Making sense out of nonsense - very long post

[xrn]

I had written a letter to the Minsiter for Public Health in the UK. A reply was received today from the customer services centre. I have chosen to reproduce my letter and the reply in full. All comments are welcome and you will note that the UK bases most of its risk assessment tools on the discredited Framingham prediction equations. Can anyone make any sense out of this nonsense?

To Caroline Flint, Minister of State for Public Health.

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 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.

[http://www.fda.gov/bbs/topics/NEWS/2006/NEW01514.html]
[http://mediaroom.pfizer.com/index.php?s=press_releases&item=130]


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 reply...

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.

[Biologist]

xrn,

Excellent job of putting them on notice. They cannot claim in the future they were caught "completely unaware" of the real issues with statins drugs.

Not true.

Also, I wish I had been as vigilant six years ago as you were recently -- and had never taken statins in the first place. I always read the inserts on my other drugs over that time period including Rhinocort (sinuses) and Ambien (sleep aid), etc., but what need for the "Ultra-Safe Wonder Drug of the Century"? Even if I had read it (and maybe I did), there surely was insufficient warning to counter the all assurances from the full force of the Worldwide Medical Establishment.

They sure got me. Completely unaware.

Very true.

A follow up to them might read in part:

"Thank you for your response to my recent Formal
Inquiry. Both letters are now posted on the website
www.Spacedoc.net for the benefit of all others, and
for future reference."

Your work could make a difference. That's how it works sometimes.

Biologist

[xrn]

[quote="Biologist"]xrn,

Excellent job of putting them on notice. They cannot claim in the future they were caught "completely unaware" of the real issues with statins drugs.
[/quote]

Thank you.

My reply follows...

Your reference: DE00000179454

Dear Mr Atkinson,
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 member's 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 unnecessary 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

[Biologist]

Great work!

(Notice I didn't say "Nice work")

That NICE is just too comically Orwellian for belief.

It's gotta be some British sense of humor thing going on, or something.

[http://en.wikipedia.org/wiki/Orwellian]

Biologist

[xrn]

[quote="Biologist"]Great work!

(Notice I didn't say "Nice work")

That NICE is just too comically Orwellian for belief.

It's gotta be some British sense of humor thing going on, or something.

[http://en.wikipedia.org/wiki/Orwellian]

Biologist[/quote]

The British sense of humour is, indeed, very well developed and oftentimes it can be both subtle and satirical. It serves to lighten the burden imposed by governments... that seemingly have long forgotten that they have a mandate to wield authority, on behalf of the populace who put them there.

It would not be appropriate to extract humour from the deadly policies of the government, save to expose the crass stupidity and indolence that has attended statin therapy to a wider audience. George Orwell was an accurate and prescient forecaster of life beyond his death.

The vision is of Newspeak and 1984 being alive and well in the UK today. The following URL shows just one appalling example from an advertsing campaign that was mounted by the Mayor of London in 2002. It was used to support the installation of CCTV cameras that were used to record the exit and entry of motorists into a part of London, so that they could be charged the congestion tax.

The ministry of truth is firmly with us in the case of statin therapy.

[http://www.signs-of-the-times.org/signs/pods/watchful_eyes.jpg]

[xrn]

Below is the disappointing response from the Department of Health...

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.

********************************************************

my response follows...

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 whiler 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.

[adec]

That was certainly lengthy all right. Xrn, I certainly admire and greatly appreciate what you're trying to do here. But after a long tiring year, I now realize what a huge monolithic and virtually impenetrable structure we're up against. They're not going anyone stop their multi-billion dollar statin operation without a huge battle. And there are so MANY of *them,* and so FEW of us.

