In the News for the Week of 8-14-07
- Terminally ill must wait for FDA approval of drugs, court says
- Study: Expanding preventive services would save 100,000-plus lives
- ACP Journal Club: Lifestyle or drug interventions prevent or delay type 2 diabetes
- Densitometry, then drugs found cost-effective for some osteoporotic men
- New HIV medication gains approval
- Early response helped cities limit deaths during 1918 pandemic
- ACP joins UnitedHealth and physician groups on medical home
- 2007 Recruit-a-Resident Program underway
Terminally ill patients do not have a constitutional right to access medication that has not been approved by the FDA, a federal appeals court ruled last week. The court decided against a patient advocacy group which had sued the government in an effort to change the current drug regulatory system.
The group, the Abigail Alliance for Better Access to Developmental Drugs, argued that forcing terminally ill patients to wait for FDA approval of a new drug violates their rights of self-defense and due process, the Aug. 8 New York Times said. Opponents, including former FDA officials, said that a decision in favor of the alliance would undermine the existing dug approval process and weaken the incentive for drug manufacturers to complete clinical trials.
A district court had ruled against the Alliance and was then reversed last year by a panel of the appeals court. The full appeals court voted 8-2 in favor of the FDA. In its opinion, the court said that the issue might better be decided by Congress. Such legislation has been introduced in the past but did not make it out of committee, the Aug. 7 Washington Post reported.
The New York Times is online.
The Washington Post is online.
Beefing up preventive care measures such as flu shots and cancer screenings would save more than 100,000 U.S. lives each year, a new study found.
The Partnership for Prevention study found 45,000 fewer people would die each year if 90% of adults took aspirin daily to prevent heart disease, instead of the 50% taking it currently. Likewise, if 90% of smokers were given cessation advice, medicine and support by a health professional, 42,000 fewer people would die each year, the study found.
Other measures that would save lives, if 90% of the target population received them, include:
- Colorectal cancer screenings for adults age 50 and over would save 14,000 lives. Fewer than 50% of these adults are screened now;
- Annual flu shots for adults age 50 and over would save 12,000 lives. Fewer than 37% get the shots now;
- Breast cancer screening every two years for women age 40 and over would save 3,700 lives. About 67% are screened now; and
- Chlamydia screenings for sexually active young women would prevent 30,000 cases of pelvic inflammatory disease annually. About 40% are screened now.
The study also found African Americans, Hispanic Americans and Asian Americans were less likely to use preventive care than whites. That’s partly because many minorities lack continuity of health care or an ongoing relationship with a health professional who can help ensure preventive measures are taken, an expert said. The study was funded by the CDC, the Robert Wood Johnson Foundation and WellPoint Foundation.
The Partnership for Prevention report is online.
The American College of Cardiology and the American Heart Association have revised their joint guidelines for managing patients with unstable angina (UA) and non-ST-elevation myocardial infarction (NSTEMI).
Major changes to the guidelines, which were last published in 2002, include:
- Different initial strategies for high- and low-risk patients, as defined by commonly used risk scores. Unstable and high-risk patients should have more invasive measures—i.e., diagnostic angiography and revascularization—while low-risk and stable patients should start with non-invasive measures like stress tests, echocardiogram or radionuclide study;
- Using clopidogrel for at least one year after receiving a drug-eluting stent;
- Halting the use of non-steroidal anti-inflammatory drugs for patients during hospitalization;
- Prescribing ACE inhibitors and aldosterone receptor blockade after a patient is released from the hospital to prevent recurrent heart attack;
- Stricter blood pressure and cholesterol management for UA/NSTEMI patients. LDL should be lower than 100 mg/dL; the ideal is 70 mg/dL. Blood pressure should fall below 140/90; those with diabetes and chronic heart disease should have a reading below 130/80;
- Stopping hormone replacement therapy in postmenopausal women.
The new guidelines reflect evidence from key trials over the past five years, a member of the guidelines writing committee said.
The ACC/AHA revised guidelines are online.
An experimental treatment for acute ischemic stroke, called NXY-059, is safe but ineffective, according to a large new study. The findings contradict a previous trial which had found that NXY-059 improved outcomes significantly more than placebo.
Researchers had undertaken the randomized, double-blind trial in the hope that NXY-059 would prove to be a safer alternative to tissue plasminogen activator (tPA) and that it could be offered to more stroke patients. In the study, 3,306 patients with acute ischemic stroke were given a 72-hour infusion of intravenous NXY-059 or placebo within six hours of the onset of stroke symptoms. Both groups had similar rates of mortality and adverse events, and there was no evidence of efficacy for any of the trial’s end points. The study was published in the Aug. 9 New England Journal of Medicine.
