More Bad News. :((((((

[jayemcee]

The global petition revealed that ALS was found among 5 statin takers in the 100 self-reported cases, which I had analysed. The sample was drawn from 259 people, of which some had not made any comments. There are now and additional 41 signatures (to 300 cases) and 2 more people have reported that they have developed ALS.

That makes a total of 7 people in 300 who have reported ALS. Lipitor was the statin taken in 5 of them. Please tell your friends and relatives never to take statins and please direct them to the global petition to sign against statin use.

The petition can be found here...
http://www.gopetition.com/online/11757.html

Thank you.
jmc

[sherry0459]

I started taking Crestor befors my systoms...HUM? sherry

[geehdee]

I was diagnosed with ALS after a few years on Lipitor. Not sure of the connection but am irritated with my PC for telling me "it's completely safe...I take it everyday myself!"

[Clbrink]

I am also leery of all the "medications" that are prescribed so liberally, and the unknown side effects.

But numbers can be deceiving, when you look at the stats, they are not always directly comparable.

Estimates suggest that ALS is responsible for as many as five of every 100,000 deaths in people aged 20 or older. ALS is most common among persons over age 60.

Most people who develop ALS are between the ages of 40 and 70, although the disease can occur at a younger age.

The Majority of people on Statins are in the age group where ALS appears. ALS statistics are based on the whole population, so one must narrow the numbers to the same age group and compare at that point.

Tina

[jayemcee]

I am also leery of all the "medications" that are prescribed so liberally, and the unknown side effects.

But numbers can be deceiving, when you look at the stats, they are not always directly comparable.

Estimates suggest that ALS is responsible for as many as five of every 100,000 deaths in people aged 20 or older. ALS is most common among persons over age 60.

Most people who develop ALS are between the ages of 40 and 70, although the disease can occur at a younger age.

The Majority of people on Statins are in the age group where ALS appears. ALS statistics are based on the whole population, so one must narrow the numbers to the same age group and compare at that point.

Tina

Hmmm... I now have 8 cases in 308 reports and 6 people were taking Lipitor.

Probability = 1 divided by (50,000^8) = 2.56 × 10-38

0.00000000000000000000000000000000000002 6

that is probability of finding 8 cases reported in 308 case reports, gioven an incidence of 1:50,000

[Thumbs Up]

This is scary, I have been on Lipitor for years. I am still trying to get the info to my sister's Dr in Bancroft. I don't know how to cut & paste. I am trying to figure out how you guys do the post and ad in blue to websites that you are refering to. I am also trying to have my neighbour print off the info so I can pass it on to my doctor because with him it has to be mailed or dropped off. I think in the meantime I better stop taking Lipitor.

[patricia1]

There Are So Many People On Statins That It Will Be So Hard To Prove. I Dont Think Statins Cause Als I Know The Side Effects Are Muscle Weakness But Thats Not Als. I Stopped My Staten Too Because I Dont Trust The Pharacuticals And My Neuro Isnt Happy. She Said A Stroke Would Be A Horrible Thing On Top Of Having Als My Lipids Are In The 300 Hundreds Pat1

[Al]

My Neuro tol me to get off the statins. I take Ezetrol now. It just eliminates the cholesterol you eat not the stuff your body makes. Not great but better than the statins. I've been taking Lipitor for at least 10-12 years.
AL.

[pldo]

My GP told me that I had high cholesterol but that statens were worse then having high cholesterol. She said that they can have horrible side effects not only on you, but also if you accidently get pregnant (know that this does not relate to the guys out there) they can have dire consequences to a fetus- if that is the case why would they prescribe these?

[jayemcee]

This is scary, I have been on Lipitor for years. I am still trying to get the info to my sister's Dr in Bancroft. I don't know how to cut & paste. I am trying to figure out how you guys do the post and ad in blue to websites that you are refering to. I am also trying to have my neighbour print off the info so I can pass it on to my doctor because with him it has to be mailed or dropped off. I think in the meantime I better stop taking Lipitor.

Norma: if you e-mail me at webmaster(at)talkingstatins(dot)com [remove the brackets and substitute @ for at and . for dot and make sure there are no spaces] and I will send you a pdf document of both the comments for the global petition and the analysis.

statins have not been shown to bestow any benefit on women, either for prinary prevention or secondary prevention. No woman should be taking statins. These are highly toxic preparations that mess with the body's ability to derive energy from food. When cells cannot get enough energy, the die.

It is called programmed cell death (apoptosis) and statins interfere with the production of Heme A in the mevalonate metabolic pathway (MMP), which is only found in the mitochondria of cells and is responsible for converting food into energy for the cell.

I can point you to a huge number of seriously abstruse and highly technical medical papers on the subject, if your doctor needs convincing. For now, just look at this illustration of the MMP. You will see how high up in the pathway statins are introduced (brown text). You will also see that all of the essential processes for cellular life (green text) are inhibited by statins because they are below the point where statins are introduced.

Mevalonate Metabolic pathway illustration here:
Oh dear, I seem to be experiencing a DOS issue... I will post the image soon. Alternatively, just e-mail me for it and I will happily send it.

Lowering cholesterol will not stop you getting heart disease. The heart is a muscle and statins weaken muscle. Statins also inhibit cholesterol production and cholesterol is need to produce the myelin sheath that protects all nerve fibres. My cholesterol has been 8.5 for all of my life and I utterly refuse to take statins. The latest research suggests that statins are implicate din ALS development.

I now have 310 signatories to the petition and there are another two people in the last 10 signatures, who have developed ALS. Six out of 9 admit to taking Lipitor. Epidemiologists will say that globally, ALS will affect 2 people per 100,000 (1:50,000) and I see 9 people affected in 310 case reports. Statistical acrobatics aside, I should collect 450,000 signatures before seeing this many people complaining of ALS. Clever statisticians will find a million excuses as to why I am wrong about this number.

I say to them that 9 cases of ALS out of 310 statin takers is a huge problem and only if you were blind, deaf and dumb as well as living on Pluto, could you fail to see it. I am writing to the FDA with my concerns. They have just turned down another application (from Merck) for statins to be made available as an over the counter medicine in the USA. Read about it here:
http://blogs.wsj.com/health/2007/12/13/fda-calls-for-research-on-lou-gehrigs-statin-link/

Please add your comments.
jmc

[jayemcee]

My Neuro tol me to get off the statins. I take Ezetrol now. It just eliminates the cholesterol you eat not the stuff your body makes. Not great but better than the statins. I've been taking Lipitor for at least 10-12 years.
AL.

Low cholesterol is undesirable, Al. statins are also undesirable. Here is a copy of something that I am unable to link to just yet...

jmc

Statins, Neuromuscular Degenerative Disease and an Amyotrophic Lateral Sclerosis-Like Syndrome: An Analysis of Individual Case Safety Reports from Vigibase.
Short Communication

Drug Safety. 30(6):515-525, 2007.
Edwards, I Ralph; Star, Kristina; Kiuru, Anne
Abstract:
Background: The WHO Foundation Collaborating Centre for International Drug Monitoring (Uppsala Monitoring Centre [UMC]) has received many individual case safety reports (ICSRs) associating HMG-CoA reductase inhibitor drug (statin) use with the occurrence of muscle damage, including rhabdomyolysis, and also peripheral neuropathy. A new signal has now appeared of disproportionally high reporting of upper motor neurone lesions.

Aim and Scope: The aim of this paper is to present the upper motor neurone lesion cases, with other evidence, as a signal of a relationship between statins and an amyotrophic lateral sclerosis (ALS)-like syndrome. The paper also presents some arguments for considering that a spectrum of severe neuromuscular damage may be associated with statin use, albeit rarely. The paper does not do more than raise the signal for further work and analysis of what must be regarded as a potentially very serious and perhaps avoidable or reversible adverse reaction, though it also suggests action to be taken if an ALS-like syndrome should occur in a patient using statins.

Methods: The 43 reports accounting for the disproportional reports in Vigibase (the database of the WHO Programme for International Drug Monitoring) are summarised and analysed for the diagnosis of an ALS-like syndrome. The issues of data quality and potential reporting bias are considered.

Results: 'Upper motor neurone lesion' is a rare adverse event reported in relationship to drugs in Vigibase (a database containing nearly 4 million ICSRs). Of the total of 172 ICSRs on this reported term, 43 were related to statins, of which 40 were considered further: all but one case was reported as ALS. In 34/40 reports a statin was the sole reported suspected drug. The diagnostic criteria were variable, and seven of the statin cases also had features of peripheral neuropathy. Of a total of 5534 ICSRs of peripheral neuropathy related to any drug in Vigibase, 547 were on statins. The disproportional reporting of statins and upper motor neurone lesion persisted after age stratification, and such disproportionality was not seen for statins and Parkinson's disease, Alzheimer's disease, extrapyramidal disorders, or multiple sclerosis-like syndromes.

Discussion: Because the cases were sometimes atypical we propose the use of the term 'ALS-like syndrome' and speculate whether this is part of a spectrum of rare neuromuscular damage. The diagnosis of ALS is often problematic, and the insidiousness and chronicity of the disease make causality with a drug difficult to assess. The disproportionally high reporting makes this an important signal nevertheless, since ALS is serious clinically and statins are so widely used. Wide use of the statins also makes a chance finding more probable, but is unlikely to cause disproportional reporting when there are no obvious biases identified.

Conclusion: We emphasise the rarity of this possible association, and also the need for further study to establish whether a causal relationship exists. We do advocate that trial discontinuation of a statin should be considered in patients with serious neuromuscular disease such as the ALS-like syndrome, given the poor prognosis and a possibility that progression of the disease may be halted or even reversed.

Copyright 2007 Adis Data Information BV

[jayemcee]

Norma, here is the image of a cholesterol factory, (mevalonate metabolic pathway) that I was unable to link to earlier.

http://talkingstatins.com/page14/page13/page13.html

jmc

[jayemcee]

My letter to the FDA:

Dr Eric Colman - Deputy Director: Division of Metabolism and Endocrinology Products

Dear Dr. Colman,
I am prompted to write to you with news of that which, on its face, appears to be a significant finding. I have been running a global e-petition, since April 3rd 2007, for the purpose of collecting sufficient signatures to encourage the World Health Organisation to initiate an impartial investigation into the risks that attend the use of statin therapies.

It has taken some time for the petition to become known about and I have recently analysed the first 100 signatures. The analysis can be found at the following URL, http://talkingstatins.com/page4/page33/page33.html The global petition can be found at the following URL: http://www.gopetition.com/online/11757.html

The petition was neutral about what people ought to write in support of their signature. (each signatory can append a 500 word commentary in support of their comments) After the analysis of the first 100 useful commentaries, I changed the rubric to reflect a desire to see more useful information being appended by the people who had chosen to write a comment in support of their signatures.

The resulting analysis had surprised me because many more people were experiencing what were obviously disruptive adverse reactions; to the statins they had been taking. The most noticeable adverse reaction was that 5% of the respondents had ascribed their development of Amyotrophic Lateral Sclerosis (ALS) to the fact that they had taken statins. Given the significant insult to several major processes within the mevalonate metabolic pathway, that follows the inhibition of cholesterol production with statin therapies, the conclusion that statins may be implicated in the development of ALS, among statin takers, is not beyond the bounds of reason.

