May 22, 2006 at 15:54:14

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Merck Litigation Strategy - Destroy Expert Witnesses

By Evelyn Pringle (about the author)     Page 9 of 11 page(s)

opednews.com     Permalink

Dr Topol, testified that 3 years before the drug was pulled off the market, he and two colleagues published a paper in the Journal of the American Medical Association that raised the issue of whether Vioxx caused heart problems.

Dr Topol pointed out that although they published clear warnings about the cardiovascular risk in 2001, the FDA never ordered a trial to determine the extent of the problem and said Merck countered the JAMA article with a "relentless series of publications" and numerous papers in peer-reviewed medical literature written by Merck employees and consultants.

During his testimony, Dr Topol told the jury how a colleague at the Cleveland Clinic, Richard Rudick, had informed him that Raymond Gilmartin, the former CEO of Merck, had called the Cleveland Clinic board of trustees and complained about Dr Topol in mid-October 2004, after he criticized Merck's handling of the Vioxx situation in the New York Times and New England Journal of Medicine.

He described how Mr Gilmartin called the chairman of the board, and said "what has Merck ever done to the Cleveland Clinic to warrant this?'

Dr Topol told the jury that Mr Gilmartin's approach "appalled" him.

Two days after his deposition was played in court, Dr Topol found himself removed as provost and chief academic officer at the Cleveland Clinic medical school.

According to Dr Topol, he was told early in the morning not to attend a meeting of the clinic's board of governors, because the position of chief academic officer had been abolished.

Dr Tope was somewhat vindicated later in December 2005, with the publication of an "Expression of Concern" by the editors of the New England Journal of Medicine, that charged that the VIGOR, published in the journal in 2000, was submitted to the journal after data on 3 heart attacks and other cardiovascular events among trial participants was deleted by Merck.

According to an article by Amanda Gardner in Health Day Reporter, right after Vioxx was removed from the market, the editors opened a computer diskette that had been submitted with the study and found a blank table with no data - lines had been drawn but not filled in.

"They did not know what should have been in there," Sandra Jacobs, a spokeswoman for the NEJM said. "It raised some concern, but we didn't know enough to act on it," Jacobs added.

On November 21, 2005, Ms Garner says, NEJM's executive editor, Dr Gregory Curfman, was deposed for a Vioxx trial and during the process, a July 5, 2000 memorandum came to light that indicated that at least 2 of the VIGOR authors knew of the problems 2 weeks before submitting the first of two revisions, and four-and-a-half months before the study was actually published.

Dr Curfman told HealthDay that electronic records showed "a pre-submission version of the study from which data, including the number of heart attacks and deaths, were deleted by a Merck editor two days before submission."

As a dedicated scientist and health practitioner with nothing to gain, in hindsight, it appears that Dr Topol certainly paid a high price for committing the simple act of truth-telling to protect the public from a dangerous drug and its pusher.

As a small law firm practitioner turned legal reform activist, Attorney Zena Crenshaw is highly critical of Merk's debilitating cross examinations of experts who essentially claim the company recognized Vioxx's potential cardiac risks before it went on the market.

Ms Crenshaw is the Executive Director for National Judicial Conduct and Disability Law Project, Inc, a legal reform organization combating abuses of the American legal system that are facilitated by judicial misconduct.

She explains that such is a signature tactic of "mega-corporations" that it seems only "mega-lawfirms" and governmental agencies can neutralize.

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