Recently a drug developed by Merck and Schering Plough was found to reduce arterial plaque, preventing angioplasty and stenting, as well as strokes in a study of 9000 patients with kidney disease and diabetes. According to Merck's research czar Peter Kim: The SHARP (Study of Heart and Renal Protection) study showed that "the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
"This drug doesn't work. Period. It just doesn't work," said Steven Nissen, head of cardiology at the Cleveland Clinic. U.S. Rep. Bart Stupak, a Michigan Democrat helping to lead a congressional investigation of the study, said, "It is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data." Investors voted with their feet, pushing Schering-Plough (nyse: SGP - news - people ) shares down 8% and Merck (nyse: MRK - news - people ) shares off 1%. "
www.forbes.com/2008/01/14/enhance-merck-schering-biz-healthcare-cx_mh_0115bizenhance.html
Oops that was 2008, when Nissen was leading the charge and making charges that a study about Vytorin was flawed and that the two companies were engaged in -- what else -- a coverup of the shoddy research and its conclusions. At least that was the narrative shaping the stories from Matt Herper, Steve Nissen's Boswell... Here is a laundry list of Matt's articles regarding the 'coverup' of the Vytorin debacle.
Herper went so far as to misconstrue Eric Topol's measured response to the study: One person who won't be convinced by ENHANCE: Eric Topol, the noted chief of translational medicine at Scripps Health in La Jolla, Calif. He still wants to see clear data on how Zetia affects heart attacks, strokes and deaths, and doesn't understand why it took so long to embark on a big study to prove it. Doctors have been "hanging in suspense for years, unnecessarily," Topol says. "It's still conceivable there would be improvement in outcomes. Until we have that data, the jury is out."
Dr. Topol emphasized the need for a larger study with outcomes data. The recent study about Vytorin is consistent with Topol's broader work on genomics and heart disease:
That driving down LDL alone is not sufficient for reducing the risk of stroke or invasive procedures in both primary care and high-risk populations. Further, the mechanism by which Vytorin did achieve a reduction in plaque build up and stroke are still not completely clear. LDL levels fell but it will be interesting to see how that decline is biologically linked with the clinical outcomes observed. Finally, linking hard clinical endpoints to reductions in plaque remains an exciting and interesting area of research in cardiology when paired with genomic research that can tailor treatments to populations with different forms of the disease.
And what did Nissen say about the SHARP results? Matt Herper channel's him:
"Without a group of patients who received just Zocor, it’s impossible to determine whether Vytorin worked any better than Zocor would have alone, says Steven Nissen of the Cleveland Clinic, another critic of the drug. "blogs.forbes.com/matthewherper/2010/11/20/finally-a-win-for-vytorin/
But let's repeart what Peter Kim said:" the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
So what was the response to this study?
"This drug doesn't work. Period. It just doesn't work," said Steven Nissen, head of cardiology at the Cleveland Clinic. U.S. Rep. Bart Stupak, a Michigan Democrat helping to lead a congressional investigation of the study, said, "It is easy to conclude that Merck and Schering-Plough intentionally sought to delay the release of this data." Investors voted with their feet, pushing Schering-Plough (nyse: SGP - news - people ) shares down 8% and Merck (nyse: MRK - news - people ) shares off 1%. "
www.forbes.com/2008/01/14/enhance-merck-schering-biz-healthcare-cx_mh_0115bizenhance.html
Oops that was 2008, when Nissen was leading the charge and making charges that a study about Vytorin was flawed and that the two companies were engaged in -- what else -- a coverup of the shoddy research and its conclusions. At least that was the narrative shaping the stories from Matt Herper, Steve Nissen's Boswell... Here is a laundry list of Matt's articles regarding the 'coverup' of the Vytorin debacle.
| Sept. 3, 2008: Top Statistician Says Vytorin Cancer Risk 'Not Ruled Out' |
| May 19, 2008: Should Schering-Plough's Chief Give Back His Bonus? |
| April 15, 2008: Vytorin's Man In The Middle |
| March 30, 2008: Vytorin Backlash |
| March 25, 2008: More Questions About Vytorin Panel |
| March 21, 2008: Vytorin On Trial |
| Jan. 11, 2008: Inside Schering And Merck's Secret Panel |
| Nov. 19, 2007: The Vytorin Question |
Herper went so far as to misconstrue Eric Topol's measured response to the study: One person who won't be convinced by ENHANCE: Eric Topol, the noted chief of translational medicine at Scripps Health in La Jolla, Calif. He still wants to see clear data on how Zetia affects heart attacks, strokes and deaths, and doesn't understand why it took so long to embark on a big study to prove it. Doctors have been "hanging in suspense for years, unnecessarily," Topol says. "It's still conceivable there would be improvement in outcomes. Until we have that data, the jury is out."
Dr. Topol emphasized the need for a larger study with outcomes data. The recent study about Vytorin is consistent with Topol's broader work on genomics and heart disease:
That driving down LDL alone is not sufficient for reducing the risk of stroke or invasive procedures in both primary care and high-risk populations. Further, the mechanism by which Vytorin did achieve a reduction in plaque build up and stroke are still not completely clear. LDL levels fell but it will be interesting to see how that decline is biologically linked with the clinical outcomes observed. Finally, linking hard clinical endpoints to reductions in plaque remains an exciting and interesting area of research in cardiology when paired with genomic research that can tailor treatments to populations with different forms of the disease.
And what did Nissen say about the SHARP results? Matt Herper channel's him:
"Without a group of patients who received just Zocor, it’s impossible to determine whether Vytorin worked any better than Zocor would have alone, says Steven Nissen of the Cleveland Clinic, another critic of the drug. "blogs.forbes.com/matthewherper/2010/11/20/finally-a-win-for-vytorin/
But let's repeart what Peter Kim said:" the investigational use of the drug significantly reduced the risk of these events in a spectrum of patients with chronic kidney disease -- and this was the first demonstration that an LDL-cholesterol lowering medicine could do so."
