This correspondence is from the personal files of the site owner. The names of all of the individuals, who are not public figures, have been reduced to a single letter so that the individuals cannot be identified from the letters which are published here. To aid the easy identification of the sender, the Department of Health letters are coloured brown and the original letter and the later responses to the Department of Health replies are coloured blue and appear in italics.
Department of Health:
The following letters were sent by the site owner in response to being prescribed statins and being unable to get sensible reasons for the prescription from the GP or Heart UK.
To Minister of State for Public Health - Caroline Flint - 21st January 2007.
Dear Minister,
I am writing to you, because of your responsibilities as the Minister of State for Public Health, in an effort to understand the current position on the group of drug therapies that are known by a collective name; Statins. My e-mail was returned with an imprecation to re-address it as I am not one of your constituents.
I was recently prescribed a drug from this group of therapeutic substances, by my family medical practitioner. I had asked him about the risks and the benefits of this particular therapy in my own case and I received the deep sigh and the withering look that one may reserve for an imbecile and the best information I could obtain from my GP was that I had fitted a particular profile that aligned with one of the targets of government. I was astonished to be treated in a such a cavalier fashion, given that I believe that the only way one can gain information about a subject, where one has insufficient native knowledge... is to ask the relevant expert.
You will not be surprised to learn that I had to undertake a considerable amount of research in order to answer my own questions. I had noticed a few web-sites that were filled with people complaining about statin therapies and the many serious adverse reactions that they appear to have suffered. Many of those sites seemed to have a secondary purpose in promoting and selling some sort of 'cure' or an alternative therapy. In the main, I avoided these web-sites on the grounds that I could not rule out the possible biases that would colour the statements, especially where there were alternative 'cures' or books being sold.
I confined myself to searching peer-reviewed medical journals (via PubMed) to discover what opinions the medical profession offered and which facts supported the various hypotheses that have been offered about cholesterol and its potential to be the root causative factor for many diseases of the circulatory system. The more I read, the less convinced I became about the value of statin therapies.
It would appear to be the case that the only significant finding in the studied cases of lower cholesterol (that many researchers have agreed upon) is that a lower serum cholesterol in the non-demented elderly is a reliable and robust predictor of mortality. The most recent paper I could find was published in the Journal of the American Geriatrics Society (Volume 53 Issue 2 pp 219~226 February 2005)
[citation: Relationship Between Plasma Lipids and All-Cause Mortality in Nondemented Elderly - Nicole Schupf PhD, Rosann Costa MA, Jose Luchsinger MD, MPH, Ming-Xin Tang PhD, Joseph H. Lee DrPH, Richard Mayeux MD, MSc (2005) Journal of the American Geriatrics Society 53 (2), 219–226. doi:10.1111/j.1532-5415.2005.53106.x]
Speaking as a person who is definitely non-demented and approaching 60 years of age, I believe that I have very good cause to worry, once this type of fully refereed research is published in acceptable medical journals. Further research that was carried out in this country, and published in the British Journal of Psychiatry in 1999, had studied men between the ages of 50~69 years and followed them up for between 5~8 years. The study concluded the following....
RESULTS: Low serum total cholesterol was associated with low mood and subsequently a heightened risk of hospital treatment due to major depressive disorder and of death from suicide.
CONCLUSIONS: Our results suggest that low serum total cholesterol appears to be associated with low mood and thus to predict its serious consequences. Perhaps this document was not available to the government when decisions about wholesale statin therapy were being made but it did extend to a sample of 29,133 men and that suggests to me that these findings are probably reproducible.
[citation: Association of low serum total cholesterol with major depression and suicide - T Partonen, J Haukka, J Virtamo, PR Taylor and J Lonnqvist (1999) The British Journal of Psychiatry 175: 259-262]
The findings that were published in The British Journal of Psychiatry, were presaged by a publication of some research carried out and published in the American Journal of Psychiatry in 1995. The authors had tried to determine what lay behind several reports of low serum cholesterol concentrations being associated with a greater than normal risk of mortality from suicide.
CONCLUSIONS: Male psychiatric patients with low cholesterol levels were twice as likely to have ever made a medically serious suicide attempt than men with cholesterol levels above the 25th percentile. Low cholesterol concentration should be further investigated as a potential biological marker of suicide risk.
[citation: Low serum cholesterol level and attempted suicide - JA Golier, PM Marzuk, AC Leon, C Weiner and K Tardiff (1995) American Journal of Psychiatry 1995; 152:419-42]
I am far more concerned about fitting the profile of a man (evidently, men are affected by these effects far more than women) of the age that appears to being included in all three of the citations I have provided. My question at this point is: why is death from suicide, low mood leading to depressive illness and low cholesterol concentration being a robust predictor of mortality in the non-demented, not a considerable rationale for NOT prescribing statins to everyone who fits the government profile for lowering serum cholesterol?
Like many people of my age, as parts of the body become worn, I have my share of minor complaints that I have decided that I just have to live with. In other words, I have some symptoms that do not cause me any great distress and I see no good reason to burden the health service with matters that could well be age-related, especially while they do not prevent me from enjoying a useful working life and some of the many leisure pursuits that are followed by most family men.
The research studies that I have read have pointed to neurological deficits and muscle weakness in subjects who are prescribed statins. Additionally, the observed adverse reactions appear to be worse in subjects who already have any degree of peripheral neuropathy or any type of myopathy.
I have had some mild but persistent symptoms of peripheral neuropathy for the last two years and it was fully investigated but no conclusion was reached. This makes me a candidate for the type of adverse reaction that has been reliably reported in two peer-reviewed journals; Annals of Internal Medicine and the American Academy of Neurology publication called Neurology.
