The excerpt below taken from Forbes by Matthew Herper-
"..... Merck and Schering behaved terribly when developing ezetimibe: burying data, heavily marketing the drug with television ads, and paying some doctors to talk it up. From the start, the companies dragged their heels on starting a study to test whether or not adding ezetimibe to a statin prevented heart attacks and strokes. Such a study didn’t begin until 2005, a year after the drug was approved.
Critics saw the whole ezetimibe franchise – both Zetia and Vytorin – as a cheap trick to extend the life of Merck’s $7-billion-a-year Zocor, which would lose patent protection in 2006. The ezetimibe pills would have another decade of patent protection. When Vytorin, an ezetimibe-Zocor combination, was approved in 2005, Steven Nissen of the Cleveland called it “a step backward.” He added: “There is not enough evidence to justify putting millions of Americans on a statin-sparing medicine. Ezetimibe and Vytorin are just marketing tools, a way to evergreen the patent on Zocor.”
"...... I found Merck and Schering’s response to the controversy infuriating. As one top cardiologist after another advised that patients shouldn’t get ezetimibe unless they couldn’t take a higher dose of a statin because of muscle aches or other side effects, the companies just seemed to keep insisting their own data was meaningless. I remember Merck PR people pushing me hard to interview Antonio Gotto, the dean of Cornell-Weill Medical School, whose views on ezetimibe seemed far more positive than anyone else I spoke to. According to investigators for Senator Charles Grassley, Merck paid him $27,146 for lectures and consulting during that five-month period.
But once this negative narrative was set, there was a tendency for ezetimibe to look even worse than it was. It became the poster-drug for not gathering enough information about a medicine before marketing it. When more patients taking Vytorin got cancer than those taking placebo, it was easy to find critics who were worried about the connection. Scientists working with Merck misplayed their hand by trying to insist that there was absolutely no risk, creating a scary-sounding debate about whether the cancer link was unlikely or completely impossible."
"..... The questions this begs: should I think about taking ezetimibe myself? I eat broccoli and take the stairs. But my cholesterol has sometimes tended to be high– though I’ve lately kept my LDL around 100 with a combination of exercise and a healthy diet rich in nuts and olive oil. If I started taking Zetia now, lowering my cholesterol further, would it decrease my risk of a heart attack or stroke over decades? We don’t know but the prospect is tantalizing.
For years, many cardiologists have been arguing that we might be able to eliminate heart disease if we could get our cholesterol down to the levels seen in hunter-gatherers. Even very healthy diets do not do this. A daily ezetimibe might — but we don’t have the data to prove it would. What would doctors say to patients who suggested it?
“The FDA has not approved it for anything like what you’re suggesting,” says Braunwald. “But you know in medical practice you sometimes have to go by the best evidence that’s around. Just recognizing the fact that the FDA hasn’t approved it for these purposes, I would certainly strongly consider it.”
There’s a big counter-argument. The study of ezetimibe from last fall – the only real test of the drug that Merck deigned to do – was in heart patients, not healthy people. Nissen, the longtime Vytorin critic, proposed a different solution to me if I insisted on being a one-person cholesterol-drug experiment: take a half-dose of the well-proven statin Pravachol, which has a great safety record and has been much more thoroughly studied. Most likely I’ll do what I always do when there’s conflicting medical evidence and I’m in no immediate peril: nothing."
The hardest thing about medicine – and about writing about it – is admitting that we don’t know what we don’t know. At some point, doctors and patients have to assemble all the evidence they can, make their best guesses as to why to do, and take leaps of faith. All we can do is collect more data and make the leaps a bit smaller.
Critics saw the whole ezetimibe franchise – both Zetia and Vytorin – as a cheap trick to extend the life of Merck’s $7-billion-a-year Zocor, which would lose patent protection in 2006. The ezetimibe pills would have another decade of patent protection. When Vytorin, an ezetimibe-Zocor combination, was approved in 2005, Steven Nissen of the Cleveland called it “a step backward.” He added: “There is not enough evidence to justify putting millions of Americans on a statin-sparing medicine. Ezetimibe and Vytorin are just marketing tools, a way to evergreen the patent on Zocor.”
"...... I found Merck and Schering’s response to the controversy infuriating. As one top cardiologist after another advised that patients shouldn’t get ezetimibe unless they couldn’t take a higher dose of a statin because of muscle aches or other side effects, the companies just seemed to keep insisting their own data was meaningless. I remember Merck PR people pushing me hard to interview Antonio Gotto, the dean of Cornell-Weill Medical School, whose views on ezetimibe seemed far more positive than anyone else I spoke to. According to investigators for Senator Charles Grassley, Merck paid him $27,146 for lectures and consulting during that five-month period.
But once this negative narrative was set, there was a tendency for ezetimibe to look even worse than it was. It became the poster-drug for not gathering enough information about a medicine before marketing it. When more patients taking Vytorin got cancer than those taking placebo, it was easy to find critics who were worried about the connection. Scientists working with Merck misplayed their hand by trying to insist that there was absolutely no risk, creating a scary-sounding debate about whether the cancer link was unlikely or completely impossible."
"..... The questions this begs: should I think about taking ezetimibe myself? I eat broccoli and take the stairs. But my cholesterol has sometimes tended to be high– though I’ve lately kept my LDL around 100 with a combination of exercise and a healthy diet rich in nuts and olive oil. If I started taking Zetia now, lowering my cholesterol further, would it decrease my risk of a heart attack or stroke over decades? We don’t know but the prospect is tantalizing.
For years, many cardiologists have been arguing that we might be able to eliminate heart disease if we could get our cholesterol down to the levels seen in hunter-gatherers. Even very healthy diets do not do this. A daily ezetimibe might — but we don’t have the data to prove it would. What would doctors say to patients who suggested it?
“The FDA has not approved it for anything like what you’re suggesting,” says Braunwald. “But you know in medical practice you sometimes have to go by the best evidence that’s around. Just recognizing the fact that the FDA hasn’t approved it for these purposes, I would certainly strongly consider it.”
There’s a big counter-argument. The study of ezetimibe from last fall – the only real test of the drug that Merck deigned to do – was in heart patients, not healthy people. Nissen, the longtime Vytorin critic, proposed a different solution to me if I insisted on being a one-person cholesterol-drug experiment: take a half-dose of the well-proven statin Pravachol, which has a great safety record and has been much more thoroughly studied. Most likely I’ll do what I always do when there’s conflicting medical evidence and I’m in no immediate peril: nothing."
The hardest thing about medicine – and about writing about it – is admitting that we don’t know what we don’t know. At some point, doctors and patients have to assemble all the evidence they can, make their best guesses as to why to do, and take leaps of faith. All we can do is collect more data and make the leaps a bit smaller.