As the number of signatories to the e-petition has started to climb, one noticeable trend is that more people are reporting the development of ALS. After 310 signatories (not all of whom have commented) the total number of people reporting the development of ALS, which they ascribe to statin treatment, now stands at nine cases, of which six people had reported that they were taking atorvastatin.

In the same sample of the population, one person had reported developing rhabdomyolysis and one person had reported what was described as a case of "near rhabdomyolysis". The incidence of rhabdomyolysis is thought to be 4 cases in every 100,000 patients, as can be seen from either of the following links. http://www.jr2.ox.ac.uk/bandolier/booth/cardiac/statmusc.html
http://jama.ama-assn.org/cgi/content/full/292.21.2585v1

The incidence of ALS in the USA and Europe is thought to be 2 cases in every 100,000 as can be seen from the following URL. http://www.neurology.org/cgi/content/full/68/13/E17

It is clear that, for my sample population of 310, I could have expected to see two cases of rhabdomyolysis to every one case of ALS. For 310 reports, I would have expected one occurrence of each condition. Nine cases of ALS suggests to me that either ALS is not being reported frequently, or that its development is on the increase and that it may be that statins are fomenting the increase. The incidence of ALS among so very few statin takers, would suggest to me that this is a very fruitful area for initiating future research efforts.

The widespread use of statins is predicated on the cholesterol/heart hypothesis, which has been comprehensively discredited by researchers investigating the links between heart disease and cholesterol since the work of the Framingham study and Ancel Keys had become instrumental in changing the way we perceive cholesterol and its role in our bodies.

Thousands of years of evolution did not equip our bodies with a statin-mediated regulatory mechanism for bringing down our dangerously high cholesterol counts. The literature appears to say, repeatedly, that lower cholesterol values are associated with earlier mortality. Regulatory bodies such as the FDA in the USA (and NICE in the UK) are apparently unable to include this revolutionary notion within their deliberations about statin therapies.

One could say much about the sample of the population that I have reported on and one could also find many reasons to exclude such a sample, based on their own self-reported and anecdotal evidence, from serious deliberation about the therapeutic value of any specific group of drugs. Many anecdotal reports about the adverse reactions to statin therapies are indicative of the highly toxic nature of this class of drugs.

The inhibition of Heme A within the mevalonate metabolic pathway presages the death of cells that can no longer derive energy from the food that we are eating. The work of Professor Bruce Ames is instructive: Bruce N. Ames, Ph.D. Professor University of California, Berkeley, Senior Scientist, Children's Hospital Oakland Research Institute; U.S. National Medal of Science; Research in delaying the mitochondrial decay of aging.

I can see that there are many technical considerations as to why statins may not be the causative agent in cases of ALS or ALS-like symptoms. Equally valid; I can see why there would be many reasons for a raised index of suspicion when one considers the toxic effects of statins that give rise to numerous adverse reactions that were not experienced by the patients before they had started to take statins to lower their cholesterol.

The medical profession appears to be unable to accept that there may be anything wrong with statin therapies. I commend the following link to you. http://www.thincs.org/NEJMcommenttoTNT.htm

My lay mind was suspicious of my findings and, at first, I thought that I must be mistaken. Accepting for one moment (for the sake of this discussion) that I am not mistaken, I wish to make a formal request that the FDA makes a determined effort to examine the possibilities raised by my letter. The FDA ought to insist on the closest scrutiny and reporting of the aetiology of every case of ALS, especially where one of the common factors was known to be a statin.

All of the petition material on the global petition website and the analysis from my own website, can be supplied as PDF files for your convenience, at your request.

[Thumbs Up]

Wow,this makes my head spin.

[Clbrink]

Hmmm... I now have 8 cases in 308 reports and 6 people were taking Lipitor.

Probability = 1 divided by (50,000^8) = 2.56 × 10-38

0.00000000000000000000000000000000000002 6

that is probability of finding 8 cases reported in 308 case reports, gioven an incidence of 1:50,000


I understand that you have 8 cases in 308, and yes I agree it seems to be a high number. Your calculation does not account for age groups, nor does it account for the fact that these 308 people are not randomly chosen, I think that when that is all accounted for you will see the number is much lower.

When you go to an ALS forum and have people fill out the questionaire, you have controlled the outcome.

[jayemcee]

I understand that you have 8 cases in 308, and yes I agree it seems to be a high number. Your calculation does not account for age groups, nor does it account for the fact that these 308 people are not randomly chosen, I think that when that is all accounted for you will see the number is much lower.

When you go to an ALS forum and have people fill out the questionaire, you have controlled the outcome.

Hi Clbrink. Interesting response, thank you.

It is now 9 cases in 310. I have really struggled with this finding. I had thought that I must be wrong and that somewhere in my thinking, there was a basic error. The population was entirely random from my own perspective. I did not pick the people who signed up to the petition requesting the WHO to initiate an investigation into statins. There was no requirement for the signatories to have taken a statin and there was no requirement for them to mention developing ALS.

What is more difficult to control is the type of person who would search the internet, for information relating to health matters that affected them or their relatives. The internet allows us all to have access to information that was previously hidden from us. As we develop our searching skills, over and above what Google provides to us, we get better at finding stuff and we can now read much that was not primarily written for our eyes.

In any event, rhabdomyolysis (a serious and very rare complication of taking statins) occurs at double the rate of cases of ALS, according to incidence figures from around the world. My population sample has only produced one single confirmed case and one possible case of rhabdomyolysis and it is known that statins do not protect against the development of rhabdomyolysis... they precipitate its development! This left me thinking that I may possibly see a single case of ALS, which would have fitted with the incidence figures that are quoted by the people from around the globe who have the work of monitoring these issues.

Nine cases of ALS within 310 cases of statin takers suggests that statin takers are at a much increased risk (8 times more likely) for developing ALS, than their neighbour who does not take statins. There are many ways for the mathematical probability to be upset by clever statisticians, confounding factors or the people who just refuse to believe that these nice safe (and highly profitable) statins are causing such terrible adverse reactions.

I did not put out an exclusive call to all statin takers who have developed ALS, to flock to the petition site and sign up. If we can accept, for the sake of the debate, that the finding is real before we look at the numerous obstacles to accepting the notion that statins are toxic in a deadly manner and thus refuse to discuss the issue, something is, evidently, putting statin takers at an increased disadvantage to people who do not take statins.

This is an area where there is a need for more research and I would support that, with the proviso that all statin prescribing is halted while the matter is being thoroughly investigated. I want to see a global moratorium on the dispensing of statins because of the probability that they are exposing (statinated)people to a very high level of risk, with respect to the development of ALS.

There is no connection between cholesterol and heart disease. There is none... to a very tiny benefit, to be derived from 10 years of statin use for men who may have already had a heart attack. Statins are of no value in the over 50 age group. Statins are of no value to women of any age group and with any medical history, including cardiac history. The only possible change following the long term use of statins (can occur after a very few doses) is a raft of persistent and destructive side effects that will kill the person taking them, from the inside. Lower cholesterol is positively associated in all of the literature that looks at the issue, with an increased risk of death.

The self-reported numbers are not just a surprising finding, they are truly astonishing. Where I can assist with putting them before the right people, I will do so because the statin gravy-train needs to be derailed. I would also hope that the notion that pharmaceutical companies have any business in directing clinical trials, will be the eminently satisfactory collateral damage.

The drugs companies have bribed their way onto all manner of medical councils and they have helped to decide what national policies on cardiovascular health and statin prescribing will be. Their ability to 'invest' in any doctor who will push the message they want the public to learn, has resulted in a religious belief in their omnipotence and a belief that they are truly untouchable. All criminals believe that they will never be caught and tried for their criminal acts.

It is no surprise to find that the wheels are coming off this particular wagon and the many dead and severely damaged people, who had trusted their drug company bribed medical practitioners (94% according to a recent New England Medical Journal article) now wont be letting these drug pushers have any more effect on them.

The few deaths that were hidden within rather poorly designed and conducted clinical trials, were written off as 'not clinically significant', but now they can no longer be hidden. They have caused millions of people to be statinated with their incapacitating agents and most of them are not taking part in any clinical trials these days. The last clinical trial was in December 2006 and Pfizer were alerted (by the independent monitor, the Data Safety Monitoring Board) that there were far more unexplained deaths from their latest compound (atorvastatin/torcetrapib) than were to be expected. The trial was halted.

http://www.fda.gov/bbs/topics/NEWS/2006/NEW01514.html

As the needless deaths and the serious side effects become more obvious and the number of damaged people continues to rise (this was inevitable given the damage done by statins at the very fundamental cellular level) among statin takers, people are now beginning to ask relevant questions.

Neurological doctors are now dealing with problems that they have never seen, in this amount or severity, nor did they expect to see them and there is now supporting evidence against statins, coming from this unexpected direction.

My tiny petition is just a drop in the ocean of the gathered intelligence against statins... but it is proof positive that damage is occurring everywhere. I did not set up the petition, on foot of inventing an ALS magnet. I had expected to gather a few thousand signatures, with some supporting commentary from the signatories. I had never expected to see more than one single case report of ALS within several thousand signatures.

Now, I would like to invite you, Clbrink, to show me the flaws in my thinking, my approach and my analysis, because I so desperately do not want to believe in that which I have found for I do not want to contemplate the notion that it may actually be the truth.

Kind regards,
jmc

[ZenArcher]

Let me preface this by saying that I am making no statements about the safety, efficacy or use of statins. I applaud your effort in fighting for a cause you believe in and I only intend to address the claims you’ve made related to ALS on this forum.

First let’s assume that all your numbers are correct. If 9 cases out of 310 where to hold up against a larger random sampling that would mean that 2.9% (9 / 310) of all statin user would develop ALS. With the number of statin users in U.S. alone estimated at 20 million that means we should have somewhere in the neighborhood of 580,000 (2.9% * 20,000,000) ALS cases in the U.S. which is slightly more than the 30,000 currently estimated by the experts. This means that either your numbers are incorrect or the number of reported ALS cases in the U.S. have been severely underestimated. Actually with numbers like that ALS would become the number one killer in the U.S. instead of a rare disease. Why are these numbers so skewed? Your sample is highly biased and your cases claiming ALS are unconfirmed. Let’s go to the other end of the spectrum and assume that only 1 case of ALS in the 310 stands up over a larger random sampling. Even at that rate we would more than double the number of cases of ALS in the U.S. and that doesn’t even take into account people like me who have ALS and have never taken statins.

I won’t argue that statin use may accelerate the progression or aggravate the symptoms of ALS but they are not the cause. Statins have been on the market for about 20 years. ALS has been killing people for 138 years. Statins are the most widely prescribed drug in the history of modern medicine. If even 0.15% of the U.S. statin users developed ALS we would double the number of estimated cases. I’ve searched the web and I can’t find any studies showing an increased relative risk of ALS for statin users. I did find reports of ALS-like symptoms. Those two are not the same thing. People with this ALS-like syndrome had their symptoms stop or reverse once they came of the drug. Do you have any idea what an ALS patient would give for those results?