In 2002, Neurology published an article that examined first-time-ever cases of idiopathic polynueropathy throughout the 5 year period; 1994~1998. The research had concluded that "Long-term exposure to statins may substantially increase the risk of polyneuropathy".
Furthermore, another study showed that normal blood levels of creatine kinase did not exclude histopathologic findings of myopathy in that subjects receiving statins were complaining of muscle weakness and it was demonstrated that they had a measurable weakness even though the creatine kinase bio-marker was normal. Persistent and often permanent muscle damage is another serious adverse effect of statin therapy.
[citation: Statins and risk of polyneuropathy - D. Gaist, MD PhD, U. Jeppesen, MD PhD, M. Andersen, MD PhD, L. A. García Rodríguez, MD MSc, J. Hallas, MD PhD and S. H. Sindrup, MD PhD (2002) Neurology 2002;58:1333-1337]
[citation: Statin associated myopathy with normal creatine kinase levels - Paul S. Phillips, MD; Richard H. Haas, MD; Sergei Bannykh, MD, PhD; Stephanie Hathaway, RN; Nancy L. Gray, RN; Bruce J. Kimura, MD; Georgirene D. Vladutiu, PhD; John D.F. England, MD (2002) Ann Intern Med. 2002;137:581-585]
I have recently read a substantial amount of the literature anent statin therapy and I am bewildered by the apparent certainty of the benefits of statin therapy (as promulgated by the government) when so many seriously inclined medical practitioners, with no obvious axe to grind, are stating that statin therapy is plainly dangerous on many different fronts. The research has been supported by hard numbers and the principle investigator's positions are supported by properly refereed articles in august medical journals.
The obvious question is how has this major body of research come to be ignored? I had even read of one clinician who is so blind to what appears to be an inherently dangerous statin therapy that he has advocated putting the statin drugs in our drinking water! This would not be healthcare that is a working partnership between the populace and the health service; this would be healthcare by fiat!
Every statin has been shown to be carcinogenic in rodents and I note that the doses were very close to those which are consumed by humans. The university of British Columbia publishes a quarterly journal (Therapeutics Initiative - Evidence Based Drug Therapy) in which was published an article in the quarter covering April, May and June 2003, entitled "Do Statins have a role in Primary Prevention?" The research has analysed the results from 3 of the major statin studies, PROSPER, ALLHAT-LLT and ASCOT-LLA. The conclusion was yet another version of what appears to have become a depressing leitmotif...
CONCLUSIONS: If cardiovascular serious adverse events are viewed in isolation, 71 primary prevention patients with cardiovascular risk factors have to be treated with a statin for 3 to 5 years to prevent one myocardial infarction or stroke. This cardiovascular benefit is not reflected in 2 measures of overall health impact, total mortality and total serious adverse events. Therefore, STATINS HAVE NOT BEEN SHOWN TO PROVIDE AN OVERALL HEALTH BENEFIT IN PRIMARY PREVENTION TRIALS. (my emphasis)
Given that the clinical trials referred to in that article are the same ones that underpin statin therapy guidelines in the UK, I am compelled to seek answers from you, with respect to the wholesale prescription of statins in the UK. I can appreciate that this type of medical research is very expensive and it is therefore natural that it is funded by the very same pharmaceutical companies that have an interest in selling their products.
These pharmaceutical companies are clearly not altruistic (one only has to look at their combined annual profits) and it is quite unlikely that the pharmaceutical companies are creating new wonder drugs, just for me to enjoy a better life. I don't want my life being managed by a drug company. I have seen numerous complaints from ordinary people (they are anecdotal so I wont cite them here) of the heart-rending damage caused by statin therapy to themselves or their loved ones.
Pfizer is a pharmaceutical company that produces drugs of the statin group. Recently (December 2006) they had to halt a phase 3 clinical trial[1] after it was noticed by the independent monitor, the DSMB (Data Safety Monitoring Board) that there was an unexplained and unexpected increase in the mortality rates for the statin compound, torceptrapib/atorvastatin, under clinical trial. Death is not an adverse reaction that one can recover from and it sounds another cautionary note. I have provided some URL links to the relevant information. viz.
I am not prepared to tolerate a vastly increased risk of depressive illness, suicide, permanent muscle damage, psychological lassitude, neurological deficit and death, just to satisfy a government target that appears to be based on mythology. My death is a certainty (as it is for us all) but I see no reason to hasten death nor do I wish to die while being robbed of my abilities to function as a normal human being.
There is something rather suspicious about the rush to put huge swathes of the UK population on statins for almost any reason that one can imagine. This behaviour flies in the face of the well established fact that low cholesteroI is a robust predictor of mortality. I am unwilling to claim a conspiracy theory but I will do all that I can to support my right to live a life that is completely unfettered by government interference insofar as my personal medical condition and treatment, especially where the government policy is so very clearly wrongheaded.
The DoH response follows...
Thank you for your email of 21 January to Caroline Flint about statins. As you will appreciate, Ms Flint receives a large amount of correspondence and cannot answer all of her mail personally. Your email has been passed to me for reply.
In response to the points that you raise, it may be helpful if I explain that Government health policy is developed from the best evidence available. This means that as more research takes place, health messages may change to take account of new findings. The National Institute for Health and Clinical Excellence (NICE) was set up to review evidence of effectiveness, including cost effectiveness, and to provide guidance for the NHS.
NICE published a Health Technology Appraisal (HTA) on statins in January 2006. Cardiovascular disease (CVD) covers a range of conditions, including coronary heart disease (CHD) and stroke. CVD is the single most common cause of death in the UK , as well as being responsible for a great deal of illness and poor quality of life.
