Cholesterol-Lowering Drugs Heavily Criticized in Australian TV Documentary

Do cholesterol-lowering drugs constitute a medical miracle, almost free of side effects? Or is this a false, and close to criminal, misleading impression that pharmaceutical companies are promoting?

Here’s the popular Australian science television show Catalyst that reactionaries tried to stop. The show aired the other day, despite the protests.

The show does an excellent job of bringing forward a more nuanced picture than that of the drug advertisements. The reality is that cholesterol-lowering drugs (statins) may be beneficial for people already diagnosed with heart disease (previous myocardial infarction or angina).

For healthy people the benefit is minimal, and the risk of side effects (such as muscle pain, fatigue, disorientation and diabetes) usually outweighs the benefits.

Watch the episode for a frightening picture of how pharmaceutical companies have inflated the benefits and hidden the risk of side effects. But don’t be surprised. This is exactly how similar companies have been demonstrated to act in many similar cases.

These are no conspiracy theories. This is just how it works in a market economy with inadequate regulation and inadequate scrutiny. Companies will take shortcuts to greater profits as soon as they think they can get away with it.

More

Here’s a transcript from the episode above

Last week on Catalyst: The Real Cause of Heart Disease

Statins May Cause Diabetes

Dr. Oz Changes His Mind on Cholesterol!

“Statins Can Drain the Life Out of Us!”

29 Billion Reasons to Lie About Cholesterol

Spectacular Study on Heart Failure and the Supplement CoQ10

All blog posts on cholesterol, margarine and statins

29 Comments

  1. FrankG
    I had watched the video already thanks Dr Andreas -- impressive and they pull no punches. But interesting to read the usual suspects trying to get it stopped. I especially noted where they try to discredit the experts in the first part as just out to promote books they had written... I wonder how little digging it would take to find financial ties from those (trying to stop the broadcast) back to the pharmaceutical companies?

    As you say, no big conspiracy to keep people sick -- just a free-market economy with policies heavily biased in favour of big, monied industries and their lobbyists. Although with that said I suspect that: just like big tobacco, there are a few high level executives with highly questionable motivation given what they must already know.

    And anybody who starts invoking "consensus science" really has no credibility in my view.

  2. Freddie
    It's fascinating to me that the article talking about how the Australian Medical Association wanted this program pulled went out ot its way to mention that "The first part of the two part program that ran last week relied on the evidence of three doctors and a psychologist and weight loss coach all of whom are promoting books they have written." But there is no mention AT ALL in that article of the BILLIONS of dollars the drug manufacturers will make on the promotion and sale of these drugs. Who really stands to profit most here?

    Also there is apparently no appreciation at all for the irony inherent in this statement: "Professor Paul Zimmet from the Baker IDI Heart and Diabetes Institute says the program has given a platform to a few people who "pick one area and look only at the evidence that supports their view"."

    Reply: #7
  3. FrankG
    Guess what "reactionaries who tried to stop this broadcast" your "concerns" convinced me to watch this presentation AGAIN, to share it with as many people as I can, and even more sure that I am doing the smart thing by NOT taking a statin.

    Telling it like it is Dr Beatrice Golomb... in its effect it is certainly Scientific Fraud and Organised Crime!

  4. GP
    Every drug should be criticized. You should take drugs when you really need them. When they can help you.

    I hate when people get a simple cold and the doctor prescribes them some kind of antibiotics. You don't need that shit. Your body will fight off the cold viruses in 7-8 days regardless of the antibiotics. But people panic and shit and I guess that is the doctor's way to calm them down.

  5. Pierson
    'This is just how it works in a market economy with inadequate regulation and inadequate scrutiny.'

    Quite the opposite; this is what happens when too much regulation tells people to conform to a standard for which there is no evidence of a benefit, and even more regulation forcefully suppresses any dissenting information which the 'experts' decide poses a threat

    Reply: #6
  6. FrankG
    I think you are confusing "regulation" with "policy" or "guidelines".. so far as I am aware there is no law which says I have to take a statin (although no doubt the pharmaceutical companies have tabled the idea) nor that a Doctor must prescribe it to me. They are however answerable to (but not bound by) the guidelines issued by their licensing boards.

