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364 thoughts on “The International Network of Cholesterol Skeptics

  1. raygee says:

    @ Harriet Hall

    Further back in the thread, you remarked that personal stories generated more heat than light.

    Would you not expect someone whose life was permanently altered for the worse by statin use to be angry and have strong views on the cause of their downfall, and do all in their power to help others avoid falling into the same trap.

    Surely it should be of the utmost concern for doctors to get to grips with methods of ameliorating the situation. Being medically qualified is assumed by many to mean that a doctor will have up to date knowledge of the operation and dangers of new drugs and their causes, for a universal medication programme like statination, one could be forgiven for believing that this is essential.

    I spent my working life in telecommunications, one still had to wind the handle to call the operator when I started, but we obtained our qualifications in the appropriate branches of technical knowledge and went on our way. But technical progress was continuous, and career long study was necessary to keep abreast of current practice.

    Is it not a little arrogant for doctors to presume that their qualifying knowledge is sufficient to cope with the problems set up by the many side effects of ever more system interfering drugs, with only the drug reps advice, as time goes on in their careers. Deeper understanding of the more molecular functions working within, as for the Krebs cycle, are needed when such basic processes are subject to interference from such things as statins and beta blockers, to name but two.

    Should it not be a priority for them to take the lead in searching for answers, and not besmirch the names of those who really are trying to stem the tide of the multi billion dollar onslaught.

    Why is it that an octogenarian such as I has to study the relevant portions of biologolical knowledge to point statin damage sufferers to hard-to-find information which can actually help them. why are there not hordes of doctors doing their utmost to help, instead of hiding behind totally irrelevant trial statements that such problems are extremely rare, and treating such patients as an embarassing statistical unit.

    Is not Farmgal, consigned to a wheelchair at 40 to be allowed to have her voice heard, or myself, struck with great weakness just as my dear late wife became affected by Alzheimers, with only me to care for her. One has to accept naturally occurring problems, but to dealt such a blow by a “safe”medication purporting to preserve one against one risk, when the makers already knew how and why damage occurs but did not reveal it, and the moguls of medical research and regulation did not pick it up, in spite of Dr Karl Folkers’ message, is beyond belief in such an advamced society as we have today.

    More individual efforts should be made to avoid continuing fresh dangers, and the efforts of those fighting against the brainwashed tide of profit motivated statin pedlars, should be applauded, and not trampled underfoot.

  2. jayemcee says:

    @ PaIMD
    [quote] Excuse the ad hom, but there is no discourse when one of the parties has fixed, false beliefs. [unquote]

    Excused.

    Technically speaking, you are correct about the nature of discourse and fixed and unshakeable ideas may seem to be vexatious and underpinning vacuous notions but the opportunity to change them is ever present.

    Belief is, on the other hand, a word that summons religion to my mind and when that way is followed then surely madness is the likely corollary.

    Disagreement is healthy for it is the agency by which we can all learn. Perhaps wisdom is knowing when persistence is no longer a useful attribute. ;)

  3. jayemcee says:

    @ Dr Hall

    [quote] After the ad hominem insults he spouted at me (above) this is really rich! Talk about the pot calling the kettle black!
    He has missed his calling as a comedian. [unquote]

    Where I come from it is a perfectly reasonable act to highlight gratuitous vitriol. I did that by means of using the same methods as you. The difference between us is that you are not particularly talented in the use of the gratuitous insult.

    Regardless of the bad start we had made, I still want to persist with moving the debate on the value of statins and the cholesterol/heart hypothesis forward. I had made my comment to PaIMD because the Haldol comment implied (at the least) that pec was suffering from schizophrenia, psychosis and delirium and possibly Tourettes. All patently false and all deeply insulting. The overall thrust of the comment was that pec was mad and had no insight into that fact.

    Later, PaIMD asked for the comment to be excused, and I have done so because it was accepted as an unnecessary comment by PaIMD. It wont prevent me from addressing any points that are made about statinisation nor will it prevent me from responding to PaIMD if I am addressed. I don’t believe that PaIMD is Satan because of one moment of thoughtlessness. See! Progress.

    You professing not to care then having another dig at me when a suitable moment presents itself, speaks loudly. I have stated that I had made a bad start and that I was not behaving well when I had responded to your first post… and the argument that “you started it” would not wash in any civilised circle. I was responding in an intemperate way because your casual dismissal of an earnest and highly regarded scientist was based in nothing but your personal prejudice.

    you said…
    1. “Its members “thinc” they are smarter than the average doctor.”
    2. “They “thinc” that cholesterol has nothing to do with cardiovascular disease and that we have been deluded into waging a “cholesterol campaign” for which the scientific evidence is non-existent.”
    3. “They tell us about those contradicting studies; but they don’t tell us about the flaws in those studies, they misrepresent some of the results, and they don’t tell us about the many good studies that support the cholesterol/heart link.”
    4. “As far as I can see, these folks have cherry-picked the literature to support an agenda. They seem to have a vendetta against statin drugs in particular.”
    5. “It provides “what the medical journals and newspapers won’t let you hear” – letters and papers that have been rejected for publication.”
    6.”These statements are not only false, they are potentially dangerous to the health of those who believe them.”

    The numbered clauses were written by you as evidence of your science. Any rational being would dismiss your commentary as emotional vitriol bereft of scientific merit.

    The fact that they are gratuitously vitriolic comments with not one iota of scientific merit, is precisely what had raised my ire. That you had sought to tar all of the THINCS membership with the one brush you had chosen to wield (to execute Dr Ravnskov) was inexcusable.

    If you want to address the science references which I have provided, I am more than willing to put our bad start behind us. If you wish to drop back into your mindless fishwife mode, just so you mete out whichever further punitive measures that you think I richly deserve, then do so, but please don’t be surprised if I refuse to tolerate your intemperate haridan personna.

  4. PalMD says:

    Just to throw it out there, one of the points made by the “skeptics” seems to lead to a difficult contradiction.

    We have always known that LDL levels are not the whole story, but at least a marker.

    We know there are subsets of patients who benefit from statins regardless of LDL levels (those with DM or CAD).

    So, I certainly agree that LDL is not the whole story (as would any physician), and we know that partly because there are patients who benefit from statins despite low LDL levels.

    This, of course, seems to mock the basic idea of the “skeptics” that statin=bad and no evidence can show otherwise.

  5. jayemcee says:

    @ PaIMD

    [quote] Just to throw it out there, one of the points made by the “skeptics” seems to lead to a difficult contradiction.
    We have always known that LDL levels are not the whole story, but at least a marker. [unquote]

    My thought is that a simple question and answer and the discussion anent the scientific support would clarify aspects of the debate. I may as well begin.

    What are the mechanisms responsible for varying the serum levels of cholesterol in individuals?

  6. pc says:

    PalMD

    [quote] This, of course, seems to mock the basic idea of the “skeptics” that statin=bad and no evidence can show otherwise. [unquote]

    Dr Malcolm Kendrick, who I believe is a member of THINCS, quite clearly states in his book, “The Great Cholesterol Con”, that if you have heart disease he strongly recommends you take a statin. So I do not think that the members of THINCS are totally against statins. What they are totally sceptical of is the cholesterol theory of heart disease. It would be dangerous of anyone to tell CAD sufferers to not take statins when we know there is a benefit to these people. (this benefit can be seen within days of starting the treatment. This strongly points to s statin effect totally unrelated to cholesterol lowering).

    [quote] So, I certainly agree that LDL is not the whole story (as would any physician), and we know that partly because there are patients who benefit from statins despite low LDL levels [unquote]

    I wish one of these physicians would speak to my cardiologist. As far as he’s concerned LDL is THE cause of heart disease.

    On a slightly different issue, it seems to me that the scientific community is only interested in developing drugs that lower cholesterol and do not seem to be looking at anything else. I think we are all agreed here that cholesterol is only part of the story but this does not seem to be interesting the pharmaceutical companies. What worries me is that because of this stance the cure for heart disease might be further off than it needs to be.

  7. PalMD says:

    That’s a great question…i’m going to wait and see if one of my betters answers it first, so that I won’t look too foolish…

  8. raygee says:

    @PalMD

    I am concerned that you do not recognise the unpredictable nature of the occurence of statin side effects, the reduction of other essential products in the mevalonate pathway when cholesterol is reduced can cause problems at any age and early or late in the treatment process. The fact that essential factors in the production of ATP for energy are depleted means that whatever function’s mitochondria is starved of energy that is also unable to function. The multiplicity of cells performing the same duty means that the loss of the odd one might be tolerable for the time being, but should by chance a large proportion of the same function become deprived at the same time, disaster!!

    The effects are more likely to occur in older patients, because their supply of Q10 is decreasing naturally, and so insufficiency will be felt sooner. I feel so strongly that this effect may occur anywhere, thyroid problems are mentioned on wustl university website, there is definitely an effect on diabetes, and the possibility of bringing forward macular degeneration has been noticed elsewhere, and has been passed to Cochrane to investigate.

    Heart failure symptoms can arise, as in my case, not because the muscle is damaged, but because such a large quantity of ATP is needed to supply pumping energy, (1000+ mitochondria per muscle cell) and angina and raised Blood Pressure occur. Muscle problems can arise from carnitine supply damage, giving either muscle wastage, or severe pain due to the inabilty to take away the products of energy production, causing lactic acidosis.
    Peripheral neuropathy is also fairly common, but also difficult to deal with, often persistent, and carpal tunnel type symptoms.

    These problems are often thought to be natural occurences, and the usual treatment applied , without success.

    I am afraid that the possible and actual effects are almost endless, but are so often seen in those asking for help on appropriate websites. The officially listed side effects are not the whole story, but fortunately, supplementary Q10 and/or carnitine may help, but are often a permanent necessity.

  9. PalMD says:

    That’s all lovely, but the data doesn’t support your hypotheses

  10. Harriet Hall says:

    I’m thinking perhaps I was remiss in not giving specific examples of the kind of distortions promulgated by THINCS. I covered many of these in correspondence in Skeptic magazine and on the JREF forum.

    THINCS member Kauffman said, “cholesterol is highly protective against cancer, infection and atherosclerosis.” His reference for this is not supportive data, but a speculative piece by Ravnskov entitled “High Cholesterol MAY protect against infections and atherosclerosis.” Cancer is mentioned nowhere in the referenced article.

    He cites a plaque progression study as evidence against statins but neglects to mention that all patients in the study were already on statins because the authors recognized their efficacy.

    He makes the J-LIT study sound like it shows low cholesterol to be a hazard, yet this study showed a clear relationship between higher LDL cholesterol levels and coronary events, and it did not recommend avoidance of statins, only close monitoring of those whose LDL levels drop very drastically with treatment.

    He reports that another study showed statin use could be associated with an increase in mortality of 1% in 10 years; the study actually showed that statin use was beneficial in all but the lowest risk groups. The authors concluded that the risk outweighed the benefit only for the lowest risk groups, and they recommended statins for patients whose overall risk was greater than 13% in 10 years.

    These are just a few examples. There are many more. My criticism of THINCS is based on their misrepresentations of evidence and gross errors in logic (which Bob Carroll addresses in Skeptic’s Dictionary). It is not based on my opinions.

    While I deplored their thinking, I actually had a rather good opinion of the individuals in THINC after my prolonged polite interactions with Marshall Deutsch. Jayemcee is making me reconsider.

  11. Harriet Hall says:

    I’d like to throw out a thought for consideration. If we disregard the results of controlled studies in favor of individual reports of harm, aren’t we in danger of giving up a lot of useful treatments and harmless products? The horror stories promulgated by groups like the anti-vaccinationists and the anti-aspartame folks come to mind.

    Individual reports are important. After-marketing surveillance is essential. Personal testimonials can point to areas where further research is needed. But sober scientists do not use them as a reason to ban a product until meaningful data can be collected in a controlled fashion.

  12. raygee says:

    @PalMD

    But what data? There so many reasons, of which I have quoted a few, why the data is incomplete, run-in periods, failure to realise what is a statin side effect, and performance and recording of trials in the hands of researchers dependant on manufacturers finance. I have long observed in many walks of life that if the sponsor/ manager calls for good statistics, he will get them, but the extent to which people will go to produce those figures doesn’t bear thinking about.

    There are also trials, as one mentioned by Harriet earlier, where the triallists are not aware of the mechanism by which things come about, it is of no value to examine muscle weakness and statins unless those individuals have been affected in that particular manner.

    Letters in the BMJ note that trial results often show favourable outcomes for the drug being sponsored.

    Until there is much more transparency in studies and research, or a completely independent body to carry them out and oversee them, they are often little more than sales promotion operations

    @Harriet

    I am in full favour of properly organised and in depth trials, and would support the outcomes if, and only if, they are carried out by organisations without reliance on the manufacturer for some of their income. In UK, a parliamentary select committee reported that 70% of drug research was financed by industry,. Now that might mean all institutions relied on getting 70%of their income that way, or at the other extreme, 70% of them relied 100% upon it. in the first instance, the use of their independant income for projects not in line with their major sponsor’s wishes, could jeopardise the larger part. There are many stories of the heavy hand being used or threatened, and there are large numbers of departments and careers which could be threatened.

    I suppose the great ogre is the drug industry, with financial power enough to challenge governments. The Codex Alimentarius committee, reportedly made up of drug industry employees, has managed to get the WHO/WTO to try to force all nations to regulate or ban many non drug supplements, carnitine needed for statin damaged folk is only available on prescription in Canada. If that were the case here, my £10 per month supply would cost £700, and nemesis would once more loom.

