In the News for the Week of 5-15-07
- Low daily aspirin dose is best to prevent CV disease
- Senate gives FDA more power to monitor drugmakers
- ACP and other groups unite for patient-centered medical home
- Annals of Internal Medicine:
- Drug market research goes back 50 years
- Managing depression in older adults linked to lower death rates
- Oral HPV infection associated with throat cancer
- PCI better than drugs for post-MI patients with silent ischemia
- COPD patients should get pulmonary rehab
- College Fellows assisted in poisoning investigation
- ACP participates in HHS roundtable on value-driven health care
- NCI seeks cancer caregivers for study
A daily aspirin dose of 75 to 81 mg is best for preventing cardiovascular disease and avoiding side effects, a new study found.
Doses larger than 75 to 81 mg/day don’t increase effectiveness and are associated with a higher risk of gastrointestinal bleeding, according to the study in the May 9 Journal of the American Medical Association. Out of an initial pool of 2,415 studies, the authors reviewed eight published randomized controlled trials and three observational studies that evaluated different aspirin doses in the setting of cardiovascular disease. Articles were excluded if they lacked dosage comparison, were non-clinical or were abstract-only.
More than 50 million U.S. adults take aspirin regularly to prevent heart attacks and stroke, with 60% of aspirin prescriptions at an 81 mg/day dose, and 35% at a 325 mg/day dose. The highest approved dose is 1,300 mg/day, yet a dose as low as 30 mg/day fully inhibits platelet thromboxane production, the authors said.
Moving forward, the biggest challenge will be determining the ideal antiplatelet regimen for individual patients, the authors said. Some small studies have found certain patients don’t respond to low doses, so large-scale studies are needed that will measure patients’ aspirin responsiveness and increase dosages accordingly, they said.
The Journal of the American Medical Association is online.
The Washington Post is online.
The U.S. Senate passed a bill last week that enhances the FDA’s ability to monitor drug safety, as well as order changes to drug labels and issue fines for misleading advertisements.
The bill calls for the FDA to set up a system for tracking adverse reactions to prescription drugs, which will have scientists analyze data on millions of patients to detect potential risks, the May 10 New York Times reported. It also gives the FDA the power to demand changes to a drug label and order more clinical trials and studies of a drug on the market—whereas before the agency could only recommend such actions.
Another provision would require the FDA to establish a public database of clinical trials and results, making it harder for manufacturers to hide safety data and easier for patients to learn about clinical trials that might help them, the New York Times said. For drugs that pose serious risks, the agency could require advertisers to spell out those risks clearly, or face fines.
The bill, which also renews the agency’s authority to collect fees from drugmakers to expedite drug reviews, appears to have House support and is likely to become law, the New York Times said. The Senate also voted against legalizing the import of lower-priced drugs from overseas.
The New York Times is online.
The College joined last week with major U.S. employers and other large physician groups to form a Patient-Centered Primary Care Collaborative (PCPCC), a coalition of employers, physicians and consumers that have agreed to work together on advancing the patient-centered medical home (PCMH)."
Collaborative members agree that the PCMH will improve the health of patients and the health care delivery system, and that it must be accompanied by a better model of compensating physicians. Compensation under the PCMH would incorporate enhanced access and communications; improve coordination of care; expand administrative and quality innovations; and promote active patient and family involvement.
The collaborative submitted a statement endorsing the PCMH to the House Ways and Means Committee Subcommittee on Health last Thursday. In its statement to the subcommittee, the College challenged Congress to make fundamental changes in Medicare payment policies through the PCMH.
“It is a rare opportunity to realign payment incentives to: help physicians deliver the care that patients need and want; recognize the value of care managed by a patient’s personal physician; support the value of primary care medicine in improving outcomes; and create the systems needed at the physician practice level to deliver the best possible care to patients,” noted ACP President David C. Dale, FACP.
"To date, the collaborative includes companies, such as IBM and General Motors, that collectively employ over 50 million people; senior representatives of human resource departments for the nation's largest companies; medical groups representing 330,000 physicians and medical students engaged in primary care; and more than 1,000 Federally Qualified Health Centers that serve 16 million people." The Collaborative is the product of many months of discussion among employers, physicians and consumers on transforming how primary care is organized and financed to provide better outcomes to patients, more appropriate payment to physicians, and better value, accountability and transparency to purchasers and consumers.
The following articles appear in the May 15, 2007 issue of Annals of Internal Medicine. This issue also includes a review finding that patients with fibromyalgia have a lower pain threshold than healthy individuals. The full text is available to College members and subscribers online.
Drug market research goes back 50 years, aided by physicians and physician organizations. Examination of physicians’ prescribing patterns and accumulation and sale of this information by the health care information organization industry is not new and was not imposed upon the medical profession by the pharmaceutical industry, according to this article. Prescriber profiling was developed through interactions by the industry with active participation by practicing physicians and their organizations. For example, the American Medical Association’s Physician Masterfile, information from which is sold by the AMA, “requires participation from both professional associations and practicing physicians,” the writer noted. Legislation or policy to remedy issues of prescriber profiling must recognize the role not only of the pharmaceutical industry but also of physicians and physician organizations which collectively bear responsibility for proper utilization. An editorial writer calls for an end to “physician participation in marketing research and the sale of physician prescribing data to marketing firms.”