    As to those guidelines I suggest you read Dr Malcolm Kendrick's post on how these come about... http://drmalcolmkendrick.org/2013/08/02/who-shall-guard-the-guardians/

  7. Freddie
    Okay, have finally found the time to sit and watch this, and I think it's very nicely done, but I have a question that's casting doubt on some of its credibility to me. One of the doctors claims patients in clinical trials are all given the drugs involved beforehand, they see who gets side effects, and the patients who do are excluded from the formal trial. I work in an industry that is tangentially connected to the pharmaceutical industry and clinical trials in the US, and I have volunteered for clinical trials myself, and this is the first time I've ever heard about something like this occurring. Does anyone know if this is actually true? Is this a common practice? I am highly skeptical on this point.
    Reply: #10
  8. Jean Staines
    Very thought provoking. An added element is that adding a statin to the treatment regimen for heart attack patients is required by CMS as a quality measure. Hospitals are required to report this to CMS. If the hospital does not comply they will begin to receve decreasd overall payments for the care that is given. So of course the hospitals are pushing the physicians to order a statin on any patient that has had a heart attack because not doing so affects their reimbursement negatively.
  9. Jan
    Yes, this is very thought provoking and I am pleased to see it is getting a lot of publicity.

    All the best Jan

  10. FrankG
    Why skeptical? This is not the first time I have heard about this... it seems like a very reasonable approach to me to pre-screen candidates for a study. After all would it be ethical for a person to suffer for the length of a study with the side-effects that you already knew they would have during that study? Especially given that statins have a life-threatening side-effect in Rhabdomyolysis.

    http://www.fda.gov/RegulatoryInformation/Guidances/ucm126430.htm

    No the ethical question is when you then turn around and claim how safe that drug is with the implication it is safe for the general population, instead of the more honest it is "safe" (so far as tested) ONLY for those who exhibit no short-term or easily attributable side-effects.

    A big issue is that these trials are industry funded so why would we NOT expect them to be stacked in favour of profit rather than health

    Related to this topic... http://www.ted.com/talks/ben_goldacre_battling_bad_science.html

  11. Z.M.
    Freddie: "One of the doctors claims patients in clinical trials are all given the drugs involved beforehand, they see who gets side effects, and the patients who do are excluded from the formal trial."

    A good example of this is the Heart Protection Study - http://www.ncbi.nlm.nih.gov/pubmed/10329064

    "63 603 people attended the initial screening clinic visit, and
    32 145 were potentially eligible and agreed to enter the
    prerandomisation run-in phase of the study"

    "Of 11 609 patients who entered the
    run-in period but were not randomized, 65% chose not
    to continue, 17% did not seem likely to be compliant
    long-term, 13% were considered by their own doctor to
    have a clear indication for (or contraindication to) statin
    therapy after review of the screening lipid results provided,
    10% had abnormal screening blood results, 9%
    reported problems associated with the run-in treatment,
    1% had had myocardial infarction, stroke, hospitalization
    for angina or cancer diagnosed during run-in,
    and 1% had other reasons for not continuing."

    So out of 63 603 screened only 20 536 were actually included.

    Reply: #13
  12. Steve
    There was suggestions that Statins be put into the water supply? Holy *&%($)!

    That Doc, is my issue with well intentioned people like Bloomberg, who is nothing more than a modern day McGovern. Can you imagine the things Bureaucrats would impose upon the public with the best of intentions?

    People like those who find themselves on your site are becoming the exception in that most people will hear their doctor say you have to take this * drug and they will do little or no personal research. They will literally take a drug based upon nothing more than another persons opinion.

    Researchers seeking to disprove the idea the cholesterol is the cause of heart disease in the US will have a hard time finding funding, and they certainly won't be getting it from the government. However well meaning, government will more often than not lead the lemmings over the cliff because that is what they bureaucrats have been told ($$$$$$$) is in the proletariats best interest.

    Teaching people to think rather than follow is a pretty scary thought to most people in positions of power.