I’m not saying that there isn’t a link. I am saying that no link has currently been proven and a link to the degree you are claiming is impossible. The World Health Organization already has a study underway which should be published shortly. Please continue your fight but be careful how hard you wave the ALS flag and make sure that the numbers you use stand up. If not then they do nothing other than trivialize your input.

[jayemcee]

Let me preface this by saying that I am making no statements about the safety, efficacy or use of statins. I applaud your effort in fighting for a cause you believe in and I only intend to address the claims you’ve made related to ALS on this forum.

First let’s assume that all your numbers are correct. If 9 cases out of 310 where to hold up against a larger random sampling that would mean that 2.9% (9 / 310) of all statin user would develop ALS. With the number of statin users in U.S. alone estimated at 20 million that means we should have somewhere in the neighborhood of 580,000 (2.9% * 20,000,000) ALS cases in the U.S. which is slightly more than the 30,000 currently estimated by the experts. This means that either your numbers are incorrect or the number of reported ALS cases in the U.S. have been severely underestimated. Actually with numbers like that ALS would become the number one killer in the U.S. instead of a rare disease. Why are these numbers so skewed? Your sample is highly biased and your cases claiming ALS are unconfirmed. Let’s go to the other end of the spectrum and assume that only 1 case of ALS in the 310 stands up over a larger random sampling. Even at that rate we would more than double the number of cases of ALS in the U.S. and that doesn’t even take into account people like me who have ALS and have never taken statins.

I won’t argue that statin use may accelerate the progression or aggravate the symptoms of ALS but they are not the cause. Statins have been on the market for about 20 years. ALS has been killing people for 138 years. Statins are the most widely prescribed drug in the history of modern medicine. If even 0.15% of the U.S. statin users developed ALS we would double the number of estimated cases. I’ve searched the web and I can’t find any studies showing an increased relative risk of ALS for statin users. I did find reports of ALS-like symptoms. Those two are not the same thing. People with this ALS-like syndrome had their symptoms stop or reverse once they came of the drug. Do you have any idea what an ALS patient would give for those results?

I’m not saying that there isn’t a link. I am saying that no link has currently been proven and a link to the degree you are claiming is impossible. The World Health Organization already has a study underway which should be published shortly. Please continue your fight but be careful how hard you wave the ALS flag and make sure that the numbers you use stand up. If not then they do nothing other than trivialize your input.


Thank you, Jeff, for a well-considered reply.
I hear what you have said and I will not argue with it. I believe that you have made sound points. With respect to statin-induced ALS-like symptoms; that particular manifestation appears to be increasing. With reference to the Dx of ALS, I gave the benefit of the doubt to the self-reporters. The reason for my approach is that ALS is a medical diagnosis, not a self-made one. It is also not usual to use ALS as the working diagnosis until after a huge number of tests have been conducted.

All of the reporters appear to think that statin use presaged the ALS and it may well have precipitated it. Without dwelling on the deeply technical, for now, it is clear that statin inhibition of cholesterol production, lessens the amount of cholesterol in the body. As pointed out elsewhere, cholesterol is vital for the production of the protective coat that covers each nerve fibre. It is also essential for cell wall integrity.

What is being seen in a small way is that people who take statins may go on to develop ALS or ALS-like symptoms that do not resolve on stopping the statin. I would like to debate the issues with you, Jeff, but I don't believe that I can say as much or say it quite as well as Dr Duane Graveline, who has impeccable references, and coincidentally has also just been Dx with ALS-like symptoms following his own statin use.

Please read here... http://www.spacedoc.net/ALS_statins.html

...and then get back to me. My basic point still stands... that rhabdomyolysis is precipitated by statins and occurs at twice the rate, yet with only one confirmed case in 310 reports, there most definitely should not have been 9 cases of ALS. I really don't want my observations to be accurate. I have nothing to gain here. I am not looking for fame and fortune. I have nothing to sell. I am retired from the health service.

I am just saying "look at this" and then asking why am I seeing it. Many of the world's leading researchers who were initially skeptical are now asking exactly the same question. If anyone wants to to explain the phenomenon in a way that is sound, then I can go sleep nights. Until then, I have no choice but to knock on the doors of people with executive power and ask them to explain this to me.

Kind regards,
jmc (also a Jeff)

[ZenArcher]

I’m always up for a friendly debate just ask my wife. :)

First to your point about self reported ALS. Take a few minutes and read this forum about people that swear they have ALS although multiple neuros have told them they do not. I’m not saying whether they do or not. What I am saying is they believe they do and in the context of an internet survey are very like to report that they do in fact have ALS. Also look at the type of testing done for each case. It varies widely from person to person. How many of your reported 9 cases were diagnosed by someone with experience in ALS? Read this forum again and look at each post where someone is asking for information following a diagnosis or arguing a diagnosis and I’m willing to bet that you will see the recommendation to see someone with experience in diagnosing ALS. Although this data may be somewhat dated it was reported that up to 10% of diagnoses of ALS are false-positives, and up to 44% may be false-negatives. (Cristini).

I won’t contest the need of cholesterol for myelin production. I will however point out the myelin is not involved in ALS. Electrodiagnostic methods are crucial for the diagnosis of ALS. In nerve conduction studies, normal sensory conduction and absence of the sign of demyelination is required. (Sonoo, 2006) Multiple sclerosis is the scarring of the myelin sheath. Any cases of demyelination I can find in terms of ALS are secondary to neuron death and atrophy which means it is not a casual factor.

At this point let me make one thing perfectly clear, ALS kills, ALS-like symptoms stop progression or reverse once the medication is stopped. They are not the same thing or even remotely similar so please stop comparing them.

On to Dr Graveline who I admit is quite an accomplished man. He is a medical doctor with expertise in the areas of weightlessness, water immersion and biological deconditioning. None of those areas relate to neurology or more specifically ALS. The published article he references on his website actually speaks to the possibility that statins my help to slow the progression of Alzheimer's disease. (Ohm TG, 2006) Both the World Health Organization and the ALS division of the MDA have reviewed the evidence and simply stated that they need more studies and at this point follow the advice of your cardiologist concerning statin use.

Now some fun with numbers. According to the WHO report 34 of the reported ALS cases sited statins as the suspect drug. (Edwards IR, 2007) Although I believe this is a worldwide number let’s assume it is U.S. only to help your cause. As I’ve said before the estimated number of statins users in the U.S. is about 20 million. (Prescription and Price Trends, 2007) A short description of relative risk, relative risk (RR) is the risk of an event (or of developing a disease) relative to exposure. Relative risk is a ratio of the probability of the event occurring in the exposed group versus the control (non-exposed) group. (Relative risk) To calculate the RR for statin users to develop ALS you use the number of reported ALS cases for statin users divided by the number of statin users and then divide that by the control which would be 2 people out of every 100,000 developing ALS. A result of greater than one means they are more likely than the norm and less than one means less likely.

RR of statin users developing ALS = (34 / 20,000,000) / (2 / 100,000) = 0.085

According to that your are much less likely to develop ALS if you are on statins. Note: I am in no way representing that this evidence is correct in any manner. I am simply using the numbers supplied. Do not use this information in any manner to influence any medical decisions concerning statin use.

I can explain your results but I don’t think you’ll like or accept the answer. Put quite simply your sampling is biased to produce these type of results. Right now we are having this discussion on an ALS forum. It also happens to be an ALS forum that ranks fairly high in Google searches. Add to that the fact the many searches related to rhabdomyolysis will also show results for ALS and the fact that the human mind will often look to worst case first. Also rhabdomyolysis is treatable whereas ALS is not meaning that more people are out there researching the web. As a point of comparison let’s look at a hypothetical survey on this forum. Let’s say I post a question asking how many PALS are capable of using a computer. Right off the bat I’m biased in at least two ways. Firstly, those that can’t use the computer can’t answer and secondly I only get those people that are on this forum. No matter what data I get the results are invalid. Take a look here for more info: http://en.wikipedia.org/wiki/Biased_sample

As I said before fight for your cause but the numbers you’re using just don’t stand up to any scrutiny. Statins may not be good for you but you need strong proof of that fact for several reasons. First big pharma is making boat loads of money off of them. Second, whether it’s true or not, people believe it’s saving them from heart disease, stroke and heart attack.

Works Cited
Cristini, J. (n.d.). Misdiagnosis and missed diagnoses in patients with ALS. Retrieved December 16, 2007, from Journal of the American Academy of Physician Assistants: http://jaapa.com/issues/j20060701/pdfs/als0706.pdf

Edwards IR, S. K. (2007). Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17536877&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

Ohm TG, M. V. (2006). Cholesterol, statins and tau. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16866917&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

Prescription and Price Trends. (2007, February). Retrieved December 16, 2007, from The Statin Drugs: http://64.233.169.104/search?q=cache:tOzQp94Hxa0J:www.crbestbu ydrugs.org/PDFs/Statins-RxTrend-FINAL-Feb2007.pdf+number+statin+prescriptions+ US&hl=en&ct=clnk&cd=9&gl=us

Sonoo, M. (2006, November). Electrodiagnosis of ALS. Retrieved 16 2007, December, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17432189&ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

For some reason my hands are tired now :) I'll play more tomorrow if you're interested.

[Clbrink]

I’m always up for a friendly debate just ask my wife. :)

First to your point about self reported ALS. Take a few minutes and read this forum about people that swear they have ALS although multiple neuros have told them they do not. I’m not saying whether they do or not. What I am saying is they believe they do and in the context of an internet survey are very like to report that they do in fact have ALS. Also look at the type of testing done for each case. It varies widely from person to person. How many of your reported 9 cases were diagnosed by someone with experience in ALS? Read this forum again and look at each post where someone is asking for information following a diagnosis or arguing a diagnosis and I’m willing to bet that you will see the recommendation to see someone with experience in diagnosing ALS. Although this data may be somewhat dated it was reported that up to 10% of diagnoses of ALS are false-positives, and up to 44% may be false-negatives. (Cristini).

I won’t contest the need of cholesterol for myelin production. I will however point out the myelin is not involved in ALS. Electrodiagnostic methods are crucial for the diagnosis of ALS. In nerve conduction studies, normal sensory conduction and absence of the sign of demyelination is required. (Sonoo, 2006) Multiple sclerosis is the scarring of the myelin sheath. Any cases of demyelination I can find in terms of ALS are secondary to neuron death and atrophy which means it is not a casual factor.

At this point let me make one thing perfectly clear, ALS kills, ALS-like symptoms stop progression or reverse once the medication is stopped. They are not the same thing or even remotely similar so please stop comparing them.

On to Dr Graveline who I admit is quite an accomplished man. He is a medical doctor with expertise in the areas of weightlessness, water immersion and biological deconditioning. None of those areas relate to neurology or more specifically ALS. The published article he references on his website actually speaks to the possibility that statins my help to slow the progression of Alzheimer's disease. (Ohm TG, 2006) Both the World Health Organization and the ALS division of the MDA have reviewed the evidence and simply stated that they need more studies and at this point follow the advice of your cardiologist concerning statin use.

