Part 1: People will die
John Abramson is a medical doctor, the author of Overdo$ed America, and an outspoken critic of the pharmaceutical industry. He also is one of the experts featured in the Catalyst documentary, and he describes himself as an expert in litigation, including cases involving statins.
Dr. Abramson noted that the MJA paper cited data from the CTT's 2005 meta-analysis, rather than its more recent 2012 paper, and that the endpoint of major vascular events was not valid, since it was not specified in advance and furthermore does not take into account other serious but non-fatal adverse events.
Professor Andrea Schaffer of the University of Sydney, one of the authors of the MJA paper, was asked why the paper relied on the 2005 data. "I'm not sure, to be honest," she replied. "It was a while ago."
A spokesperson for Australian National University indicated that Prof. Banks was not available for comment.
Moreover, the CTT based their conclusions on reduction in harm per millimole per liter of LDL reduction, rather than a straight-up comparison of harms and benefits of patients who received statins as opposed to those who got a placebo. When Dr. Abramson and his colleagues re-analyzed the 2012 CTT data, they found patients who had a low risk of developing cardiovascular disease received no benefit from statins, either in terms of mortality or serious adverse events. That study, published in November 2013 in BMJ, was greeted with outrage.
Professor Sir Rory Collins, head of the CTT, demanded the complete retraction of the paper. Professor Collins has received funding from Merck, Astra-Zeneca, and Bristol-Myers Squibb -- all manufacturers of statins. Within the last ten years, each one of these companies has paid out hundreds of millions of dollars to settle claims of illegal marketing of its products.
BMJ refused to back down, although they did publish a correction which stated, in part, "The primary finding of Abramson and his colleagues -- that the Cholesterol Treatment Trialists data failed to show that statins reduced the overall risk of morality among people with < 20% risk of cardiovascular disease over the next 10 years--was not challenged."
On July 21, an editorial in BMJ reiterated the call for the CTT to make patient-level data on adverse effects available, asking "[H]ow can it be right to recommend mass treatment of healthy people without independent review of the patient-level data, especially the data on adverse effects? ... The statins trialists have huge potential influence, and they have a choice. They can take the lead on transparency, or be pulled kicking and screaming into the light.
Regarding the MJA paper, Dr. Abramson said "This was a theoretical modeling of the harm that was done, based on an invalid endpoint and using old data, when in fact they could have asked a question of their health statistics: Was there an increase in myocardial infarction, stroke, and cardiovascular mortality and overall mortality? Why rely on modeling when you can answer that question? We have an interesting natural experiment. Two TV shows air, some sixty thousand people stop their statins. What happened? I'd like to know the answer to that question. And I think it's irresponsible to publish an article that projects harm using old data and a post-hoc endpoint when in fact there's real data available."
"I think the main findings of our study is less about statins. It's basically more about the effect the media have on people's health and behavior," Prof. Schaffer said.
List of Sources
Cholesterol Treatment Trialists' Collaborators 2012. The effect of lowering LDL cholesterol with statin therapy in people at low risk of vascular disease: meta-analysis of individual data from 27 randomised trials. Lancet 380:581-590.
