Abstract:
:In 1984, both the United Kingdom and the United States received recommendations from panels of experts specifically convened to consider the merits of Depo-Provera (depot medroxyprogesterone acetate [DMPA]) as a long-term contraceptive agent. This study compares the final reports written by these panels. We explore why, despite access to essentially the same data, the U.K. panel recommended marketing approval but the U.S. Public Board of Inquiry did not. We conclude that differing national policies helped shape the interpretation of the data and thus the divergent outcomes. :In 1984, both the UK and the US received recommendations from panels of experts convened to consider the use of Depo-Provera as a long-term contraceptive agent. Despite access to essentially the same data, the UK panel recommended marketing approval while the US panel did not. It is posited that these 2 conclusions reflected differences in the underlying biases of regulatory policies in the US and the UK. The standard practice in the US is to approve a drug for use only after the completion of extensive human trials. In the UK, however, the practice is to accumulate much of the data on human safety after the drug has been marketed. The US board tended to emphasize proof that Depo-Provera was safe, while the UK panel appeared to look for evidence to prove that Depo-Provera was unsafe. In addition, the US board was mandated to consider a set of specific questions focused on a risk-benefit analysis of Depo-Provera in comparison with other contraceptive methods, while the UK panel was given a more general mandate to act as expert analysts. Another possible explanation for the divergence of outcomes concerns the committees' judgments about the practices of physicians in the respective countries and the extent of influence regulatory agencies should have over individual medical practice. Denial of approval of Depo-Provera in the US was viewed as making little difference to physicians since the drug is currently approved for use for other indications. In the UK, on the other hand, doctors would have been inhibited from prescribing Depo-Provera by possible legal consequences. Overall, it is concluded that policies concerning the extent of human trials required to gain marketing approval, the acceptability of prescribing drugs for unapproved indications, the evidence required to prove or disprove carcinogenic potential, and the general threshold of evidence required to establish causality accounted for the different decisions reached by experts in the US and the UK.
journal_name
Ann Intern Medjournal_title
Annals of internal medicineauthors
Richard BW,Lasagna Ldoi
10.7326/0003-4819-106-6-886subject
Has Abstractpub_date
1987-06-01 00:00:00pages
886-91issue
6eissn
0003-4819issn
1539-3704journal_volume
106pub_type
杂志文章abstract::To characterize the role of cardiac function in septic shock, serial radionuclide cineangiographic and hemodynamic evaluations were done on 20 patients with documented septic shock. Although all patients had a normal or elevated cardiac index, 10 patients had moderate to severe depression of their ejection fraction wi...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-100-4-483
更新日期:1984-04-01 00:00:00
abstract:BACKGROUND:The accuracy and harms of brief cognitive tests for identifying clinical Alzheimer-type dementia (CATD) are uncertain. PURPOSE:To summarize evidence on accuracy and harms of brief cognitive tests for CATD in older adults with suspected cognitive impairment. DATA SOURCES:Electronic bibliographic databases (...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M19-3889
更新日期:2020-05-19 00:00:00
abstract:DESCRIPTION:Update of the 2005 U.S. Preventive Services Task Force (USPSTF) recommendation on screening for abdominal aortic aneurysm (AAA). METHODS:The USPSTF commissioned a systematic review that assessed the evidence on the benefits and harms of screening for AAA and strategies for managing small (3.0 to 5.4 cm) sc...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:10.7326/M14-1204
更新日期:2014-08-19 00:00:00
abstract::Doxorubicin (Adriamycin) was administered by continuous infusion to reduce peak plasma levels and thus lessen cardiac toxicity. Cardiotoxicity was monitored by noninvasive methods, and endomyocardial biopsy specimens were studied by electronmicroscopy. Cardiotoxicity was compared in 21 patients receiving doxorubicin i...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-96-2-133
更新日期:1982-02-01 00:00:00
abstract::Cataract disrupts the crystalline lens, a transparent, elastic, avascular, biconvex structure composed of a capsule, lens epithelium, and lens fiber cells. Many factors contribute to the progression of lens opacity, but aging is most frequently associated with cataract. As aging-related cataract develops, many biochem...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-102-1-82
更新日期:1985-01-01 00:00:00
abstract:BACKGROUND:No effective oral therapy exists for early coronavirus disease 2019 (COVID-19). OBJECTIVE:To investigate whether hydroxychloroquine could reduce COVID-19 severity in adult outpatients. DESIGN:Randomized, double-blind, placebo-controlled trial conducted from 22 March through 20 May 2020. (ClinicalTrials.gov...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究,随机对照试验