I actually believe you'd be better off trying to educate them about how statins should never be administered without CoQ10, and the deleterious effects of said CoQ10 depletion. Your respected and credible sources could be Merck's own United States Patent (#4933165) demonstrating that statins indeed deplete CoQ10, which in-turn can also lead to myopathy. There's also a similar warning in the Canadian New England Journal of Medicine, about both Coq10 depletion and a dangerous increase in Lp(a) levels. I've uploaded the image from the NEJM to Imageshack, as to be of use to all. I've linked both of these things for you below. Good luck, and by all means keep us updated.

[http://img259.imageshack.us/img259/4706/statinslx8.jpg]

[http://patft1.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PALL&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.htm&r=1&f=G&l=50&s1=4933165.PN.&OS=PN/4933165&RS=PN/4933165]

[Dee]

xrn...excellent work you are doing.

adec:

I would have to disagree with your statement "And there are so MANY of *them,* and so FEW of us." The problem with statins is that there are SO MANY of us, regardless of how many of "them" we are up against.

As for Q10 depletion, while I totally understand what you are saying, I believe there are many "unknown and not yet understood" ways in which statins cause damage, Q10 depletion being just one way out of an unknown number of ways. For instance, I posted a topic under "Statins" on this forum "Mitochondria, CoA, Carnitine", because I think that may be another possible pathway that is interrupted by statins, explaining the apparent mitochondria damage that statins cause in some of us.

As for Q10...I have read many posts that indicate Q10 supplementation does not "fix" many of us after the damage has been done (it did nothing for me). Also some have reported taking Q10 from the beginning of statin use, and still had problems.

I would hate for the powers that be to think that simply adding Q10 to the regimen would solve the problems created by statins. I truly believe that the statin problem is way deeper than that, unfortunately.

I do understand your frustration with everything in your statement "But after a long tiring year, I now realize what a huge monolithic and virtually impenetrable structure we're up against." I agree with you SO MUCH on that one.

You know, it seems like if other medications cause so much as a zit, there are warnings all over the place....why is no one paying attention to the disability and deadly effects caused by statins?

[xrn]

adec: That was certainly lengthy all right. Xrn, I certainly admire and greatly appreciate what you're trying to do here.

xrn: Thank you.

adec: But after a long tiring year, I now realize what a huge monolithic and virtually impenetrable structure we're up against. They're not going anyone stop their multi-billion dollar statin operation without a huge battle. And there are so MANY of *them,* and so FEW of us.

xrn: There are far more statin users than pharmaceutical companies. The multi-billion dollar statin gravy train is what has made for the apparently inpenetrable structure. Anything that men build can be torn down.

adec: I actually believe you'd be better off trying to educate them about how statins should never be administered without CoQ10, and the deleterious effects of said CoQ10 depletion.

xrn: In my view this would be a monumental mistake. It is not my role (nor my wish) to educate drug manufacturing companies in the methods required to make unsafe statin Rx acceptable to me. If the pharmaceutical companies were to add every single product (from CoQ10 to omega 3 oil) to all statin products, I would have difficulty in accepting their altruism.

The fundamental mindset, that underpins the wholesale (and indiscriminate) prescription of statin thereapies is based on poor science and misconceptions and Mammon. The steamroller (that represents statin 'therapy') is difficult to halt if you accept that there is even a remote possibility that the medication may be beneficial to some people... and the drug companies have milked this particualr cash cow for all it has been worth... and then some!

I would refer you, adec, to Pfizer's phase 3 clinical trial that was halted in December 2006 because it was causally linked to unexpected and unexplained deaths in patients, by an independent monitor. Statins have been marketed for a considerable time and one could be excused for thinking that all of the little problems of statin usage were understood and ironed out at this stage.

It should not need stating that death is a 'little' problem that cannot be resolved. How in the name of all that's good, can a drug that has been marketed to millions (and one that has had the benefit of years of production and refinement) still have death as an unwanted consequence of its use?

The drug companies need to be reigned in... not encouraged to gives us more drugs to correct the problems that were caused by their drugs in the first place! I would suggest that the starting place is to call for a global moratorium on every statin Rx and a TRULY INDEPENDENT (both politically and commercially) investigation into the risks of statin use.

