WEIGHING UP THE EVIDENCE ON STATINS - Dr Verner Wheelock

WEIGHING UP THE EVIDENCE ON STATINS

Statins are certainly in the news these days. NICE has put forward proposals that all those with a 10% risk of developing heart disease should be treated with statins. Effectively this means that everyone over the age of 50 years, including those who are fit and healthy, would be expected to have the treatment. On the other hand this strategy is being questioned by many within the medical profession. In this blog I will try to tease out the information which individuals need in order to make a sound judgment on whether or not to go on statins.

 

Essentially people need to know if they will derive any benefit from the statins which will have to be balanced against the type, frequency and severity of any side-effects.

 

According to Professor Sir Rory Collins, from Oxford University, GPs and the public are being made unjustifiably suspicious of the drug, creating a situation that has echoes of the MMR vaccine controversy(1). Collins is the leader of the Cholesterol Treatment Trialists’ (CTT) Collaboration which has been analysing data on the effects of statins which has been supplied to them by the drug companies. In their latest report it was claimed that statins significantly reduced major cardiovascular events and all-cause mortality in people at low risk (2). The results of this trial were a critical factor influencing the position taken by NICE.

 

This is somewhat surprising because other studies have concluded that statins are not beneficial to people at low risk. It is also highly relevant that the CTT study has been subject to severe criticisms.

In an exercise of this kind one would expect the investigators to compare the results of those who had been treated with statins with those of a control, consisting of a similar group of people who had not been treated. When this approach has been used, others have not been able to find that there were any appreciable benefits in the statin group. For example, Ray and co-workers analysed the results of 11 clinical trials involving 65,229 participants with approximately 244,000 person-years of follow-up and 2793 deaths (3). All of these individuals were high risk but without previous cardiovascular disease. Over an average treatment period of 3.7 years the use of statin therapy did not result in any reduction in all-cause mortality.

 

By contrast the CTT group has adopted a totally different approach which has been explained by Dr David Newman in an article on his blog (4). Instead of comparing those who were treated with statins with the controls, they selected those individuals in which the statin treatment reduced the LDL Cholesterol 1 mmol/L or 40 points in US terms. As Dr Newman describes it:

 

“…they shifted the data so that their numbers corresponded precisely to patients whose cholesterol responded perfectly.”

 

He goes on:

“Patients whose cholesterol drops 40 points are different than others, and not just because their body had an ideal response to the drug. They may also be taking the drug more regularly, and more motivated. Or they may be exercising more, or eating right, and more health conscious than other patients. So it should be no surprise that this analysis comes up with different numbers than a simple comparison of statins versus placebo pills. Ultimately, then, this new information tells us little or nothing about the benefits someone might expect if they take a statin. Instead it tells us the average benefits among those who had a 40-point drop in LDL.”

 

Furthermore the LDL Cholesterol drop cannot be predicted because the effect of the statins is unknown. This means that the conclusions of this analysis have absolutely no relevance to patients and doctors who have to decide if statins should be prescribed.

Here is a final quote from Dr Newman:

 

“Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story.”

 

But it does not stop here because the CTT also argued that the side-effects of the statin treatments are relatively small. Rhabdomolysis, which is the catastrophic breakdown of muscle tissue, has an excess incidence of about 0.1 per 1000 over 5 years according to CTT calculations. However Dr Malcolm Kendrick, author of “The Great Cholesterol Con” refers to a study conducted in the USA, which analysed data on statin side-effects recorded on the FDA’s Medwatch. Between July 2005 and March 2011 there were 186,796 case reports of which 8,111 were due to rhabdomolysis. This equates to 811 deaths over this period. As it is accepted that reporting rates are extremely low, this figure can be multiplied by a factor of 10 or even 100 to obtain the true value (5). If precedents were followed up this evidence should be more than enough to have the drugs withdrawn.

 

The CTT authors reported a 10% increase in the relative risk of developing diabetes while on statins. This equates to 5 new cases per 1000 people treated for 5 years. However other studies have reported values of up to 50% more (6).