Raised cholesterol is one of the major modifiable risk factors for CVD, and statins are the principal pharmacological treatment for lowering cholesterol. There have also been several major long term studies of the effectiveness of statins, so this was an important area for NICE to examine.
This HTA took account of all available evidence and concluded that it was effective to intervene with statin therapy in patients who scored a 20% or greater ten-year risk of developing cardiovascular disease, regardless of the starting cholesterol.
NICE is currently working on a guideline on lipid control, due for publication in September 2007, which is also looking at the issue of risk assessment.
There are a number of different risk assessment tools for coronary heart disease in use in England. Most of them derive from the Framingham prediction equations, which estimate CHD risk based on patients’ age, gender, blood pressure, total cholesterol, high-density cholesterol, presence of diabetes and smoking habit.
Relative risk reductions in CHD events in the statin trials appear similar regardless of baseline risk and baseline cholesterol (except where baseline cholesterol is <5.0 mmol/l when the relative risk reduction is less). This implies that the best way to target patients for cholesterol control and statin therapy to reduce CHD risk is to calculate absolute risk.
GPs will also use their own clinical judgement to determine treatment for individual patients. They will themselves keep up with the latest medical research and do not have to wait for NICE guidance before adopting up to date practice.
In addition, the Quality and Outcomes Framework (QOF) of the new GP Contract, rewards GP practices for monitoring and controlling cholesterol in patients with identified CHD. The current target cholesterol is 5 mmol/l or less.
QOF is reviewed and revised on an annual basis, using new evidence of effectiveness and thresholds for treatment, so it is possible that these Quality Indicators may change in the future. I hope this reply is helpful.
The reply was not as helpful as the responding civil servant had hoped it would be. A new letter was sent in response to the reply...
Thank you for this reply to my e-mail message, dated January 21st, to Caroline Flint. I appreciate the point that one person, occupying a high profile public office, is is unlikely to be able to answer all correspondence addressed to them.
My reply is to your own personally written response to my concerns, and I am sure that you will accept that I am writing this reply as if I were speaking directly to the minister for public health. That is to say that it is not my intention to discuss a matter for the minister of state, with a customer services representative who happens to be employed within the Department of Health.
I do not wish to appear to be deliberately rude to you and I hope that you will understand that, despite our civil discourse, I am aware that you have no executive power to affect the issues that I wish to be made known to the minister.
It has also occurred to me to remind you that if my original communication had never been shown to Caroline Flint, that the potential for righting a grievous wrong has passed. I am reasonably certain that the minister would like to be kept abreast of information that could prevent unnecessary harm being wrought, on a large scale, on a substantial number of members of the public. Any plan for remedial action could be produced and implemented in a timely manner.
In the alternative, I could book a meeting with my local MP (from a major opposition political party) and the wasted time in trying to get the question before the Prime Minister at PMQs or dealt with as a private members bill, would result in ongoing harm to the public, not to mention the adverse publicity this issue would bring to a government that appears to be unpopular... with a general election in a few months time.
Accordingly, I am now making a formal request for a copy of my previous e-mail message, along with this reply to your own written response to my concerns, to be submitted to Caroline Flint. She is the minister for Public Health in the UK and this is an issue that falls well within her ambit.
As a concerned member of the public, I am requesting a response from the responsible minister of the government, who is the only person with executive power and (as such) she is the most appropriate person to read my concerns.
I am obliged to you for detailing for me how the government health policy is developed. You have stated that the policy is developed from "the best evidence available". Perhaps you will forgive me for asking the compound question... what constitutes best evidence, how recent is it and who makes the decision that concludes that a certain piece of evidence is 'best' evidence?
My evidential citations from refereed and peer-reviewed professional medical journals had started at 1995 and I brought you up to date with a citation from December 2006. The weight of evidence is that statin therapy is both dangerous and possibly unnecesary and that the risk indicators were based on what has been widely regarded as dubious research i.e. Framingham. Furthermore, that statin therapy is acknowledged (by impartial investigators) as a robust predictor of mortality in the non-demented elderly.
I am a patient trying to make sense of this issue. I inform you that I am at a greatly increased risk of Iatrogenic harm, possibly resulting in my death, if not my permanent dependancy on the National Health Service, should my GP have managed to convince me that government policy is correct in this matter... and you seek to inform me about how the government policy on health is developed.
At the risk of being tedious, I am going to make this point very clearly. It is now apparent that the current government policy, concerning the prescribing and the administration of statin therapy, is more than somewhat harmful.
If I am a good citizen and follow my GPs imprecation to fill my body with statins, as per the current government policy, I stand a better than even chance of dying, with nothing more wrong with me than that I had chosen to be a model citizen and ingest the ruinous statins.
I wish to make it absolutely clear that killing people through ill-considered policies may well be an unavoidable act of government, especially where there are vital gaps in the collective knowledge of a nation. As there appears to be a wealth of evidence pointing to the harm that statins routinely cause, killing and incapacitating otherwise healthy people because of a wrongheaded policy, is clearly not permissible.
Such an act of government would be morally indefensible and it clearly impinges on Article 2 (everyone's life shall be protected by law) Article 3 (no one shall be subjected to torture or to inhuman or degrading treatment or punishment) Article 8 (everyone has the right to respect for his private and family life, his home and his correspondence) The Human Rights Act 1998.
I am horrified to learn that my GP is rewarded for following government policy that will surely result in harming me. The incentive is to prescribe, come what may. The responsibility will not rest with my GP but he will blame the government and claim to be just following orders.
The much vaunted independence of clinical judgement for clinicians, is merely an illusory device that fools medical doctors just as much as it beguiles the hapless observer. It is a foolhardy medic who will buck the trend because there will be no support in litigation cases. If NICE makes a pronouncement, there will not be any naysayers, among those who wish to remain employed, in any event.
