Timing of new black box warnings and withdrawals for prescription medications.
- K. Lasser, P. Allen, S. Woolhandler, D. Himmelstein, S. Wolfe, D. Bor
- MedicineJAMA
- 1 May 2002
To determine the frequency and timing of discovery of new ADRs described in black box warnings or necessitating withdrawal of the drug from the market, Examination of the Physicians' Desk Reference for all new chemical entities approved by the US Food and Drug Administration between 1975 and 1999 is examined.
Unethical trials of interventions to reduce perinatal transmission of the human immunodeficiency virus in developing countries.
The authors oppose the use of placebo-controlled trials as unethical in the search for alternative antiretroviral drug regimens to prevent the perinatal transmission of HIV.
Cell-free hemoglobin-based blood substitutes and risk of myocardial infarction and death: a meta-analysis.
- C. Natanson, S. Kern, P. Lurie, S. Banks, S. Wolfe
- MedicineJAMA
- 21 May 2008
Use of HBBSs is associated with a significantly increased risk of death and myocardial infarction, and subgroup analysis of these trials indicated the increased risk was not restricted to a particular HBBS or clinical indication.
Quality of care in investor-owned vs not-for-profit HMOs.
- D. Himmelstein, S. Woolhandler, I. Hellander, S. Wolfe
- MedicineJAMA
- 14 July 1999
Investor-owned HMOs deliver lower quality of care than not-for-profit plans, and investor ownership was consistently associated with lower quality after controlling for model type, geographic region, and the method each HMO used to collect data.
Direct-to-consumer advertising--education or emotion promotion?
- S. Wolfe
- MedicineNew England Journal of Medicine
- 14 February 2002
Two articles in this issue of the Journal address the rise of direct-to-consumer promotion and increased access by patients to accurate, objective information about tests to diagnose and drugs to treat illnesses.
Pharmaceutical company payments to physicians: early experiences with disclosure laws in Vermont and Minnesota.
- J. Ross, Josh E Lackner, P. Lurie, C. Gross, S. Wolfe, H. Krumholz
- Medicine, Political ScienceJAMA
- 21 March 2007
The Vermont and Minnesota laws requiring disclosure of payments do not provide easy access to payment information for the public and are of limited quality once accessed.
Financial conflict of interest disclosure and voting patterns at Food and Drug Administration Drug Advisory Committee meetings.
- P. Lurie, C. M. Almeida, N. Stine, Alexander Stine, S. Wolfe
- Political ScienceJAMA
- 26 April 2006
A weak relationship between certain types of conflicts and voting behaviors was detected, but excluding advisory committee members and voting consultants with conflicts would not have altered the overall vote outcome at any meeting studied.
Physicians disciplined for sex-related offenses.
- C. Dehlendorf, S. Wolfe
- MedicineJAMA
- 17 June 1998
Discipline against physicians for sex-related offenses is increasing over time and is relatively severe, although few physicians are disciplined for sexual offenses each year.
Relationship between low quality-of-care scores and HMOs' subsequent public disclosure of quality-of-care scores.
- D. McCormick, D. Himmelstein, S. Woolhandler, S. Wolfe, D. Bor
- MedicineJAMA
- 25 September 2002
Compared with HMOs receiving higher quality-of-care scores, lower-scoring plans are more likely to stop disclosing their quality data, and voluntary reporting of quality data by H MOs is ineffective.
Era of faster FDA drug approval has also seen increased black-box warnings and market withdrawals.
- Cassie Frank, D. Himmelstein, K. Lasser
- MedicineHealth Affairs
- 1 August 2014
The findings suggest the need for reforms to reduce patients' exposure to unsafe drugs, such as a statement or symbol in the labeling, medication guides for patients, and marketing materials indicating that a drug was approved only recently.
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