  13. Freddie
    Yes, that kind of screening is typical. What the doctor said about the patients in clinical trials not being the same as the typical patients doctors see in their practices is absolutely true, and the need to screen so many people to find the "perfect" patients to include in the trial is one reason trials are so expensive. But the passage you quoted says nothing about patients being excluded from the trial based on side effects experienced while they were on a pre-trial course of therapy with the medication to be tested. The "run-in treatment" does not mean pre-treatment with the drug being tested in the trial, it means the period before the trial starts when patients are asked to stop taking all of their other medications.

    @FrankG: I already explained why I am skeptical. I work in an industry fairly close to clinical trials and have been in clinical trials myself. Pre-screening patients for a trial is NOT the same thing as giving them a course of the medication being tested before the trial begins and then excluding patients who show side effects from the full trial in order to skew the results. Don't get me wrong, the analysis of the data *is* often skewed, and I absolutely agree with you about the ethical problems involved in manufacturers running trials for their own drugs (another one you didn't mention is this means competing drugs are never tested against one another to see which one leads to better outcomes, because no manufacturer will take a chance that their drug will be the loser in a head-to-head trial like that), but it seems like a reckless and irresponsible move for a doctor on national TV to claim patients are excluded from trials because they experience side effects from drugs before trials even begin if this isn't true. That just casts doubt on the credibility of the entire argument.

    So again I ask: does anyone know if this is actually true?

    Reply: #14
  14. FrankG
    "...it seems like a reckless and irresponsible move for a doctor on national TV to claim patients are excluded from trials because they experience side effects from drugs before trials even begin if this isn't true."

    It would indeed, so given that, why assume it is not true?

    Z.M. posted a link to the abstract above and it's 2am here so I'll look later for the full study methodology (maybe you could find it with your connections).. meantime I found this about the same study, on what seems so far a fairly reputable site...

    Patients

    Patients were eligible for inclusion if they were aged 40 to 80 years, had non-fasting blood total cholesterol concentrations of at least 3.5 mmol/L, and were considered to have a substantial 5-year risk of death from coronary heart disease due to a history of:

    Coronary disease
    Occlusive disease of non-coronary arteries
    Diabetes (type 1 or 2)
    Hypertension (requiring treatment, in men aged at least 65 years)

    Patients were ineligible if their own doctor considered that statin therapy was clearly indicated or contraindicated, or if they had:

    chronic liver disease or abnormal liver function tests,
    severe renal disease or impaired renal function,
    inflammatory muscle disease or abnormal muscle function tests,

    concurrent treatment with cyclosporin, fibrates, or high-dose niacin,
    severe heart failure,
    a life-threatening condition other than vascular disease or diabetes,
    potential for child-bearing,
    a condition that might limit long-term compliance.

    Study

    Potentially eligible patients entered a prerandomisation run-in period comprising four weeks of placebo followed by four to six weeks of 40 mg simvastatin daily. Those who remained eligible, were compliant, and did not have any serious problem during the run-in, were randomly allocated 40 mg simvastatin daily or matching placebo tablets, and antioxidant vitamins (600 mg vitamin E, 250 mg vitamin C and 20 mg beta-carotene daily) or matching placebo capsules, using a 2x2 factorial design. The aim of the run-in period was to allow general practitioners to review their patients' lipid profiles, and to limit randomisation to those thought likely to be compliant for at least five years. Patients were encouraged to start taking a non-study statin if their own doctor considered that it had become indicated.

    http://www.medicine.ox.ac.uk/bandolier/booth/cardiac/HPS.html

  15. FrankG
    Bear in mind that this trial was _after_ this statin had already passed FDA etc... approvals for use. They are not testing a novel drug but some aspect of its efficacy vs. other drugs/placebo, or its use together with additional supplements in combating disease.

    Again, this is the kind of study often cited to "prove" the safety of statins: which was not its purpose and clearly is not a conclusion which can be drawn from the outcomes observed on just the carefully pre-selected study group.

  16. Zepp
    My two cents to this debate is.. clinical studies is clinical studies.. often or always funded by those companies that want to sell the drug!