doi:10.7326/M20-4207
更新日期:2020-10-20 00:00:00
abstract::Questionnaire II of the National Study of Internal Medicine Manpower was directed to all of the 1502 subspecialty training programs in the United States and Puerto Rico. The overall response rate was 86%. For the years 1972-1973 through 1976-1977 the number of fellows in subspecialty training grew at an average rate o...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-91-2-287
更新日期:1979-08-01 00:00:00
abstract:BACKGROUND:Magnetic resonance imaging (MRI) is avoided in most patients with implanted cardiac devices because of safety concerns. OBJECTIVE:To define the safety of a protocol for MRI at the commonly used magnetic strength of 1.5 T in patients with implanted cardiac devices. DESIGN:Prospective nonrandomized trial. (C...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,多中心研究
doi:10.7326/0003-4819-155-7-201110040-00004
更新日期:2011-10-04 00:00:00
abstract::Past efforts to reverse or limit the effects of acute stroke have been largely unsuccessful, in part because of the inability to evaluate and treat most patients soon after stroke onset. One important factor in the delay of treatment has been the nihilistic attitude of medical personnel, including physicians, toward t...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:
更新日期:1995-04-15 00:00:00
abstract::The coverage, cost, and quality problems of the U.S. health care system are evident. Sustainable health care reform must go beyond financing expanded access to care to substantially changing the organization and delivery of care. The FRESH-Thinking Project (www.fresh-thinking.org) held a series of workshops during whi...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-150-7-200904070-00115
更新日期:2009-04-07 00:00:00
abstract:DESCRIPTION:The American College of Physicians (ACP) developed this guideline to present the available evidence on various pharmacologic treatments to prevent fractures in men and women with low bone density or osteoporosis. METHODS:Published literature on this topic was identified by using MEDLINE (1966 to December 2...
journal_title:Annals of internal medicine
pub_type: 杂志文章,实务指引
doi:
更新日期:2008-09-16 00:00:00
abstract::The diagnostic and therapeutic value of the angiotensin converting enzyme inhibitor teprotide (SQ 20881) was assessed in 18 patients with hypertensive emergencies. Mean blood pressure fell 31 +/- 18 mm Hg in the 10 subjects who responded to 1 mg/kg body weight administered intravenously, whereas it fell 5 +/- 3 mm Hg ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-90-1-43
更新日期:1979-01-01 00:00:00
abstract:BACKGROUND:Although several agents are available to treat osteoporosis, the relative efficacy and toxicity of these agents when used to prevent fractures has not been well described. PURPOSE:To compare the benefits in fracture reduction and the harms from adverse events of various therapies for osteoporosis. DATA SOU...
journal_title:Annals of internal medicine
pub_type: 杂志文章,meta分析
doi:10.7326/0003-4819-148-3-200802050-00198
更新日期:2008-02-05 00:00:00
abstract:OBJECTIVE:To describe 13 infections caused by Mycobacterium haemophilum. DESIGN:Identification of patients by microbiologic record review, followed by medical record review and a case-control study. SETTING:Seven metropolitan hospitals in New York. PATIENTS:All patients with M. haemophilum infections diagnosed betwe...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-120-2-199401150-00004
更新日期:1994-01-15 00:00:00
abstract::Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities d...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-146-9-200705010-00155
更新日期:2007-05-01 00:00:00
abstract::Conventional interpretation of clinical trials relies heavily on the classic p value. The p value, however, represents only a false-positive rate, and does not tell the probability that the investigator's hypothesis is correct, given his observations. This more relevant posterior probability can be quantified by an ex...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-98-3-385
更新日期:1983-03-01 00:00:00
abstract::Comprehensive palliative care, as exemplified by many state-of-the-art hospice programs, is the standard of care for the dying. Although palliative care is very effective, physicians, nurses, patients, families, and loved ones regularly face clinically, ethically, legally, and morally challenging decisions throughout ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-132-6-200003210-00011
更新日期:2000-03-21 00:00:00
abstract::In 1993, the Clinical Efficacy Assessment Subcommittee began evaluation of new topics and reevaluation of previous guidelines on common screening tests, which were published in Annals of Internal Medicine between 1988 and 1990 and republished as a collection in 1991 (Eddy DM, ed. Common Screening Tests. Philadelphia: ...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-122-12-199506150-00008
更新日期:1995-06-15 00:00:00
