Dr Singh noted that Vioxx was no more effective than any other available pain-killer and at the time, there were nearly 30 such drugs on the market in the US. Celebrex, he said, had no such risk and had been available for 6 months prior to Vioxx.
"There was certainly no emergent need to approve Vioxx without further studies if there were lingering safety concerns," he said. "The trade-off of heart attacks for the rare instances of stomach bleeds," he advised, "is not a reasonable one."
But instead, he reminded the panel, "the drug was approved by the FDA in a priority review within 6 months - with no discussion on the heart attack trade-off."
"The prescribing physicians," he noted, "remained unaware of any of these data or discussions, till much later - with the new label change in April, 2002."
Dr Singh explained, that the VIGOR study was the first public release of information about the heart attack-stomach bleed trade-off. The 500% increase in the risk of heart attacks found in VIGOR stunned him, he said.
At the time that the results were announced, Dr Singh said he was involved in teaching and some of his educational lectures were sponsored by Merck. "I was strongly in favor of this new class of drugs," he explained, "and before the VIGOR trial, was unaware of any significant heart attack issues."
Merck's press release on the study, with a brief mention of the heart attack risk was not enough for him to continue to educate doctors in his lectures Dr Singh said, so he asked Merck for more detailed data, and when he was unable to obtain the information after multiple requests, he added a slide to his presentation that showed a man - representing the missing data - hiding under a blanket.
Up until this time, Dr Singh said, Merck had responded to all of his requests promptly. But when he persisted in his enquiries, he told the committee, "I was warned that if I continued in this fashion, there would be serious consequences for me."
"I was told that Dr. Louis Sherwood, a Merck senior vice-president, and a former Chief of Medicine at a medical school, had extensive contacts within the academia and could make life "very difficult" for me at Stanford and outside," he testified.
And as it turns out, Dr Sherwood did call Dr Singh's superiors at Stanford University to complain.
However documents that have surfaced in litigation over the past couple of years reveal that Dr Singh had no idea how important he had become in the minds of Merck officials.
The documents show that for most of June 2000, Merck officials had their heads together trying to come up with a plan to rein in Dr Singh. He presented a major problem because he was widely respected at the FDA and also had connections with large institutional buyers that were vital to Merck sales.
On June 5, 2000, Merck senior business director, Terry Strombom, sent an email that shows Merck found itself caught between a rock and a hard place. "The one thing I am pretty sure of is that Dr. Singh could impact us negatively if he chose to do so," he wrote. "I would recommend we handle this very carefully... I just don't think canceling all the programs and walking away completely will serve us well in the long term," he said.
Another email shows one official acknowledging that Dr Singh's criticisms about Vioxx were valid. On June 5, 2000, Heather Robertson, a coordinator of health education projects, reported a conversation with Dr Singh's contact at Merck, who had since left the company in an email that said:
"I spoke to Kirsten directly for the first time this past week to learn that Dr. Singh makes a balanced presentation (he must since he is an FDA advisor) but reports product information that is not favorable to Merck... Kirsten feels that no amount of work would change Dr. Singh's position, and although we may not like to hear about it, his information is scientifically accurate."
On June 19, 2000, a marketing manager, Susan Baumgartner, wrote an email saying: "Dr. Singh continues to play up the cardiovascular adverse events associated with Vioxx... I think there are many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver."
"There was certainly no emergent need to approve Vioxx without further studies if there were lingering safety concerns," he said. "The trade-off of heart attacks for the rare instances of stomach bleeds," he advised, "is not a reasonable one."
But instead, he reminded the panel, "the drug was approved by the FDA in a priority review within 6 months - with no discussion on the heart attack trade-off."
"The prescribing physicians," he noted, "remained unaware of any of these data or discussions, till much later - with the new label change in April, 2002."
At the time that the results were announced, Dr Singh said he was involved in teaching and some of his educational lectures were sponsored by Merck. "I was strongly in favor of this new class of drugs," he explained, "and before the VIGOR trial, was unaware of any significant heart attack issues."
Merck's press release on the study, with a brief mention of the heart attack risk was not enough for him to continue to educate doctors in his lectures Dr Singh said, so he asked Merck for more detailed data, and when he was unable to obtain the information after multiple requests, he added a slide to his presentation that showed a man - representing the missing data - hiding under a blanket.
Up until this time, Dr Singh said, Merck had responded to all of his requests promptly. But when he persisted in his enquiries, he told the committee, "I was warned that if I continued in this fashion, there would be serious consequences for me."
"I was told that Dr. Louis Sherwood, a Merck senior vice-president, and a former Chief of Medicine at a medical school, had extensive contacts within the academia and could make life "very difficult" for me at Stanford and outside," he testified.
And as it turns out, Dr Sherwood did call Dr Singh's superiors at Stanford University to complain.
However documents that have surfaced in litigation over the past couple of years reveal that Dr Singh had no idea how important he had become in the minds of Merck officials.
The documents show that for most of June 2000, Merck officials had their heads together trying to come up with a plan to rein in Dr Singh. He presented a major problem because he was widely respected at the FDA and also had connections with large institutional buyers that were vital to Merck sales.
On June 5, 2000, Merck senior business director, Terry Strombom, sent an email that shows Merck found itself caught between a rock and a hard place. "The one thing I am pretty sure of is that Dr. Singh could impact us negatively if he chose to do so," he wrote. "I would recommend we handle this very carefully... I just don't think canceling all the programs and walking away completely will serve us well in the long term," he said.
Another email shows one official acknowledging that Dr Singh's criticisms about Vioxx were valid. On June 5, 2000, Heather Robertson, a coordinator of health education projects, reported a conversation with Dr Singh's contact at Merck, who had since left the company in an email that said:
"I spoke to Kirsten directly for the first time this past week to learn that Dr. Singh makes a balanced presentation (he must since he is an FDA advisor) but reports product information that is not favorable to Merck... Kirsten feels that no amount of work would change Dr. Singh's position, and although we may not like to hear about it, his information is scientifically accurate."
On June 19, 2000, a marketing manager, Susan Baumgartner, wrote an email saying: "Dr. Singh continues to play up the cardiovascular adverse events associated with Vioxx... I think there are many other speakers who deliver good messages, and we should not risk supporting the negative messages that he continues to deliver."
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