Among other things the editorial calls for:
"To maintain a healthy distance from industry influence, professional organizations and providers of continuing medical education courses should not condone or tolerate for-profit companies having any input into the content of educational materials or providing funding or sponsorship for medical education programs."
These papers are based on the authors having testified in Vioxx trials and having access to vast volumes of discovery. One paper claims that Merck found academic and company ghostwriters who had no involvement in the research. The other alleges that Merck fiddled with the definition of deaths attributed to the drug in a Vioxx dementia trial. One of the papers is authored by Harlan Krumholz, MD a well paid expert witness for the plaintiff attorneys in these cases. He’s published in the BMJ that Merck is guilty, contrary to the results of the majority of trials.
Response from a friend….This is old news:
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If academics were ghost authors, that arguably is fraud (fabrication), and their institutions should discipline them appropriately;
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If one were to troll any research project, commercial or academic, with such retrospective detail, I shudder to think what could be found;
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The hysterical response from JAMA is absurd; two papers, even if true, do not document "increasing evidence of misrepresentation etc," and the severe oversight recommendations proposed by its editors.
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Bottom line is that if we are suffering from an epidemic of corruption, how could Merck have introduced statins, Gardasil, ARVs, etc., that seem to be effective and safe.
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If the "vast number of researchers are honest," why do we have to "distance commercial support from CME?"
Unfortunately the fuss inflames the COI witch hunt.
It took less than twenty four hours from release of the embargoed press release for members of the US Senate to issue press statements and letters to industry on articles printed in Today’s JAMA.
Senators Grassley and Kohl issued dueling press releases under the premise that this article proves the need for the Physician Payment Sunshine Act and the need for more transparency. (see attached)
Grassley went one step further in requesting information from the company (Merck) and their publication planning company on the practices that include perceived ghost writing.
The two Senators, Kohl and Grassely, have taken this opportunity to show the need for the Physician Payment Sunshine Act. The timing of these and other recent articles is no doubt in preparation for a change in the White House, which ho doubt would aid passage of the PPSA.
Links to articles about issue in the Washington Post, the Wall Street Journal the Boston Globe, and the New York Times
Links to JAMA Papers: Ghost Writing, Mortality Data , Editorial Integrity in Science.
Bellow are the Senate Press Releases by Senators Kohl, and Grassley:
Jama Editorial Senator Kohl Press Release 4-15-08
Jama Editorial and letter to Merck – Senator Grassley press release 4-15-08.
In case you didn’t pick up a recent newspaper JAMA has just published a series of articles and an editorial concerning academic and company involvement in clinical trials, focused on data collected in the Merck Vioxx discovery by trial attorneys.