abstract:Background:More than half of enrollees in the U.S. Department of Veterans Affairs (VA) are also covered by Medicare and can choose to receive their prescriptions from VA or from Medicare-participating providers. Such dual-system care may lead to unsafe opioid use if providers in these 2 systems do not coordinate care o...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M18-2574
更新日期:2019-04-02 00:00:00
abstract:OBJECTIVE:To determine which procedures nephrologists do in practice, where they learned the procedures, and how much training they recommend to achieve and maintain clinical competence in each. DESIGN:Mailed survey. PARTICIPANTS:A random sample of 700 members of the American College of Physicians who were identified...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-113-5-392
更新日期:1990-09-01 00:00:00
abstract::This issue provides a clinical overview of plantar fasciitis focusing on prevention, diagnosis, treatment, practice improvement, and patient information. Readers can complete the accompanying CME quiz for 1.5 credits. Only ACP members and individual subscribers can access the electronic features of In the Clinic. Non-...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-156-1-201201030-01001
更新日期:2012-01-03 00:00:00
abstract:BACKGROUND:Little evidence exists to support the theory that small-bore nasogastric tubes prevent gastroesophageal reflux and microaspiration in intubated patients. OBJECTIVE:To determine whether gastroesophageal reflux and microaspiration in intubated patients can be reduced by the use of a small-bore nasogastric tub...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章,随机对照试验
doi:10.7326/0003-4819-130-12-199906150-00007
更新日期:1999-06-15 00:00:00
abstract:BACKGROUND:Primary prevention of Alzheimer disease and other types of dementia (all-cause dementia) is an important public health goal. Evidence to date is insufficient to recommend any lifestyle change to prevent or delay the onset of dementia. OBJECTIVE:To assess the association between objectively measured midlife ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-158-3-201302050-00005
更新日期:2013-02-05 00:00:00
abstract:BACKGROUND:Radiation therapy is one of many treatment options for patients with prostate cancer. PURPOSE:To update findings on the clinical and biochemical outcomes of radiation therapies for localized prostate cancer. DATA SOURCES:MEDLINE (2007 through March 2011) and the Cochrane Central Register of Controlled Tria...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-155-3-201108020-00347
更新日期:2011-08-02 00:00:00
abstract:BACKGROUND:Primary aldosteronism is a common cause of treatment-resistant hypertension. However, evidence from local health systems suggests low rates of testing for primary aldosteronism. OBJECTIVE:To evaluate testing rates for primary aldosteronism and evidence-based hypertension management in patients with treatmen...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M20-4873
更新日期:2020-12-29 00:00:00
abstract:BACKGROUND:Health care-associated infections from invasive medical devices in the intensive care unit (ICU) are a major threat to patient safety. Most published studies of ICU-acquired infections have come from industrialized western countries. In a Centers for Disease Control and Prevention (CDC) National Nosocomial I...
journal_title:Annals of internal medicine
pub_type: 杂志文章,多中心研究
doi:10.7326/0003-4819-145-8-200610170-00007
更新日期:2006-10-17 00:00:00
abstract:STUDY OBJECTIVE:To evaluate the efficacy of cisplatin-based combination chemotherapy in patients with advanced ovarian germ-cell tumors. DESIGN:Nonrandom prospective trial with endpoints of tumor response, results of repeat surgical exploration, progression-free interval, and survival. SETTING:Cooperative university-...
journal_title:Annals of internal medicine
pub_type: 临床试验,杂志文章
doi:10.7326/0003-4819-111-1-22
更新日期:1989-07-01 00:00:00
abstract:BACKGROUND:Pulmonary embolism is a common clinical disorder that is associated with high morbidity and mortality if untreated. It is important to confirm or rule out the diagnosis in patients with clinical suspicion of the disease. PURPOSE:To evaluate various diagnostic strategies for excluding pulmonary embolism. DA...
journal_title:Annals of internal medicine
pub_type: 杂志文章,评审
doi:10.7326/0003-4819-138-12-200306170-00005
更新日期:2003-06-17 00:00:00
abstract:Background:Probiotics, prebiotics, and synbiotics are used increasingly, although the safety and potential harms of these interventions are poorly understood. Purpose:To examine how harms-related information is reported in publications of randomized controlled trials (RCTs) of probiotics, prebiotics, and synbiotics. ...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/M18-0343
更新日期:2018-08-21 00:00:00
abstract::A patient with familial Mediterranean fever and amyloidosis who received a cadaver renal transplant 6 1/2 years ago was studied to determine the relation of the serum precursor of secondary amyloid (SAA) to the clinical course and to the deposition of amyloid in the transplant. Amyloid fibrils extracted from the patie...
journal_title:Annals of internal medicine
pub_type: 杂志文章
doi:10.7326/0003-4819-87-1-31
更新日期:1977-07-01 00:00:00