At what point does the persistence in ignoring science and replacing it with conjecture become an alternative reality? Read the Alex Berensen article on Vytorin in yesterday's NY Times:
"When the Food and Drug Administration approved a new type of cholesterol-lowering medicine in 2002, it did so on the basis of a handful of clinical trials covering a total of 3,900 patients. None of the patients took the medicine for more than 12 weeks, and the trials offered no evidence that it had reduced heart attacks or cardiovascular disease, the goal of any cholesterol drug."
Read New York Times article
Neither did any of the other clinical trials for any of the other statins.... So does that mean statins have not reduced heart attacks or CV disease? And PS, the study also showed that there was no risk of cancer, but you don't find that out until the end of the story. And in any event, not one story has investigated the complex relationship between lipid levels and cancer which has confounded and confused researchers for decades. Check out:
Read more here
Berensen then shifts to the Vytorin post market studies....which are focused on specific groups of patients, high risk groups that are genetically at risk for athersclerosis, aortic stenosis, etc.
The researchers in the SEAS study observe:
"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. Despite this favorable effect over a minimum period of 4 years, there was no overall effect on aortic-valve stenosis and no significant overall effect on the composite primary outcome. The lack of any effect on the progression of aortic stenosis as seen on echocardiography supports the conclusion that the lack of effect on clinical valve-related events was real and not due to a lack of statistical power. The finding of increased numbers of incident and fatal cancers in the simvastatin–ezetimibe group, as compared with the placebo group, was unexpected and requires further exploration in trials of simvastatin and ezetimibe.
http://content.nejm.org/cgi/content/full/NEJMoa0804602?query=TOC
So Berensen, Nissen and Furberg (see below) ignore the fact that Lipitor also failed to reverse aortic stenosis. Perhaps Lipitor should be removed from the market too?
Here's Nissen, who by the way received money from Pfizer but not from Merck or Schering Plough
"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. "
How about lying a littlle bit?
Now of course a more measured and targeted reassessment of the LDL heart disease relationship does exist. It is ignored by Nissen (who has never done any basic or NIH funded research on CV disease and only does research when he can make money conducting clinical trials) and pursued by Eric Topol at Scripps Genomic Health:
http://content.onlinejacc.org/cgi/content/abstract/52/5/378
Topol is working on gene-based trials to develop new drugs and diagnostics to treat people at high risk of serious heart diseases in studies that actually measure disease progression.
But Topol, who did the heavy lifting on the Vioxx safety problem, only to be shoved aside by a media hungry Nissen, is too busy doing real science in the area of biomarkers. Unfortunately, the folks on the NY Time speed dial are bio-Luddites who prescribe longer, larger (wishful thinking on their part?) clinical trials for every new drug using whatever media trumped up danger de jour to justify this outmoded position:
'Dr. Curt D. Furberg, an epidemiologist and drug safety expert at Wake Forest University, said that before approving drugs the F.D.A. should require that drug companies conduct large trials on whether they reduce death and disease, except in rare cases where no alternatives exist. If the agency approves drugs without such data, that fact should be noted prominently on a drug’s label, Dr. Furberg said.
What he and others continue to willfully overlook is that the studies in question are designed to reduce particular types of heart disease in small groups of patients and when they miss the endpoint claim the drugs don't work at all, and use that as an argument for larger, longer trials for safety and effectiveness. Conjecture and opinion replaces solid science. Unless science moves faster to occupy the space the Bio-Luddites occupy on the Web, traditional scientific institutions and science-based approaches will continue to be under attack by the ignorant and angry elite.
"When the Food and Drug Administration approved a new type of cholesterol-lowering medicine in 2002, it did so on the basis of a handful of clinical trials covering a total of 3,900 patients. None of the patients took the medicine for more than 12 weeks, and the trials offered no evidence that it had reduced heart attacks or cardiovascular disease, the goal of any cholesterol drug."
Read New York Times article
Neither did any of the other clinical trials for any of the other statins.... So does that mean statins have not reduced heart attacks or CV disease? And PS, the study also showed that there was no risk of cancer, but you don't find that out until the end of the story. And in any event, not one story has investigated the complex relationship between lipid levels and cancer which has confounded and confused researchers for decades. Check out:
Significance of alterations in plasma lipid profile levels in breast cancer.