Furthermore, I would absolutely prohibit pharmaceutical company input into ANY clinical research either in the financial or the clinical spheres. The research into disease amelioration using pharmaceutical substances, should be initiated, supervised and run purely by clinicians with recognised qualifications for conducting clinical research at a high standard and specialising in the clinical area under review.

There can be no case for the vested interest of drug company money... directing research and publishing its beneficial findings (that require expensive drugs that the pharmaceutical industry is testing so as to establish their clinical value) while burying (or hiding) knowledge of adverse reactions. Any half-sensate being will see the potential for abuse, in that cosy little arrangement.

As for not having a voice... I can empathise with that point of view but there are only solutions. Insoluble problems do not exist. It is my intention to make the responsible individuals, within the UK government, actually take on the responsibility that goes with the fine title, the large pay packet and the status of being a government minister.

This is an essential and preliminary step to getting wider publicity. Before one can complain, it is incumbent on the plaintiff to show that all grivance procedures were followed (and exhausted) and that the plaintiff had utilised every available procedure for resolution... before escalating the issue to another level. While the current responses to my concerns are disappointing, I recognise that these are just opening salvoes in what will undoubtedly prove to be a long campaign.

For now, I have established a dialogue (albeit by proxy) with the relevant government department. Now they (the Ministry for Publich Health within the wider Department of Health) will not be able to deny any knowledge of my concerns, at a later date. I am also not prepared to received any more anodyne and pre-digested bits of information that do nothing to acknowledge or address my concerns nor do they allay my fears. My post to this forum are merely another single brick in the creation of a clear audit trail. THis is a long haul issue and I am in it for the long haul. I hope to encourage other forum members to participate in similar self-initiated campaigns.

Kind regards,
xrn

[Brian C.]

Good strategy xrn

Brian.

[Dee]

xrn, a few comments for you.

First, THANK YOU!

So many of us with statin damage (or caring for someone with statin damage) just do not have the energy or stamina to fight for ourselves or our loved ones. It is SO nice to see someone who cares enough to raise a ruckus that has not even had statin damage.

Also, what you are doing will eventually help us here in the U.S. Many times it has been a red flag raised in the UK that has finally gotten our own pathetic FDA off their hind ends to address problem drugs.

It has been said that we are fighting a rich and corrupt foe. Well, money is only money, it cannot cover up the truth forever. It did not stop Dr. Graveline from publishing his books, it has not stopped newspaper and magazines from telling some statin damage stories. Money has not stopped us from gathering in many places online.

Thanks again for your kindness in sharing your knowledge, intelligence and writing skills with us. I sincerely appreciate your efforts!

[Biologist]

DITTO.

Biologist

[adec]

Sometimes it feels as if I'm swimming upstream, even in this very forum. But I'm going to further answer this tomorrow. I really think it deserves a truly thoughtful and coherent reply.

[xrn]

Brian:
Doing something is always better than doing nothing, in my opinion, and having considered my strategy, I now have a direction in which to travel and a means of getting to my destination. I am certain to modify that direction as obstacles are either presented or circumvented but for now... keeping an aim in mind is the method by which I can assess my progress.

My aim is to have excessively louche (and morally indefensible) statin prescribing, including statin usage and statin related damage, placed firmly on the agenda in any discussions that concern public health in the UK. My dismay at being proferred the standard government brick wall, in response to my questions, is substantially tempered by the knowledge that all officialdom in the UK is beset by paranoia and irrational secrecy and I had expected no more than I have received; thus far.

I believe that the minor officials at the Department of Health, who have been chosen to reply to my concerns, will ultimately be incapable of dealing with my persistent requests and will escalate the matter to a more senior official. The nature of the beast, that is British government policy and conduct, is often amenable to repeated requests because foot soldiers have no power to make decisions.

