Saturday, December 10, 2005

Academic Misconduct in its Deadliest Form

Merck deleted data of three heart attacks among Vioxx users before they submitted its study of the clinical trail to the New England Journal of Medicine (NEJM) in 2000.

Three additional patients who suffered heart attacks while taking Vioxx surfaced after the original cut-off date for information collection set by Merck researchers, but at least two weeks before submitting to the most prestigious US medical journal the first of two revisions, and four-and-a-half months before the actual publication. The extra three cases would have account for an extra 80 percent increase of heart attacks rick compared to naproxen, a generic over the counter painkiller. All three patients are in a group at low risk of heart attack.

The Journal published a rare Expression of Concern on December 8th, 2005 alleging Merck deliberated withhold the information from the journal and public after they recovered the deleted data from the original electronic media submitted by Merck for publication. The editorial found the last minute tweaks of data made certain calculations and conclusions in the article incorrect.

The Merck funded research was carried out by a team of twelve scientists. The clinical trail on Vioxx, code named VIGOR, was conducted at Toronto's Mount Sinai Hospital, where the lead author Dr. Bombardier holds a position.

In response to the editorial, Dr. Claire Bombardier of the University of Toronto said 'the VIGOR paper appropriately disclosed the data as per the pre-specified plan of analysis'. This is bullshit. Electronic records recently discovered from the computer diskette that had been submitted to the NEJM showed the numbers of heart attacks and deaths were deleted two days before submission.

Although Dr. Bombardier claimed that the missing data was later made available to FDA and the public, her 2000 paper was used extensively as strong argument for the drug's safety. "The health of the public, of many, many thousands of people, was at stake here', Dr. Geoffrey D. Curfman, the executive editor of the Journal said in an interview. He also noted that the authors deleted additional relevant data about strokes and other heart problems caused by the drug from their manuscript prior to submission.

The third author of the paper was Dr. Alise Reicin, Merck's vice president for clinical research. She is also accused of failing to reveal her Merck affiliation in the study's disclosure section. Dr. Reicin testified on December 7th, 2005 in a trail in Houston that the company never misled doctors and the public about studies linking heart attacks to Vioxx. Again, this is nothing but bullshit, and worse, it invites a perjury investigation. Dr. Eric Topol whose publication on Vioxx's safety in 2001. together with the exposure of several independent studies, leads to the drug's withdrawn in September 30th, gave an opposite story. When he noticed some discrepancies in Merck's data and contacted Merck, Dr. Alise Reicin paid him an unprecedented personal visit. She told Dr. Topol she couldn't get access to all the data. After Dr. Topol published his study, Merck launch a smear campaign sending letters to doctors all over the country to discredit his study. Merck also threatend Dr. Gurkirpal Singh, a professor of Stanford University and also a Merck consultant, of 'sevear consequences' if he kept studying the risk of Vioxx. Several top medical schools complained about a consistent pattern of intimidation of investigators by Merck. Dr. Topol accused Merck of engaging in scientific misconduct, suppressing clinical evidence and stifling medical disclosure in its promoting of the Vioxx.

The rest of the team is comprised of Drs. Loren Laine of University of Southern California, Deborah Shapiro of Merck, Ruben Burgos-Vargas of Hospital General de Mexico, Barry Davis of the University of Texas, Richard Day of the University of new South Wales, Marcos Bosi Ferraz of Universidade Federal de São Paulo, Christopher J. Hawkey of University Hospital in Nottingham UK, Marc C. Hochberg of the University of Maryland, Tore K. Kvien of Diakonhjemmet Hospital in Oslo Norway, Thomas J. Schnitzer of Northwestern University, Arthur Weaver of Arthritis Center of Nebraska Lincoln.

The painkiller was approved by FDA in 1999, and around 20 million people had been using Vioxx before its withdrawal in 2004. More than 7,000 lawsuits have been filed against Merck on Vioxx caused heart attacks and deaths, and many more are expected. In a June 9th, 2005 NPR report, it was estimated that at least 38,000 Americans were believed to have died from taking the painkiller. Because elevated risk of heart attacks only effects long-term users who had been using Vioxx for more than 18 months, had we known what Dr. Clair Bombardier decided to hide from us in her 2000 paper, many, if not all, of these lives could have been spared.

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