  13. Harriet Hall says:

    Raygee,

    I share your concern about biased researchers, but I don’t think it is fair to automatically dismiss studies just because they get some or all of their funding from pharmaceutical companies. Most scientists try hard to do good research because their reputations and future funding depend on it. I don’t think the drug companies could suppress important data for very long no matter how hard they tried. Remember Phen-Fen? – it didn’t take long for the information to get out and the drug to be taken off the market.

    And there is coherence in the data from different sources and different lines of investigation. I’m keeping an open mind, but I’m not willling to throw out all the existing research unless we can find clear evidence of fraud.

  14. PalMD says:

    BTW, this is the best blog EVER.

  15. farmgal says:

    Hi Harriet,

    I don’t think I can make the leap, “individual reports of harm” to “harmless products”. If they are in fact “harmless” where do individual reports of harm come from?

    I have to tell you, I relied on the FDA and many statin studies that I read to be assured they were in fact, quite safe.

    I was told that regular blood tests to monitor for any liver or muscle problems would add an extra layer of safety, so how could I go wrong taking it? I never had a single blood test that indicated a problem, and ended up in this mess anyway.

    I even heard of doctors taking statins “off lable” cause they were such a great, wonderful, and SAFE drug.

    Even with everything that happened to me personally via statin therapy, I would not be here, if I thought I was in fact a “RARE” case.

    It is all the other accounts, in real life, that makes it quite obvious, statins are not “harmless” by any stretch of the imagination.

    Most of the people I have spoken with about their statin experience did not stop taking them after just one negative outcome. They have been urged by their doctors to try again, some folks have been on every brand of statin available. In other words they have been “rechallenged” several times with the same results.

    Some of us out here in lay person land, do rely on something called “common sense”. If it quacks like a duck, walks like a duck, and poops duck poo on my sidewalk, I don’t need a DNA study to call it a “duck”.

    And I have to wonder, of those particpating in this discussion defending the statin class of drugs, how many are taking statins. For how long? At what dose?

    And please, don’t say you don’t need a statin, because your cholesterol is fine. With the lower and lower cholesterol targets, it would be a rare individual indeed, that would be exempt from the statin recommendation.

    I would hazard to say that those pointing to statin studies to tout how safe and beneficial statins are, have not ingested a single statin dose.

  16. UK-Bloke says:

    I have read some very good arguments and seen a lot of valid points being aired, what I cannot see is the reason for the Dr’s responding so harshly or treating what has been said as unimportant to what they have to say or want to hear.

    Statins have been prescribed for many years now, if it wasn’t for people like the Doctors in Thincs or sites like Spacedoc.net and others bringing the problems out in the open, many people like myself would be much worse than we already are after years of statin therapy.

    As far as Doctors knowing about the side effects of statins, you just do not know how wrong you are!

    My doctor and other specialists I have seen have only just started to realise that there is a connection between statins and my problems and that is only because I mentioned what I had found online and one doctor looked into it.

    Like other folk who have posted here about the effect that this “wonder drug” has had on them, I also know far too many other people that have had adverse effects from taking them. Q10 and Carnatine as mentioned elsewhere in this blog are a great help but can be expensive and it isn’t a cure.

    To all of you Doctors,

    maybe some of what has been mentioned is not 100% accurate but neither is any of the results that the drug trials state, instead of putting folk down why don’t you open your eyes to what is happening in the real world, maybe your patients would tell you what problems they may be having if you would only listen before dismissing what you do not want to know.

    The people at Thincs may not have proven everything they said but at least they went out on a limb to help people to realise that there is a problem.

    What have you done that will make a difference to so many real people?

  17. Harriet Hall says:

    farmgal,

    You ask a legitimate question: where are the reports of harm coming from if they’re not due to the drug?

    Please note that no one is saying statins are harmless. We all agree that they can harm. The question is how often, and the only way to answer that question is with good science.

    Some of the reports are of actual harm from the drug; but some reports may falsely blame the drug for something that it did not do. One of the logical fallacies people are most prone to is the post hoc ergo propter hoc fallacy: I was taking drug X when I got symptom Y, therefore X must have caused Y. They don’t stop to consider that Y might have happened for other reasons. Correlation does not prove causation. If the sun comes up every time the rooster crows, that doesn’t mean the crow raised the sun.

    There have been innumerable sad reports from parents of autistic children who are firmly convinced that because they noticed the autism after vaccination, the vaccines caused autism. This has been thoroughly refuted by good science, but the “victiims” refuse to accept the science because personal experience is so convincing.

    There are people who are convinced they get headaches from aspartame, but double blind studies have shown that they don’t get headaches if they don’t know they are getting aspartame. People have blamed aspartame for all kinds of symptoms and diseases from insomnia to brain tumors. These symptoms would be occuring in some people today if aspartame had never been discovered. The evidence does not show that they occur any more frequently in people using aspartame than in people not using it.

    I mentioned before that muscle pain is a commonly reported side effect of statins, but it may occur even more often in patients taking placebo! Look at any list of side effects of any medication compared to the side effects of the placebo control. If you assumed all reported symptoms were due to the drug without realizing how many might have happened anyway, you would be making a big mistake.

    The bottom line is that counting people who have had symptoms after taking a drug is meaningless until you compare them to the numbers of people who have had similar symptoms but did not take the drug. I know this seems counterintuitive, but humans are very prone to misattribution, and the only way to avoid misattributions is the scientific method.

  18. farmgal says:

    Harriet,

    I totally understand and appreciate what you are saying. I am aware of the many issues that cloud the venture of obtaining solid answers.

    For me, one thing I hear time and again, is that people have been repeatedly convinced to try another statin. In these cases, when symptoms return upon rechallenging, it become less likely that the statin is faultless.

    I do agree with your rooster example. However with rechallenging, it is more like a light switch. ON…symptoms…OFF…no symptoms…ON more symptoms. In this case there is a direct cause and effect between the light switch and the light going on and off.

    The best of science is full of peril and the unknown. Since we know more now than any time in history, we tend to deem ourselves pretty superior compared to the day of blood letting as a treatment. In the bigger picture, we are still taking baby steps in our knowledge.

    It seems the ability to develop new drugs has outpaced the ability to understand the complex and unpredictable effects on the human body.

    When you combine that with, for instance, the recent Vytorin case, it gets very worrisome. There are enough problems with good science, let alone drug companies that manipulate and hide negative results.

    Add that to slick marketing, relative risk vs absolute risk, doctors that are blowing off complaints (see study I posted above), then I have to question how accurate the data is when sizing up any drug.

    A very wise doctor once told me that “tests can’t think that is my job as your doctor”.

    The same applies to study data. But first the data has to be accurate, complete and honest.

  19. pec says:

    “One of the logical fallacies people are most prone to is the post hoc ergo propter hoc fallacy: I was taking drug X when I got symptom Y, therefore X must have caused Y. They don’t stop to consider that Y might have happened for other reasons.”

    Medical researchers are just as prone to that fallacy as the rest of us. Statins lower cholesterol so you assumed that lowering cholesterol prevents heart disease. You didn’t stop to consider that statins might prevent heart disease for other reasons.

  20. pec says:

    “It seems the ability to develop new drugs has outpaced the ability to understand the complex and unpredictable effects on the human body.”

    That is so true farmgal. The new drugs are artificial substances and evolution has not prepared our bodies to deal with them. Statins interfere with intricate natural processes which are part of a complex network that is very poorly understood by science. When statins interfere with the production of cholesterol they also interfere with the production of other substances which the body needs. We cannot possibly predict how this will effect the body over years or decades.

    The current philosophy in medicine is reductionist and often fails to look at the system as a whole. It also tends to focus on treating symptoms rather than searching for causes. And it often neglects to worry about long-term unforeseen consequences.

    I do not think the drug companies intend to cause harm and most people who develop drugs probably believe they are serving humanity. But what Harriet does not see is that the natural human talent for self-deception is just as prevalent among medical researchers and MDs as it is among the general public.

    Medical professionals and other scientists have a tendency to feel their education has raised them above the common level. They have the power to avoid logical fallacies and to zero in on truth.

    But Harriet the sad fact is that all of us, highly educated or not, fall into logical fallacies every day. We all think we know much more than we really do. We are all nearly complete ignoramuses, no matter how we read and think and study. Most of nature is utterly beyond our ability to comprehend.

    Yes sure our knowledge increases, but we go from .01 percent of infinity to .02 percent of infinity. Our ignorance is still infinite.

    No one has a reason to look down their nose at the non-medical public with its common sense and its logical fallacies. You are an example — with all your medical experience, you still never noticed the logical fallacy of assuming, without evidence, that statins work by lowering cholesterol.

  21. jayemcee says:

    @ Dr Hall

    [quote] I share your concern about biased researchers, but I don’t think it is fair to automatically dismiss studies just because they get some or all of their funding from pharmaceutical companies. [unquote]

    It comes down to whether it is reasonable to try and serve more than one master. Many studies are completed and the data are taken away for examination and writing up by the pharmaceutical company that paid for the study. Under that sort of arrangement it is unlikely to be a study that is impartial in every aspect.

    [quote] Most scientists try hard to do good research because their reputations and future funding depend on it. [unquote]

    Finally! We agree on something. Of course, the term ‘good research’ is relative, and it is a variable that is only used by whomsoever is paying for the research. The future funding is also an important issue and will decide what gets left out and what gets included.

    Proof? As if it were really required but try this on for size. This is taken directly from the document held by the National Cholesterol Education Program.

    The URL is here…

    http://www.nhlbi.nih.gov/guidelines/cholesterol/atp3upd04_disclose.htm

    This document is a part of the third report of the expert panel on Detection, Evaluation and Treatment of High Blood Cholesterol in Adults (Adult Treatment Panel III)

    It cannot be right that the august expert panel of clinicians that decides what the national treatment guidelines will be are all receiving honoraria, research grants and have been paid consultants and hold stocks in the very drug companies that produce statins and bile acid sequestrants… can it?

    Only one clinician had nothing to disclose.

    How can these opinion forming clinicians be permitted to speak for the profession and decide on treatment policies when they are receiving pecuniary gains from their secondary paymasters? Just must not only be done but it must be seen to be done and I have no problem with clinicians making whatever sort of living they feel is appropriate.

    The right to speak publicly (on matters which they have been paid by pharmaceutical companies to advise the company about) should be automatically withdrawn, as should the right to publish drug company research in any of the medical journals. Think of it as a career choice, where the clinician in question put large sums of drug company money and the elevated status that goes with huge research grants, before healing the sick. It appears to be a reasonable trade-off.

    In my experience, senior clinicians are in the perfect position to ensure that the required findings are found.

    [quote]I don’t think the drug companies could suppress important data for very long no matter how hard they tried. [unquote] Pfizer’s abandoned atorvastatin/torcetrapib trial in December 2006… that just so happened to kill too many guinea pigs? Please tell me where I can find the data about that trial.

    Merck had filed the CoQ10 patent on January 18th 1989. How long has it taken to get the CoQ10 message out to prescribers? If care of humans was a part of their brief, January 18th 1989 would have seen Merck release a press communique telling the world about the value of CoQ10 combined with statins. As it stands, many clinicians have no clue about CoQ10 depletion or its dreadful sequelae.

    Presumably plan B was for Merck to market their own combination as gravy train patents began to expire and generics were being permitted. Then an original patent holder (Merck) could have pointed to the inferior generics without the vital CoQ10 added, while holding yet another highly lucrative 20 year patent themselves. Tell me it isn’t so and I will demand my refund from my business 101 class.

    [quote] Remember Phen-Fen? – it didn’t take long for the information to get out and the drug to be taken off the market. And there is coherence in the data from different sources and different lines of investigation. I’m keeping an open mind, but I’m not willling to throw out all the existing research unless we can find clear evidence of fraud. [unquote]

    Clear evidence of fraud is the list of clinicians advising the NCEP and their disclosed list of ‘interests’. I don’t share your enthusiasm for the speedy withdrawal of faulty drugs as a given. Remember Thalidomide? It was sold during the 50s and 60s for around 4 years. It went under something like 40 different names and it was licenced for sale in something approaching 50 countries.

    Yes, you are correct. We can all trust that the drug companies will act swiftly to save patients from harm and the medical profession will rapidly provide the coherent data. ONLY 10,000 children suffered with severe birth deformities. It was a disaster that prompted the US Congress to enact legislation that demanded safety testing before a drug could be prescribed during pregnancy.

  22. jayemcee says:

    @ PaIMD

    [quote] That’s a great question…i’m going to wait and see if one of my betters answers it first, so that I won’t look too foolish… [unquote]

    Since there has been no other response perhaps you would care to discuss it with me.

    I promise not to laugh…

    Your rider raises an interesting point. If the very clinicians who are prescribing statins are wary of discussing these issues, is there any way that a patient can make an informed consent to be statinated?

  23. Harriet Hall says:

    pec,

    I am really, really getting fed up with your nonsense. Here you go again: “Medical researchers are just as prone to that fallacy as the rest of us. Statins lower cholesterol so you assumed that lowering cholesterol prevents heart disease. You didn’t stop to consider that statins might prevent heart disease for other reasons.”

    I not only stopped to consider it, I have said so several times in my original article and in the comments. Statins have other effects besides lowering cholesterol, including antiinflammatory effects. When the LDL level is lowered with statins, cardiovascular risk decreases. You are free to attach whatever meaning you choose to that, and you may choose to think the lowered cholesterol is nothing but a marker for some other beneficial effect of statins. I wouldn’t argue with that. But the fact that the lower the cholesterol level, the lower the risk is indisputable.

