifetime risk, as defined by BRCAPRO and other family-history dependent models
- Received chest radiation between age 10 and 30
- Li-Fraumeni syndrome, Cowden Syndrome, or Bannayan-Riley-Ruvalcaba syndrome and first degree relatives
As many as 1.6 million women in the U.S. will fall into this category, according to the March 28 Washington Post. For women with lower risk, the guideline authors found insufficient evidence to recommend for or against screening for those with a lifetime risk of 15%-20%, personal history of breast cancer, or dense breasts, among other factors. They did recommend against MRIs for women at less than 15% lifetime risk.
The guidelines also strongly urge women to receive breast MRIs at facilities that perform biopsies, to avoid the possibility of having to repeat the entire procedure. The recommendations were based on studies finding that MRIs plus mammography detected cancers in 6% of high-risk women screened, compared with about 3% for mammography alone.
The effectiveness of MRI in breast cancer screening was further supported by a new study of 969 women recently diagnosed with unilateral breast cancer. Researchers performed MRIs on the women’s contralateral breasts and found additional cancer in 30 women that had not been detected by mammograms or clinical examinations. Study authors noted that the high negative predictive value of the MRI could be valuable to women considering prophylactic mastectomy of the contralateral breast, as well as enabling women who are found to have additional cancer to undergo treatment only once. The study was published in the March 29 New England Journal of Medicine.
The ACS guidelines are online.
The Washington Post is online.
The New England Journal of Medicine is online.
Adding antidepressants to mood stabilizers in order to treat the depressive episodes of bipolar disorder offers no additional benefit nor does it induce mania, a study published in the March 29 New England Journal of Medicine said.
Researchers randomly assigned 179 of 366 patients with bipolar depression to receive up to 26 weeks with a mood stabilizer plus either bupropion (Effexor) or paroxetine (Paxil), and 187 patients to receive a mood stabilizer plus placebo. Paroxetine or matching placebo was initiated at 10mg daily and raised to a maximum of 40 mg daily, while bupropion or matching placebo was initiated at 150 mg daily and increased to a maximum of 375 mg daily. These two antidepressants are some of the most frequently recommended for bipolar depression.
Durable recovery—i.e, at least eight weeks of euthymia—rates were 24% in the antidepressant group vs. 27% in the placebo (p= 0.40) group, while rates of switching to mania were 10% and 11%, respectively. The rate of any individual adverse event occurring didn’t differ significantly between the two groups, nor did the percentages of those who discontinued treatment due to adverse events.
Study limitations include the fact that antidepressants aren’t homogenous, and thus other kinds of antidepressants may have different effects. The eight-week outcome period was also relatively brief, though it is longer than the cross-sectional outcomes used in typical efficacy studies, the authors noted. In addition, many study subjects received some form of psychosocial intervention, which may limit the study’s generalizability, they said.
The study didn’t address the possibility that antidepressants might cause mania in patients with bipolar depression who aren’t taking mood stabilizers, and clinicians should thus check for a history of mania before starting antidepressant therapy in depressed patients, an accompanying editorial noted.
The New England Journal of Medicine is online.
Cardiology conference highlights
Adding succinobucol to optimal medical therapy doesn’t reduce the likelihood of a composite of major CV events, according to a study presented at last week's American College of Cardiology (ACC) Annual Scientific Session in New Orleans.
The double-blind, multi-national trial enrolled 6,144 high-risk patients with unstable angina or who had suffered heart attacks. At least 92% were already taking medications like aspirin, statins and beta-blockers. Patients were randomized to receive 300 mg of succinobucol-- a novel anti-oxidant and anti-inflammatory agent-- or matching placebo, and were followed for 24 months, on average. The primary endpoint was the time to first incidence for CV death, resuscitated cardiac arrest, MI, stroke, use of coronary revascularization and hospitalization for unstable angina with enzyme or ECG changes diagnostic of acute ischemia.
