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.
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/e...ez.Pubmed.Pubmed_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/e...ez.Pubmed.Pubmed_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=cach...tin+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/e...ez.Pubmed.Pubmed_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