Managing depression in older adults linked to lower death rates. A new study of 1,226 older adults in 20 primary care practices found that the death rate of those with depression who were enrolled in a depression management group was lower than those with depression receiving usual care. The effect appears mainly in deaths that were due to cancer. The reason for the effect is not clear.
People whose mouths and throats are infected with human papilloma virus (HPV) face an increased risk of oropharyngeal cancer even if they do not use alcohol or tobacco, a new study found.
In the hospital-based study, researchers tested 100 patients with newly diagnosed oropharyngeal cancer and 200 controls for HPV infection. They found that patients infected with HPV were 32 times more likely to have oropharyngeal cancer. The study also uncovered an association between the cancer and a higher number of lifetime oral- and vaginal-sex partners. Study subjects who had one to five oral-sex partners had 3.8 times increased risk and subjects with more than six partners were 8.6 times more likely to develop throat cancer.
Alcohol and tobacco are established risk factors for oropharyngeal cancer, the researchers noted, and the study found that cancer was associated with alcohol and tobacco use in patients not infected with HPV. However, no such association was found in HPV-infected patients, suggesting that there may be two distinct pathways for development of the cancer. The study was published in the May 10 New England Journal of Medicine.
The results indicate that oral HPV infection is sexually acquired, mostly through oral sex, although the possibility of mouth-to-mouth transmission cannot be ruled out, study authors said. Recent annual increases in oropharyngeal cancer rates, especially among younger people in the U.S., could therefore be explained by oral sexual practices among adolescents. Such findings would provide a rationale for HPV vaccination in both boys and girls, noted the authors.
The New England Journal of Medicine is online.
Percutaneous intervention is more effective than drug therapy at reducing the long-term risk of cardiac events in patients with recent myocardial infarction and silent myocardial ischemia, a new study found.
The study assigned 201 Swiss patients with recent MI, asymptomatic (silent) myocardial ischemia verified by stress imaging, and 1- or 2- vessel coronary artery disease to PCI without stenting or to intensive, individualized anti-ischemic drug therapy. All patients were given aspirin and statins. At 10 year follow-up, there were 27 deaths or hospitalizations in the PCI group and 67 in the drug group (adjusted HR, 0.33; 95% CI, 0.20-0.55; P<.001) with 11.6% of the PCI group having subsequent ischemia vs. 28.9% in the drug group (P=.03). Left ventricular ejection fraction was preserved at baseline to 55.6% for the PCI group, but declined in drug patients at baseline to 48.8%.
The benefit of PCI over drug therapy in this group of patients became apparent after two years of observation, the study authors said. The patient group has a health profile that is distinct from those who were in the COURAGE trial, which found no long-term advantage of PCI over drug therapy, and “thus, these findings reflect the standard of clinical practice in patients with significant post-MI silent ischemia,” the authors noted. Limitations of the trial include that it wasn’t blinded, included only a minority of women patients, and was conducted between 1991-1997, and thus reflects the state of the art from a decade ago, they noted.
The Journal of the American Medical Association is online.
Patients with chronic obstructive pulmonary disease should receive comprehensive pulmonary rehabilitation for at least six weeks, according to new evidence-based guidelines from the American College of Chest Physicians (ACCP) and the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR).
A comprehensive pulmonary rehabilitation program can include exercise training, education, instruction in respiratory techniques and psychosocial support. The guidelines recommend low- and high-intensity exercise training, strength and endurance training, and lower and upper extremity exercises as well as education about self-management. Between six and 12 weeks of rehabilitation has been shown to produce benefits, with the effectiveness declining gradually over 12 to 18 months, according to the expert panel which wrote the guidelines.
Pulmonary rehabilitation can improve symptoms of dyspnea, increase quality of life, decrease hospital stays, and even improve cognitive function and reduce depression and anxiety, the experts said. They cited research which found that pulmonary rehabilitation is appropriate for any stable patient with COPD who is disabled by respiratory systems.
The guidelines, which were published in the May issue of CHEST, also suggest that rehab can be beneficial to patients with other respiratory diseases, including asthma, lung cancer and pulmonary fibrosis, although programs should be modified for individual diseases and patients.
More information on the guidelines is online.
The FDA last week called for more data before it decides whether to approve sipuleucel-T (Provenge), a prostate cancer vaccine.
The move was somewhat of a surprise, as an FDA advisory panel recommended approval of the drug in late March, saying it was safe and effective for the treatment of asymptomatic, metastatic, androgen-independent prostate cancer. Instead of following the panel’s advice, as it typically does, the FDA issued a letter asking for more clinical proof and information on the drug’s chemistry, manufacturing and controls process.