    They have to prove that it is safe.. and have those effects on the illnes they supose to cure and not to many side effects!

    Statins are potent drugs.. whit potent side effects.. the problem is that its only a cure for a few that got CVD and its only a fraction of those that got a longer life frome the drugs!

    Its this contradiction of diet advices and drug advices.. the moste problem for CVD is still hyperglycemia and hypererinsulinemia.. how statins dont have any effects on!

    But those is often caused by bad dietary advice or bad eating habitts.. not by eating to much fat.. rather of eating to much sugar!

    Soo.. statins are often prescribed for those eating to much sugar.. that got metabolic syndrome!

  17. Z.M.
    Freddie: "But the passage you quoted says nothing about patients being excluded from the trial based on side effects experienced while they were on a pre-trial course of therapy with the medication to be tested."

    The drug is used in the run-in phase. One of the reasons for a run-in is to exclude those who are intolerant to the drug. From the same paper:

    "Any patients who, during run-in, had any apparent side-effects to treatment, appeared to be non-compliant, wished to drop out for any reason or whose general practitioner wished to treat them with a non-study statin (or high-dose vitamins) were not to be randomized".

    Again:

    "65% chose not to continue, 17% did not seem likely to be compliant long-term, 13% were considered by their own doctor to have a clear indication for (or contraindication to) statin therapy after review of the screening lipid results provided, 10% had abnormal screening blood results, 9% reported problems associated with the run-in treatment, 1% had had myocardial infarction, stroke, hospitalization for angina or cancer diagnosed during run-in, and 1% had other reasons for not continuing."

    Note that specific reasons for withdrawals were not given e.g. 65% chose not to continue. For what reasons? There are possibly thousands who experienced adverse effects and this is even after applying strict exclusion criteria.

    Another example was the TNT trial which also had a run-in -
    http://www.nejm.org/doi/full/10.1056/NEJMoa050461#t=articleBackground

    " A further 5461 patients were excluded after the open-label run-in phase. Most of these excluded patients (4634, or 84.9 percent) did not meet randomization criteria. Other reasons included adverse events in 197 (3.6 percent), death or an ischemic event in 211 (3.9 percent), and lack of compliance in 70 (1.3 percent)."

  18. FrankG
    I'd agree that using a not-yet approved drug as part of the pre-screening process would not make much sense... nor likely allowed by the ethical review.

    But here again (in TNT) they were not (on the face of it) so much testing their statin per se, which one might quickly assume from it being a drug trial but rather its effect on cholesterol lowering in relation to CHD.

    Yet even with pre-screening the TNT reports, "Adverse events related to treatment occurred in 406 patients in the group given 80 mg of atorvastatin, as compared with 289 patients in the group given 10 mg of atorvastatin"

    I must say that paying for multiple trails featuring their drug and pre-screening as discussed above, seems like a great way to skew the numbers in their favour when it comes to meta-analysis for example and also to give the impression of this class having an overall great safety record -- unless you actually read the detail of the study

  19. FrankG
    Just to add that this is why I get highly skeptical of lipid specialists like Dr Dayspring who makes a a great deal of sense in some regards but then states "Statins are not only among the most effective drugs ever created (have saved more lives than anything but antibiotics and vaccines) but are also among the safest."

    Both the "saved more lives than..." and the "among the safest" are for me, severely stretching the bounds of credulity, let alone credibility.

    http://www.lecturepad.org/dayspring/lipidaholics/pdf/LipidaholicsCase...

    Sure they have lowered a great many cholesterol levels (as currently measured and/or calculated) while allowing a great many Doctors to feel good about this "improvement" but saved that many lives? I really don't think so.. and at what cost?

  20. Z.M.
    FrankG: "Yet even with pre-screening the TNT reports, "Adverse events related to treatment occurred in 406 patients in the group given 80 mg of atorvastatin, as compared with 289 patients in the group given 10 mg of atorvastatin"

    Yea! This paper about myopathy (http://www.ccjm.org/content/78/6/393.full) also describes the reasons for less adverse events in trials -

    "A reason may be that patients in clinical trials are carefully screened. To minimize toxicity, the clinical trials of statins excluded patients with renal insufficiency, hepatic insufficiency, a history of muscular complaints, and poorly controlled diabetes, as well as patients taking drugs with possible interactions. Large efficacy trials have excluded up to 30% of the participants in active prerandomization phases.