 

Uffe Ravnskov is an independent researcher in Sweden who has suggested that if you are a healthy person who is being advised to go on statins then this is what you should be told before going ahead (7):

 

“Your chance not to get a non-fatal heart event during the next five years ……is 97.1 per cent. You can increase your chance to 98.1 per cent if you take a statin every day. But then your risk of suffering muscle problems is about 25 per cent unless you never exercise (1); your risk of becoming sexually impotent is about 20 per cent (2); your risk of suffering from diabetes is about 4 per cent (3), and you also run a risk of memory loss, liver damage, peripheral neuropathy, cataract, and cancer, but we do not yet know how large these risks are. And don´t forget that many non-fatal heart events may heal with minor health consequences or none at all.”

 

The picture now becomes very clear. The positive results which have been claimed for the CTT study have only been obtained by manipulating the data. Unfortunately this is typical of how the modern pharmaceutical industry functions. It hypes up the benefits and plays down the undesirable side-effects. This is a particularly bad example because the leader of the CTT is a knighted professor from the prestigious University of Oxford. Nevertheless the case which they present should be subject to rigorous examination. It is extremely regrettable that NICE has allowed itself to be taken in by what can only be described as rubbish!

 

There is no doubt that there is growing awareness that the case in support of statins is full of holes. To-day in The Daily Telegraph there is an article by Haroun Gajraj, a vascular surgeon, no less, who decided to stop his treatment with statins. After looking more closely at the research, he concluded that statins were not going to prevent a heart attack and that his cholesterol levels were all but irrelevant. He also draws attention to a recent survey by Pulse magazine, which found that six out of 10 GPs opposed the draft proposal to lower the risk level at which patients are prescribed statins. As many as  55% said they would not take statins themselves or recommend them to a relative, based on the proposed new guidelines(8).

 

REFERENCES

1. http://www.theguardian.com/society/2014/mar/21/-sp-doctors-fears-over-statins-may-cost-lives-says-top-medical-researcher
2. CTT (2012) Lancet 380 pp 581-590.
3. http://archinte.jamanetwork.com/article.aspx?articleid=416105
4. http://cardiobrief.org/2012/05/27/guest-post-data-drugs-and-deception-a-true-story/
5. http://drmalcolmkendrick.org/tag/rhabdomyolysis/
6. http://www.abc.net.au/catalyst/heartofthematter/download/StatinsshouldNOTbebroadedtowiderpopulation.pdf
7. http://www.bmj.com/content/348/bmj.g280?tab=responses
8. http://www.telegraph.co.uk/health/10717431/Why-Ive-ditched-statins-for-good.html

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The Lancet published a meta-analysis of 27 statin trials

Data, Drugs, and Deception: a True Story

 

Wednesday, May 23, 2012

      

Last week The Lancet published a meta-analysis of 27 statin trials, an attempt to determine whether patients with no history of heart problems benefit from the drugs—true story. The topic is controversial, and no less than six conflicting meta-analyses have been performed—also a true story. But last week’s study claims to show, once and for all, that for these very low risk patients, statins save lives—true story.

Actual true story: the conclusions of this study are neither novel nor valid.

The Lancet meta-analysis, authored by the Cholesterol Treatment Trialists group, examines individual patient data from 27 statin studies. Their findings disagree with an analysis published in 2010 in the Archives of Internal Medicine, and with analyses from two equally respected publications, the Therapeutics Letter and the Cochrane Collaboration.* Despite this history of dueling data the authors of last week’s meta-analysis, in a remarkable break from scientific decorum, conclude their report with a directive for the writers of statin guidelines: the drugs should be broadly recommended based on the new analysis.

As an editorialist points out, if implemented, the CTT group recommendations in the United States would lead to 64 million people, more than half of the population over the age of 35, being started on statin therapy—true story.

