Kevin is not wrong. Large, well-controlled clinical trials are biased by design and by funding. Consider sources of funding when reviewing study reports and consider the required bias of the study design (you can't get this reading the abstract or a published article; it requires analysis of the actual study protocol and report.) Sadly, the ultimate source of funding is often obscured by foundation names or even government entities who are eternally budget-challenged. Some "key opinion-leader" investigators are paid more for one single completed patient than most middle-class American families gross in a year; and they often enroll many patients. Clinical trials are just a sideline to their core business but the competition for their opinions and their time is fierce. In addition to paying the investigator cash per patient, sponsors pay for patient visits, lab work, nurse coordinator salaries, drugs, IV pumps, controllers, computers, refrigerators, trips, dinners, and other study-related expenses as well. Sponsors even ghost-write articles for publication and fund speaking tours for the highly regarded docs. NIH and NIAID are no less driven by money but they get to deal with the political whims of the current congress and administration. Viewpoints that question the status quo haven't a chance of challenging that well-funded juggernaut. They resort to meta analyses of pooled data and other retrospective reviews to find the chinks in the armor. Apparently some of you guys believe this is blasphemy.
Is this science? Nope, it is business. Is there bias? Absolutely. Studies are extremely expensive. Someone has to pay big and sponsors intend to recover their R&D expenses and then make a profit. Antihyperlipidemia treatment is a huge business. It is a not a fair game. You are at the mercy of physicians who gets much of their most current information from drug reps. Reps only show their physicians those studies that support their products. Oh, sponsors only fund studies that support their products and agenda.
Once a notion is generally accepted as fact, more money is made and more studies are funded to more firmly embed the "fact." The world view becomes so powerful that we stop looking elsewhere for answers and those patients who do not conform are considered outliers and their data discarded or ignored. Patients like Tim Russert. No question that a clot killed him, but his lipid profile was well controlled on a statin. He is one of many outliers of the Lipitor generation that is failing us.
You should make your own choices but please do not assume that the conclusions you or your physician glean from "well-controlled clinical trials" are unbiased and scientific. High cholesterol and CVD/CAD are only statistically linked and the physical mechanism that attempts to explain that statistic is tentative at best and certainly not well understood. Yes, there are perhaps thousands of studies that "confirm" the statistics but repeating misinformation does not make it true. Figures lie and liars figure. Dismissing critics of those trials is the pot calling the kettle black and not in keeping with the open mind of true science.
By the way, I am a Pharmacist with 17 years experience as clinical project leader and director within Pharmaceutical Development and Regulatory Compliance (R&D) for the second largest pharmaceutical company in the world, 10 years of which I was directly involved in clinical trial design. Prior to that I was a clinical pharmacist in the Investigational Drug Service at a large teaching hospital. I have extensive experience on both sides of the clinical trial checkbook. I have interacted with FDA frequently and have directly influenced changes in FDA opinion and legislation relating to control of clinical trial data.
OK, I'm done now; no more on the subject from me. Apologies for the long post; it is a subject for which I am slightly passionate.