    Another reason is that these trials were designed to assess the efficacy of statins and were not sensitive to adverse effects like muscle pain. When they looked at myopathy, they focused on rhabdomyolysis—the most severe form—rather than on myalgia, fatigue, or other minor muscle complaints.15 Additionally, most trials enrolled too few patients and did not have long enough follow-up to reveal infrequent toxicities.

    Despite the strict criteria, a significant number of trial patients discontinued statin therapy during the study period. In the Treat to New Targets (TNT) trial, 5% of patients in both the high- and low-dose atorvastatin (Lipitor) groups experienced muscle toxicity, even though 35% of eligible patients had been excluded during the open-label run-in phase.14

    Also, physicians may overlook and patients may fail to report symptoms such as fatigue, malaise, or dyspnea that are not commonly accepted as signs of statin toxicity."

  21. FrankG
    "...physicians may overlook and patients may fail to report symptoms such as fatigue, malaise, or dyspnea that are not commonly accepted as signs of statin toxicity."

    As you say, even if they are reported to the Family Doctor (GP) I suspect they are often dismissed...

    "Well we can all expect a few vague aches and pains, low energy, or a bit of memory loss at our age"... right? Can't be the drugs.

    As I alluded to above: from the GP's point of view this class of drugs are an easy sell, with feel-good and measurable results... you come in with "raised cholesterol", they prescribe a statin, a few months later your "cholesterol is lower" Horray! Obviously the impression is that of a good thing, which will keep you healthy and lengthen your life... after all everybody knows what a nasty villain cholesterol is... clogging up your blood vessels, just like that gunk in the drain pipe under your kitchen sink... right?

  22. Murray
    Perhaps I am just too cynical as a lawyer, but it seems ludicrous that the same company that would profit from a drug approval would have any influence on testing for safety. It's like having a fox check the fencing around a chicken coop. Much of the difficulty is that there are few unconflicted systematic RCT experiments for side effects, so side effects only come to attention sporadically through anecdotal evidence and are routinely deflected by saying they are anecdotal and not tier 1 RCT studies, not "evidence-based" medicine. So it is left to clinicians and patients to figure out what is side effect and what is normal aging.

    My n=5 experience with statins is not encouraging. One friend of the family has taken statins for over 20 years of with no apparent side effects. My father had a stent procedure several years ago and took statins. After a few months he started having memory issues. It started getting really bad and his physician said it was just aging. I convinced him to quit (to the horror of his physician who said he would die) and he improved substantially after a few months. However, after several years he is still not where he was before statins. My mother was put on statins (early 70s). Intense muscle soreness soon after starting. She quit (to the horror of her physician who said she would die). She quit and the muscle soreness went away. It's been several years and she has not died. My cousin is in the Air Force and was told he could not fly unless he took statins. His TRG:HDL ratio was 0.4 (mmol units) and apoB in normal range but total above 5.2 mmol/l and he was remarkably fit doing triathlons. Three months on statins he could barely get out of the car after a 3-4 hour drive from muscle and joint stiffness. He also tested lower in short term memory in standard tests, but okay on long term memory. His squadron command ended and he stopped the statins. After seven months his muscle pains and poor training recovery has almost totally reverted to pre-statin and the joint pains are finally going away. The grandmother of a close friend had an angiogram when she was 100. They put her on statins. I told my friend it was insane and she should stop it. Alas, too difficult with physician bias. This woman was driving until 95 or older (I don't know the exact age she stopped) and was extremely sharp at 100. I was at a party and spoke with her at 99, talking about her upcoming birthday. She was up on current politics and insightful. She was fully mobile and normal size, though not leaping around. Within a month of going on statins she did not recognize her granddaughter. She had to be put on painkillers for the muscle pain and could barely move. She lived another year or so, to 102, and was 45 pounds when she died.