I will conclude by informing you that the an article that cited the most recent issue of The Lancet, appeared in a Canadian publication at the following URL...
http://www.canada.com/nationalpost/news/story.html?id=12819fa1-26c8-47a4-b21e-b15c60383453&k=19786
The Lancet reference follows...
Are lipid-lowering guidelines evidence-based? Abramson J, Wright J
The Lancet - Vol. 369, Issue 9557, 20 January 2007, Pages 168-169
Thank you for your further email of 2 February to the Department of Health about statins.
I hope it is helpful if I first explain that the Customer Service Centre is an integral part of the Department of Health, staffed by civil servants.
The Centre has been set up to reply on behalf of Health Ministers to enquiries and correspondence from members of the public (letters, e-mails and telephone calls). It is managed by a Senior Civil Servant, and there is close liaison with Ministers on a daily basis.
Regarding statins, as stated in my previous email the National Institute for Health and Clinical Effectiveness (NICE) published a Health Technology Appraisal (HTA)on statins in January 2006. CVD covers a range of conditions, including coronary heart disease and stroke.
Cardiovascular Disease (CVD) is the single most common cause of death in the UK , as well as being responsible for a great deal of illness and poor quality of life. Raised cholesterol is one of the major modifiable risk factors for CVD, and statins are the principal pharmacological treatment for lowering cholesterol.
There have also been several major long term studies of the effectiveness of statins, so this was an important area for NICE to examine. This HTA took account of all available evidence and concluded that it was effective to intervene with statin therapy in patients who scored a 20 per cent or greater ten-year risk of developing cardiovascular disease, regardless of the starting cholesterol.
NICE is currently working on a guideline on lipid control, due for publication in September 2007, which is also looking at the issue of risk assessment. There is nothing more I can add regarding this matter.
This was another unsatisfactory reply so a new letter was sent...
Thank you for your reply to my formal request to have this matter placed before the Minister for Public Health. I do appreciate the point, which you have made, about a senior civil servant managing the Customer Service Centre; which you have stated to me is an integral part of the Department of Health.
There may well be daily liaison between the Minister and the Customer Services Department. I am sure that you will forgive me for re-iteratintg that my questions not only concern my own and the public health in a general way but the risk of very real harm to me and any other patients who are prescribed statins.
I have read all of the materials that you have referred to... and very much more besides, which was one of the original points that I had sought to make. If this medication is going to harm me personally (and a great deal of peer-reviewed evidence suggests that this is indeed the case) do you really think that I should await the pronouncement from NICE that will not be published until at least September 2007.
I have already indicated that there is a body of scientific and credible opinion that demonstrates that Framingham was more than a little flawed. If Framingham was used to underpin the HTA appraisal, which is a likely proposition because you have personally informed me that much of the UK statin policy is derived from Framingham, then those guidelines must be more than a little awry.
You have stated here, that there is nothing you can add to the matter, and I am acutely aware of that fact because that is precisely the issue which had prompted my formal request for this matter to be referred to the relevant Minister for Public Health.
I am not trying to score some frivolous point with you nor am I being needlessly vexatious for fun. As a healthcare professional, with a long and useful National Health Service career behind me, it is my considered opinion that it is an error to sweep this issue under the carpet, by ostensibly fobbing me off with whichever standard responses have been devised and provided by the Customer Service Department at the department of Health.
This is not a difficult issue but for the sake of clarity, I will reiterate the problems I am having so that you can understand why I believe that this is not a matter that is amenable to a pre-prepared response from the department.
1. Statins are often damaging to the patient. The following URL is instructive insofar as recording the truly harrowing tales of patients and their families while undergoing various forms of statin therapies...
http://www.spacedoc.net/board/
2. The damage caused by statins is under-reported because the general case has been that statins are very beneficial. I commend the URLs to you that were included in my initial communication and I (respectfully) suggest that the material contained at those sites is both read and digested, so that it may inform future policy.
3. I have no wish to take statins, for even one day, given my concerns and the vast wealth of medical and anecdotal evidence before me
4. Financially rewarding GPs, who meet the current government targets for lower cholesterol levels, is encouraging GPs to conclude that statin therapy is safe... indeed the prescription of statins has evidently become a meme within many quarters of the medical profession.
5. Recent trials on phase 3 clinical trials of statin compounds, have caused many unexplained and unexpected deaths and the trials were halted. Where is the global concomitant note of caution to all prescribers of statin therapy?
6. To paraphrase the venerable Florence Nightingale, who insisted that "hospitals should do the sick no harm", this is not good enough... it is right that the health service (contributed to by me since I had started work) should actively be doing the patient some good.
Florence Nightingale's imprecation was far too passive, in my own opinion, and required to be more active in seeking out what constituted good patient care. Bottom of that list would be failing to heed the signs seen in numerous patients and not listening to patients who can relate to the iatrogenic damage that follows statin prescriptions.
I need to be reassured that this particular set of issues has actually been passed to the Minister for Public Health so that I can be satisfied that the matter will receive urgent and appropriate executive attention. Accordingly, I am invoking the Freedom of Information Act 2000, including any subsequent amendments and corollaries.
I am now making a formal request to see all of the documentary evidence pertaining to my requests. The documentation should include all relevant internal e-mail messages, any records of internal telephone calls, any memoranda regarding the disposal of my questions and notes of conversations (about my requests) that have taken place between unnamed and various civil servants and Caroline Flint, the Minister for Public Health.
A reply was not received from the DoH until a complaint was made about the apparent lack of interest...
