Adverse effects of statins
BMJ 2014; 348 doi: https://doi.org/10.1136/bmj.g3306 (Published 15 May 2014) Cite this as: BMJ 2014;348:g3306All rapid responses
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Many thanks for all your comments.
There is an error in the editorial, about which I will publish a correction. The editorial says that the incorrect statement relating to the Zhang et al study appeared in the initial submission from Abramson et al, and that the peer reviewers and editors didn't pick this up.
In fact the reference to Zhang et al was added at a later stage, after peer review and revision, when the editors asked the authors to provide a reference for a statement about the side effects of statins. As the editorial correctly states, the revised and edited version was not sent back for further peer review. This is in line with our current process but is something we are revisiting.
The full pre-pubication history for the article is available here. http://www.bmj.com/content/suppl/2014/05/16/bmj.f6123.DC1
I have apologised to the peer reviewers for suggesting they had missed something that wasn't actually in the version they peer reviewed.
Competing interests: As I should have said in my competing interest statement for the editorial in case it wasn't clear, I am editor in chief of The BMJ and responsible for all that it contains.
Statistics are highly relevant if you are the one who suffers an adverse or a positive reaction, whether from a medicine such as a statin or a vaccination. All parties need to be furnished with the full and honest facts. Surely this is not something to be argued with?
The use of statins is just one small part of the whole cholesterol debate which has divided opinion for the last thirty to forty years.
How much damage has been wreaked by the low fat diet fad (often accompanied inexplicably by a high carbohydrate diet) which has been aimed to stem the tide of obesity and associated diseases?
A wealth of evidence has established that cholesterol lowering statin drugs, widely used for the prevention of cardiovascular disease, do increase the risk of new-onset diabetes. (Type 2) (1)
How do efforts to reduce cholesterol levels in existing cases of diabetes effect these individuals? Type 2 diabetes constitutes a high risk factor for developing cardiovascular disease. Diabetes has therefore been a prime target market for statin therapy, including type 1 diabetes; a disease with an entirely different aetiology.
Statin therapy is not the only method involved in cholesterol management. Low fat ‘functional foods’ need urgent investigation too. Cholesterol lowering spreads and low fat margarines are recommended for inclusion within the diabetic diet. This adds a further cholesterol lowering element to the diet. Despite cholesterol lowering spreads not being recommended by organisations such as NICE. (2) These products are blatantly advertised in medical centres.
Commercialised/medicalised marketing of various low far spreads and margarines claim efficacy in cholesterol lowering and therefore being heart friendly. The link between the food and drug industries and these products is unacceptable. How much of the perceived problems of ‘good and bad’ cholesterol have been hyped by commercial interest and bias?
It is widely acknowledged that omega 3 essential fatty acid (EFA) plays a vital role in homeostatic functions within the human body, notably the eicossanoid balance. Omega 3 (balanced with the correct ratio of omega 6) is essential,
The modern diet has overemphasised the need to consume polyunsaturated fats in the belief that they were a healthy choice, particularly in cholesterol management.
The biological mechanisms (delta 5 and delta 6 desaturases) required for the uptake of essential fatty acids such as omega 3 and 6 are impaired in those with diabetes (particularly type 2 diabetes (T2DM), a population group at high risk of cardiovascular disease).
The successful absorption of EFAs also relies on adequate levels of certain vitamins and minerals. The poor absorption of EFAs is further confounded by consuming a high carbohydrate diet such as recommended to those with T2DM. High blood glucose levels also impair the absorption of EFAs
Over nutrition triggers the onset of oxidative stress in the liver due to higher availability and oxidation of fatty acids, with development of hyperinsulinemia and insulin resistance, and omega 3 long-chain polyunsaturated FA depletion, with enhancement in the omegas 6/3 LCPUFA ratio favouring a pro-inflammatory state. (3)
Commercial food processing destroys a significant amount of EFAs, along with their oxygenating ability. Consumption of good quality omega 6 and 3 EFAs is a haphazard affair. Polyunsaturated oils are unstable and very quickly become rancid. Oxidized fatty acids are dangerous to our health. Lipid peroxidation and oxidative stress are important factors in this damage. (4)
Further damage is also caused by heating polyunsaturated fats in cooking (particularly frying foods).