Where is the magic, you ask, in this latest effort? What is different? In some ways, nothing. Indeed just a year and a half earlier The Lancet published a meta-analysis of 26 of the same 27 studies, with the same results, by the same authors (true story, and an odd choice on the part of the journal). So the findings aren’t new. They are, however, at odds with other meta-analyses. Why? It is the way they calculated their numbers. This meta-analysis, like the earlier one from the same group, reports outcomes per-cholesterol-reduction. The unit they use is a “1 mmol/L reduction in low density lipoprotein (LDL)”, in common U.S. terms, a roughly 40-point drop in LDL.

That’s the magic: each of the benefits reported in the paper refers to patients with a 40-point cholesterol drop. Voilá. One can immediately see why these numbers would look different than numbers from reviews that asked a more basic question: did people who took statins die less often than people taking a placebo? (The only important question.) Instead, they shifted the data so that their numbers corresponded precisely to patients whose cholesterol responded perfectly.
Patients whose cholesterol drops 40 points are different than others, and not just because their body had an ideal response to the drug. They may also be taking the drug more regularly, and more motivated. Or they may be exercising more, or eating right, and more health conscious than other patients. So it should be no surprise that this analysis comes up with different numbers than a simple comparison of statins versus placebo pills. Ultimately, then, this new information tells us little or nothing about the benefits someone might expect if they take a statin. Instead it tells us the average benefits among those who had a 40-point drop in LDL.

But LDL drop cannot be predicted. Some won’t drop at all, some will drop just a bit, and some may drop more. Therefore the numbers here tell an interesting story about certain patients who took statins, but they have no relevance to patients and doctors considering statins. And yet, the latter group is the target of the study's concusions.

True story: in prior meta-analyses that found no mortality benefit the investigators simply looked at studies of patients without heart disease and compared mortality between the statin groups and the placebo groups. No machinations, no acrobatics, no per-unit-cholesterol. They took a Joe Friday approach (just the facts, ma’am), and found no mortality benefit.

Perhaps never has a statistical deception been so cleverly buried, in plain sight. The study answers this question: how much did the people who responded well to the drug benefit? This is, by definition, a circular and retrospective question: revisiting old data and re-tailoring the question to arrive at a conclusion. And to be fair they may have answered an interesting, and in some ways contributory, question. However the authors’ conclusions imply that they answered a different, much bigger question. And that is not a true story.

Guideline writers, doctors, patients, journalists, and policy makers will all have to pay close attention to avoid the trappings of deceptive data, dressed up as a true story.

*The Cochrane Collaboration analysis reports an overall mortality benefit with statins (RR=0.86), however their summary suggests that statins should be used for primary prevention “with caution.” In particular on p.12, after a discussion of the biases in many of the trials that led to their numerical finding, they clearly state that using statins for patients with anything less than a 2% per year risk of coronary events “is not supported by existing evidence.” This cutoff encompasses virtually all people that would be considered candidates for primary prevention.
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Dr John Briffa's response to the BMJ's withdrawal of comments.

My reaction to the BMJ’s withdrawal of statements relating to the safety of statins

By Dr John Briffa on 21 May 2014

 

You may have noticed that there’s a bit of a ‘fight’ going on over the cholesterol-reducing class of drugs known as ‘statins’. I am simplifying here, but there are essentially two opposing camps. In one corner, there are those doctors and researchers who hold the view that the statins should be given to pretty much all adults from middle-age, and there is little to be concerned with regarding their safety. In the other corner, there are those who believe that statins do no good at all for the vast majority of people who take them, and that the side-effects are more common that ‘official statistics’ suggest.
The fight went up a notch last week when the editor of the British Medical Journal announced that remarks made in two BMJ articles about the side-effects of statins had been withdrawn [1]. One of the articles was written by Dr John Abramson from Harvard Medical School and colleagues, and principally questioned whether extending statin use to those at lower risk (as has been suggested by the National Institute of Health and Care Excellence) will save lives [2].  According to their analysis, it won’t. The other piece was written by UK cardiologist Dr Aseem Malhotra, and principally questioned the role of saturated fat in heart disease [3].