Having written to you on the 20th March, I would like to know if any progress has been made in respect of my formal complaint being investigated. Nearly four weeks has passed, without any communication from you, or your department, to inform me that my complaint was received and is being investigated. If this matter has been left to languish, deliberately, kindly have the common courtesy to tell me so that I may take the action that I deem to be appropriate in these circumstances.
The next day saw the arrival of this e-mail message from the DoH...
Thank you for your email of 18 February about previous correspondence regarding statins. Your email has been passed to me for reply under the terms of the Freedom of Information (FOI) Act 2000. You ask for all documentary evidence pertaining to the requests for information you have made to this Department.
The information is attached to this message (Annex A). Mr A has been spoken to about the inappropriate tone of one of his emails, which is not in keeping with the ethos of the Customer Service Centre.
As Mr A said in his previous reply, the National Institute for Health and Clinical Effectiveness (NICE) published a Health Technology Appraisal on statins in January 2006. This Appraisal took account of all available evidence and concluded that it was effective to intervene with statin therapy in patients who scored a 20 per cent or greater ten-year risk of developing cardiovascular disease, regardless of the starting cholesterol.
As Mr A also said, NICE is currently working on a guideline on lipid control, due for publication in September 2007, which is also looking at the issue of risk assessment.
If you are not happy with the way the Department has handled your enquiries and would like to register a formal complaint please write to or email Ms F, the Customer Service Centre’s Head of Knowledge Management, Public Enquiries and Complaints at the following addresses:
A formal complaint followed was sent to the DoH...
I would like to register a formal complaint with you anent the handling of my original correspondence. It is now evident from the two desultory scraps of information that were supplied to me under the Freedom of Information Act 2000 (FOI Act 2000) that the dialogue that had taken place between Mr A and Mr T, was extremely limited in scope.
It is difficult for me to follow what must have been the usual chain of events that followed an enquiry from a UK citizen, without knowing a little about how work is assigned and carried out within the customer service department of the Department of Health (DoH). Please forgive me if I have not fully grasped the implications carried by documentation which was sent to me by Mr F, under the terms of the FOI Act 2000.
As far as I can discern, my enquiries were not passed to the Minister for Public Health, despite my requests and in the face of the issues affecting the safety and good health of the public while notwithstanding that my own health and safety were also issues that required addressing. My first e-mail message contained a wealth of information that Mr A apparently chose to ignore. He had given me that impression because he did not address the conclusions reached by many members of the medical profession, which I had taken the time and trouble to provide to him with very clear reference citations. He certainly did not address any of my specific questions in my second e-mail message to him.
Mr A's reply had suggested to me that he was not seeking advice from any of his senior civil service colleagues before answering my list of concerns. Sadly, the information which I had requested, under the FOI Act 2000, was supplied as simple text files and the date has not been appended to either of the supplied documents, that were apparently internal communications from Mr A to Mr T, so it is impossible for me to put the communications into any useful chronological sequence. Any attempt by me to assess the chronology of events is likely to be pure guesswork.
The content of the text file: DE179454... videlicet
"Hi Alan, Here the case that prompted my clarication request on the statin line. Steve"
This communication suggests to me that Mr A was referring the second e-mail communication from me to him, to a third party, Mr T. It appears to be a referral on foot of Mr A requesting clarification (I have assumed that his spelling mistake was intended to read as 'clarification') about the DoH policy for statin prescriptions, but without a full and frank explanation of Mr A's conduct, I have little choice but to assume much.
The content of the text file: 182440... videlicet
"Hello Alan, I'm set to tell him to go away (in the nicest possible terms) but would be grateful if you could give it a quick glance. Cheers, Steve"
This text message from Mr A to Mr T, appears to be a reply to the clarification that was requested from Mr T and was mentioned in DE17945. It has the appearance of Mr A having made the decision to tell me to "go away" and requesting that Mr T give the reply to me, a "quick glance". The tenor is one that suggests that Mr A saw no fault with his conduct and apparently saw no difficulty in getting Mr T to agree to the content of the newly authored "go away" communique.
I have no preconceived notions about the working relationship between the two individuals, that are named in the text documents which were sent to me under the FOI Act 2000. They appear to be on good terms with each other and I see nothing of the master/servant relationship in Mr A's communications with Mr T.
Curiously, I also see nothing of Mr T's communications to Mr A, with respect to this issue and the lack of dates notwithstanding, I wish to know why this documentation has not been provided to me, within the very clear terms of the FOI Act 2000, which I have reluctantly had to invoke, in order to understand why my concerns were not dealt with appropriately.
I appreciate that there is a method to complain about the information supplied under the FOI Act 2000 and I will request an internal review from Ms M if I do not get to see all of the information that I have requested. It is clear that Mr T must have communicated with Mr A and that communication is relevant to my request. My question for you at this juncture is to ask you why the requested information has not been supplied?
The complaint that falls within your remit is the matter of your customer services employee, Mr A. He appeared to be arrogating the executive powers of the Minister of State for Public Health, to himself. I had guessed as much when reading his first reply and I had re-stated my concerns to him in my reply to his response to my concerns. I had specifically requested that my concerns be addressed to the Minister of State for Public Health.
It is my belief that the Minister is the only person who has the executive power to make adjustments to policies and to act in the best interests of the nation. Mr A had given me the impression, in his response to my second e-mail message that he was being more than obstructive, and what is worse is that he seemed to be actively engaged in preventing my e-mail communications from reaching the appropriate person. I don't hold Mr A responsible for his being ignorant of a subject that he clearly had never studied, to judge by his parroting the ill-considered conventional wisdom on statins. His crime was not to realise that his lack of knowledge was getting in the way of any objective dialogue. Not knowing is not a problem... not knowing when you don't know is a well-defined problem.