A high fruit and vegetable consumption has a favourable effect on plasma antioxidant concentrations. (5) However, vitamin content of food is variable with age, conditions of storage and cooking methods. Modern farming methods and soil depletion have also left many foods nutritionally barren.
.Many omega 3 research trials did not consider the omega 3/6 essential fatty acid ratio which is vital to the eicossanoid balance. The correct omega 3/6 ratio is fundamental to holistic health for all. I believe that with simple dietary intervention diabetes complications such as retinopathy, nephropathy and cardiovascular problems could be ameliorated or prevented. Would it not be advisable to correct the inadequacies in the diet and lifestyle than rely on the actions of a cholesterol lowering drug such as a statin?
Further concerns of statin use have also been highlighted in the BMJ by Dr Ellen Grant who points out statins block the endogenous production of co-enzyme Q10 (CoQ10) (6) Others have also shared her concerns.(7)(8)(9) Studies conducted on CoQ10 levels provide a gathering body of evidence highlighting the importance of CoQ10 in diabetes management.(10)(11)(12) Further studies in the role of co-enzyme Q10 are obviously needed.
The vital importance of the homeostatic balance cannot be underestimated in human health. Unfortunately this is all but a small aspect of a diet related disease epidemic which is threatening world health. The statin debate which has arisen from the article by the BMJ editor Fiona Godlee (13) is very welcome and will hopefully bring positive developments in public health
(1) Do statins cause diabetes? Goldstein MR1, Mascitelli L. Curr Diab Rep. 2013 Jun;13(3):381-90. doi: 10.1007/s11892-013-0368-x. http://www.ncbi.nlm.nih.gov/pubmed/23456437
(2) Lowering cholesterol to reduce the risk of heart ... - Nice www.nice.org.uk/nicemedia/live/11982/40712/40712.pdf
(3) Valenzuela R, Videla LA.The importance of the long-chain polyunsaturated fatty acid n-6/n-3 ratio in development of non-alcoholic fatty liver associated with obesity. Food Funct. 2011 Nov;2(11):644-8. doi: 10.1039/c1fo10133a. Epub 2011 Oct 19.
(4) Moore, K., and L. J. Roberts 2nd. 1998. Measurement of lipid peroxidation. Free Radic. Res. 28: 659–671
(5) John J et al (2002) Effects of fruit and vegetable consumption on plasma antioxidant concentrations and blood.
(6)Ellen CG Grant,Rapid response. Inevitable adverse effects due to blockage of co-enzyme Q10?
http://www.bmj.com/content/348/bmj.g3306/rr/698281
(7) David L Keller Rapid response. Discussion of Dr. Grant's point regarding coenzyme Q10
http://www.bmj.com/content/348/bmj.g3306/rr/698414
(8) Sergio Stagnaro. Rapid response. Adverse effects of statins. http://www.bmj.com/content/348/bmj.g3306/rr/698206
(9) Andrew N Bamji. Rapid response. Adverse effects of statins.http://www.bmj.com/content/348/bmj.g3306/rr/698457
(10) Mitochondrial factors in the pathogenesis of diabetes: a hypothesis for treatment. Lamson, D.W.. Plaza S.M. Altern Med Rev, 2002. 7(2): p. 94-111.
(11) Brownlee, M., The pathobiology of diabetic complications: a unifying mechanism. Diabetes, 2005. 54(6): p. 1615-25.
(12) CoEnzyme Q10:The State of the Science in Diabetes Ryan Bradley, ND, MPHDiabetes Action Research and Education Foundation February 2007 http://www.diabetesaction.org/site/PageServer?pagename=complementary_2_07
(13) Godlee F. Adverse effects of statins. BMJ 2014;348:g3306
Competing interests: No competing interests
My analysis of the drama that unfolded on Radio 4 is that....
Well intentioned doctors wish to help patients
patients wish to be helped.
A dynamic of Victim - Rescuer may sometimes arise (Karpman's Drama Triangle)
Man trained to use a hammer sees many thanks as a nail - so doctors prescribe medication.
