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Fresh questions raised about prominent cardiologist's role in "ghostwritten" 2001 meta-analysis of Vioxx trials
April 30, 2009 | Lisa Nainggolan
Melbourne, Australia - Prominent cardiologist Dr Marvin Konstam (Tufts University Medical Center, Boston, MA) agreed to be lead author on a 2001 Circulation paper about the COX-2 inhibitor rofecoxib (Vioxx, Merck) [1], which was written in-house by Merck scientists, according to claims made in a federal court in Australia last week [2]. The paper was designed to deflect safety criticisms, some experts believe, following the publication of an article in the Journal of the American Medical Association (JAMA) two months previously that first demonstrated an increase in cardiovascular side effects with the drug [3]. Rofecoxib was not withdrawn from worldwide sale until 2004
This is very significant, says Dr Steve Nissen (Cleveland Clinic, Cleveland, Ohio), who was an author on the JAMA paper. "During the three years after publication of the Konstam manuscript, millions of patients around the world were prescribed rofecoxib by physicians who believed that the drug was safe. In this case, a ghostwritten article caused great harm to the public health."
The suggestion that Konstam did not significantly contribute to the Circulation paper is not newit was most recently reported a year ago in a Boston Globe article by Alice Dembner [4]. The most recent questions about Konstam's role have been raised in Australian media coverage, including a report by Kate Hagan in Melbourne's The Age newspaper. The "ghostwriting" issue comes as the Pharmaceutical Research and Manufacturers of America (PhRMA) has issued "revised principles" on the communication of clinical trial results [5], including restricting authorship on medical manuscripts to individuals who have made "substantial contributions."
Nissen told heartwire: "We must not view this situation as 'old news.' We had long suspected that this [Circulation] manuscript was ghostwritten, but definitive proof was lacking. These court documents finally confirm our suspicions
http://www.theheart.org/article/965721.do
Fresh questions raised about prominent cardiologist's role in "ghostwritten" 2001 meta-analysis of Vioxx trials
April 30, 2009 | Lisa Nainggolan
Melbourne, Australia - Prominent cardiologist Dr Marvin Konstam (Tufts University Medical Center, Boston, MA) agreed to be lead author on a 2001 Circulation paper about the COX-2 inhibitor rofecoxib (Vioxx, Merck) [1], which was written in-house by Merck scientists, according to claims made in a federal court in Australia last week [2]. The paper was designed to deflect safety criticisms, some experts believe, following the publication of an article in the Journal of the American Medical Association (JAMA) two months previously that first demonstrated an increase in cardiovascular side effects with the drug [3]. Rofecoxib was not withdrawn from worldwide sale until 2004
This is very significant, says Dr Steve Nissen (Cleveland Clinic, Cleveland, Ohio), who was an author on the JAMA paper. "During the three years after publication of the Konstam manuscript, millions of patients around the world were prescribed rofecoxib by physicians who believed that the drug was safe. In this case, a ghostwritten article caused great harm to the public health."
The suggestion that Konstam did not significantly contribute to the Circulation paper is not newit was most recently reported a year ago in a Boston Globe article by Alice Dembner [4]. The most recent questions about Konstam's role have been raised in Australian media coverage, including a report by Kate Hagan in Melbourne's The Age newspaper. The "ghostwriting" issue comes as the Pharmaceutical Research and Manufacturers of America (PhRMA) has issued "revised principles" on the communication of clinical trial results [5], including restricting authorship on medical manuscripts to individuals who have made "substantial contributions."
Nissen told heartwire: "We must not view this situation as 'old news.' We had long suspected that this [Circulation] manuscript was ghostwritten, but definitive proof was lacking. These court documents finally confirm our suspicions
http://www.theheart.org/article/965721.do