I gave most of my working life over to the work of the National Health Service and as a clinical specialist, I fully understand how national policies concerning public health are developed. I do not need to be lectured on what NICE are intending to do 6 months from now and neither do I need to be pointed to research that is deeply flawed and scientifically poor. I fully expect any civil servant, who is working within the customer services department of the DoH, to recognise when they are out of their depth and to ask for advice from a senior member of the service.
Mr A went as far as stating how the customer service centre was an integral part of the DoH and he referred to a "close liaison with Ministers on a daily basis". There has been no evidence provided to me that the issues which I had raised were discussed with the relevant minister. I now accept that fact on its face and I am left wondering why a serious issue has not been addressed to the relevant minister.
It is depressing to discover that the much vaunted, and oft touted 'open government' that we are supposed to enjoy in the UK, has no actual basis in reality. That a concerned individual can have their serious concerns lightly brushed aside by a minor civil servant acting as customer services operative (who has somehow managed to assume far more power than he is entitled to) is a sad reflection of the sorry state that the NHS has fallen into. The constant micro-managing of precious resources by people with a little or no understanding of what it takes to deliver health care to the nation, is deeply distressing.
I wish to know why my concerns were never addressed to Caroline Flint. I wish to know by what mechanism my concerns came to be disregarded. I wish to know by whose authority I was told to go away. I wish to know under which piece of legislation the citizenry of the UK are to be dealt with in such a cavalier fashion, by one of the servants of the people.
A month later another reply from the DoH was received...
Thank you for your email of 16 April about your formal complaint of 20 March regarding the Department of Health's handling of your correspondence. I understand that you also requested and internal review of your Freedom of Information request and you will receive a separate reply for this. I have been asked to investigate how the department treated your concerns about statins and reply.
Firstly, I would like to apologise again for the inapproriate tone and language in Mr A's email. All staff in the Customer Service Centre have been reminded about our standards and the need to treat all correspondents with respect. You ask why your concerns were never addressed to Caroline Flint, Minister of State for Public Health and whether the information you provided about possible adverse effects of statins was handled by a member of staff with no knowledge of the subject.
I hope it is helpful if I explain why the Department responded as it did. As you will appreciate, Ms Flint and the other Health Ministers receive a large amount of correspondence, and it is simply not possible for them to reply personally to every letter. The Department has established a Customer Service Centre to answer enquiries and submissions from the public and organisations, including the NHS, on their behalf, as Mr A explained in his reply to your second email of 2 February.
Customer Service Centre staff work closely with the Department's policy teams to ensure that the information they use is up to date and, in return, provide regular feedback to Ministers and policy teams on the issues and concerns that are being raised in correspondence. The Department's role is to set broad health and social care strategy for England and it devolves a considerable amount of responsibility for implementation to local NHS organisations. In making decisions and setting policy guidelines, Ministers take advice from policy specialists within the Department and draw on the expertise and knowledge of specialist organisations such as the National Institute for Health and Clinical Effectiveness (NICE).
Clinical decisions and care plans are made by clinical practitioners on the basis of clinical need using their knowledge, experience and the best possible evidence and in discussion with their patients. The Department expects clinicians to keep up-to-date with developing medical knowledge as part of their continuing professional development and assists with this by commissioning and publicising clinical evidence, for example via the National Library for Health (NLH).
This library can be viewed at www.library.nhs.uk/. The Department also provides evidence based patient information at www.nhsdirect.nhs.uk/. If you are unhappy with a decision or treatment made by a clinical practitioner treating you, you may wish to use the NHS complaints procedure. Details of this procedure can be found at www.nhsdirect.uk/england/aboutTheNHS/complainCompliment.csmx.
I am aware that your intention was to clarify whether statin tretament would have an adverse impact on your health and to draw the Department's attention to your concerns about this. I would like to explain a little more about how your correspondence was treated. Staff working in the Customer Service Centre are expected to respond promptly and accurately to all correspondence and to provide as much information as possible about the context of decisions made. I hope this explains why Mr A provided information about NICE work on statins and lipid control.
To answer enquiries and respond to submissions such as yours, Customer Service Centre staff have access to records of policy decisions, including the Government's current position on statins. When necessary, they also contact the Department's relevant policy specialist to check on any recent developments, for example the reports you quoted on adverse effects related to the use of statins, that might affect the accuracy of the Department's response.
This is normally done via email or telephone call and confirmed again on our correspondence system. In this case Mr A contacted Mr T, who works in the Department's Vascular Programme Directorate, which is headed by Professor Roger Boyle CBE, National Director for Heart Disease and Stroke, in order to clarify that the information he had was up-to-date. Unfortunately, his email request for information was couched in highly informal tones and I am sorry that this has provided the impression that the Customer Service Centre does not treat correspondence with the respect it deserves.
To summarise, Mr A was responding as requested on the Minister's behalf and correctly gave the most up-to-date account of the Government's current position on the use of statins, checking his response with the relevant policy specialists. He also explained that, in determining the Government's position, Health Ministers and the Department rely on expert assessments by specialist individuals and organisations, and the Department is currently awaiting the outcome of NICE's work on lipid control. NICE operates independently of the Department, and therefore I cannot say whether their experts are reviewing the articles your have quoted.
I have checked with Mr T and understand that there is no further recorded information relevant to your correspondence and FOI request. I understand that Mr T confirmed changes to Mr A's draft reply by telephone. I hope I have explained how your correspondence was handled and would like to repeat the apology offered above.
After this reply from the DoH, the following response was made...
(the response is in blue letters and italics)
Thank you for your email of 16 April about your formal complaint of 20 March regarding the Department of Health's handling of your correspondence. I understand that you also requested and internal review of your Freedom of Information request and you will receive a separate reply for this. I have been asked to investigate how the department treated your concerns about statins and reply.