Doctors are not trained to think of nutrition - we learnt less than a day at medical school (though increasing evidence that refined sugar in quantity contributes to chronic disease and cardiovascular disease)
Doctors therefore help patients (using medication)
It is easy for some to leave 'Health' to the doctors rather than take responsibility (power given away). "Doctor, what are you going to do for me?" - and doctors may take the lead on this, and take the power - and prescribe not exercise but a tablet.
Some vested interests would rather prescribe medication than concentrate on the food we eat, exercise we take, etc. The NNTs for exercise are impressive for many illnesses - and safer than most medications!
Some vested interests see doctors as their sales force and market heavily, lightly, subtly and for an end game of sales, not just (or sometimes even) for patient benefits - so a drug for heart disease prevention, a drug for weight, a drug for.... (rather than society and individuals making healthier choices....)
A specialist may become seduced into being particular enthusiast in prescribing drug X
The studies on positive benefits of statins, if framed as NNT (numbers needed to treat) are not nearly so impressive as '30% risk reduction'
The BMJ is utterly correct in raising doubt about the claimed benefits and claimed minimal side effects
Dr Godlee was involved on Radio 4 in the classic drama triangle, where someone else takes the role not of victim or rescuer, but of persecutor. She responded well, but it is a shame when a fellow health professional, well-meaning on behalf of his/her patients, is attracted to move into the Persecutor role. www.medicalprotection.org/uk/practice-matters/issue-5/the-drama-triangle
Competing interests: No competing interests
ADVERSE EFFECTS OF STATIN AS WEAPONS AGAINST BRITISH MEDICAL JOURNAL
Juan Gérvas, MD, PhD, retired general practitioner , Equipo CESCA (Madrid , Spain). Visiting professor International Health, National School of Public Health (Madrid, Spain)
jjgervas@gmail.com @ JuanGrvas www.equipocesca.org
SUMMARY
It appears that the adverse effects of statins are being used as a smokescreen to avoid the debate over its lack of effect in primary prevention.
The ultimate intention is likely to change the line of independence of the British Medical Journal, to change its editor and to promote industrial interests.
Statins
The statins are drugs which limit cholesterol synthesis by inhibiting HMG – CoA reductase.
Like all drugs, statins have precise indications.
Statins, like all medications, have potential for adverse effects.
Benefits and harms
Like all drugs, statins produce benefits in some cases but all patients are subject to the risk from its harms and its adverse effects.
This is because, in general, the harms occurs in a fixed proportion of the patients that receive treatment, while the benefits depend on the number of patients "who need" the medication after being diagnosed and treated.
Therefore, it is those patients who have been prescribed correctly and comply with treatment that reap the benefits.
The risk of incurring in harm and adverse effects concerns all patients that are prescribed statins, whether appropriately or not, and that comply with treatment.
Indications of statins
Statins should be used in those cases where its expected benefits exceed its likely harms.
Statins are effective in secondary prevention For example, in patients that have suffered a myocardial infarction.
Statins have dubious benefits in primary prevention (in patients who so not have any cardiovascular problem but have risk factors such as "high cholesterol ", are smokers, belongs to low social class, have diabetes, etc). Some clinical trials suggest that statins may have some benefit in patients with "high cardiovascular risk," but there is no agreement on the "intensity" of such cardiovascular risk or about the beneficial effect in itself.
Statins and primary prevention in the British Medical Journal
The British Medical Journal published two studies in 20131,[1][2] on the effect of statins in primary prevention and both concluded that there was no benefit in those who had a low cardiovascular risk (less than 20 % at 10 years). To highlight the absurdity of employing statins, an observational study about statins was cited which showed that intolerance to treatment with statins affected 18-20% of patients.[3]
Later on, the two studies were corrected, as the percentage of intolerance was actually 18% in the observational study, but figures could not be extrapolated as this percentaje was “substantially higher than the 5% to 10% usually described in randomized, placebo-controlled, clinical trials".