Now some fun with numbers. According to the WHO report 34 of the reported ALS cases sited statins as the suspect drug. (Edwards IR, 2007) Although I believe this is a worldwide number let’s assume it is U.S. only to help your cause. As I’ve said before the estimated number of statins users in the U.S. is about 20 million. (Prescription and Price Trends, 2007) A short description of relative risk, relative risk (RR) is the risk of an event (or of developing a disease) relative to exposure. Relative risk is a ratio of the probability of the event occurring in the exposed group versus the control (non-exposed) group. (Relative risk) To calculate the RR for statin users to develop ALS you use the number of reported ALS cases for statin users divided by the number of statin users and then divide that by the control which would be 2 people out of every 100,000 developing ALS. A result of greater than one means they are more likely than the norm and less than one means less likely.

RR of statin users developing ALS = (34 / 20,000,000) / (2 / 100,000) = 0.085

According to that your are much less likely to develop ALS if you are on statins. Note: I am in no way representing that this evidence is correct in any manner. I am simply using the numbers supplied. Do not use this information in any manner to influence any medical decisions concerning statin use.

I can explain your results but I don’t think you’ll like or accept the answer. Put quite simply your sampling is biased to produce these type of results. Right now we are having this discussion on an ALS forum. It also happens to be an ALS forum that ranks fairly high in Google searches. Add to that the fact the many searches related to rhabdomyolysis will also show results for ALS and the fact that the human mind will often look to worst case first. Also rhabdomyolysis is treatable whereas ALS is not meaning that more people are out there researching the web. As a point of comparison let’s look at a hypothetical survey on this forum. Let’s say I post a question asking how many PALS are capable of using a computer. Right off the bat I’m biased in at least two ways. Firstly, those that can’t use the computer can’t answer and secondly I only get those people that are on this forum. No matter what data I get the results are invalid. Take a look here for more info: http://en.wikipedia.org/wiki/Biased_sample

As I said before fight for your cause but the numbers you’re using just don’t stand up to any scrutiny. Statins may not be good for you but you need strong proof of that fact for several reasons. First big pharma is making boat loads of money off of them. Second, whether it’s true or not, people believe it’s saving them from heart disease, stroke and heart attack.

Works Cited
Cristini, J. (n.d.). Misdiagnosis and missed diagnoses in patients with ALS. Retrieved December 16, 2007, from Journal of the American Academy of Physician Assistants: http://jaapa.com/issues/j20060701/pdfs/als0706.pdf

Edwards IR, S. K. (2007). Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17536877&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

Ohm TG, M. V. (2006). Cholesterol, statins and tau. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16866917&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

Prescription and Price Trends. (2007, February). Retrieved December 16, 2007, from The Statin Drugs: http://64.233.169.104/search?q=cache:tOzQp94Hxa0J:www.crbestbu ydrugs.org/PDFs/Statins-RxTrend-FINAL-Feb2007.pdf+number+statin+prescriptions+ US&hl=en&ct=clnk&cd=9&gl=us

Sonoo, M. (2006, November). Electrodiagnosis of ALS. Retrieved 16 2007, December, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17432189&ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

For some reason my hands are tired now :) I'll play more tomorrow if you're interested.


Glad to see I am not the only one who sees this! I hope and pray that there is no connection, a lot of people are using statins...

[Thumbs Up]

Since we have familial ALS in our family, and I am told that since my Mom had it, I have a 50/50 chance of ALS. I have been taking Lipitor for many years. I have had mini strokes (TIA's) which I am certain was from Vioxx. I was sent to Dr Gawol to make sure it wasn't ALS because orginally they thought I had MS from the results of the MRI and CT scan. It was not. My sister was taking Lipitor and its seems to have damaged her liver, I have notified her Dr. to watch for ALS. So the odds are pretty high for me, wish I had those odds for a lotery.

[Jamiet]

I am NOT dx with ALS, but, i think i will be in this category of the so called "ALS like Syndrome" that is brought up so much in statin research.

I did have some intersting issues prior to taking statins, but, they were never consistent and were always spotty, like....sore throats, feeling a little ill every now and then. Lymph nodes like 10 years ago, Reflux....

One month into taking statins (Advicor, which is basically lipitor on steroids), the twitches started, then the muscle loss, then the cramps....it all started spiraling about 4 weeks into statin therapy. It's been downhill ever since.

I am utterly convinced that, not only do they likely cause some ALS, it brings out ALS in people whom may have not had symptoms and issues for years to come......basically, i say it speeds it up and starts it too....

I'm sorry, i'll take my chances with high cholesterol and i even ate fried chicken yesterday.

Rgds,

Jamie

[jayemcee]

I‚ am always up for a friendly debate just ask my wife. :)
Thanks, Jeff. It's good to know. (the gentle sound of fingertips being sharpened) ;)
Please forgive a tardy response... my access to net was restricted by computer failure but I am now back online.


First to your point about self reported ALS. Take a few minutes and read this forum about people that swear they have ALS although multiple neuros have told them they do not. I am not saying whether they do or not. What I am saying is they believe they do and in the context of an internet survey are very like to report that they do in fact have ALS.
My response to this point is possibly unsatisfactory. I have no way of knowing which of the respondents were self-reporting. I take your point about people who may be unwilling to listen to a formal consultation, where the patient has been assured that they do not have ALS.

I hope you wont think it churlish of me to indicate that I was not running a survey; I was merely collecting signatures. There was no compulsion for people to accompany their signature with anything and there were no checkboxes that had to be completed. I don't see what the profit would be for a person to state that they had ALS (in some anonymous internet petition which was not directly related to ALS) if they knew that they did not have ALS. Many years ago I became embroiled in some work that had tried to determine under which conditions patients had apparently wanted to remain unwell.

The context was hospital beds and the patients who should have been well enough to be going home. The patients had all appeared to be reluctant to leave the hospital. I think the phenomenon was labelled something like the 'secondary gain of illness' and the term was, I believe, coined by Freud around 1913. Of course, there is supposed to be a primary gain of illness too.

In simple terms, there can be no benefit devolving to the person signing the e-petition against statins, if they told me that they had developed ALS. Reading the self-reported accounts, I am in no doubt that the respondents had suffered hugely.

Also look at the type of testing done for each case. It varies widely from person to person. How many of your reported 9 cases were diagnosed by someone with experience in ALS? Read this forum again and look at each post where someone is asking for information following a diagnosis or arguing a diagnosis and I am willing to bet that you will see the recommendation to see someone with experience in diagnosing ALS. Although this data may be somewhat dated it was reported that up to 10% of diagnoses of ALS are false-positives, and up to 44% may be false-negatives. (Cristini).

Part of the problem is that the diagnosis of ALS does not rely on a single simple test that can be thought of as clinically diagnostic, such as that found in the case of say... Myasthenia Gravis. In myasthenia gravis, the patient exhibits weakness of their muscles and it gets worse as the day progresses.

There can be lots of subtle signs but as the patient sits in front of you, you may notice that their eyelids starting to droop. One IV injection of edrophonium bromide (Tensilon), a rapid and short-acting cholinergic drug, may be considered to be diagnostic, with the proviso that the muscle strength returns and ptosis (drooping eyelids) resolves. There will be cases where this may not be true but, generally speaking, the dramatic improvement will confirm the diagnosis, without any other lab work having to be done.

Contrast this with the complex diagnostic procedures for ALS. It is widely believed (within the medical profession) that ALS is not a particularly well understood condition. In my own experience of delivering healthcare I was always guided by the following simple maxim... if the patient complains of something, then they must be experiencing something. It is not as trite a saying as it may seem at first blush.

People may not have the specialist language nor will they have the observational skills required; to guide the attending clinician in assisting them. The word 'disease' is instructive. They are ill at ease with their bodies and I would always trust the patient's own assessment of their bodily state before choosing to substitute my own interpretation from external appearances and imposing that assessment over the patient's own. I worked in the field of trauma and orthopaedics and if a bone is broken, it is easy to see alignment problems or detect what function remains in an injured limb. It is very difficult for patients to fake bony injuries.

I won't contest the need of cholesterol for myelin production. I will however point out the myelin is not involved in ALS. Electrodiagnostic methods are crucial for the diagnosis of ALS. In nerve conduction studies, normal sensory conduction and absence of the sign of demyelination is required. (Sonoo, 2006) Multiple sclerosis is the scarring of the myelin sheath. Any cases of demyelination I can find in terms of ALS are secondary to neuron death and atrophy which means it is not a casual factor.

One of the commonly reported adverse reactions to statins is peripheral neuropathy. There is some interference with the ability of the nervous system to deal with electro-chemical impulses. The neuropathy can affect every part of the peripheral nervous system ranging across the whole spectrum of effects from the sensory to the motor and not forgetting the autonomic nervous system. in my first 100 reports analaysed, there were 56% recording muscle problems and 11% recording peripheral neuropathy.

Statins inhibit cholesterol production but they also inhibit several other products within the mevalonate metabolic pathway. To be precise, dolichols, prenylated proteins, heme a and ubiquinone are also inhibited.

At this point let me make one thing perfectly clear, ALS kills, ALS-like symptoms stop progression or reverse once the medication is stopped. They are not the same thing or even remotely similar so please stop comparing them.

I believe that you will find that there are records of ALS-like symptoms neither stopping and going on to kill the patient. I am not in the least bit convinced that the medical profession are correctly ascribing adverse effects of therapies such as statinisation, to the appropriate checkbox. Patients who complain of muscle aches and weakness (damaged muscle tissue) are told it is because of their age.

Complaining of parasthesia is also likely to get age written down as the root cause. It is important to be clear that age is not an illness and neither does it cause patients to become unwell. The aged body makes different responses to challenges than younger bodies but we should be clear that getting older doers not automatically mean that one will be come ill with a life-threatening condition.

On to Dr Graveline who I admit is quite an accomplished man. He is a medical doctor with expertise in the areas of weightlessness, water immersion and biological deconditioning. None of those areas relate to neurology or more specifically ALS.

Heaven knows that I don't have to speak for Duane Graveline because he is more than able to do so for himself. I hope that he will forgive me for attempting to set the record straight. What I will say is that he has devoted the last decade of his life to nothing but statins and the horrible effects which they have on the human body, including the abstruse biochemistry and electrical disruption at the cellular level.

He holds case notes on many hundreds of patients that have reported anything untoward and significant. He writes intelligently and he is all too painfully aware of the neurological complications promoted by statins. His ALS-like symptoms have not resolved on removing statins. The epithet "ALS-like" is ascribed by the profession because it cannot be sure of the aetiology nor the course of such symptoms. On the other hand, if it looks like a duck, walks like a duck and quacks...

Expert neurologists may be expert but they may also be content to have reached a certain plateau of knowledge, sufficient for a good income, and not wish to dig into learned journals anymore. Perhaps it is a natural process for many people... achieving what they want and then not trying particularly hard to do better. Duane Graveline has not stopped trying to know more, nor has he stopped trying to do a much better job.

The published article he references on his website actually speaks to the possibility that statins my help to slow the progression of Alzheimer's disease. (Ohm TG, 2006) Both the World Health Organization and the ALS division of the MDA have reviewed the evidence and simply stated that they need more studies and at this point follow the advice of your cardiologist concerning statin use.

