How Radiation Oncologists Would Disclose Errors: Results of a Survey of Radiation Oncologists and Trainees
Showing posts with label patient harm. Show all posts
Showing posts with label patient harm. Show all posts
Monday, May 07, 2012
paywalled: How Radiation Oncologists Would Disclose Errors: Results of a Survey of Radiation Oncologists and Trainees (patient safety)
How Radiation Oncologists Would Disclose Errors: Results of a Survey of Radiation Oncologists and Trainees
add your opinions
disclosure
,
errors
,
foregiveness
,
litigation
,
minor errors
,
near misses
,
patient harm
,
patient safety
,
risk management
Tuesday, January 24, 2012
open access: PLoS Medicine: Challenging Medical Ghostwriting in US Courts - eg. ethics, legal liabilities, patient harm.....
Introduction
"Complaints about the ethics of medical ghostwriting have increased in the last decade, but little has changed [1]–[14]....."Summary Points
- Despite growing concern about medical ghostwriting, pharmaceutical companies, universities, medical journals, and communication companies employing ghostwriters have thus far failed to adequately stem the problem. As a result, some commentators have proposed that legal remedies could be sought by patients harmed by drugs publicized in ghostwritten papers.
- In this Essay, we build on a recent analysis by Stern and Lemmens in PLoS Medicine to outline specific areas of legal liability.
- For example, when an injured patient's physician directly or indirectly relies upon a journal article containing false or manipulated safety and efficacy data, the authors, including guest authors, can be held legally liable for patient injuries.
- In addition, guest authors of ghostwritten articles published by Medicare- and Medicaid-recognized peer-reviewed medical journals used as clinical evidence for indications for off-label uses may be liable under the federal False Claims Act for inducing the United States government to reimburse prescriptions under false pretenses.
- Paying guest authors of ghostwritten papers may influence clinical judgment, increase product sales and government health care costs, and put patients at risk by misrepresenting risk-benefit. Therefore, both physicians and sponsor companies may be liable under the federal Anti-Kickback Statute.
- Although guest authors and pharmaceutical defendants may argue a First Amendment right to participate in ghostwriting, the US Supreme Court has firmly held that the First Amendment does not shield fraud.
add your opinions
ethics
,
ghostwriting
,
patient harm
,
patient safety
,
pharma
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