Adverse effects of statins
The problem is that we do not know the real figure regarding harms and adverse effects caused by statins. The harms probably affect 9%, even if whether 20% have myalgia and myopathy.[4] Muscle adverse effects are the most reported problem both in the literature and by patients; include muscle pain, fatigue and weakness as well as rhabdomyolysis.[5] The Women's Health Initiative data showed an adjusted increase of 48% in the risk of diabetes among women receiving statins.[6]
In fact, studies about the safety of statins only started being carried out in 2002, after the hundreds rhabdomyolisis deaths caused by cerivastatin[7] (by the way, no one death in its clinical trials). In general, the statins mortality risk from fatal rhabdomyolysis is approximately 0.3 per 100,000 person-years8. That means, for example, 36 deaths per year in the UK when 12 million people will take statins under new NHS guidelinest.[9]
Safety studies should take into account the situations in clinical practice in which statins are taken (along with other drugs, with several diseases, age groups not included in the clinical trials, etc).
The issue is more complicated because of the lack of access to the raw data from the clinical trials, and its funding by Pharma. In many occasion side effects data is collected in clinical trials but not reported in the scientific papers. The German governments' cost effectiveness agency found complete information for 87% of adverse event outcomes in documents of the industry but only 26% in the journal publications.[10]
The British Medical Journal under attack
The British Medical Journal depends on the British Medical Association.
The British Medical Journal has always stood for independence, and in recent times is taking an active part, for example, in the # AllTrials movement that promotes access to all the raw data from clinical trials. It has also helped Cochrane Reviews in the analysis of the antivirals Tamiflu and Relenza (which are useless and cause side effects). It promotes and helps the "Overdiagnosis" campaign that includes, for example, criticizing the lack of efficacy of breast cancer screening with mammography. It has facilitated the publication of, for example, studies about the excesses around ADHD.
The British Medical Journal is independent from the pharmaceutical and technology industries, whom it dislikes, irritates and bothers.
It is therefore not surprising that the President of the Cholesterol Treatment Trialists ' Collaboration CTT) visits the editor of the British Medical Journal ( BMJ) to ask for the retraction of the two articles about primary prevention of cholesterol due to the error about the harms of statins.[11]
It is the CTT against BMJ, and more.
Without delving into the scientific debate, the President of CTT approached the tabloid press, which has in turn attacked the British Medical Journal as if the problem was about discussing the rate of the adverse effects of statins.
To retract or not to retract
The problem is that statins have no use in primary prevention, particularly in patients with a low risk. In these patients, prescribing and monitoring statin treatment is unethical, as "a drug that is not necessary and is used in a situation that is not justified under any circumstances, does not compensate is harms with potential benefits in cases in causing adverse effects".
The British Medical Journal agreed to correct the figure regarding the adverse effects, but does not intend to retract the two articles. In scientific journals, retraction of articles occurs in situations of fraud or misconduct.[12] In fact the British Medical Journal has decided that the right thing to do is to pass this decision to an independent panel.
The members of the Cholesterol Treatment Trialists ' Collaboration have in many cases strong relationships with industry. They also don’t have access to the raw data from clinical trials, which industries do not share, and therefore do not know the percentages of adverse effects, except for the published summaries.
It appears that the adverse effects of statins are being used as a smokescreen to avoid the debate over its lack of effect in primary prevention.
Far from the scientific debate
The campaign against the British Medical Journal may be included in an intense campaign that is even changing the new and positive attitude of the European Medicines Agency to fulfill the mandate of the Parliament of the European Union to grant free access to the raw data of clinical trials.
As such, the attack on the British Medical Journal is far from the scientific debate. The ultimate intention is likely to change the line of independence, to change the editor and to promote industrial interests.
The least problem is the rate of adverse effects of statins; a bigger problem is its lack of effectiveness. Without neglecting such adverse effects, which can be deadly and the hundreds of deaths caused by cerivastatin just over a decade demonstrated that.
The attack on the British Medical Journal is the least problem; a bigger problem is the loss of independence of a scientific journal.
We should follow this saga because we played a lot in it.
To know more
Prof Sir Rory Collins told the Guardian in March that a paper and a subsequent article in the BMJ were inaccurate and misleading.
http://www.theguardian.com/society/2014/may/15/statins-bmj-statement-pro...
Statins row: Critics are biased, says doctor [Malhotra] who warned of drugs' side-effects.
http://www.independent.co.uk/life-style/health-and-families/health-news/...