Please don't make the basic error of thinking that a reference to a research paper, on a personal website, is evidence of the personal position that one adopts. I would also reference papers on my website which adopt positions that I could never support. It is done in the interests of presenting a balanced argument.

Given the damage that has been thought to be caused by statins, I would not hold my breath waiting for statins to 'cure' (or to slow) the progression of Alzheimer's disease, Multiple Sclerosis, Parkinson's disease or ALS. All you are seeing is the statin producers trying to find a value and a market for their products. They are aware that the products have been subjected to mounting criticism. The voices against statin therapy are become more strident, more coherent and more certain.

Now some fun with numbers. According to the WHO report 34 of the reported ALS cases sited statins as the suspect drug. (Edwards IR, 2007) Although I believe this is a worldwide number let's assume it is U.S. only to help your cause. As I've said before the estimated number of statins users in the U.S. is about 20 million. (Prescription and Price Trends, 2007)

I have nine people who have cited statins as the possible causative agent in ALS. This is nowhere near the tiny figure quoted by the WHO. I am accepting the case that they all have formally diagnosed ALS. The reason I accept the worst case scenario, as the patients have stated, is that I have no reason to avoid the conclusion that what they say may be true.

Avoiding the unpleasant truth thereby failing to investigate the number of cases, because I choose not to believe their accounts, would be to invite consequences that are an unmitigated disaster. The recent full page ad, for Lipitor, in the Wall Street Journal quoted 26 million Americans as taking statins.

A short description of relative risk, relative risk (RR) is the risk of an event (or of developing a disease) relative to exposure.

I have no wish to appear rude, Jeff, so I hope you will forgive me for dismissing this psuedo-scientific field of knowledge... as complete nonsense. Part of the difficulty of getting the pro-statin cases examined; is the years of research workers who are paid by the pharmaceutical industry to deal in relative risk rather than all-cause mortality figures.

Bluntly, we can all understand the concept of body counts... Pfizer were forced to stopped a clinical in December 2006 because the body count was unsustainable. The relative risk of being killed in a clinical drug trial was immaterial because it was low enough for the ethical approval to poison numerous people. What was significant was that people were being killed by the drug compound and no amount of dressing it up as relative risk could affect the death count.

Another reason for rejecting relative risk as a sensible unit of measure is that there is no universal risk scale that is shown to be applicable to all cases and so... RR users can make it mean whatever they so choose. It may help them to produce fine academic screeds bolstered by erudite explanations of the relative risk factors used to determine whatever is being supported but the truth is that the emperor is not only not wearing any clothes... he has never owned any clothes!

Relative risk is a ratio of the probability of the event occurring in the exposed group versus the control (non-exposed) group. (Relative risk) To calculate the RR for statin users to develop ALS you use the number of reported ALS cases for statin users divided by the number of statin users and then divide that by the control which would be 2 people out of every 100,000 developing ALS. A result of greater than one means they are more likely than the norm and less than one means less likely.

RR of statin users developing ALS = (34 / 20,000,000) / (2 / 100,000) = 0.085

As explained above... this bears no relationship to the world as it is.

According to that your are much less likely to develop ALS if you are on statins.
There are many people who want to ignore or to rubbish my observation and as I have said previously, I don't mind because it is not affecting my living nor my personal sense of worth and self-esteem. What no-one has done is to say what it is that I have observed. I find that oddly strange, if the answers are so obvious to all and sundry bar my own stupid self.

Note: I am in no way representing that this evidence is correct in any manner. I am simply using the numbers supplied. Do not use this information in any manner to influence any medical decisions concerning statin use.
I have this deep distrust of numbers because they can be manipulated to emphasise anything. We are all familiar with politicians who are diametrically opposed to what the other person believes and yet... they can both take the same data set and make it support their own cases. Q.E.D.

I can explain your results but I don't think you'll like or accept the answer. Put quite simply your sampling is biased to produce these type of results.

Let's examine the nature of the bias. :)

Right now we are having this discussion on an ALS forum. It also happens to be an ALS forum that ranks fairly high in Google searches. Add to that the fact the many searches related to rhabdomyolysis will also show results for ALS and the fact that the human mind will often look to worst case first.

A single word search in Google, reveals 599,000 pages related to the word, 'rhabdomyolyis'. I checked the first 250 entries and could not find a single reference to ALS. Your comment, "many searches related to rhabdomyolysis will also show results for ALS", is not supported by my testing of your statement.

I have linked to a page that will take some time to read but it says quite a bit about worse-case scenarios. It also has something useful to say on managing risk. I commend it to you...

http://www.psandman.com/col/birdflu.htm

Also rhabdomyolysis is treatable whereas ALS is not meaning that more people are out there researching the web. You have pointed out that people with ALS-like symptoms appear to recover. Rhandomyolysis, in isolation, is thought to be associated with a mortality rate of about 5% but that is where there are no other factors. Often the case is that there are other factors. Where a statin has been the causative agent, recovery is often elusive.

Statins cause apotosis and because the cells are dying at a fundamental level, recovery from rhabdomyolysis is not a likely event. The free movement of myoglobins serves to cause acute renal failure and total organ failure often ensues . Be assured that a Dx of multi-factorial rhabdmyolysis does not carry a good prognosis and it is not a set of circumstances that the knowledgeable patient would want to hear is to blame for his illness.

As a point of comparison let's look at a hypothetical survey on this forum. Let's say I post a question asking how many PALS are capable of using a computer. Right off the bat I'm biased in at least two ways. Firstly, those that can't use the computer can't answer and secondly I only get those people that are on this forum. No matter what data I get the results are invalid.

Comparing like with like... I did not limit the signatories of the petition to any particular group or subset of people and neither did I knowing exclude anyone from participating and there were no pre-conditions. I accept as we all would, that some limitations exist. If you are neither computer literate nor own a computer, then signing my petition form is not going to be an option. There is a danger of throwing out the baby with the bath-water here.

I am reporting what was reported and it is no less valid for the manner of its collection. Nine people reported ALS in 310 people. At the very least it requires an explanation, given the rarity of ALS.

Thanks for all of the links which you have provided, by way of explanation for your position.

Take a look here for more info: http://en.wikipedia.org/wiki/Biased_sample

As I said before fight for your cause but the numbers you're using just don't stand up to any scrutiny.

9 cases of ALS within 310 unrelated cases of statin use. It bears investigation. The relationship may be wrong or unusual and the frequency is far too many people, according to epidemiologists. I want a sensible answer as to why nine people out of 310 statin takers, believe that stains have caused them to develop ALS. The chances of that happenstance are remote, given all that we know about ALS and Statins.

Nevertheless, it appears to me that nine unrelated people have all come, independently, to the very same conclusion about statins and the development of ALS. It appears to me that we have an event concerning 9 unrelated individuals and it surely doesn't stand up to serious scrutiny.

Statins may not be good for you but you need strong proof of that fact for several reasons. First big pharma is making boat loads of money off of them. Second, whether it's true or not, people believe it's saving them from heart disease, stroke and heart attack.

There is a wealth of peer-reviewed medical literature that underpins the notion that statins are deeply toxic and inimical to life as we know it. The destruction of cells because they can not get sufficient energy from food ought to be enough. There is a vast amount more material and, on foot of an appropriate e-mail address, I would be both willing and delighted to e-mail you technical and abstruse papers, that are by highly regarded clinicians and fieldworkers, that make the comprehensive case against statins. The public are guided by their clinicians and 94% of doctors in the USA, admitted to working in tandem with drug companies.

Works Cited
Cristini, J. (n.d.). Misdiagnosis and missed diagnoses in patients with ALS. Retrieved December 16, 2007, from Journal of the American Academy of Physician Assistants: http://jaapa.com/issues/j20060701/pdfs/als0706.pdf

OK, help me out here, Jeff. Earlier, you said "How many of your reported 9 cases were diagnosed by someone with experience in ALS?" You also said "I am willing to bet that you will see the recommendation to see someone with experience in diagnosing ALS"

I may be wrong but I do not see how one physician's assistant, however good, can equate to a fully trained neurologist, who is legally responsible for the sequelae that devolve from their clinical decisions. Are you seriously suggesting that people without a diagnosis of ALS, but who are worried by some inexplicable symptoms, should consult a physician's assistant, who just happens to work within the field of ALS, rather than have a consultation with a fully qualified neurologist?

I would also suggest to you that however expert Christini may be, there is insufficient background upon which to base portentous comments about misdiagnosis. in my own field I am considered to be an expert's expert. I have carried out original and well-received research. I am not a clinician and cannot know what I do not know so any statements I may make have to be accepted in the light of that tempering knowledge.

When I first worked in the health services a after becoming a qualified person, I knew everything there was to know about my subject. Three decades of continuous service later and I much was less certain about the accepted certainties which were both received wisdom and 'known facts that were accepted by all' in the beginning.

Edwards IR, S. K. (2007). Statins, neuromuscular degenerative disease and an amyotrophic lateral sclerosis-like syndrome: an analysis of individual case safety reports from vigibase. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17536877&ordinalpos=2&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

An initial paper that could not possibly account for all reports of statin involvement in the development of ALS. The primary flaw with thinking that all occurring cases are diligently reported, is countered by the numerous cases of people arguing for years with their medical practitioner, trying to convince them that statins are causing them to have lifestyle changes that are painful, immobilising or downright dangerous such as TGA.

Ohm TG, M. V. (2006). Cholesterol, statins and tau. Retrieved December 16, 2007, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=16866917&ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

A paper that says not very much about Tau Phosphorylation. The inhibition of Cholesterol in the MMP causes problems for people who were previously normal. A commonly complained of series of adverse reactions to statins is 'foggyness' or loss of memory, catastrophic memory failure as in transient global amnesia and other cognitive effects. In the face of these occurrences, I fail to understand how any medic, worth the title, would prescribe statins as the way forward to ameliorate dementias of the type seen in Parkinson's disease and Alzheimer's disease.

Prescription and Price Trends. (2007, February). Retrieved December 16, 2007, from The Statin Drugs: http://64.233.169.104/search?q=cache:tOzQp94Hxa0J:www.crbestbu ydrugs.org/PDFs/Statins-RxTrend-FINAL-Feb2007.pdf+number+statin+prescriptions+ US&hl=en&ct=clnk&cd=9&gl=us

This appears to be a broken link

Sonoo, M. (2006, November). Electrodiagnosis of ALS. Retrieved 16 2007, December, from PubMed: http://www.ncbi.nlm.nih.gov/sites/entrez?Db=pubmed&Cmd=ShowDetailView&TermToSearch=17432189&ordinalpos=8&itool=EntrezSystem2.PEntrez.Pubmed.Pubme d_ResultsPanel.Pubmed_RVDocSum

I note this is the viewpoint of a single author. Of course diagnostic accuracy is not the issue here. The issue is that nine people believe that they have developed ALS and all of them ascribe that development to statins.

Without a greater knowledge of the diagnostic tools to reach the conclusion that a person has developed ALS, I am unable to comment further. I will say that it is extremely unusual to cite a single source (from a single author) as the authority for any proposition. Equally, I would want to see the opposing arguments for the approach of Sonoo, to better understand the mechanisms involved.