Firstly, I would like to apologise again for the inapproriate tone and language in Mr A's email. All staff in the Customer Service Centre have been reminded about our standards and the need to treat all correspondents with respect. You ask why your concerns were never addressed to Caroline Flint, Minister of State for Public Health and whether the information you provided about possible adverse effects of statins was handled by a member of staff with no knowledge of the subject.
It is disappointing to find that you should be apologising to me in the first instance. I do thank you for the apology but it is shameful that you should have to provide me with an apology on behalf of one of your staff, who had failed to carry out the work to the standards that you would have expected and I would have liked to see. A little more 'civil' and a lot more 'service' would not have gone amiss. It is the very least which I would expect, in terms of the prevailing standards of decency, when members of the public are dealing with members of the Civil Service.
I was attempting to alert the Department of Health (the most appropriate agency for the government) to some potentially very serious hazards to public health. It was clear to me that Mr A had thought me some kind of madman and had pre-judged the issue to the point where he had decided to tell me to 'go away' albeit in a nice manner. By dint of whose authority (and which legislation) can a minor civil servant make a decision about matters that have implications for millions of people?
I hope it is helpful if I explain why the Department responded as it did. As you will appreciate, Ms Flint and the other Health Ministers receive a large amount of correspondence, and it is simply not possible for them to reply personally to every letter. The Department has established a Customer Service Centre to answer enquiries and submissions from the public and organisations, including the NHS, on their behalf, as Mr Atkinson explained in his reply to your second email of 2 February.
I had not asked for a personal reply. I was attempting to make the appropriate Minister aware of some significant issues relating to statin therapeutic solutions. I had only requested that the matter be placed before the Minister for Public Health. It was neither requested, nor was it necessary that I should have a dialogue with Caroline Flint. Making an appropriate person aware of facts and issues, that may be unknown to them, is a reasonable act in any democracy. Having my e-mail turned into some sort of private funny joke for the benefit of Messrs, A and T was not my intention, as would have been clear to any half-sensate adult, even to those who occupy positions of little responsibility.
The so-called Customer Service Centre is a misnomer. There was no service rendered to me and it is entirely wrong to label ill people as 'customers'. In a business environment it is doubtful that Mr A would have retained his position. As far as I can tell, there was no intention to pass my e-mail to The Minister and there was also no intention to discuss the matter with the Minister. I believe that no attempt was made to make Caroline Flint aware of the dialogue I was having with her inept proxy, Mr A.
Customer Service Centre staff work closely with the Department's policy teams to ensure that the information they use is up to date and, in return, provide regular feedback to Ministers and policy teams on the issues and concerns that are being raised in correspondence. The Department's role is to set broad health and social care strategy for England and it devolves a considerable amount of responsibility for implementation to local NHS organisations. In making decisions and setting policy guidelines, Ministers take advice from policy specialists within the Department and draw on the expertise and knowledge of specialist organisations such as the National Institute for Health and Clinical Effectiveness (NICE).
The regular feedback to Ministers would be very useful. I would like to know what is the frequency of this regular feedback. If Mr A's contact with Mr T was typical of the Customer Service Section working closely with one of the Department's Policy Teams, then words fail me. Permit me to remind you of the written evidence (as supplied to me under the Freedom of Information Act 2000, and this was apparently the only evidence in existence) of the close working relationship between the Customer Services Department, Mr A and the Policy Team Member, Mr T...
The content of the text file: DE179454... videlicet
"Hi Alan,
Here the case that prompted my clarication request on the statin line
Steve"
The content of the text file: 182440... videlicet
"Hello Alan,
I'm set to tell him to go away (in the nicest possible terms) but would be grateful if you could give it a quick glance.
Cheers
Steve"
I would have to say that this informal exchange does not pass muster as the evidence of one section working closely with another, within the same organisation. Rather... it appears to be an informal chat (with very little of the actual work being allowed to intrude on the obviously friendly relationship) between these two employees.
On the basis of this exchange, it is stretching the boundaries of reality to cite this particular evidence; as an example of the close working relationship between two sections of the Department. It is merely an unproductive exchange between two employees, who appear to be intent on taking the opportunity to idle away some time.
Clinical decisions and care plans are made by clinical practitioners on the basis of clinical need using their knowledge, experience and the best possible evidence and in discussion with their patients. The Department expects clinicians to keep up-to-date with developing medical knowledge as part of their continuing professional development and assists with this by commissioning and publicising clinical evidence, for example via the National Library for Health (NLH). This library can be viewed at www.library.nhs.uk/. The Department also provides evidence based patient information at www.nhsdirect.nhs.uk/. If you are unhappy with a decision or treatment made by a clinical practitioner treating you, you may wish to use the NHS complaints procedure. Details of this procedure can be found at www.nhsdirect.uk/england/aboutTheNHS/complainCompliment.csmx.
I beg to differ. Clinical decisions and care plans are made by clinical practitioners on the basis of clinical need (and in the case of General Practitioners) their contract of employment (now including QOF criteria) and the needs of the government as expressed through National Guidelines in written policies and soon too be those expressed by NICE, who appear to have changed their name from the National Institute for Clinical Excellence (suggesting a search for excellence in clinical practice) to the more pedestrian sounding National Institute for Health and Clinical Effectiveness. (suggesting that their much vaunted independence has been lost and they are now a formally incorporated arm of the executive). Indeed, the National Policy on Statins mentions on page 23, that in 2007, after NICE have reported on statins, that their guidelines will be the ones that will be followed nationally.