It is clear that my requests fall far outside of the sphere of operations that my respondent can personally affect and he must now pass the matter to a higher official, for consideration. The Freedom of Information Act 2000 is still a frightening prospect for ill-performing government departments and officials that do not work to the civilised world's commonly accepted standards of efficiency, morality and decency. Having now invoked the FOI act... the individual with whom I have been corresponding only has two alternatives from which to make his decision. He can ignore my request and close the correspondence... only to become the recipient of further correspondence by way of complaint under the relevant legislation or he can wash his hands of a responsibility, which is not rightfully his own in the first instance, and inform a senior member of staff. Either way, I will not permit the issues to slip under the radar of the Department of Health.

Administrative decisions by the executive, within the bicameral system of government that is used within the UK, are all subject to judicial revue. I am not unfamiliar with the workings of our legal system and I believe that initiating the case for judicial revue is unlikely to present much of an obstacle. The dialogue that I have opened with the Department of Health has to conclude with a reasonable endpoint. I suspect that my concerns have not yet reached the eyes of the minister responsible for public health and that is unacceptable... from a democratic government. I am concerned by the obfuscation that I have witnessed and I require reasonable answers to my concerns. If I cannot be given the response which my concerns deserve in one way, then I will extract that response in any of the other ways that I am lawfully permitted and able to follow.

Dee:
So many of us with statin damage (or caring for someone with statin damage) just do not have the energy or stamina to fight for ourselves or our loved ones. It is SO nice to see someone who cares enough to raise a ruckus that has not even had statin damage.

xrn:
Dee, I could no more undo the years of my training and clinical practice; during which my work was always underpinned by the search for excellence while living up to an explicit moral and ethical code... than I could fly to the stars. If I were still providing healthcare to people who were suffering from an illness, it would be my bounden duty to be an advocate for those people with insufficient understanding of the issues surrounding their healthcare and no voice. I have yet not lost the habit despite no longer working to provide acute healthcare to people who are unwell.

Dee: Also, what you are doing will eventually help us here in the U.S. Many times it has been a red flag raised in the UK that has finally gotten our own pathetic FDA off their hind ends to address problem drugs.

xrn:
My sense of what is happening with the official bodies which are concerned with public safety is this: Statin therapy has come to be known as a 'good thing'â„¢ and so the widespread Rx for statins is widely accepted. Breaking the intertia of decision-making bodies such as the FDA seems, on its face, to be an uphill task. There is a tipping point that, once reached, will alter the perception about statin treatment and safety.

I suspect that a truly independent assessment of all every bit of currently available evidence is likely to be the tipping point in this issue. Once it has been reached, there will be no going back and the statin group of drug therapies will be acknowledged as harmful to health. The risk/benefit equasion will have to be re-calculated and the ancient (in a medical historical context) Framingham study, will probably be dropped as the guiding light for initiating statin therapy... in the face of further and better evidence.

Dee:
It has been said that we are fighting a rich and corrupt foe. Well, money is only money, it cannot cover up the truth forever. It did not stop Dr. Graveline from publishing his books, it has not stopped newspaper and magazines from telling some statin damage stories. Money has not stopped us from gathering in many places online.

xrn:
The usefulness of the internet cannot be under-estimated. Information is power and knowledge is the means to wield that power. A recent government proposal in the UK (for a completely unrelated issue) was met by more than a million and a half signatures delivered online within a week. The government is now on the back foot, with respect to the issue, having acknowledged that there is clearly a large body of public opinion that they had not considered when framing proposals for a new wheeze to deprive the hapless and long-suffering citizens of the UK of yet more money, while imposing draconian restrictions. (you can read this as a million and a half voters whom the government did not want to annoy... before the forthcoming general elections)

Dee:
Thanks again for your kindness in sharing your knowledge, intelligence and writing skills with us. I sincerely appreciate your efforts!

xrn: Thank you for your kind comments:

Biologist:
Thank you for echoing Dee's comments. Making any impact in on what, initially, appeared to me to be the natural inertia and indolence of government and current clinical opinion... is not a short term task. The feedback from members of this forum is a useful guide for me and is sufficient incentive to keep my nose to the wheel. My ethical stance (as a healthcare worker) was never to let faulty administrative decisions deflect me from seeking to bring common-sense and compassion to all of my work.