For some reason my hands are tired now :) I'll play more tomorrow if you're interested.

I am always interested in a good debate... :)

also a Jeff

[Saubier]

At the 18th annual ALS conference in Toronto this year, a study was presented on statin use by ALS patients. The study was called "SHOULD PATIENTS WITH ALS CONTINUE TAKING STATIN MEDICATIONS?" by ZINMAN L, SADEGHI R, PATTON D, KISS A, of the University of Toronto, Toronto, ON, Canada. E-mail address for correspondence: lorne.zinman@sunnybrook.ca. It's on page 146 of the Abstract book.

Results: The study included 131 patients with clinically probable or definite ALS followed from January 2006 to June 2007. Thirty-two patients (24%) were taking statin medications and 99 (76%) were in the control group. After adjusting for covariates, we found a highly significant increase in the rate of decline in the ALSFRS-R for the statin group (1.29 units/month) compared to the control group (0.77 units/month; p50.0015). Patients in the statin group also reported significantly greater muscle cramp frequency (pv0.0001) and severity (p50.0005). CK values were lower in the statin group, but no significant difference was found.

Conclusions: This observational study demonstrates that statin medications are associated with an increased rate of disease progression in patients with ALS. Statins also appear to significantly increase muscle cramp frequency and severity. These findings indicate that statin medications may be harmful in patients with ALS and clinicians should consider discontinuing or replacing these medications in the context of ALS disease progression and cardiovascular risk.

What else do you need to know?

[Saubier]

Statins prolong life? Check out these articles:
H Iso, DR Jacobs, D Wentworth, JD Neaton, and JD Cohen, “Serum cholesterol levels and six-year mortality from stroke in 350,977 men screened for the multiple risk factor intervention trial.” NEJM, Volume 320:904-910 April 6, 1989 Number 14.
Muldoon MF, Manuck SB, Matthews KA, “Lowering cholesterol concentrations and mortality: a quantitative review of primary prevention trials,” BMJ (British Medical Journal), 1990 Aug 11;301(6747):309-14.
K. M. Anderson, W. P. Castelli and D. Levy, “Cholesterol and mortality. 30 years of follow-up from the Framingham study.” JAMA, Vol. 257 No. 16, April 24, 1987.
J. D. Neaton, H. Blackburn, D. Jacobs, L. Kuller, D. J. Lee, R. Sherwin, J. Shih, J. Stamler and D. Wentworth, “Serum cholesterol level and mortality findings for men screened in the multiple risk factor intervention trial. multiple risk factor intervention trial research group,” JAMA, Vol. 152 No. 7, July 1, 1992.
Forette B, Tortrat D, Wolmark Y., “Cholesterol as risk factor for mortality in elderly women.” Lancet. 1989 Apr 22;1(8643):868-70.
Ulmer H, Kelleher C, Diem G, Concin H., “Why Eve is not Adam: prospective follow-up in 149,650 women and men of cholesterol and other risk factors related to cardiovascular and all-cause mortality.” J Womens Health (Larchmt). 2004 Jan-Feb;13(1):41-53.
Alan M. Garber, MD, PhD; Warren S. Browner, MD, MPH; and Stephen B. Hulley, MD, MPH, “Clinical guideline, part 2: Cholesterol screening in asymptomatic adults, revisited.” Annals of Internal Medicine, 1 March 1996, Volume 124, Issue 5, Pages 518-531.
Peter Cummings and Bruce M. Psaty. “The association between cholesterol and death from injury.” Annals of Internal Medicine, 15 May 1994, Volume 120 Issue 10. Pages 848-855.
S. Bandyopadhyay, A.J. Bayer and M.S. O'Mahony. “Age and gender bias in statin trials. Q J Med, 2001; 94: 127-132.
Yadon Arad, MD, Louise A. Spadaro, MD, Marguerite Roth, RN, David Newstein, DrPh and Alan D. Guerci, MD. “Treatment of asymptomatic adults with elevated coronary calcium scores with Atorvastatin, vitamin C, and vitamin E.” J Am Coll Cardiol, 2005; 46:166-172.
Krumholz HM, Seeman TE, Merrill SS, et al. “Lack of association between cholesterol and coronary heart disease mortality and morbidity and all-cause mortality in persons older than 70 years.” JAMA 1994;272:1335-1340.
Anderson KM, Castelli WP, Levy D. Cholesterol and mortality. 30 years of follow-up from the Framingham study. JAMA 1987;257:2176-2180.
Foody, JM; Yun Wang; Kiefe, CI; Ellerbeck, EF; Gold, J; Radford, MJ; Krumholz, HM. “Long-term prognostic importance of total cholesterol in elderly survivors of an acute myocardial infarction: The cooperative cardiovascular pilot project.” Journal of the American Geriatrics Society, Volume 51 Page 930 - July 2003.
Michael H. Davidson, MD, Sara B. Kurlandsky, PhD, Ruth M. Kleinpell, PhD, RN, Kevin C. Maki, PhD. “Lipid management and the elderly.” Prev Cardiol 6(3):128-133, 2003.
Brescianini, S; Maggi, S; Farchi, G; Mariotti, S; Di Carlo, A; Baldereschi, M; Inzitari, D. “Low total cholesterol and increased risk of dying: are low levels clinical warning signs in the elderly? results from the Italian longitudinal study on aging.” Journal of the American Geriatrics Society, Volume 51 Page 991 - July 2003.
Andrew R. Lockman, M.D., Andrea D. Tribastone, M.D., Karen V. Knight, M.S.L.S., and John P. Franko, M.D., University of Virginia School of Medicine, Charlottesville, Virginia. “Treatment of cholesterol abnormalities.” American Family Physician, Vol. 71 No. 6, 15 Mar 2005.
Krumholz HM, Seeman TE, Merrill SS, et al. “Lack of association between cholesterol and coronary heart disease mortality and morbidity and all-cause mortality in persons older than 70 years.” JAMA 1994;272:1335-1340.

These are all articles in peer-reviewed journals such as JAMA, NEJM, etc. You can find the abstracts on line if the drug companies haven't disappeared them. I have found that negative articles on statins cost far more than positive articles.

[ZenArcher]

First to Saubier, at no point have I argued for or against the use of statins. I will openly admit I have no experience or knowledge in regards to statins and as such hope to avoid sticking my foot my mouth simply by keeping quiet. I disagree with two points in this entire thread, those being:

1. That statins cause ALS, there is no proof of this to date and if it were true at any statistically relevant level the number of ALS cases should have skyrocketed over the last 20 years.

2. That the number of ALS cases show in the petition (Jeff sorry for the survey misprint, fingers got ahead of brain) hold up across a larger, unbiased sample.

Let me make a few things clear. I don't condone statins. My cholesterol has been fine throughout my life and I've made it so through the use of the highly costly beer and garlic :) My downfall being that I'm a Guinness Draught fan which is expensive and the garlic is usually accompanied by a nice sauce or meat or some such. I do realize that big pharma does its best to influence the market and again have never argued that. I did in fact make a statement to that effect in my last post.

Now to Jeff, first off no fair. I do have arm onset ALS after all, typing gets difficult after awhile :) I'm going to keep this relatively short due to time constraints.

Firstly to the people who reported that statins could have been a causative agent in the development of their ALS. That statement in unfounded and has no proof. I don't want to sound callous but the best medical minds researching this disease for the last 138 years have been unable to find a cause. Given the rarity of the disease and the vast numbers of statin users if it significantly impacted the development of ALS it would no longer be an orphan disease. The age demographic for ALS, high cholesterol and thusly statin use overlap strongly which will help to elevate the numbers. I won't argue that you have 9 cases that may be entirely true and diagnosed experts. I wouldn't argue having it looked into further is a good idea. What I do argue is that in my eyes as a PALS there are more important things with facts that hold up against scrutiny they should take precedence. As an example, a recent trial of Minocycline increased the rate of disease progression by 29%. In my eyes a change of that magnitude although for the worse is extremely significant. It is the largest change affected in any study to date. Why? There is something there. I would rather see the WHO focus their attentions there than on the relevance of statin use to ALS when to date statistically there is no relation. Again, I am not arguing whether or not it worsens symptoms or affects progression simply cause.

Secondly Dr. Graveline, as I said an extremely accomplished man with a good amount of gray matter :) A search of PubMed shows nothing relating ALS to statins by Graveline DE. The relations discussed on the website are personal accounts totaling 10 if I remember correctly. I have complete faith that Dr. Graveline is very knowledgeable about the ways in which statins affect the body but he does not know the cause of ALS. He can speak to similarities in symptoms or theorized processes but since science knows little else anything more is conjecture. You dismiss relative risk as "psuedo-scientific field of knowledge" although it is simply a ratio or probabilities similar to the probability you used in your first posts. Fine we'll ignore relative risk and let's look at simple percentages. Let's look at it this way if 0.1% of all statin users in the U.S. went on to develop ALS the number of cases in the U.S. would almost double in a year, the number of diagnosed cases per year would almost quadruple. I will concede that the current means of tracking ALS patients and getting annual cases is lacking but quadruple numbers tend to jump out at people.

Thirdly the Google search. I phrased this poorly. I'll be honest I'm not even sure I can say 'rhabdomyolyis' hell I'll even admit I probably couldn't spell it without copy & paste. Two of the main symptoms of rhabdomyolyis are muscle weakness and stiffness. The top two results I got referenced ALS along with several other maladies. I didn't count put I'd say at leat 50% of the first two pages contained references to ALS, none singly.

I won't make any more statements concerning rhabdomyolyis, I was simply repeating what the web told me in terms of treatment.

Last point and then one statement (so much for short), I still say your sample is biased. Let me ask this question, where do the people who believe statins are beneficial sign? Ok maybe that was a little low but I use it only to illustrate the point that there is bias. If you can show me how the numbers stand up I will concede gracefully. As I said above I have no issue with further investigation but within the realm of ALS there isn't enough there to justify, in my eyes, spending money to research this when other much more important matters lie directly in front of me. If you review the paper written by the PA the specific portion I quoted was further referenced to a study conducted in Finland and published I was just to lazy to go get it. I won't go on to argue the references they have already stood against peer review by people much more knowledgeable than I.

In closing, as I said in the beginning and again several times throughout, my only reason for debate is that if the cause of ALS is unknown how can you know that statins cause ALS and that the numbers reported in this post don't hold up across a larger unbiased sampling. I am not arguing for or against the use of statins. I am not arguing that statins improve or worsen symptoms. I won't even argue that big pharma is actually controlling the government and they have little GPS chips in all the pills so they can keep an eye on us <please note the sarcastic grin> :mrgreen: Again, cause and numbers ;)

[Al]

Boy you guys just broke the record for the longest and wordiest post ever. I have no idea which is right but Saubier makes a good point with Dr. Zinman's study. He recommended to me a while back to get off Lipitor. I have no idea if it will help at this late stage but it can't hurt.
AL.