As for complaining about my GP, what use will that be? He was only following government's imprecations and because he is human, I presume that the additional QOF points are sufficient inducement to prescribe me a medication that I must take for life, irrespective of any risks that may bring to me. I understood from Mr A that the UK's national guidelines on statin therapy, are based on the often cited Framingham study. More than 22 years of data was gathered from that particular community. The conclusion was that high cholesterol was a significant factor in causing heart disease.
Last night, I had discovered a newspaper clipping from Framingham. It is taken from 'The News, Framingham-Natick' and dated October 30th 1970. It is headed "Findings of the Framingham Diet Study Clarified".
"Although there is no discernible relationship between reported diet intake and serum cholesterol levels in the Framingham Diet study group, it is incorrect to interpret this finding to mean that diet has no connection with blood cholesterol", Dr William B Kannel, director of the Framingham heart study has stated.
That was from the director of the Framingham study! I put it to you, Ms Fraser, that if there was no discernible relationship been reported diet intake and serum cholesterol, after testing the citizens of Framingham for 22 years, then regardless of what Dr Kannel wanted to think, that relationship could not have existed. The clipping goes on to reveal more of this psuedo-scientific claptrap, that even my 7 year old son would have no difficulty in seeing the flaws of reasoning.
Should you be inclined to take this matter more seriously than Mr A, at your request, I will be happy to forward you a copy of the clipping, with my own typed transcription of the faded text. I am seriously trying to alert the Department of Health (generally) and the Minister for Public Health (specifically) that the whole Cholesterol Hyposthesis is wrongheaded and to keep lowering cholesterol levels and raising statin prescriptions is an ill-considered policy that will bring harm and havoc to the lives of millions.
I am aware that your intention was to clarify whether statin treatment would have an adverse impact on your health and to draw the Department's attention to your concerns about this. I would like to explain a little more about how your correspondence was treated. Staff working in the Customer Service Centre are expected to respond promptly and accurately to all correspondence and to provide as much information as possible about the context of decisions made. I hope this explains why Mr A provided information about NICE work on statins and lipid control.
If this was just about me and my health, I would say, "fair enough", that is life and I would just get on with making decisions for myself. As a citizen of the UK, I have a duty to act responsibly and... I should also have a care to my fellow citizens and my country. It misses the point to see these concerns as exclusively mine and concerning just my health. I am more than able to care for my own health and I do not need the guidance of medical practitioners, who appear to be lining their own pockets with QOF money, to tell me how to live. Mr A responded, as I had expected when I first opened the dialogue with the Department. His second response was not the response of a responsible person. You may well judge that he followed the Departmental diktat to the letter, but he did not act responsibly.
To answer enquiries and respond to submissions such as yours, Customer Service Centre staff have access to records of policy decisions, including the Government's current position on statins. When necessary, they also contact the Department's relevant policy specialist to check on any recent developments, for example the reports you quoted on adverse effects related to the use of statins, that might affect the accuracy of the Department's response.
What you say, Ms F, sounds and reads as utterly reasonable. In the face of being told to 'go away' by Mr A, I submit that a substantial procedural irregularity must have ensued.
This is normally done via email or telephone call and confirmed again on our correspondence system. In this case Mr A contacted Mr T, who works in the Department's Vascular Programme Directorate, which is headed by Professor Roger Boyle CBE, National Director for Heart Disease and Stroke, in order to clarify that the information he had was up-to-date. Unfortunately, his email request for information was couched in highly informal tones and I am sorry that this has provided the impression that the Customer Service Centre does not treat correspondence with the respect it deserves.
It would be tedious for you, Ms F, if I were to repeat what I have already said above. Suffice it to say that I am no nearer to having my concerns heard by the Minister of State for Public Health. I had written to Caroline Flint, initially, on January 21st and if I was writing to advise the Department of some terrible new fatal condition that was contagious, it would appear that it would have been useless. I am no further forward now than I was when I had first written to the Minister. I find that to be a lamentable and rather tardy state of affairs.
To summarise, Mr A was responding as requested on the Minister's behalf and correctly gave the most up-to-date account of the Government's current position on the use of statins, checking his response with the relevant policy specialists. He also explained that, in determining the Government's position, Health Ministers and the Department rely on expert assessments by specialist individuals and organisations, and the Department is currently awaiting the outcome of NICE's work on lipid control. NICE operates independently of the Department, and therefore I cannot say whether their experts are reviewing the articles you have quoted.
In other words, Mr A made the decision to tell me to 'go away' because he was aware that the Department were awaiting the outcome of the NICE report on lipid control and because that was due to be published in December 2007, he saw no reason for any material to be passed to the Minister for Public Health and accordingly, Mr A thought that he could tell me to 'go away' with impunity. I am astonished that the Department of Health would tolerate such a lacklustre and egregious performance from a member of its own permanent staff.
I have checked with Mr T and understand that there is no further recorded information relevant to your correspondence and FOI request. I understand that Mr T confirmed changes to Mr A's draft reply by telephone. I hope I have explained how your correspondence was handled and would like to repeat the apology offered above.
Thank you for your apology. I understand that nothing further has been recorded. It is to be expected and it confirms that my communication was not taken seriously by Mr A, Mr T or the Department of Health. I have tried my level best to inform the most appropriate people that statins are a disaster that is happening now. The prescription of statins has reached epidemic proportions and, speaking in general terms, they are not helping the people who are receiving them.
The population of the UK are in a unique situation in that health care is provided for free, at the point of delivery. With that service comes the issue of accepting and trusting what the assigned medical personnel have to to say and do. We have no option but to trust the medics and the government and in this particular case the authorities have got it wildly wrong.
[1] FDA Statement - Pfizer phase 3 clinical trial, December 3rd 2006
A response from the DoH will be added to this page, if they reply.