    You say, “But what Harriet does not see is that the natural human talent for self-deception is just as prevalent among medical researchers and MDs as it is among the general public.”

    I do see it. I not only see it, I know that rigorous use of the scientific method is the only way we can hope to avoid fooling ourselves. In fact, that is the whole point of this blog. How could you miss that? What did you think the blog was for?

    pec, I can’t believe you are incapable of reading and understanding simple English. I can only assume you are deliberately pretending to misunderstand and putting up straw men just to cause trouble. It really makes me angry when you say I don’t think something that I just got through saying I think. You have done this over and over. Please stop it.

  24. jayemcee says:

    The Thalidomide numbers were incomplete… must have fallen off the end of my post.

    4 years sales is 1461 days

    10,000 birth deformities is equivalent to approximately 7 children being born every day for 4 years.

    Good job, Grünenthal

  25. jayemcee says:

    Inflammation and heart disease – some reading

    Cutting Edge: T Cell Ig Mucin-3 Reduces Inflammatory Heart Disease by Increasing CTLA-4 during Innate Immunity

    (from the year 2006)

    http://www.jimmunol.org/cgi/content/full/176/11/6411

    In search of the grail: the never-ending story of biomarkers for coronary risk prediction

    (from the year 2004)

    http://eurheartj.oxfordjournals.org/cgi/reprint/25/15/1271

    Low grade inflammation and coronary heart disease: prospective study and updated meta-analyses

    (from the year 2000)

    http://www.bmj.com/cgi/content/full/321/7255/199

    Band neutrophil count and the presence and severity of coronary atherosclerosis.

    (from the year 1996)

    http://pt.wkhealth.com/pt/re/amhj/abstract.00000406-199607000-00002.htm;jsessionid=HnLC3p4nQM9SSG0Tg2WZtLQg3G0GyyqP5BTH96RPTvjBYy2W3qJ1!-809317659!181195629!8091!-1

  26. Harriet Hall says:

    Thalidomide, like phen/fen, is an example of recognizing a problem and removing the drug from the market in a timely manner. It was a particularly interesting drug, because it was perfectly benign in most patients, and passed initial testing with flying colors. It was even sold over the counter in Europe. The connection to birth defects was not easy to detect, because it was only a danger when taken in a small window of a few days in early pregnancy – between days 20 and 36. Pregnant women could take it with impunity before and after those dates. It was a tragedy, but within a short time it was recognized and appropriate action taken. Teratogenicity studies sound like a good idea, but they’re fallible. A drug can be safe for one species and teratogenic in another. Aspirin is teratogenic in mice and would never have been approved for humans because they would never have learned that it isn’t teratogenic in humans. At any rate, we are now doing better testing, and thalidomide was never approved for marketing in the US, so for once our much-maligned FDA did something right.

    I think the thalidomide story just reinforces my contention that if a drug has serious side effects that fact can’t remain unrecognized for long. In both the fen/phen and thalidomide cases, doctors noticed the problem, published reports, and then the drugs were off the market in short order. If there was some conspiracy to suppress the truth, it sure did’t work very well.

  27. kathleen says:

    Dr Hall
    I have recently been told that my cholesterol is high and have come across a multitude of conflicting views about what this means and what should be done about it. Can I just thank you for your sensible, rational approach. It has helped me enormously. Great blog.

  28. pc says:

    I am deeply concerned that this discussion is developing into a bit of a slanging match. Can we try getting back to a factual discussion about Statins, heart disease and potential solutions?

    I have CVD and am desperate for the medical world to come up with an answer to the problem. When I was diagnosed with CVD I had none of the risk factors. I was not overweight, my cholesterol was 4.87 (in UK currency) and there was no family history of heart attacks. My cardiologist said I had just been unlucky (not very helpful).

    All of this makes me sceptical of the cholesterol theory of heart disease. My own investigations into the subject only raised more questions, rather than answered any. So let’s get back to a proper discussion.

    To jayemcee I would like to say I know you have suffered at the hands of Statins (I am not completely enamoured with them either). I have read about your experiences on the spacedoc forum. However not everyone has suffered like you and the rest of the correspondents on that site. Statins, for some people, are their only hope of making it to old age to enjoy their retirement. Until something better comes along we are stuck with them. Also I have to object to this conspiracy theory stance you are taking. I admit there are some dodgy doctors and some unscrupulous companies (a view rather unfortunately borne out of the recent ENHANCE debacle) but on the whole these people are working hard to find solutions to very difficult questions. They do not always get it right (as I believe with the current cholesterol theory) but this does not make them bad people. Yes they need people to question their research and findings but they do not need to be hounded so vociferously.

    I am a programmer by trade and so am quite accustomed to writing an application that works fine in my test environment but as soon as I start dishing it out to the customer things start going pear shaped. Some may argue I did not test it enough (and they might be right) but the bottom line is sometimes these things happen. Problems that appear in the real world do not materialise under test. So is the case with Thalidomide from the 60’s. I agree my application going wrong is nowhere near as serious as a drug going wrong, but it does not mean that the scientists and doctors did not do their jobs properly.

    So let’s get back to a healthy, friendly discussion.

  29. jayemcee says:

    @ Dr Hall

    [quote] It was a tragedy, but within a short time it was recognized and appropriate action taken. [unquote]

    I understand what you have said.

    The passage of 4 years would seem to be stretching the definition of ‘a short time’.

    I accept that there was a small window of danger, with the likely corollary that an adverse reaction of teratogenicity was perhaps initially difficult to ascribe to the drug.

    I don’t happen to believe that drug company executives sit around discussing their next scam to make money (well not quite in those terms anyway) but there seems to be a general reluctance to accept the mountains of anecdotal accounts of drug-induced harm that may well provide an earlier warning than current formal reporting systems permit.

    In 100 self-reported accounts of statin adverse reactions, I had noticed 5 people complaining of ALS/ALS-like symptoms. This is not a self ascribed diagnosis. It is made by suitably qualified clinicians and it suggests that far more people than the expected number of 2 cases per 100,000 people are dealing with a tragedy.

    We could await the advent of well-designed studies that ask and answer a single question and when all of the component parts of this conundrum have been examined and all of the relevant questions asked and answered, we may conclude that statins and their activity may be a pre-cursor of ALS.

    How many good research projects and knowledgeable scientists will this take? What sort of time scale are we going to be looking at? How many people will be needlessly damaged by the delay? Instead of dismissing all reporters as cranks and non-scientists, it would behove the medical profession to call for the establishment of a short moratorium on prescribing, while the phenomenon is examined.

    I know that there will be people who will claim that this approach may be harming people if we do not let them take statins. Of course, death certificates never say that the cause of death was that the person did not have sufficient statins in their body. It is far too easy (given the specialist knowledge that medics enjoy) to dismiss the words of lay-people.

    Perhaps an approach that can respect what the patient says to the clinician would be better. If the patient is talking nonsense, it should be an easy matter to disprove it and to remove any anxieties that the patient may express. On the other hand, if the clinician cannot address the patient’s concerns with science (and be certain that they themselves understand the issues) then warning bells ought to be sounding in the head of the clinician, in my view.

    UPDATED: In 300 self reported cases of stain adverse reactions, I have now come across 9 cases of ALS. However I dress it up, it would seem to be excessive. We can argue about RCTs and double-blind trials until we have blue faces. It is futile and it denies (the people who have made these reports) access to our most diligent efforts.

    I have not specifically trawled for ALS sufferers and I have not offered any inducement for ALS sufferers to come forward. I am aware of the so-called viral effect of internet information but I don’t feel that is the sole reason why I am seeing what I have seen.

    What if the patients are right? Who will prevent further iatrogenic harm. It wont be the drug companies that have only the one interest and that over-riding duty to their shareholders bank accounts. Only clinicians can stop this statin gravy train in its tracks. Dismissing the anecdotes of patients is far too easy.

    I would also suggest that it is entirely wrong-headed.

  30. pec says:

    Harriet,

    I agree with you that the truth cannot be hidden for very long. I don’t believe in giant conspiracies to fool the public. The results of research eventually come out. And patients talking about their experiences, as on this blog, can also make a difference.

    As I have said, I have nothing against science. But unlike you I also respect and consider personal experience. Clinical trials take a very long time and must be extremely expensive.

    How many years did it take before they discovered the dangers of HRT for women, for example? Millions of women took their doctors’ advise and went on hormones. I didn’t, of course, because it was perfectly obvious to me that messing with nature has unforeseen consequences. If I were not so skeptical of the reductionist approach, I would have gone on HRT and found out years later that it may have been harmful.

    So I agree with you that science is valuable (especially when it avoids reductionism) and I agree that all humans are limited and fallible and capable of self-deception. I do not agree, however, that science saves us from error. We have to use common sense most of the time, while years for research results.

    We can’t get all our questions answered by research because many of our questions are not asked, and many others will take years to answer.

  31. pec says:

    Harriet,

    I agree with you that the truth cannot be hidden for very long. I don’t believe in giant conspiracies to fool the public. The results of research eventually come out. And patients talking about their experiences, as on this blog, can also make a difference.

    As I have said, I have nothing against science. But unlike you I also respect and consider personal experience. Clinical trials take a very long time and must be extremely expensive.

    How many years did it take before they discovered the dangers of HRT for women, for example? Millions of women took their doctors’ advise and went on hormones. I didn’t, of course, because it was perfectly obvious to me that messing with nature has unforeseen consequences. If I were not so skeptical of the reductionist approach, I would have gone on HRT and found out years later that it may have been harmful.

    So I agree with you that science is valuable (especially when it avoids reductionism) and I agree that all humans are limited and fallible and capable of self-deception. I do not agree, however, that science saves us from error. We have to use common sense most of the time, while waiting years for research results.

    We can’t get all our questions answered by research because many of our questions are not asked, and many others will take years to answer.

  32. marblue says:

    Again, I’d like to see cardiologists and internists take at least some time driving home the importance of lifestyle change. They should hire a nurse or assistant to do this if they don’t because of time constraints.

    And, we’re talking minimal lifestyle change giving one the same results as one can get from statins.

    Here’s an example from one physician who couldn’t take statins:
    http://health.usnews.com/articles/health/heart/2008/02/06/lowering-ldl-cholesterol-without-drugs.html

  33. PalMD says:

    Perhaps, Jay, given that your collection of anecdotes has never been investigated by a professional, as far as you or I know, and that millions of cases have been monitored, and hundreds of studies have been done…given that, perhaps your anecdotes are not the best evidence.

    The plural of anecdote is not “data”. Modern medical decision making is impossible without statistics.

  34. daedalus2u says:

    jay, I have looked and can’t find any evidence to support any association between ALS and statin use. The incidence of ALS hasn’t changed much over the time that statin use became common.

    http://www.ncbi.nlm.nih.gov/pubmed/15990445?ordinalpos=187&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum

    If the incidence of ALS didn’t change when statins were introduced, than statins are not a cause of ALS.

    Given that so many people are taking statins, it is likely that some of them will get ALS. But if there is no increase in the incidence of ALS when statins are used, then statins are not causing ALS.

  35. Harriet Hall says:

    9 cases of ALS in 300 self-reports of statin adverse reactions? What does that even mean?

    If those 9 people had reported auto accidents instead of ALS, would you conclude that statins caused auto accidents? Would you stop to ask how many people have auto accidents when they are not on statins? Would you stop to think that statin takers might have the same incidence of auto accidents but might be falsely attributing them to statins?

    It is a gross calumny to suggest that doctors are dismissing patient’s anecdotes. We take them very seriously, but we try to understand what they really mean rather than jumping to conclusions or panicking.

    I think we’re all in favor of better post-marketing surveillance programs. But few would agree that unexamined anecdotal horror stories are enough to justify a moratorium on prescribing a drug that is known to save lives.

  36. PalMD says:

    Responding to above, I prescribe statins based on evidence based guidelines. My biochem is not up to date, but because of my education and background, I can catch up very quickly when needed.

    The fact that I don’t keep the minutiae of cholesterol metabolism memorized hardly disqualifies me from prescribing statins, any more than not being an electrophysiologist prevents me from prescribing metoprolol and warfarin for atrial fib.

    I’m sorry but the comment was (ad hom warning) idiotic.

  37. jayemcee says:

    @PaIMD

    [quote] Perhaps, Jay, given that your collection of anecdotes has never been investigated by a professional, as far as you or I know, and that millions of cases have been monitored, and hundreds of studies have been done…given that, perhaps your anecdotes are not the best evidence.

    The plural of anecdote is not “data”. Modern medical decision making is impossible without statistics. [unquote]

    I agree that anecdotes don’t constitute data, for they are two different animals. All clinical care is based on the anecdote discussed by the patient, where they are conscious and capable of giving the relevant history of their complaint.

    Time and experience may permit the clinician to arrive at a working diagnosis in cases of say… the gross deformity attending a bimalleolar fracture. In such cases the history provides corroboration of the clinicians suspicions. Subtle clinical signs, if unusual, may also alert the well-read clinician to possibilities that would be missed by junior clinicians.

    Would, for example, angor (if associated with precordial tightness/pain) direct your mind to the possibility of myocardial infarction, absent a 12 lead ecg reading? A positive apprehension test, when dealing with an account of a presenting complaint history that sounds like a possible dislocation of the patella, would alert a clinician to the veracity of the account.

    Taking the patient’s anecdote at face value is unlikely to blind an alert clinician to the underlying problem. I am not sure that I can support the idea that patients will deliberately lie (with notable exceptions that have pecuniary gain, secondary benefits of illness and abuse of drugs) when trying to get a clinician to understand what is happening to them. If people feel unwell, then they would usually want to feel ‘better’ as soon as practicable.