[vmd]

Zen Archer and jayemcee:

Actually, neither of you are necessarily in disagreement about the issue of statin use and ALS. ZenArcher is correct in that the observed correlations do not necessarily imply causation. But then, this is not what jayemcee is claiming. Rather, he believes it wise that further research needs to be conducted to establish a stronger connection. Ideally, one conducts experiments under controlled conditions to answer the causality question more definitively, but such an experiment would be unethical in human populations. Yet, statisticians have some fairly powerful correlational techniques that could get us close to a causal connection between statins and ALS (if the relationship exists).

[patricia1]

My neuro say there is a study on statins to help people with ALS and the benifits of statins. She agrees it is a very toxic drug but noththeless it is being study for benifits in ALS .
So go figure

[jayemcee]

As an example, a recent trial of Minocycline increased the rate of disease progression by 29%. In my eyes a change of that magnitude although for the worse is extremely significant. It is the largest change affected in any study to date. Why? There is something there. I would rather see the WHO focus their attentions there than on the relevance of statin use to ALS when to date statistically there is no relation.

Yes, Jeff, it is important that funding and time and effort go into research that provides effective answers. Would that it were such a simple matter... WHo gets to decide on what is effective spending on research, given a level playing field where all research conducted is equally effective? Is time best expended on a lifesaving answer for Marburg Haemorrhagic Fever (green monkey disease) which many in the western world will never hear of or have their lives touched by despite it killing 126 souls in March 2005, in Angola? Should it be choryza (upper respiratory tract infection that we know as the common cold) which affects millions daily?

I suspect that neither of us would want to be in the position of making any choices, given that the limitations on resources mean that some worthy cause is always going to be left to languish. My position on chasing down the link between statins and ALS is this... There are enough anecdotal reports of a link, of which my petition provides a very small number. The mechanism of action of statins would appear to precipitate many very bad reactions in the body and interference with neurological pathways has been document over a long period of time.

With statins being handed out like sweets, there are now multi-millions taking them and it would appear to be the proverbial time bomb, if proven, and would make the thalidomide disaster look like a walk in the park. The medical profession have not been joining the dots because they do not see any dots and it is crucial that their awareness is raised. I don't want you to get the wrong impression from my position, as stated, Jeff. If one can prevent the development of ALS in millions, or treat ALS in thousands, which choice should one make? All our efforts should be bent on doing both and I feel it is vital that no single area of endeavour is ignored.

The reality is that humans make bad choices and someone, somewhere will have the task of making a decision. I believe that an ounce of prevention is better than a ton of cure and to that end, I am trying to alert those who need to know, to the possibility of a disaster on an unprecedented scale. I really want to be wrong about this but, as yet, I have seen nothing to suggest that the development of ALS... mediated by statin therapy, is an impossible happening.

Secondly Dr. Graveline, as I said an extremely accomplished man with a good amount of gray matter :) A search of PubMed shows nothing relating ALS to statins by Graveline DE. The relations discussed on the website are personal accounts totaling 10 if I remember correctly. I have complete faith that Dr. Graveline is very knowledgeable about the ways in which statins affect the body but he does not know the cause of ALS. He can speak to similarities in symptoms or theorized processes but since science knows little else anything more is conjecture.
Suffice it to say that I am a member of a group to which Duane writes and he appears to understand a great deal more than your paragraph above would suggest. Pubmed is not the be-all and end-all... it is mere one portal (of many) that index medical publications. With that knowledge is the fact that the publications will use several processes to 'gatekeep', including peer-review, editorial veto and refusal to publish. Where a notion upsets the current medical thinking, it takes a brave editor to buck the commonly held beliefs.

You dismiss relative risk as "psuedo-scientific field of knowledge" although it is simply a ratio or probabilities similar to the probability you used in your first posts. Fine we'll ignore relative risk and let's look at simple percentages. Let's look at it this way if 0.1% of all statin users in the U.S. went on to develop ALS the number of cases in the U.S. would almost double in a year, the number of diagnosed cases per year would almost quadruple. I will concede that the current means of tracking ALS patients and getting annual cases is lacking but quadruple numbers tend to jump out at people.

Within this context relative risk says nothing about what actually kills people. I believe that neurologists are now seeing unexplained increases in neurodegenerative conditions. The phrase I had heard recently, was that the subject of statin-induced ALS had become 'coffee table talk' among neurologists. That is to say that it was not being trivialised but that it occupied large slices of non-work time and it would only be a short time until we see the first formal papers discussing the subject from a neurology perspective. If that were true, the neurological speciality findings would kill all statins; overnight.

Thirdly the Google search. I phrased this poorly. I'll be honest I'm not even sure I can say 'rhabdomyolyis' hell I'll even admit I probably couldn't spell it without copy & paste. Two of the main symptoms of rhabdomyolyis are muscle weakness and stiffness. The top two results I got referenced ALS along with several other maladies. I didn't count put I'd say at leat 50% of the first two pages contained references to ALS, none singly.

OK. Muscle weakness may well be a feature of ALS and so it is unsurprising it gets a mention. As muscle weakness/damage, is a principle effect of statin therapy, one can see why they share the same page. I would theorise that clinically, the action of statins causes a chain of events that effect the neurological system and thereby, effectively, mimic ALS.

I won't make any more statements concerning rhabdomyolyis, I was simply repeating what the web told me in terms of treatment.

OK. Understood.

Last point and then one statement (so much for short), I still say your sample is biased. Let me ask this question, where do the people who believe statins are beneficial sign? Ok maybe that was a little low but I use it only to illustrate the point that there is bias.

A petition that is trying to get statins investigated for risks in use, has no place for a statin lover to sign. Statin prescribers who may be unsure that statins are safe are not prohibited from signing. Life is like that... I would not expect a person (who goes into Macdonalds) to complain that they sell burgers. I would not attend an Ice Hockey game (go Canucks!) and complain that I could not see any horse-racing so the event location must have been biased against horse-racing fans. If one had to be all things to all people simultaneously, nothing would ever be done. I fully acknowledged the limitations of my sample, within the analysis.

If you can show me how the numbers stand up I will concede gracefully.

Now that would spoil my fun and I would not get the chance to beat you into submission. ;)

Seriously, Jeff, this is not about winning or losing. within its own frame of reference, the numbers stand well enough without any support. In real life, if you were to meet 310 people who all admitted to taking statins and then you discovered that 9 of them had developed ALS, seemingly after taking statins, what would you conclude?

You could ask them about lifestyle, family Hx, medical Hx, drug therapy, location and so on... any way you slice it, you would have 9 people where you should only see one. I see that and am asking for more light. The ascription of these improbable events to sample bias is ok and I can accept that. I just temper my acceptance with the knowledge that statins can and do disrupt the body systems at a fundamental level. It is a flag, no more, but it would be a poor scientist who was not curious and I believe that a scientist would want to shine a little more light on this tiny corner of that which appears to be a growing problem.

As I said above I have no issue with further investigation but within the realm of ALS there isn't enough there to justify, in my eyes, spending money to research this when other much more important matters lie directly in front of me. If you review the paper written by the PA the specific portion I quoted was further referenced to a study conducted in Finland and published I was just to lazy to go get it. I won't go on to argue the references they have already stood against peer review by people much more knowledgeable than I.

I will look at the referenced paper in closer detail. To paraphrase Einstein, for every research proposition, there is an equal and opposite research proposition (and it is particularly evident in medical research).

In closing, as I said in the beginning and again several times throughout, my only reason for debate is that if the cause of ALS is unknown how can you know that statins cause ALS and that the numbers reported in this post don't hold up across a larger unbiased sampling. I am not arguing for or against the use of statins. I am not arguing that statins improve or worsen symptoms. I won't even argue that big pharma is actually controlling the government and they have little GPS chips in all the pills so they can keep an eye on us <please note the sarcastic grin> :mrgreen: Again, cause and numbers ;)

Of course, I cannot 'know' that statins cause ALS. My position is that I do know that statins operate on the body in such a way, as to leave me unable to rule out the complicity of statins in the development of neurodegenerative disease.

Kind regards,
also Jeff

[jayemcee]

Boy you guys just broke the record for the longest and wordiest post ever. I have no idea which is right but Saubier makes a good point with Dr. Zinman's study. He recommended to me a while back to get off Lipitor. I have no idea if it will help at this late stage but it can't hurt.
AL.

you aint seen nuthin' yet.:mrgreen:

also Jeff

[jayemcee]

Zen Archer and jayemcee:

Actually, neither of you are necessarily in disagreement about the issue of statin use and ALS. ZenArcher is correct in that the observed correlations do not necessarily imply causation. But then, this is not what jayemcee is claiming. Rather, he believes it wise that further research needs to be conducted to establish a stronger connection. Ideally, one conducts experiments under controlled conditions to answer the causality question more definitively, but such an experiment would be unethical in human populations. Yet, statisticians have some fairly powerful correlational techniques that could get us close to a causal connection between statins and ALS (if the relationship exists).

Yes, you are correct, vmd. Ethical approval is very unlikely to be granted for further research because one should not be making making any patient's position worse to prove a point. My issue with statistics is that while remaining true to mathematical and statistical principles, it bears little relationship to life. The dead, who were killed by a clinical trial, that discounted them as clinically insignificant, is how we first got to this point; vis-à-vis statins. I don't believe that more than 5% of the medical profession, have a sufficient grasp of statistical analysis to enable clinicians to understand that which they write about so glibly.

Kind regards
also Jeff

[Clbrink]

Jeff,

Again, let me state that I agree, this should be investigated.

But I believe you are to personally involved to be able to collect such information in a non-biased manner. It has become more than that for you. You have developed a "passion" to prove your point. I hope you are wrong, ALS is as my husband says "his worse nightmare", that is the best way to describe it...

I quickly glanced at the signatures on your petition, I see some people signed for their parents... and two siblings put ALS, now is that a count of 2? I believe that would count as 1.

That is just a quick review, as I am limited on time being a CALS, and I am not in the medical profession, nor do I remember much of my Statistics class (back in the Stone Age as my kids say). I am just a regular person seeing some big holes...


300----------------Oakville ON Canada Dec 09, 2007
299----------------Oakville ON Canada Dec 09, 2007

I am by trade a designer, and have learnt over the years to take criticism, please take the information that Jeff and I are giving you, and make your point stronger, instead of spending your time fighting back here.

Tina

[jayemcee]

Jeff,

Again, let me state that I agree, this should be investigated.

But I believe you are to personally involved to be able to collect such information in a non-biased manner. It has become more than that for you. You have developed a "passion" to prove your point. I hope you are wrong, ALS is as my husband says "his worse nightmare", that is the best way to describe it...

I quickly glanced at the signatures on your petition, I see some people signed for their parents... and two siblings put ALS, now is that a count of 2? I believe that would count as 1.

That is just a quick review, as I am limited on time being a CALS, and I am not in the medical profession, nor do I remember much of my Statistics class (back in the Stone Age as my kids say). I am just a regular person seeing some big holes...


300----------------Oakville ON Canada Dec 09, 2007
299----------------Oakville ON Canada Dec 09, 2007

I am by trade a designer, and have learnt over the years to take criticism, please take the information that Jeff and I are giving you, and make your point stronger, instead of spending your time fighting back here.

Tina

Thanks for your response, Tina. I only counted the two signatures you have indicated as a single signature because it is only one case. As for "fighting back here" I am not engaged in any such thing. Clarifying points that may not be clear is all that I am engaged in and I see no reason not to.

