Scale of side effects still not clear
This is remarkable. Twenty years after these drugs were first introduced and after they have been prescribed to hundreds of millions of people, two leading experts don’t know where the side effect information is stored that would allow researchers to make an accurate estimate of risk. And only now is there talk of “full disclosure of all adverse events.”
In an interview Professor Baigent confirmed that the CTT did not actually hold any side-effect data. The reason, he said, was that when the CTT was set up one of its key aims was to investigate the risk of death from statins. At the time people were concerned that lowering cholesterol might cause an increase in deaths from suicide, cancer or other causes not connected with heart disease.
So when requesting raw data from the companies the CTT only asked for anything about death. As a result their data base doesn’t have any information on side effects. He added: “We are now planning to look at other adverse effects and will soon be collecting the data.” This is for drugs that have been available for so long that the patents for most have run out.
So how had they arrived at their conclusions that the risks of taking statins were very low? “The individual trials run by the companies have published their own results and that has allowed us to establish the level of risk.”
Reports of side effects just hypotheses
But what about the many patient reports of problems such as muscle pain or cataracts or depression? “These claims are based on unreliable studies,” says Baigent. “They are just hypotheses at this point. They haven’t been tested in randomised clinical trials. We know about the risks from individual studies and we do hold the data that shows statins benefit primary patients (without heart disease).”
So what needs to be done? Critics of the way the CTT operates point to the stand taken by a different group of Cochrane reviewers who were assessing the benefits of the anti-flu drug Tamiflu several years ago. They asked the manufacturer Roche to see the raw data about what happened to individual patients. When the company refused to supply it they reported they could not asses the drug as they didn’t have enough evidence to make a judgement.
“The same thing needs to happen with statins,” says Dr John Abramson, a physician at Harvard Medical School. “Access to patient-level data is similarly necessary for Cochrane reviewers of statin therapy so they can perform a thorough and independent evaluation. At the very least we need an independent analysis of all the trials to find out if patients getting statins have fewer serious adverse events than those on a placebo.”
“The Tamiflu review has set a new standard,” agrees BMJ editor Fiona Godlee,. “From now on that is what people will, and should, expect – conclusions based on access to the full data that can be validated by others who also have access to the full data.”
Refusing access to data not wrong
However it’s not at all clear that this will necessarily change the way the CTT works. At the moment, Godlee says she can’t see that CTT have done anything wrong. “Their arrangement is by no means ideal, and doesn’t help them or the Cochrane review group when they are challenged about their interpretation of the data. It would be much better if they were able to share the individual patient data but the fact that they have not done this is, in my view, acceptable by current standards.”
The problem, Abramson explains, is that current standards place more importance on industry’s claim that it owns the data than the public’s need for accurate information. “What’s needed is a campaign to educate physicians and the public what serious consequences hiding data has on quality of medical care.”
It’s hard to think of another industry where the solution to standard practices that were putting clients at risk of sickness and death was an awareness program.
”So the question remains: Should a professional body, however eminent, be allowed to keep data on clinical trials hidden so they and no one else can evaluate the benefits of the products those trials were testing?
Jerome Burne
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WINNER: 
Couldn’t the Cochrane Collaboration force the issue by simply refusing to consider results produced from secret data when producing its recommendations?
That is certainly what another Cochrane group did when assessing Tamiflu and would would certainly seem logical to apply that same principle to statins. As mentioned in the piece though what the CTT doing is not actually illegal and infact follows “standard practice” so it would involve some sort of a standoff between the two organisations. I have no information about the internal politics that would involve.
I have found it troubling that when a newspaper like the Daily Mail through its correspondents, draws the attention of its readership to various health concerns, the newspaper concerned is pilloried in the media at large, and it always seems to be when it questions the veracity of en bloc medication of the general public, whether or not they show symptoms of illness. I would suggest that there is more to this than meets the eye. As an individual I would never take statins, whoever much my GP insists. I am fit, healthy, good weight and eat a healthy diet and take exercise. I have no health issues apart from a touch of arthritis (I am 60) for which I take supplements (Glucosamine and Omega 3) We, as individuals should be in charge of our health, not self appointed professionals with ulterior motives.
The Nobel Prize in Physiology or Medicine 1998 was awarded jointly to Robert F. Furchgott, Louis J. Ignarro and Ferid Murad “for their discoveries concerning nitric oxide as a signalling molecule in the cardiovascular system”.
That statement alone was good enough for me -(a former Bradychardia, T.I.A & pacemaker recipient, who suffered chest & left-arm angina symptoms when exercising/walking fast)-to begin a recommended supplementing that involved taking twice a day a drink-powder that included 5grams of L-Arginine & L-Citrulline. These 2 amino-acids combined are more productive than is L-Arginine alone in producing Nitric Oxide. Within a few days I felt a seemingly miraculous benefit to my vascular system that in less than a week virtually eliminated all angina symptoms allowing me to double my walking pace in comfort. H.Recommend.
P.S What I meant to add –pertinent to the discussion on statins–was that I dropped my prescribed statin for L-Arginine combo supplement -and no regrets!
my views are expressed in an essay which goes to the heart of the failure.
50 years ago we failed to recognise that sugar-damaged lipoproteins broke the lipid nutrition cycle leading to raised LDL due to receptor failure.
It wasn’t overproduction in the liver, but a failure of damaged LDL to feed organs.
Most stain adverse-effects relate to a lack of fatty nutrients reaching ldl receptors – ldl is glycated (AGE)
Please read my essay:-
http://www.lizscript.co.uk/glyn/paradox.pdf
Glyn, I have read it, printed it and will begin to preach it. Thank you