In both articles, the authors referred to a study [4] that found that 17.4 per cent of people taking statins had adverse effects as a result attributed to statins. In the articles this figure was expressed as 18 per cent or ‘about 20 per cent’ which, apparently, was the first error. However, other issues, according the BMJ, was that the authors claimed that the 17.4 figure related to the percentage of people who stopped statins (at least temporarily) due to side-effects – this is not correct (it represented the percentage of people who had adverse effects). Also, the study in question was ‘observational’ in nature, which means that we don’t know if the adverse effects are due to statins or are the result of the ‘nocebo’ effect (like a placebo effect, only with negative effects rather than positive). The Editor of the BMJ, Fiona Godlee, tells us in her editorial that the caveats concerning the observational nature of these findings should have been made.

Both the articles made it through the peer-review process, so how did these errors come to be picked up? Well, apparently, they were brought to the attention of Fiona Godlee by Professor Sir Rory Collins, who heads up what is known as the Cholesterol Treatment Trialists (CTT) collaboration based in Oxford, UK. The CTT holds data on statin studies and periodically assesses it to tell us that statins are safe and very effective.

However, the CTT has in the past made grand claims about the effectiveness of statins that are based on the extrapolation of data (rather than actual data). Plus, as some have pointed out, the CTT refuses to release its data for independent inspection. The CTT can basically say what it likes about the effectiveness and safety of statins, but no-one can challenge what it says because no-one else has access to its data.

Apparently, Professor Sir Collins was invited by Fiona Godlee to put his concerns in writing for publication but he refused. He and Fiona Godlee met, and this set the ball rolling which culminated in the withdrawal detailed above. However, apparently this is not enough for Professor Sir Collins: he is demanding retraction of both articles, even though he has not challenged the main points raised in the articles. Fiona Godlee has set up an investigation to determine whether or not the articles should be retracted.

I have written to the BMJ in the form of an online ‘rapid response’ that was posted yesterday. You can read my response here.

In my response I accept that errors were made, but ask if a simple correction might have done.
Professor Sir Collins bases his assertions regarding the safety of statins on data from randomised controlled trials, like the ones analysed by the CTT. However, there are many reasons why randomised controlled trials may not adequately identify and report adverse effects from statins. Fiona Godlee acknowledges this herself and lists some of the issues, and I add to that list in my response. In all, there are about a dozen reasons why randomised trials stand to ‘miss’ adverse effects.

I also raise the issue of a recent study which appeared to confirm the safety of statins [5]. The study also detailed many reasons why results from clinical trials are an unreliable assessor of side effects. The study was reported in the BMJ [6], but the report included none of the caveats listed in the paper (or any other ones). As I explain to the Editor, these omissions may lull individuals into a false sense of security, and put people at unnecessary risk of adverse effects of statins, some of which can be serious.

One might argue that the ‘crime’ committed by the BMJ is roughly equivocal to the ones perpetrated by Drs Abramson and Malhotra. I point this out to Fiona Godlee in my response, and request a meeting with Fiona Godlee to discuss my concerns. After all, why should I not be afforded similar privileges as Professor Sir Collins”

You can read the response in full here. If you agree with the sentiments expressed in it, please click on the ‘thumbs up’ symbol to the right of the response to log your agreement.