Some people on this forum are taking statins still. I believe that it is right to give them enough information with which they can make informed choices about their own health care needs. I am not trying to legislate for others here. I am passionate about preventing harm to others. Ignorance is a difficult state to move from and I am bound to advocate for those that cannot advocate effectively for themselves, with respect to issues concerning their health, and that is all I am doing with this issue.

Kind regards,
also Jeff

[ZenArcher]

Al, I think we're having as much fun playing point counter-point as anything else :-D

A well natured intelligent debate is healthy for the mind. I have felt no malice at any point to Jeff just had fun arguing. I don't disagree with the points made in the arguments only the weight given to the numbers and the assumption of cause. I respect both the cause and the dedication and applaud the efforts. Now if only we can get him to sign up on the ALS advocacy page <wink, wink, nudge, nudge> :-D

http://capwiz.com/alsa/home/

Just in case :mrgreen:

[Al]

No problem but the Readers Digest Condensed version wouldn't hurt once in a while. My scrolling finger is getting overworked. LOL.
AL.

[jayemcee]

Al, I think we're having as much fun playing point counter-point as anything else :-D

A well natured intelligent debate is healthy for the mind. I have felt no malice at any point to Jeff just had fun arguing. I don't disagree with the points made in the arguments only the weight given to the numbers and the assumption of cause. I respect both the cause and the dedication and applaud the efforts. Now if only we can get him to sign up on the ALS advocacy page <wink, wink, nudge, nudge> :-D

http://capwiz.com/alsa/home/

Just in case :mrgreen:

Yes, Jeff, Agreed! Have just tried to signup to the advocacy program(me) and was dismayed to find that I have to be a US resident to do so. No international branch? For shame. ;)

also Jeff :mrgreen:

[jayemcee]

No problem but the Readers Digest Condensed version wouldn't hurt once in a while. My scrolling finger is getting overworked. LOL.
AL.

Al, that was the Readers Digest Condensed version. They are having a competition to win $1 million. Just contribute to a condensed forum discussion to win... besides having to pay for the lifetime subscription to Readers Digest by way of the entry fee. :mrgreen:

also Jeff

[Thumbs Up]

I have stopped taking my Lipitor for a week now and going to the dr on Dec 27th to speack with him about this. I will be referring my dr to www.peoplespharmacy.com and have also referred my sisters dr to this website.

Thanks

[patricia1]

This thread is somewhat distrubing People shold not stop their statins until they consult with their MD As a nurse I find that people that stop their meds run into big problems >We do not know the extent of the problems people are having and why they are takng statins Having a stroke and or heart disease on top of MND would be horrible. That being said, I stopped my Statin after consulting my MD, He is not happy and I will take full responsibilty for my actions If I found no change I will continue my statins, becase I am possitive my ALS was from a Tetnus shot,and if you read the inclosure on a bottle of Tetnus there is prove of it causing MND I just want to see if it is aggrevating the disease so thats why I am stopping
So please consult with your MD The people o the forum have wonderful information but they are not doctors Thank you and Merry Christmas, Pat

[jayemcee]

This thread is somewhat distrubing

Dear Patricia,
I agree with you that this thread is somewhat disturbing. It should never have been necessary, in my view. it became necessary when the pharmaceutical industry produced 'facts' that they will not allow the medical profession to verify. That is that statins are good for you and that low cholesterol is good for you. Both are clearly untrue and both are protected by the pharmaceutical company's own research, that never has to be made public because it constitutes a 'trade secret' so ethics becomes subordinate to profits and the force of law protects the pharmaceutical industry's trade secrets rather than the public.


People shold not stop their statins until they consult with their MD
I cannot support the view that encourages people to continue taking poisonous substances. Our MD's have shown themselves to be woefully ill-educated in this matter and that highly regarded publication 'The New England Journal of Medicine' had recently published the results of a survey they carried out among clinicians. It seems that 94% of all respondents admitted to having a relationship with the pharmaceutical companies. In the face of that staggering piece of information, how many MD's, would you think, are going to approve of the patient stopping their medication?

As a nurse I find that people that stop their meds run into big problems
As a human being, I find that people who never question and always accept the word of their clinician, run into big problems. there are more than enough people who have been damaged by statins to justify exercising extreme caution... which should extend to a point blank refusal to put noxious substances in one's body without checking what they are actually doing to the body.

While I think it is a good idea that we are all cautious about acting on advice from people who do not know us and we do not know if they have any clinical acumen, it is not the case that 'all doctors are good and everyone else is bad'. the medical profession have shown themselves to be especially tardy (with regards to statins which have been available for almost two decades) in telling the public that there may be a problem with the concepts. All research papers point to a lower cholesterol preceding depression, suicide, muscle problems, neurological problems and worse.

The internet has uncovered much information that would have remain hidden and it is a proper use of the internet to warn one's fellow humans, when one knows that they ware walking into danger. Currently, very few clinicians are warning their patients of the danger so I am one of the people that are adding to their previously exclusive rights, to inform the patients about anything they think may be relevant to the patient.

We do not know the extent of the problems people are having and why they are takng statins Having a stroke and or heart disease on top of MND would be horrible. Despite me agreeing with you that we know nothing of the personal medical Hx of people that are writing here, it behoves us to state categorically that stains are a class of drugs so deeply toxic, that there can be no case for their prescription.

If you want chapter on verse on the technical details, please PM me and I will send you more than a boatload of technical references. For now, suffice it to say that statins destroy cellular life in a fundamental manner, that guarantees that recovery from just the side effects of statins will be difficult. Overlay statin toxicity with other conditions and you will readily see how the additional burden will prove to be too much for the organism.

That being said, I stopped my Statin after consulting my MD, He is not happy and I will take full responsibilty for my actions If I found no change I will continue my statins, becase I am possitive my ALS was from a Tetnus shot,and if you read the inclosure on a bottle of Tetnus there is prove of it causing MND I just want to see if it is aggrevating the disease so thats why I am stopping So please consult with your MD The people o the forum have wonderful information but they are not doctors Thank you and Merry Christmas, Pat

I am truly glad that you have stopped your statin medication, Patricia. There is not a single learned article in all of the medical literature that shows support for the use of statins in women. It has never been shown to be the case that statins have benefited women. Doctors who prescribe statins to women (in either a primary a secondary care situation) should be held to be criminally negligent, in my view, for there is no supporting science and no possible justification for such an action.

Males over the age of 50 in both primary and secondary care, have also been shown to derive no benefit from statins. Cholesterol is essential (inter alia) for cell integrity and myelin production and it has never been positively shown that it is linked to heart disease aetiology, since the days when Ancel Keys and the initial Framingham study promulgated such nonsense.

Unless the medical profession can provide proof of the science that is driving wholesale stainisation of people, there is no case for it. If you were to ask for the proof of the cholesterol/heart hypothesis from your doctor, he/she would not be able to provide it to you... at any price, for it does not exist.

As for attenuated tetanus vaccine being responsible for your ALS, can you provide a copy of the enclosure that proves it was the responsible agent? I have had to give people tetanus shots over my decades of health service work and I have never been aware of a risk of ALS from vaccine. Perhaps the USP information sheet is different to that which is included with Tetanus vaccine in the UK.

Kind regards,
also Jeff

[vmd]

I'm curious about the tetanus vaccine and MND connection as well because some here have stated that they were vaccinated sometime before their symptoms of MND became apparent (including myself).

[patricia1]

Go To Tetnus Package Insert Then Scroll Down To Tetnus Vaccine

[Al]

I think a lot of people missed post # 24 in this thread. Well worth looking at again.
AL.

[patricia1]

We All Want To Blame Somethingthe Where We Live, Work, Play, Eat ,ingest The Truth Is We Really Dont Know. We All Have A Story. The Answer Is We Need Answers. Pat

[jayemcee]

Go To Tetnus Package Insert Then Scroll Down To Tetnus Vaccine

OK, I went to the FDA site and pulled up the package insert for Tetanus Toxoid Adsorbed. I was shocked by what I had found. The reason for my shock is that I have administered this vaccine to people in their tens of thousands throughout my career in trauma and orthopaedics and hospitals usually buy the stuff in bulk. Pharmacies in hospitals tended to remove the inserts from individual doses kept in multi-vial packages (single does glass vials in 5s and 10s)so I never got to see this information.

For clarity for people unfamiliar with this particular information, I have taken it from the package insert supplied by Aventis Pasteur and held by the FDA.

"Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines. A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré syndrome.

Other neurological conditions that have been reported include: demyelinating diseases of the central nervous system, peripheral mononeuropathies, cranial mononeuropathies, and EEG disturbances Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines.

A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré syndrome."

Patricia, I am so sorry to learn of yet another drug-induced route to ALS. :(

Kind regards,
also Jeff

[jayemcee]

We All Want To Blame Somethingthe Where We Live, Work, Play, Eat ,ingest The Truth Is We Really Dont Know. We All Have A Story. The Answer Is We Need Answers. Pat

I have just seen the latest comment (#346) on the global petition site. Another woman, from the USA and she was taking Lipitor for a short while. This is yet another heart-rending account...

"After less than 6 months on Lipitor, I developed the side effects of brain fog, muscle weakness, balance problems and slurred speech. I have stopped taking Lipitor and hope that the symptoms will cease, but they have not after 3 months.

I have been told by a neurologist that I may have a motor neuron disease based on a failing a nerve conduction study, and continue to seek clarification of my illness. My neurologist is now hoping to rule out ALS. Please do not take Lipitor or any statins."

also Jeff

[jayemcee]

I think a lot of people missed post # 24 in this thread. Well worth looking at again.
AL.

Indeed it is, Al.

also Jeff

[patricia1]

OK, I went to the FDA site and pulled up the package insert for Tetanus Toxoid Adsorbed. I was shocked by what I had found. The reason for my shock is that I have administered this vaccine to people in their tens of thousands throughout my career in trauma and orthopaedics and hospitals usually buy the stuff in bulk. Pharmacies in hospitals tended to remove the inserts from individual doses kept in multi-vial packages (single does glass vials in 5s and 10s)so I never got to see this information.

For clarity for people unfamiliar with this particular information, I have taken it from the package insert supplied by Aventis Pasteur and held by the FDA.

"Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines. A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré syndrome.

Other neurological conditions that have been reported include: demyelinating diseases of the central nervous system, peripheral mononeuropathies, cranial mononeuropathies, and EEG disturbances Certain neurological conditions have been reported in temporal association with some tetanus toxoid containing vaccines.

A review by the Institute of Medicine (IOM) concluded that the evidence favors acceptance of a causal relation between tetanus toxoid and both brachial neuritis and Guillian-Barré syndrome."

Patricia, I am so sorry to learn of yet another drug-induced route to ALS. :(

Kind regards,
also Jeff
Jeff I too am guilty of giving tetanus vaccine to thousands of people and infants I guess not enough people get reacts to take it off the market Like penicillin it kills some and saves others. I for one became veryill after the shot I has head tingling for days followed by a sterile abcess at the site,and then slurred speech, I also was on lipitor so who knows it all speculation Pat