Integr Cancer Ther. 2008 Mar;7(1):33-41Read more here
Berensen then shifts to the Vytorin post market studies....which are focused on specific groups of patients, high risk groups that are genetically at risk for athersclerosis, aortic stenosis, etc.
The researchers in the SEAS study observe:
"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. Despite this favorable effect over a minimum period of 4 years, there was no overall effect on aortic-valve stenosis and no significant overall effect on the composite primary outcome. The lack of any effect on the progression of aortic stenosis as seen on echocardiography supports the conclusion that the lack of effect on clinical valve-related events was real and not due to a lack of statistical power. The finding of increased numbers of incident and fatal cancers in the simvastatin–ezetimibe group, as compared with the placebo group, was unexpected and requires further exploration in trials of simvastatin and ezetimibe.
The lack of effect on aortic-valve stenosis is in agreement with the findings of the smaller Scottish Aortic Stenosis and Lipid Lowering Trial, Impact on Regression (SALTIRE) study, in which atorvastatin was used.34 The results of the Rosuvastatin Affecting Aortic Valve Endothelium (RAAVE) study (ClinicalTrials.gov number, NCT00114491 [ClinicalTrials.gov] ) indicated a favorable effect on aortic stenosis, but the study had a nonrandomized and open-label design, with comparisons of various categories of patients with aortic stenosis.39
Our study population did not represent all patients with aortic-valve stenosis, since high-risk patients with severe hyperlipidemia requiring active lipid-lowering treatment, known atherosclerotic disease, or diabetes mellitus were not included in order to allow for placebo treatment. This factor may explain the relatively low rate of progression of aortic-valve stenosis in our study, as compared with that in other studies."http://content.nejm.org/cgi/content/full/NEJMoa0804602?query=TOC
So Berensen, Nissen and Furberg (see below) ignore the fact that Lipitor also failed to reverse aortic stenosis. Perhaps Lipitor should be removed from the market too?
Here's Nissen, who by the way received money from Pfizer but not from Merck or Schering Plough
“The F.D.A. set the bar too low on the initial approval,” said Dr. Steven Nissen, chairman of cardiology at the Cleveland Clinic. “It would have been a lot better if the agency had said, ‘Show us that you do more than lower LDL a little bit, show us evidence of effectiveness.’ ”
Further, when the F.D.A. approved Zetia, several statins were already on the market, giving patients other options to lower their cholesterol. So the agency’s decision to approve Zetia without requiring larger trials is especially puzzling, Dr. Nissen said.
Lower LDL a little bit?"The combination of simvastatin and ezetimibe resulted in an average reduction in LDL cholesterol of at least 50%, as compared with placebo. "
How about lying a littlle bit?
Now of course a more measured and targeted reassessment of the LDL heart disease relationship does exist. It is ignored by Nissen (who has never done any basic or NIH funded research on CV disease and only does research when he can make money conducting clinical trials) and pursued by Eric Topol at Scripps Genomic Health:
http://content.onlinejacc.org/cgi/content/abstract/52/5/378
Topol is working on gene-based trials to develop new drugs and diagnostics to treat people at high risk of serious heart diseases in studies that actually measure disease progression.
But Topol, who did the heavy lifting on the Vioxx safety problem, only to be shoved aside by a media hungry Nissen, is too busy doing real science in the area of biomarkers. Unfortunately, the folks on the NY Time speed dial are bio-Luddites who prescribe longer, larger (wishful thinking on their part?) clinical trials for every new drug using whatever media trumped up danger de jour to justify this outmoded position:
'Dr. Curt D. Furberg, an epidemiologist and drug safety expert at Wake Forest University, said that before approving drugs the F.D.A. should require that drug companies conduct large trials on whether they reduce death and disease, except in rare cases where no alternatives exist. If the agency approves drugs without such data, that fact should be noted prominently on a drug’s label, Dr. Furberg said.
What he and others continue to willfully overlook is that the studies in question are designed to reduce particular types of heart disease in small groups of patients and when they miss the endpoint claim the drugs don't work at all, and use that as an argument for larger, longer trials for safety and effectiveness. Conjecture and opinion replaces solid science. Unless science moves faster to occupy the space the Bio-Luddites occupy on the Web, traditional scientific institutions and science-based approaches will continue to be under attack by the ignorant and angry elite.