For me... it was always the patient that was the raison d'être for my being involved with healthcare provision in the first place. I no longer work within an acute healthcare provision environment and I feel incensed on behalf of the people who have related such awful tales here. I feel angry that my own medical practitioner cannot be honest with me nor can he address my sincerely put questions, ergo, the situation has to be dealt with.

Kind regards to all,
xrn

[Brian C.]

xrn

With today's "news" that drug companies have been overcharging the NHS (Good Lord!! Really???) perhaps the climate in govt may now favour consideration of evidence of reckless over-prescribing.
Perhaps....

Brian.

[xrn]

[quote="Brian C."]xrn

With today's "news" that drug companies have been overcharging the NHS (Good Lord!! Really???) perhaps the climate in govt may now favour consideration of evidence of reckless over-prescribing.
Perhaps....

Brian.[/quote]



One is suprised, isn't one? I doubt it will have any impact on the way that drug companies operate in the UK. This is old news and we have been here many times in the past (see my URL below that refers to a paper that was written in 1999. You should note just how long the various drug companies have been deliberately non-compliant with the relevant legislation)

I can recall when Hoffman La Roche Ltd., were found to have overcharged the UK government to the tune of millions of pounds... for the first generation benzodiazepine known as chlordiazepoxide (Librium) referenced in the document looking at benzodiazepine dependency at the following URL...

[http://www.parliament.the-stationery-office.co.uk/pa/cm199899/cmselect/cmhealth/549/99072723.htm]

What follows is an excerpt from paragraph 21 but the rest of this document makes for rather sorry reading and shows the pharmaceutical industry to have acted in breach of the law on rather too many occasions. viz.

21. The pharmaceutical industry has a long history of convictions for illegal activities on a world wide basis. In 1950, Hoffman La Roche were convicted in the USA of failure to warn of the hazards of a drug. As a result of a Department of Health initiative a Monopolies Commission in 1973 into un-competitive practices and profiteering by Roche Products Ltd resulted in the payments of several million pounds to the UK Government. Very recently (May 1999) Roche has been fined $500 million in the USA for a global price fixing conspiracy.

When caught red-handed, Roche handed back their ill-gotten gains but the very next day, they increased the price of Librium by 100%.

Plus ca change...

Kind regards,
xrn

[Brian C.]

"Plus ca change... "

Indeed

And so it goes.

Just come back from chelation therapy clinic where I sat next to a racing driver who was told he would have to have a triple bypass 20 years ago. He elected to pay for chelation and is still racing. Total cost of 20 years chelation probably a fraction of that of bypass surgery.
I asked him if he was on Lipitor.
He is and is suffering muscle pains....another "surprise"
Mind you, he has been "reassembled" a few times
I'll be seeing him again next week.

Brian.

[cjbrooksjc]

BrianC: Tell me, please, how chelation therapy helps with the effects of statin drugs. I know what chelation is, but what is being removed during the chelation process?

Thanks,
Brooks

[Brian C.]

Hello Brooks, the chelation is not for amelioration of the effects of statins but to reduce arterial plaque by removing the calcium deposits. It is the only thing that has reduced my atherosclerosis. Years of "low cholesterol" have done nothing to that end in spite of early hopes that statins would help reverse the build-up of plaque.
Of course, now we know better than to believe the hype.

Brian.

[cjbrooksjc]

BrianC: Thanks for your prompt reply. Yes. that makes perfect sense to me. I thought I was on to some sort of breakthru cure. Ratz!

Regards,

Brooks