16. Februar 2012
Es werde Licht - Transparenzregelungen in den USA werden konkretisiert
Beitrag im Forum Gesundheitspolitik Link
Seelsorge für die Industrie. SPIEGEL 16.5.2011
Seelsorge für die Industrie
Von Jörg Blech
Link
(versehentlich im Mai nicht veröffentlicht, aber immer noch lesenswert)
Being the Ghost in the Machine: A Medical Ghostwriter's Personal View
PLoS 9.8.2011
Link
Introduction Top
Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.
(versehentlich im August nicht veröffentlicht, aber immer noch lesenswert)
Link
Introduction Top
Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.
(versehentlich im August nicht veröffentlicht, aber immer noch lesenswert)
13. Oktober 2011
Leitlinien zu Diabetes und Cholesterin: 52% der Autoren mit Interessenkonflikten
3. September 2011
PLoS Medicine. Beiträge zu Ghost Writing, Aug. 2011
Gegen ghost writing. Die Herkunft von Studien offen legen - schwierig aber notwendig
in Forum Gesundheitspolitik
in Forum Gesundheitspolitik
10. August 2011
Being the Ghost in the Machine: A Medical Ghostwriter's Personal View
PLoS 9.8.2011
Link
Introduction
Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.
Link
Introduction
Ethical concerns about medical ghostwriting have been directed primarily at “guest” authors and the pharmaceutical companies that pay them. One voice that is largely missing is that of the ghostwriters themselves who, after all, create the documents that are in the ethical and legal crosshairs. Without them, one could argue, there can be no fraud, because it is they who create the fraudulent product.
For almost 11 years, I worked as a medical writer, creating a variety of pieces including the occasional ghostwritten article. For the most part, I never saw the finished paper, nor did I care to. This article describes what I did, why I did it, why I stopped doing it, and what I think might be done about the problem of fraud in authorship.
How Industry Uses the ICMJE Guidelines to Manipulate Authorship—And How They Should Be Revised
PLoS 9. August 2011
Link
Summary Points
Academic authorship boosts the credibility of industry publications and masks their commercial function.
Alongside traditional “guest authorship” and ghostwriting, industry may simply exaggerate the contribution of named academic authors and downplay that of commercial writers, who are excluded from authorship but listed as contributors in the small print.
Rather than obstructing industry, the current International Committee of Medical Journal Editors (ICMJE) authorship guidelines provide a ready tool for misattributing authorship. Industry also relies on selective interpretations of key authorship concepts.
The ICMJE guidelines should be fundamentally revised and the concept of origination given comparable importance to authorship and contributorship.
Companies and writers who work on industry publications should be listed as byline authors.
Link
Summary Points
Academic authorship boosts the credibility of industry publications and masks their commercial function.
Alongside traditional “guest authorship” and ghostwriting, industry may simply exaggerate the contribution of named academic authors and downplay that of commercial writers, who are excluded from authorship but listed as contributors in the small print.
Rather than obstructing industry, the current International Committee of Medical Journal Editors (ICMJE) authorship guidelines provide a ready tool for misattributing authorship. Industry also relies on selective interpretations of key authorship concepts.
The ICMJE guidelines should be fundamentally revised and the concept of origination given comparable importance to authorship and contributorship.
Companies and writers who work on industry publications should be listed as byline authors.
16. Mai 2011
Pillentrick des Pharmalobbyismus. Wie man Patienten um den Finger wickelt
Financial Times Deutschland 14.5.2011
Link
Link
Many US medical associations and disease awareness groups depend heavily on funding by drug manufacturers
BMJ 2011; 342:d2929 doi: 10.1136/bmj.d2929 (Published 10 May 2011)
Cite this as: BMJ 2011; 342:d2929
News
Many US medical associations and disease awareness groups depend heavily on funding by drug manufacturers
Jeanne Lenzer
+ Author Affiliations
1New York
Many medical societies and non-profit disease awareness organisations in the United States receive much of their funding from drug and device manufacturers, show documents recently released to the US senator Charles Grassley.
Senator Grassley, a Republican of Iowa, asked for financial information in December 2009 from 33 professional associations and groups that conduct research or promote disease awareness.
Among the organisations responding to Senator Grassley’s request was the American Medical Association, which reported that 16 drug, device, and communications companies donated nearly $5m (£3.1m; €3.5m) in 2007 for “continuing medical education” programmes and “communications conferences.”
Large donations to the association included $499 000 from Takeda Pharmaceutical Company, which makes the blockbuster antidiabetes drug pioglitazone, to conduct a continuing medical education programme on diabetes. Teva Neuroscience, maker of rasagiline, a treatment for Parkinson’s disease, gave $450 000 for a programme on Parkinson’s disease; and Purdue Pharma, maker of OxyContin, a formulation of the painkiller oxycodone, donated $212 000 for a programme on pain management.