The study authors did not find any explanation for the difference between this study and the first trial of NXY-059, which found that the drug reduced stroke-related disability. They considered that the discrepancy could have been due to chance and noted the need for additional study. However, the researchers concluded that the most reasonable interpretation of their work is that NXY-059 is ineffective. One study author told the Aug. 8 Washington Post that development of the drug had been halted because of the negative findings.
The New England Journal of Medicine is online.
The Washington Post is online.
A new review found that lifestyle or pharmacologic interventions prevent or delay type 2 diabetes mellitus in people with impaired glucose tolerance.
The meta-analysis examined 17 randomized controlled trials that evaluated an intervention to delay or prevent type 2 diabetes mellitus (DM) in persons with impaired glucose tolerance, and had an outcome measure of diabetes. The 8,084 subjects ranged in mean age from 39 to 57 years, and had an average follow-up range of 0.4 to 4.6 years. Lifestyle interventions included diet, exercise or both. Pharmacologic interventions included oral diabetes drugs acarbose, flumamine, glipizide, metformin or phenformin; or antiobesity drug orlistat.
Results showed both lifestyle and pharmacologic interventions reduced the incidence of type 2 DM. Two trials addressing troglitazone were excluded from the meta-analysis because the drug had been removed from several markets worldwide due to liver toxicity. The study is abstracted in the July/August ACP Journal Club.
Diabetes drugs cost more than lifestyle interventions, and are more commonly associated with side effects like gastrointestinal upset and hypoglycemia, said Journal Club reviewers Sumit Bhagra, ACP Member, MBBS, and Steven A. Smith, FACP, of the Mayo Clinic. Some drugs have also been reported to lack sustained diabetes prevention properties after washout. Taking into account the cost, adverse effects and nonsustained efficacy associated with diabetes prevention drugs, lifestyle interventions should remain the mainstay of diabetes prevention, they concluded.
Peer ratings for this review: GIM/FP/GP, Endocrinology: 6/7 stars.
ACP Journal Club is online.
A cost-effective way to prevent fractures in some older men with osteoporosis is by giving them bone densitometry, then five years of oral biphosphonate, a new study found.
The study evaluated cost-effectiveness via computer simulation for hypothetical cohorts of men aged 65, 70, 75, 80 or 85 years, with or without previous fractures. It evaluated costs per quality-adjusted life-year (QALY) with treatment versus no treatment. Data included age-specific proportions of men with osteoporosis, population-based estimates of fracture rates and medical costs from fractures. The study was in the Aug. 8 Journal of the American Medical Association.
For the treatment cohort, lifetime costs per QALY were less than $50,000 in men aged 65 and older who had a previous fracture, and in men aged 80-85 who never had a fracture. Densitometry plus biphosphonate may also be cost-effective for men starting at age 70 who haven’t had a fracture, as long as the drug costs are less than $500 per year, or if society agrees to pay $100,000 per QALY gained, the study found.
Study limitations include the fact that it involved only white men, and the results apply to only five years of treatment. The authors concluded that while densitometry followed by drugs is cost effective in certain cases, it isn’t uniformly cost-effective for men 70 and older due to current drug costs.
The Journal of the American Medical Association is online.
A new HIV medication was approved by the FDA last week, after the agency had delayed approval of the drug in June. The medication, maraviroc, is the first to block a pathway that HIV uses to infect cells, instead of targeting the virus directly.
Maraviroc is part of a new class of drugs called CCR5 receptor agonists, and will be the first novel oral HIV medicine to hit the market in more than a decade. The drug is approved for use in adults with CC5-tropic HIV-1 who have been treated with other HIV medications but still have an elevated viral load.
The label carries warnings about hepatoxicity and the possibility of heart attacks. According to the Aug. 6 Washington Post, manufacturer Pfizer reported that clinical trials found more cardiovascular problems in users of the drug, which they plan to market in the U.S. under the name Selzentry. Outside of the U.S., the drug will be sold as Celsentri.
The FDA news release is online.
The Washington Post is online.
Communities that enforced strict social distancing and quarantine procedures early in the course of the 1918 influenza pandemic were the most successful in mitigating the spread of the virus and preventing deaths, according to an analysis that may hold lessons for current pandemic planning.
In the study, published in the Aug. 8, 2007 Journal of the American Medical Association, researchers looked at social distancing measures taken by 43 U.S. cities between Sept. 8, 1918 and Feb. 22, 1919 in order to determine whether differences in death rates were associated with three types of interventions: school closures, public gathering bans, and isolation and quarantine. They found a significant reduction in the weekly death rate in the 34 communities that closed schools and banned public gatherings, with the best outcomes in communities that took action the earliest.