Succinobucol had no effect on whether a patient experienced CV death, cardiac arrest, MI, stroke, UA or revascularization, with 17.2% experiencing these vs. 17.3% on placebo. The drug did, however, reduce the secondary endpoint of the “hard” atherosclerotic composite of CV death, cardiac arrest, MI or stroke by 19% (p=0.028), with 6.7% of succinobucol patients experiencing these vs. 8.2% of the placebo group. It also reduced new onset diabetes by 64% (1.6% on succinobucol became diabetic vs. 4.2% for placebo), mainly by improving glucose and HbA1C levels.
Though more research is needed, succinobucol offers “some hope” in the fight against atherosclerosis based on the secondary endpoints, opined E. Murat Tuzcu, MD, chairman of the Scientific Sessions program committee. Committee member Robert Harrington, MD, was more cautious however, saying that “on balance, (succinobucol) had no effect” and the study was “a big disappointment.”
In another study presented at the ACC conference, Nesiritide (Natrecor) did not reduce death or cardiorenal hospitalization when added to standard treatment for outpatients with stage D heart failure, nor did it cause excess harm.
Nesiritide is a recombinant form of human B-type natiuretic peptide that is primarily administered to hospitalized patients, but this study aimed to test its safety and efficacy in outpatients. Previous studies have found nesiritide increased death and renal dysfunction among acute decompensated heart failure patients.
The double-blind trial randomized 920 chronic decompensated heart failure outpatients to nesiritide 2 mcg/kg bolus and 0.01 mcg/kg/min for 4-6 hours or matching placebo once or twice weekly for 12 weeks, with a 4-week taper and 8-week follow-up. All patients received standard heart failure therapy.
At study’s end, there was no difference in all-cause death, CV or cardiorenal hospitalization between the groups (36.7% in nesiritide group vs. 36.8% in placebo). Safety outcomes were also similar, with an 88.7% adverse event rate in the treatment group and an 86.9% rate in the placebo group. There were, however, more drug-related adverse events in the nesiritide group (42%) versus placebo (27.5%).
The outcome supports further investigation, said lead study author Clyde W.Yancy, M.D., of Baylor University Medical Center at Dallas, but added “practitioners should follow the current guidelines and strive to achieve optimal medical and device therapy in this patient population.”
--Conference coverage by Jessica Berthold, ACP Observer senior writer
The following articles appear in the April 3, 2007 issue of Annals of Internal Medicine. This issue also includes new guidelines for screening mammography in women age 40 to 49 and a study of the relationship between kidney dialysis outcomes and race and region. The full text is available to College members and subscribers online.
Long-term effects of false-positive mammography screening not clear. Authors reviewed 23 published studies of the long-term effects of false-positive mammography screening results on the behavior and feelings of women older than age 40. Authors found disparate results. For example, in an American study, women with false-positive results were more likely to return for routine mammography screening; in a European study, false-positives had no effect on returning for routine mammography, and in a Canadian study, women with false-positive mammograms were less likely to return for routine screening. In general, women who received false-positives worried more about breast cancer than those with normal readings, but results suggest no long-term symptoms of depression.
New injected drug added to traditional drug may help type 2 diabetes. A study of 233 people with type 2 diabetes not well controlled with thiazolidinediones (with or without metformin) found that the addition of exenatide improved glycemic control better than a thiazolidinedione plus placebo. An editorial writer raised concerns about the study, such as studying patients not receiving maximal conventional therapy when the study began, not using lifestyle interventions to maximize diabetes control at baseline, and not providing information about subgroups prone to develop adverse drug reactions.
Patients and physicians should decide on an individual basis whether to begin or defer androgen-deprivation therapy (ADT) in the treatment of androgen-sensitive metastatic, recurrent or progressive prostate cancer, according to new guidelines from the American Society of Clinical Oncology (ASCO).
Based on a number of recent studies, the panel of experts who wrote the guidelines found that patients who received early ADT had a 17% decrease in mortality from prostate cancer but a 15% increase in mortality from causes not associated with prostate cancer, indicating no overall advantage to early therapy over deferred therapy. Doctors should discuss the risks and benefits of ADT with patients, and those who defer should be monitored every three to six months, said the lead author of the guidelines.