    People spontaneously claiming they have developed ALS would seem an odd way to get enjoyment out of life. It is undoubtedly not data but the numbers suggest that something may be happening, that we are just starting to learn about. I wont gainsay it because the possibility of neurological damage being caused by the biochemical action of statin therapy is a very distinct possibility.

    The 4 papers that I had referenced earlier deal with cellular destruction that is well within the ambit of statins to create. I have seen no evidence to refute the role of heme a, as laid down by Professor Ames. My crie de coeur is that some system of hearing the patients, that does not rely on the yellow card system or the FDA, is required in addition to the pre-existing systems.

    I consider it interesting that statinated patients are complaining of the development of ALS, in what appears to be greater numbers than the incidence rate generally accepted. Hearing that peripheral neuropathy, total global amnesia and ‘foggy’ cognition are all complained about by patients who have been taking statins, it should not be so difficult to consider the small step to thinking about the possibility of catastrophic disruption of the neurological system.

    I would stress that this not wish fullfilment on my part and I desperately want to be shown that I am as wrong as it is possible to be… for the alternative is far too horrible to contemplate. The research required is expensive and time consuming and the funding of such an enterprise is unlikely to be easy.

    Whither the patients who develop ALS post statinisation and if there is a link, who will protect the patients who will be statinated? The lack of data has these people falling below the clinically significant line, just as in studies that were not looking for whatever malady carried the trial patient off. I can do no more than sound the cautionary bell.

  38. PalMD says:

    You have created a non sequitur. The point is not that patients are untruthful…Of course, every day medicine is individual encounters, informed by evidence based medicine.

    The point is, if I were to use each patients experience to try to form evidence based decisions, I would be doing bad science and bad medicine. EBM informs decisions that you make for individuals and their situations. Individual anecdotes do not, conversely, form data.

  39. Harriet Hall says:

    Jayemcee repeats his claim that “statinated patients are complaining of the development of ALS, in what appears to be greater numbers than the incidence rate generally accepted” but he has offered no information that would support that claim. Daedalus has offered evidence that would tend to refute it.

    No one has suggested patients are lying about ALS. We don’t question that they have ALS; we question whether ALS is more common among patients taking statins.

    Just as the “anecdote” of reported symptoms is the beginning of the diagnostic process for individual patients, multiple anecdotes of symptoms in patients taking statins must be the beginning of a diagnostic process to determine whether those symptoms are due to the drug.

  40. daedalus2u says:

    jay, the “cause” of ALS remains unknown. The incidence hasn’t changed much during the time that prescriptions of statins went from zero to many millions. If statins were a significant cause of ALS, the rate of ALS would have gone up. It hasn’t gone up, therefore statins are not a significant cause of ALS. No matter how much the symptoms of statin induced muscle damage mimic those of ALS, if there is no change in the incidence of ALS, statins are not causing it.

  41. UK-Bloke says:

    @ jayemcee,

    I have read all of your posts up to the present in this Blog and I am pleased to see someone who is in touch with the real world and what actually is happening to this day when it comes to statins.

    The medical profession have had around 20 years to sort out my particular poison and yet here we are today and we are still being made to look foolish by DRs who obviously have not seen past what is selectively laid out for them to read.

    Why on earth in that length of time are doctors still unaware of the severity and frequency of side effects and blindly prescribing this rubbish to unsuspecting patients.

    When I have read on other sites, the very same symptoms that I have mentioned to my own doctors over the years and seen that the poster’s were also made to believe that it was nothing or you are just getting older etc it makes me very angry.

    Most of the papers written from trials for statins and other drugs contradict themselves or have been poorly set out and even interpreted to give a false or rather enhanced outcome.

    Remember in years to come when people say can you remember that Doctor who wrote about ????, what a plonker he/she was, always trying to be clever and talking utter rubbish well I think a few of the names I will remember are in this Blog.

    My excuse for being sceptical are 1 MI 12 years of Zocor-Simvastatin and a triple bypass and most of the symptoms that come with taking statins (the ones doctors don’t know exist for some reason).

    If anyone needs any information about false or misleading results, all you have to do is Google “statin side effects” and plenty of newspapers, TV and Radio reports as well as many sites there for your selection. You will also have access to many Medical sites where the written papers are published.

    Even youtube has a Talk given by Dr Malcolm Kendrick and a few others. There are links at THINCS for Dr Malcolm Kendricks meeting of the Leeds branch of the Briish Medical Association

    If anyone has not actually looked at the THINCS site and read what is there then you are really missing a lot of good and valid material. Whether you are a supporter of statins or a disbeliever it is a pretty darn good site to see what has gone on in reality and not someone trying and failing to be a critic of any notability.

  42. Harriet Hall says:

    I hope readers will follow the advice of UK-Bloke to read what is on the THINCS website. I hope they will seek out the original sources that the THINCS folks quote and be able to recognize how THINCS misrepresents those findings by quoting out of context, selective quotation, and putting their own spin on the way they report the studies. I hope they will also seek out the studies that THINCS does not mention, the many studies that refute THINCS’ claims. I hope they will also read what the Skeptic’s Dictionary says about the logical errors of THINCS, and I hope they will consult other independent sources such as The Medical Letter and Wikipedia, which mentions THINCS only briefly as dissenters to what Wikipedia accepts as based on good evidence. http://en.wikipedia.org/wiki/Statins

    UK-Bloke’s opinion is obviously colored by his personal experience. Others who don’t share his prejudices will be better able to see that some of what THINCS says is true and some of it is fallacious.

    If you are determined to dispute the scientific consensus, THINCS will give you plenty of ammunition (albeit of poor quality). If you are objectively looking for the truth based on the best available evidence, you will almost certainly find some of the THINCS’ claims as ridiculous as I did.

    I was criicized for expressing an “opinion” of THINCS, but it’s curious that after I responded by giving specific examples of “facts” demonstrating how THINCS distorted the truth, no one has even tried to refute those facts.

    And we’re still being classified as “supporters of statins” or “disbelievers” when most of us are neither. We realize there are both risks and benefits, and we’re only trying to better define the risk/benefit ratio, which is clearly different in different populations of different risk levels.

  43. jayemcee says:

    @ daedelus2u

    [quote] jay, I have looked and can’t find any evidence to support any association between ALS and statin use. The incidence of ALS hasn’t changed much over the time that statin use became common.
    http://www.ncbi.nlm.nih.gov/pubmed/15990445?ordinalpos=187&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum
    If the incidence of ALS didn’t change when statins were introduced, than statins are not a cause of ALS.
    Given that so many people are taking statins, it is likely that some of them will get ALS. But if there is no increase in the incidence of ALS when statins are used, then statins are not causing ALS. [unquote]

    I don’t believe that the incidence rate is currently keeping up with reality. The reluctance to ascribe any ill to the taking of statins may be one reason. I have seen the term ‘ALS-like symptoms’ being used to describe what for the patient is effectively ALS, with the same devastating outcome. The death certificate does not record ALS and the likelihood is that the death is recorded as “possible neuro-degenerative disorder of unknown aetiology”. That sort of approach will add nothing to the ALS database.

    Despite any appearances that I may be giving to the contrary, I am not a complete fool. Not a single scientific reference which I have provided to this site has been questioned. For what it is worth, I will provide a few more…

    The issue of neuro-degenerative conditions such as ALS, potentially being induced by statins (as yet another aetiological pathway rather than a sole causal mechanism) has been addressed in part by the references provided.

    NEJM 353:93-96, 2005
    Central nervous system and limb anomalies in case reports.

    Edison R and Muenke M.

    Eur J Neurosci. 2003 Jan;17(1):93-102.
    Blockade of HMG-CoA reductase activity causes changes in microtubule-stabilizing protein tau via suppression of geranylgeranylpyrophosphate formation: implications for Alzheimer’s disease.

    Meske V, Albert F, Richter D, Schwarze J, Ohm TG

    (abnormal tau protein phosphorylation induced by a statin drug)

    Molecular and Cellular Biology, January 2005, p. 278-293, Vol. 25, No. 1
    Increased tau Phosphorylation on Mitogen-Activated Protein Kinase Consensus Sites and Cognitive Decline in Transgenic Models for Alzheimer’s Disease and FTDP-17: Evidence for Distinct Molecular Processes Underlying tau Abnormalities

    Sarah L. Lambourne, Lynda A. Sellers, Toby G. Bush, Shewly K. Choudhury, Piers C. Emson Yoo-Hun Suh and Lawrence S. Wilkinson

    Lancet 363:892-94, 2004
    Selenoprotein synthesis and side effects of statins.

    Mooseman B and Behl C

    Pharmacotherapy 23(7) 871-880, 2003
    Statin associated memory loss: analysis of 60 case reports and review of the literature.

    Wagstaff L, et al

    It would be a real pleasure to have any of the references that I have provided to this site addressed rather than being shown how unscientific I am being because I choose to use a common language to describe my thoughts.

    I don’t want to waste my time trying to produce a fully referenced academic breakdown of my thought processes, that would meet with the approval of Lancet’s finest minds and editors. I would respectfully suggest that all of the references I have provided, to press, are read and understood before fruitful debate can begin. To complain about my words without reading what lies behind them, is an act that is unlikely to provide fertile ground for further debate.

    Cellular disruption, and neurological effects that are likely to have devolved from statin use have been well documented. I could point to a wealth of scientific documentation that underscores the position that the cholesterol/heart disease hypothesis is nonsensical. I don’t see the point, when even a simple question cannot be addressed. The question that PaIMD described as a great question, yet it has languished unanswered while I have been told repeatedly how poor my science is.

    To ignore the provided scientific papers and then point to my ‘written speech’ as evidence of my anecdotal approach to science, is not the way that one would expect a site that purports to devote itself to evidence-based medicine to conduct its affairs. The least one would expect is that an interested scientist would read the supplied material for it may contain something novel and interesting.

  44. Harriet Hall says:

    References related to ALS don’t mean a darn thing unless those references show that the rate of ALS is higher in patients taking statins.

    Sure you can “point to a wealth of scientific documentation that underscores the position that the cholesterol/heart disease hypothesis is nonsensical.” But the scientific consensus has been formed by looking at all that documentation plus an even greater wealth of documentation that underscores the position that lowering elevated LDL cholesterol reduces the risk of heart disease. It’s not what you can cite, it’s the total weight and quality of the evidence that matters.

  45. jayemcee says:

    @ Dr Hall

    [quote] References related to ALS don’t mean a darn thing unless those references show that the rate of ALS is higher in patients taking statins.
    Sure you can “point to a wealth of scientific documentation that underscores the position that the cholesterol/heart disease hypothesis is nonsensical.” But the scientific consensus has been formed by looking at all that documentation plus an even greater wealth of documentation that underscores the position that lowering elevated LDL cholesterol reduces the risk of heart disease. It’s not what you can cite, it’s the total weight and quality of the evidence that matters. [quote]

    A hypothesis is a provisional idea that requires evaluation. To be considered as useful, the hypothesis would, ideally, be capable of predicting the behaviour of variables that have been described and included as a part of the hypothesis.

    When the hypothesis fails to predict the behaviour of the variables, the hypothesis must be considered to be false. This is elementary knowledge and there are many documented examples of the cholesterol heart disease hypothesis being unable to predict the outcome of the various studies, where the hypothesis broke down.

    Only one failure of the hypothesis to predict the outcome of the variables is sufficient to negate the hypothesis and the sheer number of positive reports cannot outweigh a single negative falsifying report… that is science. I suspect that is the bit that you are having having a problem with so I will paraphrase and repeat it.

    10 million supporting cases for the hypothesis will be negated by one single case that can falsify the hypothesis. The cholesterol heart disease hypothesis has failed to support the outcome of many studies. To continue to think that it remains a good hypothesis and that it is suitable for incorporation into theoretical medicine, betrays a poor understanding of the meaning of the terms ‘science’ and ‘evidence-based medicine’.

    I don’t believe I can serve any useful purpose in writing any more…

    I’m done with this.

  46. daedalus2u says:

    jay, are you saying that “The reluctance to ascribe any ill to the taking of statins” is causing physicians to not diagnose cases of ALS? That if the patient ever took a statin they misdiagnose ALS as something else?

    ALS is rare enough that a primary care physician will only see a few cases. They will then diagnose those cases not from their own experience, but by reading diagnostic criteria. Unless the ALS diagnostic criteria include an exclusion for statin use, a physician would have no reason to exclude patients who used statins from an ALS diagnosis (if that is what they had).

    If there was such an exclusion, then the diagnosis would be “statin caused neuro-degenerative disorder”.

    If there is no such exclusion, then you are saying that in addition to the ~5,000 cases of ALS that are diagnosed each year there are additional cases that are misdiagnosed because the patient took a statin?

    In the absence of any data, that idea doesn’t make sense to me. That thousands of physicians would independently misdiagnose ALS because the patient took a statin. There would have to be a vast conspiracy with complete buy-in of every physician.

  47. raygee says:

    Referring back to the disbelief of doctors that statins are the cause of a multitude of ills, I am reminded of a saying of my father, many years ago :”There are none as blind as those who won’t see”

    Harriet talks of the need for RIGOROUS trials, but one can hardly say that trials that just dish out pills and note the symptoms resulting, (overlooking some because they sometimes occur without the pill in question), and leaving it there. are rigorous. Especially so when the reason for serious side effects was demonstrated 18 years ago. It is hard to imagine any research authority ignoring these failings, and continuing their work without real investigation of the fundamentals of the working of the statin. There is no evidence of any such work being carried out after Dr Karl Folkers’ studies, the reverse appears to have happenned, and Q10 has been marginalised and subject to a taboo in mainstream quarters.