The online investigative news organisation ProPublica (www.propublica.org), which scrutinised the documents received by Senator Grassley, says that manufacturers provided more than half of the total funding of the North American Spine Society in 2009, nearly half the funding of the Heart Rhythm Society in 2010, and more than 40% of the funding of the American Academy of Allergy, Asthma and Immunology in 2008.
Many organisations issue professional recommendations and guidelines on drugs and devices manufactured by the companies that fund the organisation. For example, the Heart Rhythm Society issues guidelines on drugs, catheters, pacemakers, and implantable defibrillators used for rhythm disturbances. A ProPublica report says that the device manufacturers Medtronic, Boston Scientific, and St Jude Medical gave the society $4m in 2010. Twelve of the society’s 18 directors also received undisclosed amounts of funding from the companies.
Senator Grassley told ProPublica, “If a group gets millions [of dollars] from a company that makes a product [prescribed] by its members, it is reasonable to wonder whether the guidance it offers on treatments would benefit that company.”
ProPublica reported that Bruce Wilkoff, the incoming president of the Heart Rhythm Society, said, “We either get out of the business or we manage these relationships. That’s what we’ve chosen to do.”
Jerome Hoffman, professor of emergency medicine at the University of Southern California in Los Angeles and an expert on industry influence in medicine, told the BMJ, “It’s unclear just what ‘business’ [Dr Wilkoff] is referring to, but the business of finding non-conflicted experts to write evidence based guidelines that serve the public in no way requires taking industry largesse.
“The very notion of ‘managing’ such relationships is . . . self serving. We need to ask what purpose medical societies should serve, and if the answer has anything to do with promoting the public health we should insist that they stop, consciously or otherwise, serving a very separate master.”
The American Medical Association did not respond to an inquiry by the BMJ regarding the reports.
Notes
Cite this as: BMJ 2011;342:d2929
Cite this as: BMJ 2011; 342:d2929
News
Many US medical associations and disease awareness groups depend heavily on funding by drug manufacturers
Jeanne Lenzer
+ Author Affiliations
1New York
Many medical societies and non-profit disease awareness organisations in the United States receive much of their funding from drug and device manufacturers, show documents recently released to the US senator Charles Grassley.
Senator Grassley, a Republican of Iowa, asked for financial information in December 2009 from 33 professional associations and groups that conduct research or promote disease awareness.
Among the organisations responding to Senator Grassley’s request was the American Medical Association, which reported that 16 drug, device, and communications companies donated nearly $5m (£3.1m; €3.5m) in 2007 for “continuing medical education” programmes and “communications conferences.”
Large donations to the association included $499 000 from Takeda Pharmaceutical Company, which makes the blockbuster antidiabetes drug pioglitazone, to conduct a continuing medical education programme on diabetes. Teva Neuroscience, maker of rasagiline, a treatment for Parkinson’s disease, gave $450 000 for a programme on Parkinson’s disease; and Purdue Pharma, maker of OxyContin, a formulation of the painkiller oxycodone, donated $212 000 for a programme on pain management.
The online investigative news organisation ProPublica (www.propublica.org), which scrutinised the documents received by Senator Grassley, says that manufacturers provided more than half of the total funding of the North American Spine Society in 2009, nearly half the funding of the Heart Rhythm Society in 2010, and more than 40% of the funding of the American Academy of Allergy, Asthma and Immunology in 2008.
Many organisations issue professional recommendations and guidelines on drugs and devices manufactured by the companies that fund the organisation. For example, the Heart Rhythm Society issues guidelines on drugs, catheters, pacemakers, and implantable defibrillators used for rhythm disturbances. A ProPublica report says that the device manufacturers Medtronic, Boston Scientific, and St Jude Medical gave the society $4m in 2010. Twelve of the society’s 18 directors also received undisclosed amounts of funding from the companies.
Senator Grassley told ProPublica, “If a group gets millions [of dollars] from a company that makes a product [prescribed] by its members, it is reasonable to wonder whether the guidance it offers on treatments would benefit that company.”
ProPublica reported that Bruce Wilkoff, the incoming president of the Heart Rhythm Society, said, “We either get out of the business or we manage these relationships. That’s what we’ve chosen to do.”
Jerome Hoffman, professor of emergency medicine at the University of Southern California in Los Angeles and an expert on industry influence in medicine, told the BMJ, “It’s unclear just what ‘business’ [Dr Wilkoff] is referring to, but the business of finding non-conflicted experts to write evidence based guidelines that serve the public in no way requires taking industry largesse.
“The very notion of ‘managing’ such relationships is . . . self serving. We need to ask what purpose medical societies should serve, and if the answer has anything to do with promoting the public health we should insist that they stop, consciously or otherwise, serving a very separate master.”
The American Medical Association did not respond to an inquiry by the BMJ regarding the reports.
Notes
Cite this as: BMJ 2011;342:d2929
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