"We don't have Boston Scientific or Johnson & Johnson paying for this study -- they certainly won't pay for something that could show we should be buying less of their product," he told the Globe.
With drug-eluting stents, experts say, the increased adverse event rate is particularly alarming because the condition that the stent is used to prevent is a common but relatively benign process, while stent thrombosis is "a rare but life-threatening disease," according to Dr Steg.
Dr Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, called the new findings "potentially explosive."
He says there was already a modest shift back to bare metal stents in the US and predicts more doctors would take a conservative approach, pending definitive safety data. "If there's a suspicion, why take the risk?" Dr Nissen told Reuters News.
"If this is true," he advised, "I would recommend more selective use of drug-eluting stents and I would recommend consideration for longer-term use of dual anti-platelet (blood-thinning) agents."
Critics say the bad news about stent thrombosis is great news for Plavix maker Bristol Myers Squib. Along with Dr Nissen, Dr Yusuf also says there may be a need to continue dual antiplatelet therapy of aspirin plus Plavix in drug-eluting stent patients beyond the one year mark, and possibly for life.
Plavix is already a real moneymaker for Bristol-Myers, selling for about $4 a pill in the US. According to a February 27, 2006, article in Forbes.com, based on numbers obtained from IMS Health, a healthcare information tracking firm, the top 20 drugs in the US in 2005 included Plavix in the number 6 position with sales of $3.5 billion.
On July 18, 2006, the New York Times, reported that Bristol-Myers had already see a double-digit sales increase for Plavix in the US this year, up 26% to $850 million.
In addition to its extra costs, Plavix is not without its own serious side effects. A study published in the January 20, 2005, New England Journal of Medicine, found patients taking Plavix experienced more than 12 times as many ulcers as patients who received aspirin plus a heartburn pill.
The study treated 320 patients whose ulcers had healed and gave Plavix to half of the patients and aspirin plus Nexium, a heartburn pill to the other half.
The results showed 13 of the patients taking Plavix experienced renewed ulcer bleeding during the year while just one of the patients taking aspirin and Nexium had an ulcer bleed.
Medical experts also point out that Plavix is a long-lasting drug with no readily available antidote, which means once a patient takes it, their platelets are pretty much out of commission for about 7-10 days, the time it takes for the body to get rid of the old platelets and make new ones.
That is why some surgeons say they do not like the drug. One surgeon described performing a major emergency operation on a patient taking Plavix as either a "death-defying high wire act above Niagara Falls, or a death-producing disaster."
Critic note the added expense and risks of Plavix for all the people who would not ordinarily need the drug, and who may not even need it now if no clotting occurred, but who have to take it as a precautionary measure.
A precautionary measure that may in itself be dangerous or as useless as the drug-eluding stents. A study published in the April 20, 2006, New England Journal of Medicine, led by Dr Eric Topol and Dr Deepak Bhatt of the Cleveland Clinic, found that the combination of aspirin and Plavix not only did not help most patients with heart disease, it almost doubled the risk of death, heart attack or stroke for those with no clogged arteries but with conditions like high blood pressure and high cholesterol.
The researchers gave one group of patients a daily dose of aspirin plus Plavix, and another group was given aspirin plus a placebo. After 28 months the researchers found that adding Plavix made little difference to the group as a whole other than reducing hospitalizations slightly.
With drug-eluting stents, experts say, the increased adverse event rate is particularly alarming because the condition that the stent is used to prevent is a common but relatively benign process, while stent thrombosis is "a rare but life-threatening disease," according to Dr Steg.
Dr Steven Nissen, head of cardiovascular medicine at the Cleveland Clinic, called the new findings "potentially explosive."
He says there was already a modest shift back to bare metal stents in the US and predicts more doctors would take a conservative approach, pending definitive safety data. "If there's a suspicion, why take the risk?" Dr Nissen told Reuters News.
Critics say the bad news about stent thrombosis is great news for Plavix maker Bristol Myers Squib. Along with Dr Nissen, Dr Yusuf also says there may be a need to continue dual antiplatelet therapy of aspirin plus Plavix in drug-eluting stent patients beyond the one year mark, and possibly for life.
Plavix is already a real moneymaker for Bristol-Myers, selling for about $4 a pill in the US. According to a February 27, 2006, article in Forbes.com, based on numbers obtained from IMS Health, a healthcare information tracking firm, the top 20 drugs in the US in 2005 included Plavix in the number 6 position with sales of $3.5 billion.
On July 18, 2006, the New York Times, reported that Bristol-Myers had already see a double-digit sales increase for Plavix in the US this year, up 26% to $850 million.
In addition to its extra costs, Plavix is not without its own serious side effects. A study published in the January 20, 2005, New England Journal of Medicine, found patients taking Plavix experienced more than 12 times as many ulcers as patients who received aspirin plus a heartburn pill.
The study treated 320 patients whose ulcers had healed and gave Plavix to half of the patients and aspirin plus Nexium, a heartburn pill to the other half.
The results showed 13 of the patients taking Plavix experienced renewed ulcer bleeding during the year while just one of the patients taking aspirin and Nexium had an ulcer bleed.
Medical experts also point out that Plavix is a long-lasting drug with no readily available antidote, which means once a patient takes it, their platelets are pretty much out of commission for about 7-10 days, the time it takes for the body to get rid of the old platelets and make new ones.
That is why some surgeons say they do not like the drug. One surgeon described performing a major emergency operation on a patient taking Plavix as either a "death-defying high wire act above Niagara Falls, or a death-producing disaster."
Critic note the added expense and risks of Plavix for all the people who would not ordinarily need the drug, and who may not even need it now if no clotting occurred, but who have to take it as a precautionary measure.
A precautionary measure that may in itself be dangerous or as useless as the drug-eluding stents. A study published in the April 20, 2006, New England Journal of Medicine, led by Dr Eric Topol and Dr Deepak Bhatt of the Cleveland Clinic, found that the combination of aspirin and Plavix not only did not help most patients with heart disease, it almost doubled the risk of death, heart attack or stroke for those with no clogged arteries but with conditions like high blood pressure and high cholesterol.
The researchers gave one group of patients a daily dose of aspirin plus Plavix, and another group was given aspirin plus a placebo. After 28 months the researchers found that adding Plavix made little difference to the group as a whole other than reducing hospitalizations slightly.
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