Rapid answers to the BMJ editorial
http://www.bmj.com/content/348/bmj.g3306?tab=responses
Ben Goldacre' post "statins side effects"
http://www.theguardian.com/science/blog/2014/mar/14/statins-side-effects...
Going deep to data access and money (and power). It's not about statins. It's about censorship.
http://www.zoeharcombe.com/blog/
Clinical trials systematically get the wrong answer, especially on adverse events. They are the gold standard way to hide adverse events.
http://davidhealy.org/fucked/
From BMJ blog
http://blogs.bmj.com/bmj/2014/05/19/the-bmj-today-statins-and-the-bmj/
From Forbes, panel members
http://www.forbes.com/sites/larryhusten/2014/05/19/bmj-names-panel-membe...
Going deep to data access and money (and power). It's not about statins. It's about censorship.
http://www.zoeharcombe.com/blog/
As a class, adverse events associated with statin therapy are not common. Statins are not associated with cancer risk but do result in a higher odds of diabetes mellitus. Among individual statins, simvastatin and pravastatin seem safer and more tolerable than other statins.
http://www.ncbi.nlm.nih.gov/pubmed/23838105
How to increase the use of statins for primary prevention in the UK
http://blogs.bmj.com/bmj/2014/05/20/azeem-majeed-three-obstacles-to-incr...
References:
1 Abramson JD, Rosenberg HD, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ2013;347:f6123.
2 Malhotra A. Saturated fat is not the major issue.BMJ2013;347:f6340
3 Zhang H, Plutzky J, Skentzos S, Morrison F, Mar P, Shubina M, et al. Discontinuation of statins in routine care settings. Ann Intern Med2013;158:526-34.
4 Grundy SM. Statin discontinuation and intolerance: the challenge of lifelong therapy. Ann Intern Med 2013;158:562-3.
5 Golomb BA, Evans MA. Statin Adverse Effects: A Review of the Literature and Evidence for a Mitochondrial Mechanism. Am J Cardiovasc Drugs. 2008; 8(6): 373–418.
6Culver AL, Ockene IS, Balasubramanian R, et al. Statin use and risk of diabetes mellitus in postmenopausal women in the Women's Health Initiative. Arch Intern Med 2012;172:144-152.
7 Gérvas J, Pérez Fernández M. Cerivastatin and fatal rhabdomyolisis: not just a safety issue. Healthy Skepticism International News. 2002;20 (2) http://www.healthyskepticism.org/global/news/int/hsint2002-06
8Guyton JR. Benefit versus Risk in Statin Treatment. Am J Cardiol. 2006; 97 (Suppl 1):S95-S97.
9Donelly L. Statins: 12 million Brits will be advised to take cholesterol-lowering drug. 11 Feb 2014. The Telegraph http://www.telegraph.co.uk/health/healthnews/10632047/Statins-12-million...
10 Wieseler B, Wolfram N, McGauran N, Kerekes MF, Vervölgyi V, Kohlepp P, et al. Completeness of Reporting of Patient-Relevant Clinical Trial Outcomes: Comparison of Unpublished Clinical Study Reports with Publicly Available Data. PLoS Med. 2013 Oct 8;10(10):e1001526.
11 Godlee I. Adverse effects of statins. BMJ 2014;348:g3306 http://www.bmj.com/content/348/bmj.g3306
12 Committee on Publication Ethics. Retraction guidelines. http://publicationethics.org/files/retraction%20guidelines.pdf.
Competing interests: No competing interests
Last year I was prescribed simva statins by my doctor to lower my cholesterol. Fairly soon I started noticing that I was getting muscle cramps. Things like not being able to walk my child the quarter mile to school without having to stop to let my calf muscles recover. I also had severe pains in the joints of my elbows. This culminated in January last year, I picked up an internal door which are not very heavy and my bicep muscle popped loudly 3 times. I ended up in a&e being treated for a torn ligament which was the wrong diagnosis. My concerns regarding the statins as a probable cause were dismissed. When I took alternative medication, the joint pain persisted and my cholesterol went back up. Now I take no statins what so ever and I feel much better although I still have much reduced strength in my left arm due to the muscles being still detached.
I know that I am not the only person who has had severe side effects with stations as my mother also had severe muscle damage and now walks with a frame.