For example, the authors noted, New York City reacted to the crisis early with compulsory isolation and quarantine procedures and a staggered business hour ordinance, and ended up with the lowest death rate on the East Coast. In contrast, Pittsburgh, which delayed closing schools and did not sustain its public gathering ban, had the highest mortality of the cities studied. Overall, communities that responded early with a combination of the three strategies sustained over the course of the outbreak had the best outcomes, they said.
The findings suggest that non-pharmaceutical interventions can have a significant impact on the severity of a pandemic, said the authors. Social distancing and quarantine measures should be considered along with drug development in current pandemic response planning efforts, they added.
The White House used findings from the JAMA study to emphasize the importance of community response in a recently released one-year progress report on national pandemic planning. Community mitigation measures, the report stated, will serve as a "first line of defense" to slow the spread of disease, especially since a matched vaccine likely would not be available at the beginning of an outbreak.
The government has developed a Pandemic Severity Index (PSI) for assessing the health threat of a pandemic virus and allow cities to balance the need to protect the public's health with minimizing social and economic disruptions, the progress report stated. The government also developed a web site designed as a one-stop source of all federal avian and pandemic flu information.
The College recently participated in the 2nd National Congress on Health System Readiness, a pandemic planning forum led by the CDC and the American Medical Association. ACP participated in the Congress' planning committee and provided input on community responses to a pandemic outbreak.
The JAMA abstract is online.
The White House's National Strategy for Pandemic Influenza Implementation Plan One Year Summary is online.
Last week ACP joined with UnitedHealth Group, the American Academy of Family Physicians (AAFP), and the American Academy of Pediatrics (AAP) to announce the planned launch a pilot project of the patient-centered medical home.
The patient-centered medical home is a model of care designed to improve patients’ total health and care delivery through patients partnering with their primary care physicians. The physician, as leader of a multidisciplinary care team, takes responsibility for the whole care of the patient and coordinates that care with other physicians and professionals across the full spectrum on an ongoing basis. The pilot program will be launched in approximately six primary care practices in Florida.
This program will mark the first time that physicians are compensated with enhanced payments to reward the extensive work related to patient care that takes place outside the physician-patient encounter and to recognize the costs to the practice of maintaining the capability to provide patient-centered care. UnitedHealth Group and the medical societies have commissioned an independent research study on the pilot program.
The medical home model was developed by medical professional societies including ACP, AAFP and AAP. Earlier this year these groups and the American Osteopathic Association agreed to joint principles to define a patient-centered medical home.
“A key element of the patient-centered medical home model is a commitment to improved quality. Primary care practices should exemplify attributes such as dedication to team care, utilization of clinical information systems, coordination of care with other health professionals and support networks, as well as continuous performance assessment and improvement, among others,” said David C. Dale, FACP, president of ACP. “It is our hope that the full realization of this model will result in increasing numbers of physicians who choose primary care practice and who experience greater professional satisfaction.”
The pilot program press release is online.
The joint principles of a patient-centered medical home are online.
Associate membership in the College offers residents the opportunity to strengthen their career in internal medicine through teaching, research and networking with other ACP members. The Recruit-a-Resident program encourages residents to enroll by giving free educational resources to residency programs that recruit at least 90% of their residents for ACP Associate membership.
Each resource offers a unique benefit to residents. Updates, important papers in internal medicine subspecialties, provides the latest in research and policy; Multiple Small Feedings of the Mind contains answers to essential clinical questions for the practicing internist; and MKSAP OneTwenty, the exclusive Recruit-a-Resident product, contains 120 pre-tested MKSAP questions that meet the ABIM's high statistical standards. It is designed to help residents test their knowledge, compare their performance to practicing physicians, and receive focused, in-depth instruction on the questions they answer incorrectly.
As of Aug. 1, 26 programs have successfully recruited at least 90% of their residents to become ACP Associates. Interested participants are encouraged to sign up now, as the 90% participation rate must be achieved by Dec. 31, 2007 in order for residents to secure these free educational products from the College.
More information about the 2007 Recruit-a-Resident program is online.
If you have any questions about the program, contact Jodi Siegrist, Programs and Services Coordinator, at 800-523-1546, ext. 2611, or firstname.lastname@example.org.
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A 42-year-old woman is evaluated for an 8-month history of crampy abdominal pain and three loose bowel movements per day. The pain is relieved by a bowel movement. There are no nocturnal bowel movements, and there is no blood or dark tarry material in the stool. She has not had fever, night sweats, or weight loss. She has a history of Hashimoto disease and is treated with levothyroxine. Following a physical exam, rectal exam, and lab tests, what is the most appropriate next step in management?
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