References:
1.    Godlee F. Adverse effects of statins. BMJ 2014;348:g3306
2.    Abramson JD, Rosenberg HD, Jewell N, Wright JM. Should people at low risk of
cardiovascular disease take a statin? BMJ2013;347:f6123
3.    Malhotra A. Saturated fat is not the major issue. BMJ2013;347:f6340
4.   Zhang H, et al. Discontinuation of statins in routine care settings. Ann Intern Med 2013;158:526-34
4.    Finegold JA, et al. What proportion of symptomatic side effects in patients taking statins are genuinely caused by the drug? Systematic review of randomized placebo-controlled trials to aid individual patient choice. European Journal of Preventive Cardiology 2014;21(4):464-74
5.    Wise J. Statins may have fewer side effects than is claimed, meta-analysis finds BMJ 2014; 348:g2151
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It’s not about statins – it’s about censorship - Zoë

It’s not about statins – it’s about censorship

Written by Zoë on May 19, 2014

Two very serious things happened last week – one in Australia and the other in the UK, although both are about information on line, so they have global impact…

Catalyst – Australia
Last October, two programmes aired on ABC television under the “Catalyst” banner (Catalyst is like Horizon – a science/investigation kind of programme). The first programme was called “Heart of the Matter Part 1 – Dietary Villains” and it aired on 24th October 2013. A transcript and copy has been preserved by someone on line. You can currently see it here, but I’m not sure for how long. The transcript of the programme is also available on this link. In essence – this programme challenged the widely held view that saturated fat causes heart disease.

The second programme aired on 31st October 2013 and, again, it can currently be seen here (video and transcript). This programme was called “Heart of the Matter Part 2 – Cholesterol drug war.”
Those who stand to gain from the diet-heart-cholesterol hypothesis did not want these programmes aired. There were calls for the second programme to be cancelled, after the first programme had been shown. The person making these demands, professor Emily Banks, admitted that she “didn’t have a lot of detail” about the cholesterol programme, but wanted it pulled anyway.

Both programmes aired. Catalyst is the only science show on Primetime Australian TV and it pulled in approximately 1.5 million viewers. That’s approximately half the number of people who take statins in Australia, by the way.

Barely had the closing credits run before the pro-statin brigade swung into action. A formal complaint was lodged with the body that reviews “Audience and consumer affairs” and a few months later, the findings were published in a 49 page document. In between airing and publication, Catalyst – producers and presenter (Maryanne Demasi) – were pretty much paralysed from doing further work by the demands placed upon them by the investigation.

You can read the full report. You may like to wait for a Dr Malcolm Kendrick blog – due any time now – where he summarises all the complaints made against the two programmes and those rejected and upheld. Nothing was upheld against the first programme on dietary fat and yet this has been pulled. For the second programme on cholesterol, I lost count of the judgements that recorded “no breach” of any of the codes – 16 I think. There was 1 breach upheld – and 1 alone. This is on P46 of the 49 page report.

The investigation concluded that in one part of one programme the presentation favoured an anti-statin view more than a pro-statin view. The report did not recommend that the programme be removed from the ABC web site and condemned to the scrap heap. You can see the recommended remedy on p4 of the report “We suggest it would be appropriate for additional material to be made available on the special ‘Heart of the Matter’ program website.” And that’s about it. Yet this programme has also been pulled – ABC have caved in to the pressure placed upon them by statinators. The intention of those who promote statins was no doubt to ensure that a programme like this is never aired, touched or conceived of again. They didn’t want this one to air. Tragically, they have almost certainly achieved their aim.

I tweeted the irony of the judgement – that the pro-statin bias prevails 365 days a year and yet 1 hour of a TV programme, where one small part was slightly less than balanced towards both pro and anti-statin views, is silenced – for bias! This isn’t about statins. It’s about censorship.

UK – BMJ
In the UK, in the same week, same drug, we also experienced censorship. Only this time, thanks to the robustness of BMJ editor-in-chief Fiona Godlee, we experienced only a small censorship – for now anyway.

On 15th May, Fiona Godlee published this editorial in the BMJ Godlee noted that, in October 2013, the BMJ “published an article by John Abramson and colleagues that questioned the evidence behind new proposals to extend the routine use of statins to people at low risk of cardiovascular disease. Abramson and colleagues set out to reanalyse data from the Cholesterol Treatment Trialists’ (CTT) Collaboration. Their contention was that the benefits of statins in low risk people were less than has been claimed and the risks greater.”

