Meta-analysis of clinical trials by the pharmaceutical industry unravels on re-analysisThe rationale for the new guidelines was a Cochrane review published in 2013 [4], which radically overturned its previous 2011 review of statins for the primary prevention of CVD [5] that was consistent with the 2006 NICE guidelines. The 2013 Cochrane review [4] concluded that statins reduce all-cause mortality and cardiovascular events without increasing the risk of adverse events among people at low risk of CVD of less than 10 % risk over ten years. The change from its 2011 review was based largely on a meta-analysis by the Cholesterol Treatment Trialists’ (CTT) Collaboration published a year earlier [6].
The CTT 2012 meta-analysis [6] was designed to assess the “overall net benefit” of cholesterol lowering with statins in the subgroup of participants at low risk of cardiovascular disease - defined as five year risk <10 % - in 27 clinical trials published by the end of 2009. The average five-year risk in participants in this group was 2.6 %. The authors concluded that statin therapy significantly reduces the risk of all-cause mortality by 9.1 % and of major vascular events, including major coronary events (non-fatal myocardial infarction or coronary death), strokes and coronary revascularization procedures – by about 20 % per 1.0 mmol/L reduction in low density lipoprotein (LDL) cholesterol, regardless of baseline risk level. The authors calculated that in low risk patients, statins prevented 11 major vascular events per 1 000 people treated for five years for each 1.0 mmol/L reduction in LDL cholesterol. They concluded that this significant benefit of statins in low risk patients “greatly [exceeded] any known hazards of statin therapy.”
However, John Abramson at Harvard Medical School and three colleagues in US and Canadian universities re-evaluated the 2012 CTT meta-analysis and published their results in the BMJ in October 2013 [7]. They found that for people with less than a 10 % five-year risk of CVD, there was no significant reduction in overall mortality with statin treatment. Concentrating on ‘hard cardiovascular events’, i.e., cardiovascular death, myocardial infarction and stroke, as the most reliable endpoints least vulnerable to bias in judgement, which constitute 65 % of major vascular events that occurred in people with a five year risk of <10 %, the was 7.15 per 1 000 low risk patients treated for five years. In other words, 140 people with a five-year risk of less than 10 % need to be treated with statins for five years in order to prevent one heart attack or stroke, but with no reduction in overall mortality and no reduction in serious adverse events overall.
Serious adverse events from statin therapy not included in meta-analysisIn order to judge the net effect of a treatment on overall health, it is necessary to know the total number of serious adverse events, including death from all causes, hospital admissions, prolongation of admission, cancer, or permanent disability. Despite having access to patient-level data, the CTT meta-analysis [6] did not consider the effect of statins on serious adverse events. Only 3 or the 5 largest trials included in the meta-analysis reported data on serious adverse events, none of which reported a reduction associated with statin.
The 2013 Cochrane review [4] relied on two earlier reviews that included only published data to conclude that the rate of serious adverse events was similar in the statin and placebo groups. Abramson and colleagues [7] listed known side effects from the literature: myopathy at 100 to 400 times the rate reported by the CTT meta-analysis of 0.5 per 1 000 patient, diabetes at more than five times the 5 per 1 000 reported by CCT meta-analysis, and a string of others including liver dysfunction, acute renal failure and cataracts, cognitive symptoms, neuropathy and sexual dysfunction, decreased energy and exertional fatigue, and psychiatric symptoms including depression, memory loss, confusion, and aggressive reactions. One positive association is a decreased risk of oesophageal cancer. However, they misinterpreted an epidemiological study that side-effects could be as high as 18 – 20 %, which was later corrected [8].
Opposing statins “a serious disservice to British and international medicine”On 21 March 2014, Sir Rory Collins, professor of medicine and epidemiology at the Clinical Trial Service Unit of Oxford University and head of the CTT collaboration, told The Guardian that the Abramson et al paper was “a serious disservice to British and international medicine” [9], and claimed it was probably killing more people than had been harmed as the result of the paper on the MMR vaccine by Andrew Wakefield (but see [10] MMR Controversy Reignites, SiS 66). Collins claimed they have “good data from over 100 000 people that show statins are very well tolerated, with only one or two well-documented [problematic] side effects.” Myopathy, or muscle weakness, occurred in one in 10 000, he said, and there was a small increase in diabetes. However, he had refused to release the data to the public.
On 15 February 2015, Collins had changed his tune. He told the Sunday Express [11] that his team will carry out a “challenging” reassessment of the evidence which will include studying all reported side effects. They had looked at only heart and cancer risks in the original research, and had not examined other side effects.Fiona Godlee, editor in chief of BMJ, which has led calls for access to statins data, said: “This is of real concern. We wrongly assumed all the details of possible side effects had been thoroughly assessed before new guidance effectively made tens of thousands of people eligible for this drug. We now know this is not the case and would urge any re-analysis is done in the most transparent way.”
Meanwhile, Dr. Sarah Wollaston, Chair of the Commons Health Select Committee, called for drug companies to release all their trial data. Her demand was echoed by experts at BMJ, asking the authors of all the major statin trials to release the findings for independent analysis.
Collins had requested BMJ to retract the paper of Abramson and colleagues [7]. An independent panel appointed by the editor of BMJ ruled unanimously (6 to 0) against Collins [12].
http://www.i-sis.org.uk/Statins_for_the_Healthy_are_Harmful.php 
Posts : 3807
Seriously, the bloke is going increasingly batshit. Hence why I asked if he is still a mod. The flog should get Phoenix to become a mod, then the joint will have a full deck of idiots on the mods team. Looks like one of my New Years resolutions have gone down the crapper faster than usual. 
Re: Osidge the forum of flogs drug marketing expert. 
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