The experts favored either bilateral orchiectomy or luteinizing hormone-releasing hormones as initial ADT treatments. Nonsteroidal antiandrogen therapy may be discussed with patients as an alternative, but only in combination with orchiectomy or LHRH, according to the guidelines. Combined therapy results in a slightly higher survival rate, but side effects may be increased, noted the lead author. The guidelines were published in the April 2 issue of the Journal of Clinical Oncology.
Another possible advance in prostate cancer treatment came last week when an FDA advisory panel endorsed approval of Provenge, a novel therapy for advanced prostate cancer. In this new personalized therapy, some of a patient’s white blood cells are removed, mixed with a genetically engineered protein that is a combination of an immune booster and a molecule often found in prostate cancer cells, then infused back into the body three or four days later, reported the March 30 New York Times. In a trial of 127 patients, the treatment extended median survival by 4.5 months. The FDA has a May deadline to determine whether it will follow the panel’s findings and approve the therapy.
The guidelines are online.
The New York Times is online.
Recent statistics have found overall declines in breast cancer mortality, but a new study revealed that two subgroups--women over age 70 and those with ER-negative tumors --showed more modest or no decreases in mortality.
Among women under 70, mortality declined 38% for those with ER-positive tumors and only 19% for those with ER-negative tumors, according to a National Cancer Institute study of 234,828 cases of invasive breast cancer between 1990 and 2003. In women age 70 and older, mortality was down 14% for ER-positive tumors and showed no decrease for ER-negative tumors. Overall, breast cancer mortality decreased 24% in the study period.
Researchers credited the overall decline to the use of tamoxifen after surgery, which substantially reduces the risk of recurrence in ER-positive tumors, and use of screening mammography, which is more likely to detect slow-growing, ER-positive tumors. Although the study did not explore the cause of the age-related differences in mortality, previous studies have shown that older women are less likely to receive adjuvant therapy for breast cancer.
The study authors advocated recruitment of more older women into clinical trials, in order to develop better treatments and outcomes for the over-70 age group. They also noted that the study was not able to assess the impact of recently introduced drugs—such as trastuzumab, approved in November 2006--that are likely to benefit women with ER-negative tumors. The study was published in the April 2 issue of the Journal of Clinical Oncology.
The Journal of Clinical Oncology is online.
The FDA last week launched a Web site to warn consumers against buying acne drug isotretinoin (Accutane) via the Internet, the agency said in a release.
Isotretinoin, which is indicated to treat acne that doesn’t respond to antibiotics, can cause severe side effects including birth defects, mental health problems and liver damage. The FDA and isotretinoin manufacturers put safeguards in place last year to reduce the risks of the drug, including a strict distribution program aimed at ensuring it isn’t used in pregnant women.
The FDA’s new Web site should appear when consumers do a search for Accutane or generic versions of Amnesteem, Claravis and Sotret, the FDA said. It warns patients that the drug should be taken only under the close supervision of a doctor or pharmacist, and provides links to other information, such as how to ensure that drugs bought online come from legitimate pharmacies.
For more information, go to the isotretinoin Web page.
The FDA release is online.
Pergolide drugs, used to treat symptoms of Parkinson’s disease, are being pulled from the market because of the risk of damage to patients’ heart values, the FDA announced last week. The drugs are being voluntarily recalled by manufacturer Veleant Pharmaceuticals (brand name: Permax) and generic producers Par and Teva.
Two recent New England Journal of Medicine studies confirmed previous findings associating pergolide with increased chance of regurgitation of the mitral, tricuspid and aortic valves of the heart, the FDA said. In 2006, the FDA placed a black box warning on the drug warning of the potential side effects.
Last year, about 12,000 U.S. patients received prescriptions for pergolide from retail pharmacies, according to the FDA. The agency warned patients not to immediately quit taking the medication, as stopping abruptly can be dangerous, and to contact their physicians to discuss alternative treatments, which include three other dopamine agonists that have not been associated with valvular heart disease.
The FDA release is online.
Novartis Pharmaceuticals Corp. will suspend marketing of tegaserod (Zelnorm) for irritable bowel syndrome because it appears to increase the risk of serious cardiovascular events, the FDA said last week.
A prescription drug marketed in 55 countries, tegaserod was approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. In August 2004, it was approved to treat chronic constipation in men and women under age 65.