Not everybody has a positive experience with statins.
Competing interests: No competing interests
As a science journalist, I am concerned that one of our most prestigious publications should be considering the step of retraction in this matter. Correction of any errors, by all means; but does this warrant retraction, normally saved for the most egregious of errors?
Competing interests: None
I think the Editors response is perfectly right! We should be not be intimidated like what happened in the case of MMR. Have we not recently come to appreciate the affect statins can sometimes have on blood glucose levels? The editor is right to reserve comment until the panel concludes.
Competing interests: No competing interests
I have two points to add to those made thus far:
1) If side effects are as rare as Collins claims, why does the patient leaflet for Lipitor (ref 1) – the most lucrative statin - indeed the most lucrative drug ever (ref 2), 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“
This may also explain why the statins' diabetes lawsuit is gathering pace in the US.
2) Collins should have declared his conflicts of interest in his complaint to the BMJ. As a contributor to lipidsonline.org Collins declares support from AstraZeneca, Bristol-Myers Squibb, Merck, Sanofi (ref 3). No such interests were declared in this 'game-changing' statin paper (ref 4).
I found a "current and recent grants" declaration from fellow Cholesterol Treatment Trialists' (CTT) Collaboration secretariat member, Colin Baigent, on his and Collins' behalf, to be particularly enlightening (ref 5):
Merck & Schering £39M;
Merck £52M;
British Heart Foundation £9M + £2.7M;
Medical Research Council £13.8M - recent council appointees being Senior Vice-President and Chief Scientific Officer of Pfizer Neusentis, and Executive Vice President of Innovative Medicines at AstraZeneca (ref 6).
Bayer £965,000
Solvay £978,000
That’s £116 MILLION before you get into the small change.
Ref 1 http://www.medicines.org.uk/emc/medicine/2498/PIL/Lipitor+10mg,+20mg,+40...
Ref 2 http://usatoday30.usatoday.com/news/health/medical/health/medical/treatm...
Ref 3 http://www.lipidsonline.org/site/editorial.cfm#collins
Ref 4 http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3437972/
Ref 5 http://www.britishrenal.org/getattachment/85252dcb-765f-40fb-b6ba-81201b... (See page 5)
Competing interests: No competing interests
Muscular adverse effects are very common with statins
The 2011 Cochrane review of statins for the primary prevention of cardiovascular disease reported a risk ratio of 1.03 for muscle pain, i.e. 3% more patients developed muscle pain on drug than on placebo (1). However, industry-funded randomised trials are notoriously unreliable when it comes to the harms of drugs (2). A publicly-funded randomised trial from 2012 that studied the impact of statins on energy and exertional fatigue got results that could be interpreted as 20% of the men and 40% of the women experiencing a worsening in either energy or exertional fatigue (3).
I therefore wonder why Sir Rory Collins has pressured the BMJ in a most unacademic fashion for having published a paper that reported a similar incidence of harms based on a cohort study (4). He has even called for a retraction of the paper, just like drug companies have often done when a paper appeared that could threaten their sales (2). Collins and his colleagues publish meta-analyses based on company data to which no one else has access because of the confidentiality clauses Collins and colleagues have accepted.
I believe science ceases to exist when no one else than those who have conflicts of interest are allowed to see the data.
1. Taylor F, Huffman MD, Macedo AF, Moore THM, Burke M, Davey Smith G, et al. Statins for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev 2013;1:CD004816.
2. Gøtzsche PC. Deadly medicines and organised crime: How big pharma has corrupted health care. London: Radcliffe Publishing, 2013.
3. Golomb BA, Evans MA, Dimsdale JE, et al. Effects of statins on energy and fatigue with exertion: results from a randomized controlled trial. Arch Intern Med. 2012; 172: 1180–2.
4. Abramson JD, Rosenberg HD, Jewell N, Wright JM. Should people at low risk of cardiovascular disease take a statin? BMJ 2013;347:f6123.
Competing interests: No competing interests
Re: Adverse effects of statins
In reply to John Briffa:
Dear John, I will be very pleased to meet you - you had only to ask. Best wishes, Fiona
Competing interests: I am editor in chief of The BMJ and responsible for all that it contains.