    Where any Q10 trials were done, in such as heart failure cases, the trials failed, because far too small doses were administered, eg 100mg Q10, whereas my daily dosage needs to be 900mg. The other weapon used against Q10 has been to name it as Alternative medicine and try to show it in the same category as homeopathyand such.

    In May 2007, the Annals of pharmacy published a study of the effects of Q10 on blood pressure, it was under the section Alternative Medicine, and those who carried it out were either totally ignorant of the function of Q10 in the body, or had some ulterior motive, the trial used men in their 20s, and measured BP at intervals before and after taking Q10.
    Now Q10 is known to be at its maximum level at about 20 years of age, diminishing slowly through life, so adding Q10 is a rough equivalent of testing the power output of an engine, whose fuel tank is nearly full, and filling that tank to overflowing to see if that altered matters.

    They recorded virtually no change in BP, pharmacists are used to BP drugs which drag BP down, but Q10 works in older people by giving the heart access to more ATP for its energy, and normalising matters.

    I feel certain that we will read references to this trial noting the lack of effect of Q10 on Blood pressure, but it will be totally misleading.

    As Q10 is at its maximum level at age 20, and falls to 50% at 80, in rough terms, that works out at 8% per decade, probably it falls exponentially, but for simplicity, we will just consider it to be linear. Statins lowered my cholesterol by 20%. It is fair to assume that all other products in the mevalonate pathway were simillarly affected. and thus Q10 falls by 20%, a loss of energy production capability of 20%, equivalent to the loss of some 24 years. It is not surprising that often seen problems of age occur much earlier in statin users, it does not bode favourably on the chances of younger patients to have a problem free old age after many years of statin Q10 attenuation.

    Statins should really be named Alternative or herbal medicine, being little more than cleaned up versions of Red Yeast Rice, the old Chinese herbal, made on sufficient different bases to permit separate patents for the various drug companies to have their own share.

    In all my experiencce at the time of statination, my own GP was very supportive, but he had no more to go on than I had, and predicted the worst, but continued to take great interest in the saving factors which I later managed to unearth

  48. mgl says:

    To PalMD, I remember a quote from a beloved professor “you can’t find a fever if you do not take a temperature”. thus, the thrust of the problem with statins–. May I suggest, anyone with a clinical practice that includes PD patients, drug histories be scrutinized for statin use–esp those pts with “atypical PD” or who are somewhat “sinemet resistant”?
    In answer to your question regarding case reports in the literature, there have been 3 case studies published. One case report appears in a German Medical Journal–a translated copy of the article appears at end of this posting. the other 2 case reports appear in

    Ann Neurol 1995: 37:685-686
    Parkinsonism unmasked by lovastatin.
    Muller T, Kuhn W, Pohlau D, P
    Blocking the mevalonate pathway to isoprenylated proteins by statins interferes with the production of selenoproteins (specificially selenoprotein N) and glutathione synthase(major antioxidants within the brain–deficits theorized to result in increased ROS–definition of oxidative stress) as well as a myraid of other compounds.There is scientific evidence that use of statins lowers muscle, platelet and serum coq10.
    Statins interefere with production of dolichols, necesary for N-glycosylation of proteins, and interestingly, dolichols constitute the largest % of fats that make up the substantia nigra. What effect does that have on the function of the SN? No one has looked at this, I suppose hoping specificity of the drug for cholesterol lowering predominates –but over a life time of taking the drug???Glutathione and coenzyme q10 are found to be depleted in PD pts irregardless of their previous/present statin status. Mt dysfunction and oxidative stress are theorized to be etiopathologic in PD. Seems counterintuitive to give a drug that further depeltes glutathione and CoQ10 to pts with a disease where these compounds are already deficient. Given the recent in vitro studies determining cholesterol and APOe4 as the principal components in synaptogenesis and neurotransmission, if you believe the theory of brain plasticity, statin use seems even more than questionable. Also, critical levels of brain cholesterol may not be reached with statins for >5yrs, given that brain cholesterol is thought to have a half life of ~5 yrs. Consequently, temporal association btn the initiation of statin therapy and symptoms of neurodegenerative diseases may not exist.
    You are probably aware of the article authored by clifford Shults, et al published in annals of neurology, 2002, showing a decrease in progression of disease in early stage PD patients who received 1200 mgm/day of coenzyme Q10. this was a small study (80 patients total),thus multiple center studies are underway using megadose coq10 in PD, ALS and mt cytopathy. (recent published data from these studies concluded that use of megadose coq10 was “safe and tolerable”.)

    I assume one of the studies you noted was Dr. Lieberman’s small study looking at progression rates of 2 different groups of PD patients–one group on a statin, the other group not taking statins. His conclusion after following these 2 groups for a period of 2 yrs was that their rates of progression were “similar”. Included in this study was a small paragraph noting that of the original group who were not taking a statin, 5 patients were started on a statin during the trial period (from the report, one would assume that only 5 individuals were started on a statin during the study period). Important (to me anyway) was the fact that all five patients experienced an increase in severity of their symptoms within 3 months of beginning a statin. I know that is a very small #, but that’s 100% of all the patients who were started on a statin during the trial period. The statin was stopped for a “washing out” period and when the symptoms did not revert, the drug was re-started. (I assume the possibility that whatever statin damage occurred could be permanent was not considered)
    . Dr. Paul Phillips, interventional cardiologist from san diego who has been studying statins, maintains that tissue half life of statins is more important than serum half life in reference to “wash-out” period of this class of drugs, and that this # is unknown–could be months to years..

    Statins interfere with Lipid rafts (excerpted from a chapter which appears in the following book: AXON GROWTH AND GUIDANCE)

    Carmine Guirland and James Q. Zheng

    The plasma membrane of cells contains a variety of lipid and protein molecules that are often segregated and heterogeneously distributed in microdomains. Lipid rafts represent a generalized concept of membrane microdomains that are enriched in cholesterol and sphingolipids and, characteristically, resistant to cold detergent extraction. Lipid rafts have recently received considerable attention because they are thought to be involved in many cellular functions, in particular, signal transduction for extracellular stimuli. Many of these functions are also intimately related to the processes involved in neural development, including neurotrophic factor signaling and synaptic plasticity. Recent studies from our lab and others have indicated an important role for lipid rafts in axonal growth and guidance. Specifically, our data show that lipid rafts on the plasma membrane provide platforms for spatial and temporal control of guidance signaling by extracellular cues. In addition, lipid rafts may also function in other aspects of axonal growth and guidance, including spatial and temporal regulation of adhesion, cytoskeletal dynamics, and growth cone motility. Further elucidating how membrane rafts are involved in guided axonal growth would provide important insights into the intricate signaling mechanisms underlying neuronal wiring, which is fundamental for normal brain development and functional recovery after injury and diseases.

    Statins interfere with geranylgeranlypyrophosphate synthesis:
    Journal of Neurochemistry
    Volume 89 Page 24 – April 2004
    doi:10.1046/j.1471-4159.2003.02305.x
    Volume 89 Issue 1

    HMG-CoA reductase inhibition causes neurite loss by interfering with geranylgeranylpyrophosphate synthesis
    Joachim G. Schulz, Julian Bösel, Magali Stoeckel, Dirk Megow, Ulrich Dirnagl and Matthias Endres
    Abstract

    To determine whether neurite outgrowth depends upon the mevalonate pathway, we blocked mevalonate synthesis in nerve growth factor-treated PC12 cells or primary cortical neurones with atorvastatin, a 3-hydroxymethylglutaryl coenzyme A (HMG-CoA) reductase inhibitor, and substituted different intermediates of the mevalonate pathway. We show that HMG-CoA reductase inhibition causes a profound reduction of neurite length, neurite loss and ultimatively cell death in undifferentiated and pre-differentiated PC12 cells and also in rat primary cortical neurones. Geranylgeranylpyrophosphate, but not farnesylpyrophosphate, squalene or cholesterol, completely compensated for the lack of mevalonate. Our data indicate that, under HMG-CoA reductase inhibition, geranylgeranylpyrophosphate rather than farnesylpyrophosphate or cholesterol is critical for neurite outgrowth and/or maintenance. Loss of neurites is an early manifestation of various neurodegenerative disorders, and dysfunction of isoprenylation might play a role in their pathogenesis.

    Letter with case report:

    Der Nervenarzt
    Issue: Volume 74, Number 2
    Date: February 2003

    pages 115-122

    Letter in response with case study of
    statin-unmasked Parkinsons

    “To the excellent review about the development
    of myopathies following long-term medication of
    cholesterol level decreasing fibrates and statins, there
    should be considered additional differential diagnostic
    possibilities.

    Because of the similar clinical symptomatology
    with muscle aches and increased stiffness, the
    diagnosis of statin-> induced aggravated
    Parkinson Disease Syndrome should be
    discussed. The development of such muscular
    side effects is seen more with statins than with
    fibrates.

    The case report in Table 1 indicates the
    history of a 60 year old patient with statin-induced
    Parkinson Syndrome occurring over a long time.

    On the other hand, with central effective
    statins, a possible neuro-protective effect in
    neuro-degenerative diseases has been considered,
    especially in dementia. But long term use of statins,
    especially Lovastatin, leads to the reduction of
    coenzyme Q10 and can cause damage of the
    mitochondrial breathing chain. Co Q-10 is an electron
    receptor in the mitochondrial complexes 1 and 2 and
    very effective absorber of radicals. This antigen
    substance increases the complex 1 activity.
    Co-Q10 shows a certain therapeutic effect with
    encephalomyopathy where there is a lack of
    various enzyme functions of the breathing chain.

    Dysfunction of various parts of the mitochondrial
    breathing chain is also considered in the
    pathophysiological mechaism of idiopathic
    Parkinson’s disease.

    Treatment with Co-Q10 in patients who are not
    treated with Dopamine for Parkinson patients,
    caused less disease symptomatology and
    progression than patients treated with
    placebo, though placebo treatment can cause
    stimulation of dopaminergic neurotransmission.
    Therefore, the long-term treatment with Co-Q10
    possibly is neuroprotective in idiopathic morbid
    Parkinson, though new evidence shows it
    appears to cause mild symptomatic effect.

    Under these circumstances treatment with
    prophylactic medication of Co-Q10 which has
    been well tolerated in doses up to 1200mgm in
    patients with neurodegenerative diseases should
    be considered for statin myopathy or statin-
    induced Parkinson syndrome in addition to
    discontinuation of the cholesterol decreasing
    medication.

    The Table 1 summarizes a patient with Parkinson
    syndrome.

    1995: start of therapy with Fluvastatin 40 mg.

    1997: increasing weakness with shoulder and hip
    pain on the right

    1999: diagnosis of right sided Parkinson
    syndrome of akinetic dominance type.
    Careful induction of Pergolid with daily doses
    of 3 mg and Salagen 7.5 mgm

    2000: complaints about increasing edema
    development in legs, loss of hair, start of a
    potas.sium sparing diuretic and increasing
    of Pergolid medication from 4.5 mg
    in June 2000 to 6 mgm in December.

    March 2001: discontinuation of Fluvastatin,
    continuation of Pergolid 6 mg

    June 2001: reduction of Pergolid to 4 mgm

    Sept 2001 Pergolid 3 mgm. Improvement of edema

    December 2001 discontinuation of Pergolid and
    diuretics

    March, 2002 discontinuation of Salagen”

    Dr. Th. T. Muller

    I need to stop now–have not even touched on effects of statins upon GTPases and TNF-a, nor the gene expression with exercise for those on statins, or the decrease in cellular membrane fluidity and membrane electrical potential.

    Perhaps these 8 instances are due to genetic variation interacting with an environmental agent–in this case a lipophilic statin–to produce disease. Given the millions of individuals who are taking statins, even if this genetic variation is very low, the numbers affected could be very high indeed. So incidence of Alzheimer’s and PD are both increasing; are we certain it is all attributable to aging baby boomers and not to ubiquitous use of statins?

    http://www.ncbi.nlm.nih.gov/sites/entrezSaeedm AM, Siddique, N,et al: Paraoxonase Cluster Polymorphisms are Associated With Sporadic ALS

    1: Neurology. 2006 Sep 12;67(5):771-6. Epub 2006 Jul 5.

    Genetic variations in three enzymes that detoxify insecticides and nerve gas agents as well as metabolize cholesterol-lowering statin drugs may be a risk factor for developing sporadic amyotrophic lateral sclerosis , and possibly responsible for a reported twofold increased risk of ALS in Gulf War veterans.PON gene cluster variants have previously been associated with other neurodegenerative and vascular disorders, including Alzheimer’s disease, Parkinson’s disease, coronary artery disease and stroke.

    The genes for human paraoxanases (PON 1, PON 2 and PON 3), which are located on chromosome 7q21.3, code for the production of detoxifying enzymes involved in the metabolism of a variety of drugs including statins, organophosphate insecticides, such as parathion, diazinon and chlorpyrifos, and nerve gas agents such as sarin.

    The mavelonate pathway blocked by HMG CoA Reductase Inhibitors is the pathway to many biolgical substances. Why block production of selenoproteins, Coenzyme Q10, Dolichols, GTPases, TNF-a, Lipid rafts in an attempt to reduce cholesterol, which may or may not be the principal substance in the etiopathology of CAD? Statins impact more than cholesterol….