Novartis analyzed 18,600 patients who were treated with tegaserod or placebo in 29 short-term clinical trials, and found a 0.1% risk of serious cardiac event with the drug compared with 0.01% with placebo. The FDA concluded that for most patients the benefits of the drug no longer outweigh the risks, but it is working with the manufacturer to keep the drug available for those who have no other treatment options. It is also possible the drug could be reintroduced if it is determined there is a population for whom the benefits outweigh the risks, the FDA said in a March 30 news release.
The FDA advised patients currently taking tegaserod to discuss alternatives with their health care providers and to seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.
The FDA release is online.
The American Medical Association (AMA), with the support of the ACP and more than 60 other medical specialty societies, will conduct a multi-specialty survey of America’s physician practices in 2007. The purpose of the survey is to collect up-to-date information on physician practice characteristics in order to develop and refine AMA and ACP policy. Data related to professional practice expenses will also be collected. The AMA will survey thousands of physicians over the year from virtually all physician specialties to ensure accurate and fair representation for all physicians and their patients.
During the year 2007, you may be contacted by the Gallup Organization to participate in this study. We encourage your participation in this survey, as the data obtained will be a critical source of information for the AMA and ACP. Should you be called upon to contribute, your participation ensures that the information collected will represent you and your patients’ concerns to national policy-makers. Please watch for this survey in 2007 and do your part in completing it in a thorough and accurate manner.
The College’s Practice Management Center (PMC) has released preliminary guidance on Medicare’s upcoming Physicians Quality Reporting Initiative (PQRI). The PQRI is a new pay-for-reporting program from Medicare that will begin on July 1, 2007 and run through Dec. 31, 2007. The program was established under federal law in December 2006 and the CMS has spent the first few months of 2007 designing the details of the program.
Under the PQRI, CMS will pay physicians for reporting on specified quality measures. Internists will need to successfully report on three of 74 different quality measures to receive the 1.5% bonus to their Medicare payments.
Physicians do not have to register in advance for the program, just include the applicable quality measure code on the same claim form used to bill the Medicare service. CMS will know which physicians are participating in the voluntary program when it processes the claims.
As CMS releases further details about the program, the PMC and ACP will provide additional information related to the PQRI—information describing the program and information aimed at helping interested members to participate with minimal burden.
More information on the PQRI from CMS is online.
ACP President Lynne M. Kirk, FACP, last week testified to Congress about the value of health information technology (HIT) in solo and small medical practices.
Dr. Kirk, who was one of five health-care panelists who addressed the House Committee on Small Business, Subcommittee on Regulations, Healthcare and Trade on “The Value of Health IT to Solo and Small Practices,” testified that the benefits of full-scale adoption of HIT will be significant, leading to a higher standard of quality in the U.S. health care system.
Other panelists included Mark Leavitt, the chairman of the Certification Commission for Health Information Technology, and several practicing physicians.
In her testimony Dr. Kirk noted that, “depending on the size of the practice and its applications, acquisition costs on average are $44,000 per physician. The average annual ongoing costs are about $8,500 per physician. The ‘business case’ does not exist to make this kind of capital investment.”
“To achieve immediate quality and healthcare savings through HIT,” Dr. Kirk concluded, “Congress must recognize the significant financial barriers for solo and small practices. It must offer creative solutions to stimulate adoption of HIT where most Americans receive health care – in offices of 1-5 physicians.”
In 2002, ACP’s Foundation joined the American Board of Internal Medicine (ABIM) Foundation and the European Federation of Internal Medicine to launch the Physician Charter on Medical Professionalism, a set of standards addressing the ethical issues related to the practice of medicine today.
The Charter is founded on three principles related to patient welfare, patient autonomy, and social justice. The ABIM Foundation is sponsoring a project to identify individuals and clinical organizations that have demonstrated practices or behaviors of medical professionalism that closely align with the Physician Charter or other medical professionalism models. ACP members interested in participating may contact Sue Sabatino, Program Administrator/Analyst at the ABIM Foundation at 215-606-4123 or email@example.com.
The charter is online.
Click on the link for “Medical Professionalism in the New Millennium: A Physician Charter.”
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Copyright 2007 by the American College of Physicians.
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