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13. Oktober 2011

Leitlinien zu Diabetes und Cholesterin: 52% der Autoren mit Interessenkonflikten

Neuman J, Korenstein D, Ross JS, Keyhani S. Prevalence of financial conflicts of interest among panel members producing clinical practice guidelines in Canada and United States: cross sectional study. BMJ 2011;343.Volltext Link
Beitrag im Forum Gesundheitspolitik Link

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

10. August 2011

Being the Ghost in the Machine: A Medical Ghostwriter's Personal View

PLoS 9.8.2011


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


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

Cardiac Society Draws Bulk of Funding From Stent Makers

by Charles Ornstein
ProPublica, May 13, 2011, 1:27 p.m


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


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.

Cite this as: BMJ 2011;342:d2929

30. April 2011

Interessenkonflikte bei Erstellern amerikanischer kardiologischer Leitlinien

Mendelson TB, Meltzer M, Campbell EG, Caplan AL, Kirkpatrick JN.
Conflicts of Interest in Cardiovascular Clinical Practice Guidelines.
Arch Intern Med 2011;171(6):577-84. (28.3.2011)

Beitrag im Forum Gesundheitspolitik: Amerikanische kardiologische Leitlinien: kann man ihnen vertrauen? Link

3. April 2011

Lücken in der Transparenz: Meta-Analysen zumeist ohne Angaben von Interessenkonflikten

Roseman M, Milette K, Bero LA, Coyne JC, Lexchin J, Turner EH, et al. Reporting of Conflicts of Interest in Meta-analyses of Trials of Pharmacological Treatments. JAMA: The Journal of the American Medical Association 2011;305(10):10

Lücken in der Transparenz: Meta-Analysen zumeist ohne Angaben von Interessenkonflikten
Beitrag im Forum Gesundheitspolitik Link

17. Februar 2011

Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research

Die Offenlegung von Interessenkonflikten ist nicht nur theoretisch wichtig, sondern hat praktische Komsequenzen für die Verschreibungspraxis, denn sie trägt zur Skepsis bei. Das zeigt dieser kleine Versuch von Lacasse und Leo. Eine Schlussfolgerung der Autoren: "For industry [...] our results suggest that decreased disclosures are preferable" ist dann wohl auch eher als Warnung zu verstehen.

While the impact of conflicts-of-interest (COI) is of increasing concern in academic medicine, there is little research on the reaction of practicing clinicians to the disclosure of such conflicts. We developed two research vignettes presenting a fictional antidepressant medication study, one in which the principal investigator had no COI and another in which there were multiple COI disclosed. We confirmed the face validity of the COI vignette through consultation with experts. Hospital-based clinicians were randomly assigned to read one of these two vignettes and then administered a credibility scale.

Jeffrey R Lacasse, Jonathan Leo
Knowledge of ghostwriting and financial conflicts-of-interest reduces the perceived credibility of biomedical research
BMC Research Notes 2011, 4:27

The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health

Der Artikel, dessen Schwerpunkt die Ursachen irrationaler Verschreibung ist, weist besonders auf die Rolle von Interessenkonflikten bei der Erstellung von Leitlinien und deren Folgen hin.

Recent highly publicized withdrawals of drugs from the market because of safety concerns raise the question of whether these events are random failures or part of a recurring pattern.
The inverse benefit law, inspired by Hart’s inverse care law, states that the ratio of benefits to harms among patients taking new drugs tends to vary inversely with how extensively the drugs are marketed. The law is manifested through 6 basic marketing strategies: reducing thresholds for diagnosing disease, relying on surrogate endpoints, exaggerating safety claims, exaggerating efficacy claims, creating new diseases, and encouraging unapproved uses.

Howard Brody, MD, PhD, and Donald W. Light, PhD
The Inverse Benefit Law: How Drug Marketing Undermines Patient Safety and Public Health
Am J Public Health 2011

14. Januar 2011

"Interessenkonflikte sind etwas ganz Natürliches"

Medizinprofessor fordert Professoren auf, ihre Nebeneinkünfte zu offenbaren
Deutschlandfunk 13.1.2011
Audio on demand

Gläserner Professor

Spiegel online 3.1.2011 Link