Godlee continued, “In their conclusion and in a summary box they said that side effects of statins occur in 18-20% of people. This figure was repeated in another article published in the same week in The BMJ by Dr Aseem Malhotra. The BMJ and the authors of both these articles have now been made aware that this figure is incorrect, and corrections have been published withdrawing these statements. The corrections explain that although the 18-20% figure was based on statements in the referenced observational study by Zhang and colleagues—which said that “the rate of reported statin-related events to statins was nearly 18%”. The BMJ articles did not reflect necessary caveats and did not take sufficient account of the uncontrolled nature of Zhang and colleagues’ data.”
Godlee had been alerted to ‘the error’ by Rory Collins, head of the Cholesterol Treatment Trialists (CTT) Collaboration, whose data were reanalysed by Abramson and colleagues. Godlee says in her editorial that Collins visited her at The BMJ in early December and then took the matter up in the UK media towards the end of March 2014.

The Guardian article references Collins as follows: “The Oxford academic said the side-effect claims were misleading and particularly damaging because they eroded public confidence. “We have really good data from over 100,000 people that show that the statins are very well tolerated. There are only one or two well-documented [problematic] side effects.” Myopathy, or muscle weakness, occurred in one in 10,000 people, he said, and there was a small increase in diabetes.”

The challenges that the Guardian should have made:
The Guardian should have ascertained how independent/conflicted their source was. These are the two pertinent questions:

1) How much, Professor Collins, have you/your department/your charity/your family – whatever outlets you have – received directly and/or indirectly from the pharmaceutical industry during your lifetime?

2) You head the CTT. Why will the CTT not release Serious Adverse Effect data (and raw data generally) from clinical trials so that researchers, doctors and patients can fully understand the side effects of statins? How can you claim that statin side effects are negligible when you won’t share the data?

The Guardian should have done their own (simple) research into statin side effects. Here are two pertinent questions:

1) If side effects are as rare as you say, why does the patient leaflet for Lipitor – the most lucrative statin, indeed the most lucrative drug ever in the history of mankind, state the following:

“Common side effects (may affect up to 1 in 10 people) include:
• inflammation of the nasal passages, pain in the throat, nose bleed
• allergic reactions
• increases in blood sugar levels (if you have diabetes continue careful monitoring of your blood sugar levels), increase in blood creatine kinase
• headache
• nausea, constipation, wind, indigestion, diarrhoea
• joint pain, muscle pain and back pain
• blood test results that show your liver function can become abnormal“

2) If diabetes is to be dismissed so lightly, why is the diabetes statins lawsuit gathering pace in the US? (Google diabetes statins lawsuit) and why is “increases in blood sugar levels” listed as one of the common side effects in the patient warning leaflet?

Funding
The web of funding around Collins, CTT, CTSU (Clinical Trial Service Unit) has proved astoundingly difficult to get to the bottom of. I had a bit of a breakthrough recently and came across a declaration of interest for Colin Baigent – CTT secretariat and close senior colleague of Collins. Check page five for current and recent grants. The following have been awarded to Colin Baigent and Rory Collins, (with other names mentioned alongside):

Merck & Schering	£39 MILLION (2002-2011)
Merck	£52 MILLION (2005-2013)
British Heart Foundation	£9 MILLION (2005-2013) (Where does the BHF get that kind of money?) & then another grant from the BHF for £2.7 MILLION (2004-2013) & then a couple more for several hundreds of thousands of pounds.
Medical Research Council	£13.8 MILLION (2008-2013) (Check the most recent appointees to the MRC - a Senior Vice President of Pfizer and Executive Vice President of Astra Zeneca).
Bayer	A mere £965,000
John Wyeth Ltd	£500,000
Novartis	£350,000

That’s £114 MILLION before you get into the small change.