Manufacturer Dendreon Corp. currently has a 500-patient study underway to address its claim that the treatment prolongs survival, but the FDA’s action still could mean another two years—at least-- before the product is available, the May 10 Wall Street Journal reported. Two earlier, small trials found the drug seemed to extend survival for patients with metastatic prostate cancer by about 4.5 months.
The Wall Street Journal is online (subscription only).
A release from Dendreon Corp. is online.
Erythropoietin is overused in cancer treatment and should be more closely scrutinized by the FDA, a panel of expert government advisors said last week. The panel did not recommend any specific changes to the drug’s labeling but asked for more intensive safety reviews.
The panel’s concerns were prompted by studies of breast, lung, lymphoid and throat cancer patients which found that erythropoietin promoted tumors and shortened survival, said the May 11 Washington Post. Representatives of Amgen, which manufactures the drug, argued that the studies used earlier and larger doses of the drug than is current practice.
Further studies of the drug are currently underway, and panel members called for additional research, the Washington Post said. The experts also suggested that the FDA should consider tighter restrictions on erythropoietin, including allowing fewer patients to take it for shorter amounts of time. In March, the FDA added a warning to the label, noting that erythropoietin can cause heart problems and blood clots in kidney-disease patients.
An FDA official also announced last week that the agency will investigate advertisements for Procrit which suggest that erythropoietin increases energy and improves quality of life. The drug is currently approved only to treat anemia and avoid blood transfusions, the Washington Post noted.
The Washington Post is online.
Fellows assisted in poisoning investigation
A recent New York Times investigation of international medication poisonings highlighted the crucial roles two ACP members played in uncovering the cause of a mysterious illness outbreak in Panama.
Last September, Nestor Sosa, FACP, and Jorge Motta, FACP, noticed an unusual number of patients suffering from symptoms similar to Guillain-Barre syndrome. Dr. Sosa, an infectious disease specialist, and Dr. Motta, a cardiologist, initially suspected an infectious disease as the cause of the outbreak, but eventually realized that the patients were being sickened by a common cough syrup.
In total, at least 100 Panamanians died and many more were sickened after taking the government-produced syrup. The syrup turned out to contain diethylene glycol, an industrial solvent, instead of glycerin. According to the Times, a Chinese supplier had sold the less expensive, toxic solvent labeled as glycerin and the substitution went undiscovered through numerous intermediaries and the medication production process.
Once lab tests confirmed the physicians’ suspicions that the cough syrup was responsible for the outbreak, the Panamanian government launched a nationwide campaign to stop people from using the syrup. According to the New York Times, the government of China has conducted limited investigations into the poisoning and concluded that Chinese suppliers involved were not licensed to produce pharmaceuticals.
The New York Times is online.
College joins HHS roundtable on value-driven health care
ACP Executive Vice President and CEO, John Tooker, FACP, MBA, participated last week in a Health and Human Services (HHS) roundtable discussion on health care reform.
Dr. Tooker joined key business, union, federal, state and local governments and community leaders to discuss the need to shift toward a value-driven health care system that is intended to provide better care at lower costs and empower consumers to make better health care decisions. ACP was the sole physician organization in attendance at the discussion, hosted by HHS Secretary Michael Leavitt.
The movement promoting value-driven health care has received strong support since its launch in 2006, with more than half of the top 200 U.S. corporations committing to the movement’s cornerstone standards: the use of health information technology, public reporting of quality information, public reporting of costs, and incentives for value comparison. Under the initiative, employers and unions, along with federal, state and local governments commit their health plans to provide useful information to consumers about the quality and cost of care delivered by different doctors, hospitals and other providers.
Dr. Tooker said the initiative aligns with ACP policy on improving the quality of patient care and restructuring the payment system. “The goals of the initiative parallel our policies calling for a patient-centered medical home and payment reform,” he said. “This was an opportunity to represent the needs of internists and ensure our voice is heard.”
The full article is available online.
Study seeks cancer caregivers
The National Cancer Institute and the George Washington School of Public Health is looking for women who are providing care for a family member or friend with cancer to participate in a study about their caregiving experience and coping strategies.
Specifically, investigators would like to hear from women who are:
- Between the ages of 31 and 80
- Currently providing care for someone over the age of 20 with cancer, OR provided care for someone over the age of 20 with cancer at end-of-life within the last year.
Women who call the toll-free number below will be asked some questions about their caregiving experience. Participating involves a total of 15-20 minutes by phone. Some eligible participants may be asked to provide additional information about their caregiving experiences in a follow-up telephone interview that will last approximately 45-60 minutes.
To participate, call 1-888-249-0029 (Monday to Friday, 9am-5pm EDT).
About ACP ObserverWeekly
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Copyright 2007 by the American College of Physicians.
A 53-year-old woman is evaluated for a 3-month history of swelling of the face, hands, and feet. She has untreated hepatitis C virus infection. She takes lithium for bipolar disorder. She has no additional symptoms. After a physical exam, lab results and kidney biopsy, what is the most likely cause of this patient's nephrotic syndrome?
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