  49. PalMD says:

    “To PalMD, I remember a quote from a beloved professor “you can’t find a fever if you do not take a temperature”. ”

    It’s hard to take seriously anything that comes afte a quote from “House of God”.

  50. mgl says:

    Had no idea the quote is from House of God–(never read the book–never had time)I heard the quote (among many others)years before House of God was even thought of. Though your response is quite a good one–ridicule of a quote unrelated to the science works when you are unable to refute any of the science. (I suspect you did not read any of the rest of the post)
    if memory serves, the author trained at the Beth Israel, a well respected institution back in the late 60′s early 70′s anyway.
    I am much dismayed at the response–i truly thought you were curious about a link btn statins and neurodegenerative ds. Disregard for all the biological functions of the products of the mevalonate pathway, esp those functions within the neuro system is what has gotten us here. Seems you are satisfied with the status quo…..

  51. pec says:

    This blog is censored. If you bring up a serious objection that they can’t answer, they will first try ridicule and, if that fails, they just won’t publish your comment.

  52. Harriet Hall says:

    pec,

    The nonsense you have been spouting is bad enough, but this is a gross calumny.

    This blog is not censored. If it were censored, you would have been the first to go.

  53. Roy Niles says:

    Would that that were true in your case at least.

  54. PalMD says:

    Look, I know I’m snarky—that’s just me. But really, I did read your entire post…it just happens that it adds nothing new to the discussion.

    The discussion has preceded thusly:

    1) Presentation of evidence for cholesterol/statin use in clinical medicine based on vast preponderance of evidence.

    2) Individuals presenting case reports, published or otherwise, claiming some specific harms of statins.

    3) The rest of us trying to explain why it is not sufficient evidence to prove anything.

    So, the snarkiness comes from your basic inability to grasp the nature of how science works.

  55. pec says:

    I posted comments that were not published, because you didn’t like them. We have no way of knowing how many other comments, including patients’ experiences, were deleted because you had no logical answer.

    I have nothing at all against evidence-based medicine. I think it’s great, and I think the scientific method is great. But it is not an all-knowing infallible oracle. It can easily be distorted to serve propaganda and business interests.

    It is wrong to discount people’s experiences just because there does not happen to be a controlled study to support them. As this blog has acknowledged, research is imperfect and we often require many studies in order to reach a conclusion. And most things have not been addressed by research yet. And furthermore, general research conclusions may not apply to individuals — some people are highly sensitive to unnatural substances.

    I have also tried to point out that there are important limitations in the reductionist approach to medicine, and to science in general. Biological systems are unimaginably complex and it is naive and/or arrogant to think you can change any variable you like without unexpected and long-term consequences.

    Most people like to think they have the answers, or the means to find the answers. This applies in science, religion, politics; all areas of life. The desire to know and to be right tends to overshadow skepticism and prevents us from acknowledging that our ignorance is, and will always be, infinite. This is especially true for experts and professionals whose reputations and careers depend on having answers and inspiring trust.

    The medical profession has probably inspired more trust than any other. But it has taken advantage of that trust, in certain things. My mother trusts her MD like a god — this is typical of her generation. Her MD is not careful enough about what he puts into her body. He follows the current trends and seems to believe the drug commercials.

    Things are getting out of hand and patients are suffering. I do not mean that the medical industry is evil or worthless. Just that, like any powerful institution, it needs to be controlled. It needs to be watched and questioned by outsiders.

  56. pec says:

    “1) Presentation of evidence for cholesterol/statin use in clinical medicine based on vast preponderance of evidence.

    … your basic inability to grasp the nature of how science works.”

    Oh I understand how science works, maybe better than you. At least I know enough to look for confounds. I tried hard to explain — but you apparently did not get it — that the heart disease – cholesterol association may be incidental. The cholesterol skeptics obviously are not right about everything, but they have some valid criticisms.

    The crusade to get everyone’s cholesterol below a certain number may turn out to be harmful.

    If I question the conclusions of medical science you accuse me of not understanding how science works. But questioning and doubting is supposed to be the essence of science. Science is not supposed to be a religion or a club, but that is what it’s becoming. Anyone who doubts the consensus on any topic is ostracized and ridiculed.

  57. PalMD says:

    “I do not mean that the medical industry is evil or worthless. Just that, like any powerful institution, it needs to be controlled. It needs to be watched and questioned by outsiders.”

    The thing is, there is no “medical industry”. From the level of the individual doctor, no one “controls” how we practice.

    If I were a quack, the only thing controlling my practice is basically law suits and maybe, just maybe, my state medical board.

    It is a common fallacy to believe that there is some body that regulates or controls how physcians practice, but that just isn’t the case.

  58. mgl says:

    somehow I remember PaImd asking for any case reports in the literature linking PD and statins. I did not say it was science–I listed the case reports as per the request. ALso requested was any science to explain how there could possibly be a relationship btn statin and PD–I listed several mechanisms for which statins could trigger or unmask neurodegenerative diseases. Obviously disregarded/dismissed. The personal “anecdote” concerning 8 individuals with whom I am acquainted who developed PD which they all attribute to having taken a lipophilic statin was not presented as science.

  59. pec says:

    They delete anything they are not able to ridicule. They say I don’t understand science, and when I post a comment that shows I obviously do understand science, they delete it.

  60. pec says:

    I should have said — they delete SOME of my comments that show I obviously understand science. They delete whatever is most difficult to dismiss or ridicule.

  61. pec – you are lying. We have not censored your posts.

  62. daedalus2u says:

    pec, you are correct when you say that physiology is extremely complex. Physiology is inherently non-linear and coupled and comprises many thousands if not more parameters. Such systems are inherently chaotic. Such systems cannot be modeled beyond certain levels of precision.

    When you say “things are getting out of hand”, I think they are better than they have ever been. Treatments now are a lot better than they used to be. 75 years ago the “standard of care” for neurosyphilis was to give the patient malaria, let them go through about 10 cycles of fever (about 40 days) then cure the malaria with quinine. It was called “fever therapy”, and the man who developed it won the Nobel Prize. His treatment cured many thousands of people who would have otherwise died. I discuss it on my blog in the context of resolution of autism symptoms with fever. I think both effects are due to NO from iNOS. Fever therapy was a desperate treatment for a desperate condition. It had serious side effects. The side effects were considered acceptable because they were worse than the disease (for those who didn’t die).

    Physiology is not getting more complex but some of us are beginning to understand some of just how complex it is. It is scientists and medical professionals who are doing the research that is leading to that understanding. There are plenty of individuals who are trying to hold us back. The authors of this blog are not among them.

    It is extremely difficult to keep up with even a tiny fraction of the scientific literature. Even the literature that directly intersects with your field of research. I know because I am trying to do that in the NO field. PubMed now lists 86,000 citations under “nitric oxide”. NO regulates ATP levels via sGC. There are 112,000 citations for ATP. NO controls O2 consumption by cytochromes. There are 110,000 for cytochrome and 326,000 citations for oxygen. Cholesterol has 167,000. Statins only have 18,000. Cardiovascular disease has 1.4 million. A tremendous amount of effort has gone into doing the research that is documented in those papers.

    There is a lot of material in the literature that is wrong. Not because people are evil, or greedy, or not paying attention to details, but because science is really difficult to figure out and sometimes people don’t get it exactly right. There are some frauds, but those are rare in the scientific literature. Virtually all of the error comes from people who are trying to get it right, but don’t despite their best attempts to do so. In most cases of error the data is ok, but it is the interpretation of the data that is wrong.

    I know how frustrating it is to have insight which is ignored because it doesn’t fit with preconceived notions that are wrong. Even when that insight fits the actual data in the literature better than the preconceived wrong notions. Virtually all researchers don’t have the time to read enough of the literature to get enough perspective on it and sort out what is wrong. They are unable to evaluate claims because they don’t have enough background. They are still caught up in scientific paradigms that are wrong, but don’t have the time or the inclination to evaluate them. These wrong paradigms hurt real people. The recent ACCORD trial testing tighter control of blood glucose was stopped because more people were dying in the treatment arm.

    http://whitecoatunderground.com/2008/02/07/diabetes-more-questions/

    The reason people more people were dying when their blood sugar was controlled more precisely is because the “real” problem with diabetes type 2 isn’t too much glucose in the blood, the “real” problem is not enough glucose reaching the peripheral tissues (which is where it really matters). Those tissues “need” more glucose because they don’t have enough mitochondria and so “need” to make more ATP via glycolysis. The only way to deliver more glucose is via raising blood sugar, and if that is blocked (by “better” control), then the peripheral tissues don’t get “enough”, they can’t make enough ATP, and so they go down the low ATP death spiral.

    An interesting article showing the difference between blood glucose and the glucose level in the peripheral tissues (at a single site, perhaps not representative or accurate (the dialysis sampler was much larger than the actual sites for glucose utilization)).

    http://www.minervamedica.it/index2.t?show=R02Y2005N11A0711

    How did they figure out what glucose level to try and reach in the ACCORD trial? Via the (wrong) paradigm of “homeostasis”. They simply assumed that “normal” blood glucose (the level in people without diabetes type 2) was the “best” blood glucose to have. Too high a blood glucose is bad, but too low a blood glucose is worse. The optimum level depends on how many mitochondria you have (and in what tissues), and how much glycolysis those tissues need to do (and how much glucogenesis your liver can sustain). A “better” treatment would be to increase the number of mitochondria which greatly reduces the need for glycolysis.

    But still, 100 years ago the treatment for diabetes type 1 was inanition, gradually starving oneself to death. Treatments are a lot better now. Treatments have gotten better because the scientists and health care professionals have discovered better treatments with fewer side effects. Improvements have not come from outsiders exerting control.

  63. UK-Bloke says:

    @ Harriet Hall

    You wrote:
    “I hope readers will follow the advice of UK-Bloke to read what is on the THINCS website. I hope they will seek out the original sources that the THINCS folks quote and be able to recognize how THINCS misrepresents those findings by quoting out of context, selective quotation, and putting their own spin on the way they report the studies. I hope they will also seek out the studies that THINCS does not mention, the many studies that refute THINCS’ claims. I hope they will also read what the Skeptic’s Dictionary says about the logical errors of THINCS, and I hope they will consult other independent sources such as The Medical Letter and Wikipedia, which mentions THINCS only briefly as dissenters to what Wikipedia accepts as based on good evidence”. http://en.wikipedia.org/wiki/Statins

    The Wikipedia reference you mention is pasted below and link 19 is a good paper with plenty of references, however I am unable to get very far with link 20.

    Some scientists take a skeptical view of the need for many people to require statin treatment. The International Network of Cholesterol Skeptics is a group that has questioned the “lipid hypothesis” that supports cholesterol lowering as a preventive measure for heart disease, and has argued that statins – especially at higher doses – may not be as beneficial or safe as suggested.[19] Similarly, some authors argue that recommendations for the expanded use of statins to stave off cardiovascular disease are not supported by evidence.[20]

    This is 19
    http://www.bmj.com/cgi/content/full/332/7553/1330 Read this and its Rapid response before commenting

    This is 20 (I am unable to access this information).
    Abramson J, Wright J (2007). “Are lipid-lowering guidelines evidence-based?”. Lancet 369 (9557): 168-9. doi:10.1016/S0140-6736(07)60084-1. PMID 17240267.

    Sorry to see that you have such a hard time in believing what THINCS and the people who have actually taken this rubbish and experienced what it can do, as scientific proof. I can offer no explanation as to why you so strongly think everyone else’s experience with this medication does not matter. I have no doubt that I am biased against statins as you previously mentioned, if you actually know what they do to your body and your ability to think and function like a human being then you would not be doubting everyone the way you do. The proof/evidence of what happens when people take statins is all around, if you choose to ignore it then, what can anyone say except “well we did try to tell you!”

    In another post you wrote:
    “I think we’re all in favor of better post-marketing surveillance programs. But few would agree that unexamined anecdotal horror stories are enough to justify a moratorium on prescribing a drug that is known to save lives.”

    Talking about good science, where is the proof that taking Statins actual does save lives, I have not seen or heard of any proven results that supports this as a FACT, isn’t this just a theory and could you tell me the name of the person or persons that would have died if they had not been taking this medication?

    All that I see is the very same selective cherry picking going on that you accuse THINCS of but without the actual referenced material to back up your claims, not really scientific proof. I also did have a previous post that mentioned among other things that THINCS didn’t always get it right but at least they brought the matter to our attention, this post didn’t actually appear in this blog so I can only assume it was deleted.

    People are giving you the insight to make a difference, instead of trying to disprove all they are saying, why not take advantage of the situation and any newly gained knowledge and put it to good use.

    You must also take into consideration that the doses of statins over the last few years have increased in size dramatically, I know when my dose was changed from 10mg straight up to 40mg (Zocor-Simvastatin) things went downhill even faster but I was at the time unaware what the cause was.

  64. pec says:

    “pec – you are lying. We have not censored your posts.”

    Then how do YOU define “censor?” According to my definition, if you delete some of my comments, those comments have been censored.

    Your readers should be aware that not everything everyone says here actually appears.

  65. pec says:

    And by the way Dr. Novella, I think I understand why you have no problem with tossing arbitrary combinations of synthetic chemicals into patients’ brains. You wrote at neurologica that the brain is a product of “messy evolution.”

    That explains your attitude towards the new drugs, and it explains the current medical approach in general. Evolution has produced a mess. It’s a wonder we are alive at all. We need those drugs.

    But the reality is that evolution has produced systems that are far beyond the comprehension of modern science. Your understanding of how the brain works is minimal, yet feel you can judge the quality of its design.