Censorship
ABC has caved in, despite no judgement requiring them to do so. Godlee has asked a third party to review both articles to see if the current revisions are sufficient, or to decide if the two articles should be pulled. Collins wants both articles to be retracted. As Godlee points out: Malhotra’s article is primarily about saturated fat – it merely references the Zhang article, which Collins is not happy about and the Abramson article is primarily about the fact that the CTT data failed to show that statins reduced the overall risk of death in people with a <20 10="" an="" available.="" be="" cardiovascular="" disease.="" fact="" important="" is="" of="" openly="" p="" risk="" this="" to="" which="" year="">I have no doubt that Collins would like these two articles deleted from the records forever. For him it may be about the statins that have funded him/his department/wherever to the tune of over one hundred million pounds. For the rest of us it’s about censorship.
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CTT the house of statin secrets - Burne

SOS: Sanity over Statins – CTT the house of statin secrets

by Jerome Burne

Should a professional body, however eminent, be allowed to keep information about the safety of products they are supplying to public hidden so no one else can run tests on them?

That is the question raised by HealthInsightUK’s finding that a large and respected organisation whose job it is to analyses the findings of statin trials – The Cholesterol Treatment Trialists’ (CTT) Collaboration in Oxford – has an agreement to keep secret much of the information contained in its huge database which holds results from 27 trials of these drugs, nearly each of which was run by a drug company.

Questions about the secrecy of the CTT have been put in the spotlight following the recent recommendation by NICE to change the guidelines on statins. If the proposals are accepted, millions more healthy people in the UK who have no sign of heart disease will be prescribed these drugs. A key part of the evidence supporting this proposal was a study by CTT published in the Lancet in 2012.

HealthInsightUK has also established that the CTT do not hold data on the side-effects of statins. A spokesman confirmed that they base their estimate of risk on the published results of trials conducted by the drug companies. He dismissed claims that side-effects such as muscle pain and depression were wide spread, saying they were only “hypotheses”.

Denied access to data

This could explain why the CTT has regularly reported a much lower rate of side-effects than trials run by independent researchers. Knowing the true rate of side-effects is particularly important with statins because many patients have to take them for one to benefit. If the estimate of side effects is too low the benefits may not outweigh the risks.

Concern about the secrecy surrounding CTT’s data is not new. Dr Jim Wright editor of the highly respected and independent journal Canadian Therapeutics Initiative which analyses drug studies has described how several years ago he had tried and failed to get access to statin data held by CTT.
“They had agreed someone from my team could have access to their data, although the researcher would have to go to Oxford to see it. However after travelling 6000 miles, they were told that the data was not available.”

This is just an anecdote but many others have since reported the same thing. The latest concern about access to CTT data was triggered last year when the Cochrane Collaboration – famed for its rigorous assessment of the benefit of drugs and other treatments – produced a report saying that statins should be more widely used on people without heart disease. The report was heavily based on the CTT Lancet study. Was it actually possible to check their findings?

Everyone wanted the data

A number of senior researchers approached by HealthInsight have supported Dr Wright’s claim that the data held by CTT hasn’t been available. Professor Rita Redberg cardiologist and editor of the journal JAMA Internal Medicine, has stated in an email that: “CTT will not make their data available to any colleagues and other researchers who wish to study risks and benefits of statins. The CTT data is not accessible publicly.”

“I have not requested access to the CTT data,’ says Dr David H. Newman, Director of Clinical Research, Mount Sinai School of Medicine, New York.

‘However, I’m not aware of anyone who has gained access to these data, which speaks volumes since everyone has wanted it. For the science to be considered even potentially credible, another independent group will have to replicate their analysis.”

Professor Harriet Rosenberg of the Health and Society Program at York University in Toronto commented that: “many scholars have asked the CTT for data without success” in a formal reply to the Cochrane review last year.

The response by the CTT when such individual claims are made is to say that anyone with a well formulated proposal can get access to their data. But emails seen byHeathinsightUK throw doubt on that. They were exchanged between one of CTT’s top researchers Professor Colin Baigent and an Australian TV journalist researching a story about statins.
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