1993 EPA report said SHS caused lung cancer because of a 19% risk as reported by cherry picked questionaire studies.

Vytorin causes cancer because of 50% risk from case-control studies and this can be explained by 'CHANCE'??

Gary K.

http://www.medpagetoday.com/Cardiology/Dyslipidemia/tb/10195
Ezetimibe/Simvastatin (Vytorin) Misses Major Cardiovascular Endpoints in SEAS Trial
By Peggy Peck, Executive Editor, MedPage Today
Published: July 21, 2008
Reviewed by Zalman S. Agus, MD; Emeritus Professor
University of Pennsylvania School of Medicine.


LONDON, July 21 -- Treatment with ezetimibe/simvastatin (Vytorin) has revealed no slowing of progression of aortic stenosis in asymptomatic patients but found an association with a lower risk of ischemic events, researchers here reported.

At the same time, in the 1,800-patient SEAS study (Simvastatin and Ezetimibe in Aortic Stenosis), investigators found a marked increase in the number of malignancies, reported Terje Pedersen, M.D., of Ulleval University Hospital in Oslo, Norway.


He said the study, which compared eztmibe/simvastatin to placebo, found no difference in the primary endpoint of major cardiovascular events, but in the secondary endpoint of ischemic events there was a significant difference in event rate favoring the study drug (15.7% versus 20%).



Most troubling, said Dr. Pederson, was the finding that the rate of new cancers was 50% higher in the active treatment arm -- 106 cancers in the ezetimibe/simvastatin group versus 67 in the placebo arm.
(NOTE:the difference is 58%,closer to 60%-GK)

Those data, which were discovered after the data-set was locked on June 30, led to a series of rushed consultations among the SEAS investigators and investigators in two ongoing trials of ezetimibe/simvastatin -- IMPROVE-IT and the SHARP trial. All agreed that an emergency analysis was needed so they sent the data to Richard Peto, Ph.D., a widely acclaimed biostatistician.


Dr. Peto analyzed data culled from the two ongoing trials and concluded that those data do not support an increased risk of cancer. Moreover, he said it was highly unlikely that a risk factor could explain a 50% increase in cancer in only three years. But that type of increase could be explained by the play of chance.

From another article:
"When data analysis began, the researchers were startled to see about 50 percent more new cancer cases and cancer deaths in patients who received Vytorin, compared with those who took a placebo. Peto, who is co-director of Oxford's clinical trial service unit, then rushed to crunch data from the new study with patient data from two much-larger, ongoing Vytorin studies.

Peto and other researchers, speaking on a hastily organized, trans-Atlantic teleconference with reporters, said combining data from all three trials showed there was no elevated risk of cancer. In addition, they noted that if Vytorin were somehow triggering cancer, new cases would first become more common after several years and would be concentrated on one type of cancer, rather than many. Neither was the case."

That almost sounds like Peto was working for/with them from the start.

"'This absolutely excludes the idea of a 50-percent increase in risk,' Peto said of the multi-study analysis."

Absolutely?

link


Below is from a comment to this story at www.pharmalot.com I have no idea if he's correct.

"I’m not sure how anything important can be coming out of the IMPROVE-IT experience at this point. Just how many of the total patients are enrolled? Also, how many patient years of exposure exist in that trial? However many are in, they cannot average much more than 6 months. SEAS was a longer trial. In addition, if I remember correctly, SHARP is in another specialized population - patients with renal disease. Will it be three strikes and you’re out? Or will they get an extra pitch come 2012-2014? Will MSP provide any update on when they project results from IMPROVE-IT will be known?"