  66. mgl says:

    PalMD, since the references I quoted “added nothing to the discussion”, I am quite impressed that you were aware of the various metabolic substrates blocked by statins and their functions. Is it your opinion the blockage of these products are of no consequence?

  67. pec- we have not deleted your posts. This is simply wrong. You are making false accusations and drawing insulting, self-serving, and paranoid conclusions.

    Your interpretation of the significance of “messy evolution” is an absurd straw man.

  68. kathleen says:

    UK-Bloke said
    “I also did have a previous post that mentioned among other things that THINCS didn’t always get it right but at least they brought the matter to our attention, this post didn’t actually appear in this blog so I can only assume it was deleted.”

    You mean this one on the 9th Feb at 5.38pm where you said

    “The people at Thincs may not have proven everything they said but at least they went out on a limb to help people to realise that there is a problem.”

    It’s been there on the blog all the time (as a UK-person, I remembered).

    I’m a bit wary of trusting anything you say if you can’t even find your own posts on the blog.

  69. UK-Bloke says:

    @kathleen,

    you are quite right, I refreshed the page after posting that comment and found it to be there.

    What can I say Aren’t Statins great!

  70. Harriet Hall says:

    pec persists in demonstrating his defects for all to view. He has lied, repeatedly. He has also contradicted himself, set up straw men, responded to things he imagined people wrote that they didn’t, and committed frequent errors of logic.

    Fortunately, he has also done some good by serving as a bad example. One of his comments was used on episode 131 of the podcast Skeptic’s Guide to the Universe, in the segment “name that logical fallacy.” http://www.theskepticsguide.org/archive.asp

  71. Harriet Hall says:

    UK-bloke apparently can’t read very well. He asks “where is the proof that taking Statins actual does save lives, I have not seen or heard of any proven results that supports this as a FACT, isn’t this just a theory and could you tell me the name of the person or persons that would have died if they had not been taking this medication?”

    If he had read my article carefully and followed the links, or if he had bothered to enter a clinical query on PubMed, he would have had no trouble finding the evidence that shows statins save lives – in high risk groups, when prescribed appropriately.

    And he is demonstrating his ignorance of science when he asks for names of individuals. Statistics can tell us that hundreds of thousands of smokers die prematurely, but it can’t name names. That’s not the point. Analogously, when people take antibiotics and survive pneumonia, we can’t name which ones would have survived anyway.

  72. UK-Bloke says:

    @Harriet Hall,

    once again where is the evidence?

    Your statement is speculative at best, I followed the Wikipedia reference about THINKS and found that you obviously had not read what you are saying so why would I just use PubMed when there are so many other sources to choose from.

    Please add the document source to verify your claims about how these drugs are proven to save lives because I would really like to read it.

    Oh yes I think after a MI and years of taking statins then needing a triple bypass, that I may just fit the “high risk group”, this stuff almost killed me.

    Why not take a look at this site and see all the people who had a great time with statins!

    http://www.askapatient.com/viewrating.asp?drug=19766&name=ZOCOR

  73. pec says:

    When Harriet can’t answer our objections with logic she resorts to insults and ridicule.

    It is rational to be skeptical of the cholesterol hypothesis. It is rational to question the recklessness of some MDs in prescribing combinations of synthetic drugs.

    Many patients are on several drugs, each prescribed by a different specialist. I doubt that clinical trials have tested all likely combinations.

    When we express sensible and rational doubts, Harriet, and some others, respond with condescension and insults. It’s easier to call us ignorant or crazy than to address our very sensible concerns.

  74. pec says:

    And when Steve Novella calls the brain a “messy” product of evolution, that does tell us something about his approach to medicine, and about the current approach in general. One reason CAM is gaining acceptance is that is does not see the products of evolution as “messy” or random. When you perceive a system as intricate, efficient and complex, you are less likely to treat it carelessly.

    The complexity of living systems is far beyond the understanding of modern science, and it is arrogant to forget this. Yes, you can toss in artificial chemicals and observe that the system continues to function. But that is because these amazing natural machines are extremely intelligent, flexible and adaptable, and can therefore take a lot of abuse.

    CAM is more likely to respect natural systems and try to work with them to encourage healing. This is NOT to say most CAM treatments have value — that is a question for scientific research. But it IS true that the general CAM philosophy makes more sense to a lot of people.

    Modern medicine is highly effective in certain limited scenarios — when emergency surgery or antibiotics are required, for example. But success in some areas does not warrant applying the same philosophy in all areas.

    The over-use of the new synthetic drugs is an example of a good thing gone haywire.

  75. daedalus2u says:

    pec, which is the more reckless strategy, allowing people with known risk factors for heart disease to die because of nebulous “unknowns”? Or to treat them with drugs that have been shown in clinical trials to be safe and effective? Your reservation of “skepticism” for only what is considered mainstream science is telling. Why don’t you have this degree of skepticism about homeopathy? And I can’t see why you think the idea of water holding some kind of electromagnetic information is so absurd. How would that defy your established laws? (http://www.sciencebasedmedicine.org/?p=35#comment-723) Your notion that there is something credible about an electromagnetic memory effect in water only illustrates your ignorance of electromagnetism, the properties of water, and your ignorance of your own ignorance. There will always be unknowns about physiology. Physiology is vastly more complicated than can be understood mechanistically. Each person’s physiology is unique due to genetic and epigenetic factors. None of those factors are completely understood for even a single person. Putting off all medical treatments until everything about that treatment is completely understood for all individuals is to put it off forever.

  76. UK-Bloke says:

    @pec

    “When Harriet can’t answer our objections with logic she resorts to insults and ridicule.”

    I had noticed that on just about all the posts she has replied to. It is a shame though because a lot of the information that yourself and many others have provided is mainly high quality documentation.

    I have also come across at least one person that has posted here who has an appearance in the BMJ and has had his papers published elsewhere.

    Anyone who has knowledge good or bad about cholesterol should be able to pass on that information to help others make a constructive choice about what is best for them, they should also know what to look out for if they are amongst the people that are not suitable for statin drugs.

    The facts and choices were not available to me and a heck of a lot more people in the past (including doctors) there is no excuse now though for pretending if I close my eyes and can’t see it then it doesn’t exist.

    @daedalus2u

    your comment about allowing people with known risk factors for heart disease to die because of nebulous “unknowns”? Or to treat them with drugs that have been shown in clinical trials to be safe and effective? in a perfect world this would be right. The problem is that what happens in selected individuals who are screened before trials are started, does not always cover what happens when someone outside this controlled selection has to take the medication in real life. Q10 deficiancy and Carnitine are just part of the problems that statins cause, also heart failure, brain fog, exhaustion, pain etc all of which as you know were not passed on to doctors and patients.

    I do know about this as I am one of many who have found out the hard way, thankfully in the UK the multitude of tests that you have to go through are free. However the very same tests in America cost $1000s and if you have no insurance you are dammed to say the least, I have friends in America.

    This is not a jab at you but it should be pointed out that not only do you pay for what may make you ill, but you will have to also pay a fortune to survive sometimes a low quality of life.

    @kathleen

    not a dig at you but before you make your mind up about treatment for your high cholesterol have a quick look at this site, I did post you a better note but it didn’t seem to go anywhere so if another note to you appears just ignore it ok.

    http://www.askapatient.com/viewrating.asp?drug=19766&name=ZOCOR

  77. pec says:

    “Why don’t you have this degree of skepticism about homeopathy?”

    I am completely skeptical about homeopathy, and I have expressed that here. I have no idea if homeopathy works ever, or sometimes, or never. I said that I do not think homeopathy is necessarily impossible. I think more research is needed.

    I am just as skeptical about CAM therapies as I am about mainstream therapies. However I do have serious objections to the philosophy behind some maintream treatments. Throwing arbitrary combinations of synthetic chemicals into a system as complex and poorly understood as the brain, or other organs for that matter, is madness.

    Evolution has done an amazing job of building these systems, and they are not messy or haphazard. They are incredibly resilient and flexible and able to withstand years of abuse. But why abuse them? Why not stop the madness?

    I’m sure there are cases where statins can save a patient’s life so he or she can go one to make radical lifestyle changes and recover. I’m sure the same is true of many other drugs.

    But these drugs are being used with reckless abandon and unconcern. Biological systems are seen as piles of haphazard junk that need improvement.

  78. Harriet Hall says:

    I will not be commenting any more on this thread. Those who can read carefully and are not blinded by emotions will fully understand why and will only wonder why I didn’t quit long ago.

    It’s frustrating to provide links to high qualilty evidence and then to be told I haven’t presented any evidence. It’s very frustrating to keep saying X is green and be answered by “You said X is blue and it isn’t.” It’s also frustrating to hear lies repeated (“This blog is censored”) even after they have been exposed as lies.

  79. kathleen says:

    UK-Bloke
    I did have a very good look at the site you posted (thank you) but I do have a lot of problems taking such a site as being any kind of evidence for or against taking a particular drug. For a start, I think that you would find that it is often people who have had a problem with a drug who post to such a site. Those who are happy with their medication don’t necessarily do so. I did also search the site for drugs that I have taken (with great success) in the past and for drugs that my husband is currently taking (again successfully and with no side effects). Yes, they had lots of negative comments too. It also seems to me that people tend to become ill from all sorts of causes, during the time that they are taking a particular drug and are likely to blame the drug, particularly if they are hearing lots of negative publicity about it.

    In fact I think such sites are pretty scary. I found one comment, and I quote, “I took 20 mg. of zocor for about four yearswith only minimal side effects like neckaches, anxiety, and hair thinning. Now, I have developed tingling in both arms, hands and fingers. My first though was angina, but after reading all the comments here, I am pretty certain that zocor is the cause. Will stop the drug tonight.”
    Why did this lady immediately put her symptoms down to the drug? To me, this just shows how much sites like this can influence gullible people.

    In fact, I have been told that I don’t need treatment for my high cholesterol. Both my GP and cardiologist are happy for me to reduce it with diet and exercise. I have been recently investigated for cardiovascular disease and have been told that my heart is fine. But having weighed up the evidence I can assure you that if I had been told that I had CVD I would have jumped at the chance to take statins.

  80. UK-Bloke says:

    Hiya kathleen,

    I agree some people do jump to conclusions and can blame their ailments on the wrong thing.

    Most people like me though who have had heart problems have been putting up with a lot of nasty problems for years and the doctors have just put it down to getting older or your memory problems have nothing to do with anything you are taking and all the time you are getting worse.

    A lot of people including myself were ok for a year or two, then slowly things started to happen like getting tired more easily and forgetting names and what you were doing or even how to do things. You might think that some of those posts are extreme but the reality of what happens in real life is very much what has been written there.

    I only recently found out after many years of taking Zocor what the cause of my problems were and that was by trying to find out why I was always so very tired all the time and unable to think properly, I can assure you that what I have put up with over the years is much the same as what those posters have written.

    The truth is that I wished I had never taken a statin, it is almost a year since I had the last one and I am on long term incapacity benefit now, I cycled miles to work for over 18 years and now I find it hard to cycle 100 yards, My thinking ability is just starting to improve and I would hate to see anyone else go through this nightmare for the sake of a little excercise and possible diet change.

    All the best,

    UK-Bloke (I am really pleased you don’t need them).

  81. raygee says:

    @kathleen

    I took zocor for 4 years, getting progressively weaker, with muscle wastage, and heart weakness with no-one attributing it to the statin, until I saw a newspaper article which pointed out that statins cause these effects. I later found out that Merck knew this in 1990 when they filed patents to add Coenzyme Q10 to statins to try to overcome the problem, but failed to publish this information.
    The problems are very real, and lifelong supplementation of Q10 and carnitine, whose production may be permanently damaged, as in my case, will often be necessary.

    I have a friend who was given statins after a heart attack, they had to be ceased because his CK (muscle wastage) figure rose to 9 times normal, only falling to 5 times normal when the statin was ceased by the hospital.(mine was just over twice normal, and I had severe muscle loss) He was in severe pain and unable to work over the next 4 years, with no solution but very strong pain treatment from his doctors, until he found the Q10 information, unknown to doctors generally, Merck seems to have had a hand in that. All is not sweetness and light in the world of cholesterol treatment, as Harret’s stone walling treatment so clearly shows

    Keep away from statins if you possibly can, the trials show very little, if any, benefit for women. I will never take another one, ever.

  82. Synaptix says:

    “Throwing arbitrary combinations of synthetic chemicals into a system as complex and poorly understood as the brain, or other organs for that matter, is madness.”

    Another glaring example of ignorance in the form of a strawman. Please try to understand what you are talking about before you write, it makes you look less dumb.

    Raygee – so over 4 years of muscle wastage and you didn’t try to do some simple weight lifting or exercise? I hear resistance training will increase muscle mass and bone density – even in people who are nearly 90 years old. The story about your friend is nice but testimonies have a tendency to amount to a lot of white noise and bs. I don’t believe you.

  83. pec says:

    “Throwing arbitrary combinations of synthetic chemicals into a system as complex and poorly understood as the brain, or other organs for that matter, is madness.”

    “Another glaring example of ignorance in the form of a strawman.”

    I realize that individual drugs are not arbitrary combinations of chemicals, obviously. You intentionally misinterpreted my statement. We know that it is also obvious that each patient may be taking several drugs prescribed by different specialists. And that combination is often arbitrary. The various specialists do not necessarily investigate to find out what other drugs each of their patients is taking. You cannot possibly think that all of these possible combinations are tested in clinical trials.

  84. pec says:

    And besides, even if we were just talking about one drug, you must admit that you do not know exactly how the system as a whole is effected by a statin, for example. Especially over long periods of time, and in genetically varied individual patients.

  85. Egaeus says:

    Since the acrimony seems to have died down, I’d like to interject a related, but tangential request. While I have no problem with the correlation between cholesterol and heart disease, there is one “risk factor” I don’t yet believe: salt. I’d like to see a discussion here about it. The shoddy research (or reporting on the research as the case may be) on salt is a personal pet peeve of mine.

    I recently (well, in the last year) saw a news article on a scientific study (yes, I know, but I am not a physician, and don’t have ready access to journals) that follow high risk heart patients for 10 years and those who did not lower their salt intake died at a very significantly higher rate. What it did not say is whether other dietary changes were made or taken into account. People with high blood pressure typically have poor diets and typically consume lots of saturated fat and simple carbohydrates along with their salt. If the salt was reduced, then the overall diet was probably changed as well. I mean, they don’t sell low-sodium Big Macs or Whoppers.

    Then on the CSPI web site, there was a report on a study that compared similar (identical?) diets with varying salt intake. Finally?! Something that settles the issue? No. The reduction in blood pressure was quite modest, and reflected, in my opinion, what you would expect from having lower levels of salt (any salt) in solution.

    I still am not convinced by what I’ve seen that it’s bad, and it seems that things such as arteriosclerosis and hypertension play a much bigger role than the modest reductions in osmotic pressure gained from a low-salt diet. It seems to me that the low-salt craze has come out of the same paradigm that brought us the low-fat craze. That is, simplistic notions and little science to back them up.

    I’m going to admit my biases though. I hate bland food. I season food properly. I find that my taste for salt is on par with most chefs, as I have no problem with the salt content at most “good” restaurants. I don’t particularly like over-salted snacks, but I will not eat bland food, and it’s bland without salt, no matter how many herbs and spices you put in it. I just want to know whether I’m in the same league with THINCS or whether my skepticism is justified.

    I know this thread is not the forum for this particular discussion, but having come over here from the JREF website, I was disappointed not to find an article on this so far. So here’s a prod. :) You guys are much more knowledgeable than I am in this area. I simply know how science is done, and am not happy with the research (reporting?) that I’ve seen.

  86. UK-Bloke says:

    @Synaptix

    I have just seen the posting that you left for pec and Raygee.

    the comment to pec was a pretty stupid thing to come out with and when you commented about Raygee and weight lifting it just goes to show that your reference to ignorance is a reflection of your knowledge of this subject.

    Statins are known to cause muscle wastage and exercise intolerence, excercising the muscles tend to make them break down at a faster pace and raise the cpk levels in the blood.

    Please look up mevalonate pathway.
    Please look up Coenzyme Q10 deficiency.
    Please look up Excercise Intolerence.

    I could go on to give you a full account of the process but everything you should really be aware of is available at http://www.spacedoc.net/ and various sites ie PubMed BMJ and many others and they do have the referenced papers pointed out.

    —————————————————–
    “Throwing arbitrary combinations of synthetic chemicals into a system as complex and poorly understood as the brain, or other organs for that matter, is madness.”

    Another glaring example of ignorance in the form of a strawman. Please try to understand what you are talking about before you write, it makes you look less dumb.

    Raygee – so over 4 years of muscle wastage and you didn’t try to do some simple weight lifting or exercise? I hear resistance training will increase muscle mass and bone density – even in people who are nearly 90 years old. The story about your friend is nice but testimonies have a tendency to amount to a lot of white noise and bs. I don’t believe you.

  87. raygee says:

    @synaptics

    Disbelief of the truth in the sufferings of others is a simple way to bolster up your own false ideas. I had polio 50 years ago, and my back has had insufficient strength to think of weight lifting. The statin damage added to the carnitine deficiency which post polios experience, and energetic exercise can only use up the carnitine stocks in the body, so that muscles have to metabolise their own protein to produce that energy need, and so waste away.

    I am now only a few years off 90, and can only just manage to keep my independence, my back strength is virtually nil, so no snide remarks about weight lifting, that may be ok for undamaged folk. I have lived an active life, I still fume at my inability to do the physical tasks I always did, I have no lack of determination, hence my persistence in trying to find the truth about statin damage and spread that truth around the world.

    I resent being called a liar, the stories are not white, pink, or any other form of noise, they are truthful and backed up by hospital tests and figures. if you cannot believe them, you are deceiving yourself and burying your head in the sand. I had to care for my late wife with Alzheimers when at my weakest

    The Washington University of St Louis, neuromuscular, on its website speaks of lipid lowering myopathies and statin toxicity, and gives treatment requirements, are they not to be given some credence? or are their findings, which are in line with those of thousands who suffer, to be dismissed in a totally irrational and illogical manner by one who believes in hearsay, and will not try to understand what is really going on. I believe the title Science Based Medicine is a misnomer for this site, something more like Biassed Status Quo Medicine might be more apt, there are so many blind spots apparent.

  88. daedalus2u says:

    pec, I completely don’t understand how you arrive at your positions.

    On the one hand you say physiology is so complex and scientific methods so limited and physicians don’t know enough to be able to prescribe pure compounds which have known effects via known mechanisms that have been tested in the lab, tested on animals and tested on humans, with these compounds being administered by physicians who have studied physiology, have been tested on that understanding and are licensed under conditions which require maintaining their knowledge base.

    On the other hand you seem to have some confidence in CAM modalities which were arrived at via unknown or non-scientific methods and which (at best) are very complex and variable mixtures of nothing or of unknown herbal compounds, which have no known effects via no known mechanisms and which have not been tested in the lab, on animals or on humans, were developed and are being promoted by individuals who have either zero understanding of physiology or what they believe about physiology is actually wrong.

    I understand you are dissatisfied with EBM because it doesn’t accomplish what you want it to accomplish. But the reasoning by which dissatisfaction with EBM leads to confidence in CAM is completely beyond me.

  89. raygee says:

    @daedalus2u

    I realise that you trust EBM, but do not seem to be aware of the blinkered nature and lack of breadth of that evidence, for example, there is true evidence, false evidence, and being “economical with the truth” The suppression of the known fact that statins damaged Q10 and thereby caused myopathy and other damaging effects should have set alarm bells ringing, and the naming of the most necessary product to manufacture ATP for all kinds of energy needs in all animal species, especially our own, as alternative medicine beggars belief.

    Has biological knowledge become subserviant to the wishes of drug manufacturers wealth creation schemes? I am as eager as the next man to know the real answer to CVD, but some research, and trials beyond the influence of the western world should not be ridiculed because they had no enormous funding available, and homocysteine levels are still an insufficiently researched factor, I am hedging my bets by taking a folic acid/Bvits pill every day, since statins nearly led to my demise.

    I am not anti conventional medicine, but I see many treatments where drug interference can be made much less necessary if more trials were to be made into the use of supplementing essential, but not hugely profit making substances, such as Blood pressure reduction, and heart failure treatment with Q10, and the realisation that carnitine deficiency is not only found in newborns and dialysis patients, but in post operatives, penicillin derivative users, and post polios. These are well founded matters, but somehow they have not reached mainstream medicine.

  90. pec says:

    “the low-salt craze has come out of the same paradigm that brought us the low-fat craze.”

    Egaeus,

    Yes I completely agree. The low-salt and low-fat crazes were not based on good scientific evidence. Salt may have important benefits. It’s really too bad because so many Americans are depriving themselves of good-tasting food, while still getting sicker. The main culprit is probably refined carbohydrates. And trans-fats.

    daedalus2u,

    You simply missed the point of everything I said. Mainstream medical science focuses on one variable at a time, such as cholesterol, and seldom worries about the system as a whole. Alternative medicine tends to be holistic, and that is why I prefer its general approach. That does NOT mean I believe every treatment that calls itself holistic is worthwhile.

    Contemporary medical science has evolved into an extremely reductionist approach. This approach works well in certain situations — emergency surgery is the best example. In many other situations the reductionist approach can harm more than it helps.

    It’s true that MDs have at last acknowledged the role of lifestyle factors. This is great but should be taken farther. We need more skepticism regarding drugs such as statins and more emphasis on lifestyle changes. Many patients think it’s much easier to take a pill than to exercise or avoid junk food. They believe the pill is keeping them healthy in the same way that lifestyle changes would — and this is completely untrue.

    Holistic medicine makes much more sense because it understands that when you change one variable many others may change in unexpected ways.

    Again, this does NOT mean I think every hare-brained idea that calls itself holistic must be a good idea. Holistic medicine doesn’t have the answers, any more than mainstream medicine. But there has been much less research funding for holistic medicine. Hopefully, that is changing and the holistic approach will make progress.

    The authors of this blog want to do exactly the opposite — they want to prevent progress in holistic medicine by depriving it of funding. I think this is only because they do not understand holistic philosophy. They really should try to learn something about the science of complex systems.

  91. daedalus2u says:

    pec and ray, let me paraphrase what you are saying to see if I actually understand it.

    EBM looks at only a few variables at a time and attempts to control for variables that are known to interact and uses systems such as double-blind trials to eliminate bias. Results are published in peer reviewed journals which require disclosure of conflicts. Therefore EBM can’t possibly address the complexity of physiology.

    “Holistic medicine” looks at dozens or hundreds of variables at a time none of which are measured, none of which are understood, none of which are characterized in advance, none of which are controlled for, none of which are kept constant, using trials that are not blinded and the results of which are not published in journals but collected as anecdotes usually by those who derive their income from sales of these “treatments”. Therefore “holistic medicine” will work better because physiology is complex.

    It seems to me that every complaint you have of EBM is actually worse in “holistic medicine”, but with no safeguards to try and mitigate those complaints. Every drug in EBM has been tested and has been shown (in some cases) to be safe and effective. That is not true of any CAM based treatment. If it were true of a CAM based treatment then the treatment isn’t CAM any more, it becomes an EBM based treatment.

  92. pec says:

    No daedalus2u you deliberately misinterpreted everything I said. You don’t get it.

  93. pec says:

    In studying complex systems we WANT to isolate variables. But in treating a malfunctioning complex system we DO NOT WANT to change variables in isolation, without concern for the overall system.

    I’m sure you will find a way to misunderstand that.

  94. daedalus2u says:

    So how do you treat a complex system while being concerned for the overall system without knowing the details of that overall system?

  95. Synaptix says:

    raygee: I apologize for any insult to you about your condition. In terms of this arguement though, anecdotes hold no water. I was just trying to highlight this fact. Though it seems I became frustrated after hearing more and more of them.

    UKguy – I’m not argueing with the fact that Statins can cause the problems brought up here. I just completely disagree that the “truth” is being somehow suppressed – the science is being done to adress these issues and the medical community does it’s best to make it so that people can get treatment. No system is perfect, people are going to have bad side effects – to misrepresent and what the authors of this blog are trying to accomplish helpes no one.

  96. tailspin45 says:

    I had muscle and joint pain (I’d call it 7 or 8 on a 10 scale starting about two weeks after taking Lipitor. So I stopped taking it and within a week felt better. So I started taking it again. Within three weeks I had the same pains again. Again I stopped taking the medicine and again the pain went away. I’ve tried all the others too, with the same result. No surprise, my 82 year old mother recently was given Lipitor and began complaining of severe arthritis pain. I recounted my experience, she stopped taking it and within 3 days felt better.

  97. PalMD says:

    One of the reasons we do large outcomes studies, such as 4S, is that we don’t know all the variables. This allows us to see the effect of statin use on important outcomes, regardless of mechanism, etc.

  98. pec says:

    “So how do you treat a complex system while being concerned for the overall system without knowing the details of that overall system?”

    Obviously we can’t know all the details of a system like the human body. But we can recognize that we don’t know, and use caution and restraint.

    The medical industry has not been using caution or restraint in prescribing certain kinds of drugs in recent years.

    CAM treatments are much less likely to be toxic, because the philosophy respects the intricacy of natural systems. That is NOT to say CAM treatments work. Many probably don’t, some might. But I am talking about the underlying philosophy, not the efficacy of treatments. There may be less potential for harm with CAM — unless of course a patient rejects a needed mainstream treatment in favor of a useless CAM treatment. If you fall off the roof, you need surgery not accupuncture.

    I am not expressing any opinion on any particular CAM treatment right now. Effectiveness of CAM treatments should be studied scientifically.

    In the mean time, our knowledge of what works or not for heart disease, for example, is very limited. I think we should refrain from ingesting synthetic chemicals unless we are very sure they are necessary, and lifestyle changes should always come first.

    And we do not always have to wait for the results of clinical trials before making health decisions. If you take a statin and get a pain, and you stop the statin and the pain stops, and you repeat this with the same results, that should be good enough for the time being.

    Similarly, if every time you eat a strawberry you get an asthma attack, you don’t need a clinical trial to tell you to stop eating strawberries.

    We all do informal experiments all the time, and it would be irrational not to. If I sleep only 4 hours I feel tired the next day. Do I need a formal study to tell me how much sleep I need? There is nothing wrong with formal research, but it’s silly to doubt everything that has not been confirmed by big, expensive controlled experiments.

    And the research results are often confusing and misinterpreted. The statin research was interpreted as showing that high cholesterol causes heart disease, but that conclusion does not follow from the evidence.

    We have to think. We cannot expect scientific research to replace common sense.

  99. PalMD says:

    “CAM treatments are much less likely to be toxic, because the philosophy respects the intricacy of natural systems.”

    That statement is, prima facie, ridiculous. No, this isn’t an ad hom statement, simply an observation.

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