    Reply: #23
  23. FrankG
    Those "anecdotes" make me so angry and sad Murray. Just as Dr Beatrice Golomb states... in its effect it is certainly Scientific Fraud and Organised Crime!

    I too have been faced with an Endocrinologist who frankly, forcefully (and quite angrily) stated that I would likely drop dead of an heart attack quite soon if I did not re-start statins. This despite all my other significantly improved health markers. Fortunately I am not so easily swayed by "experts" but I can see how it can be hard to ignore them. The worst part of that interview was was my meeting with a medical student, under training and working with the Endo. I am only too glad to assist when I can with up-and-coming Doctors. This took place on two separate appointments at this Endo's office, with two different medical students. On each occasion I was dismayed, not so much that they did not agree with my assessment of my lipids (that would be understandable at least), but rather that there was seemingly not even the slightest indication that they were even aware of _any_ controversy concerning the role of "cholesterol" in CVD!

  24. m.ceu barros
    tive enfarte a 3 anos tomei atorvastatina durante muito tempo.fez-me muito mal.dia para dia uma infeçao baginal para os medicos nao podia ser .disseram.podia ser .tiroide.que provocava estes problema.
  25. Gemma
    An interesting review of a book by James & Hannah Yoseph written by Zoë Harcombe. The book describes the discovery and approval process of statins. Unbelievable information even in this shors summary: http://www.zoeharcombe.com/2013/10/how-statin-drugs-really-lower-chol...
  26. Jo tB
    Frank, you wrote: it seems like a very reasonable approach to me to pre-screen candidates for a study. After all would it be ethical for a person to suffer for the length of a study with the side-effects that you already knew they would have during that study?

    I agree you don't want people to suffer during a trial. But, after the trial, and after it has been approved the drug will be prescribed to EVERYONE. Obviously, if these people had been included in the trial, then our doctors would know who NOT to prescribe the statin to. At the moment drugs are peddled as "one size fits all" when quite clearly they don't. Patients have to find out the hard way that they have adverse reactions to statins.

    Reply: #27
  27. FrankG
    I agree entirely Jo. But given the (reportedly small) potential for the life-threatening condition of Rhabdomyolysis with statins, I think it would be considered highly questionable and unethical to continue treatment despite the clear indication of adverse reaction(s) -- especially muscle pain.

    BUT what I think should be addressed is that the data relating to this pre-secreeing process seems to be hidden in the study methodology, or barely even recorded (they skimp on the recording as this is outside the study proper) and is not readily broadcast at the end of the study. Instead we are told about how safe it was.... which in reality means it was deemed relatively safe ONLY for those who did NOT have obvious adverse reaction(s) that appeared during the short-run of the study.

    Again, the studies linked above were NOT drug-approval trials but were effectively "padding the statistics" in favour of already pre-approved drugs.

  28. Stacy in USA
    One organization that wasn't mentioned at all in this video is the FDA. The Food and Drug Administration is the federal agency responsible for setting standards and evaluating the efficacy of drugs (obviously). So, we already have a huge, well funded agency responsible for regulating the drug industry in the US. Why are we not discussing their complicity in this fiasco?

    The video takes the easy way out my placing blame on "Big Pharma", but Big Pharma lives by the policies and rules established by government. Our government agencies are corrupt and incompetent. We have regulatory capture. Surprise, Surprise!

  29. Dan H
    Doctor, please don't blame this on the unregulated "market economy". Better drugs - or alternative lifestyles which do the job drugs are supposed to do - would emerge in a market economy without regulation. Who shuts down websites that give out alternative-lifestyle advice? The government. Who subsides the production of high fructose corn syrup? The government. Who tells people to eat MyPlate, the diet likely to cause diseases like type 2 diabetes and metabolic syndrome? The government.

    You want a single entity telling people what can and can't be said. Do you really think such a powerful entity is going to be immune to regulatory capture, the situation where the regulated buddy up with the regulators?

    The solution to getting paleo out there is free markets. Every individual and every company in a free market becomes its own experiment. What doesn't work fails and what works is spread. This is how paleo has spread up to now, so please don't call for its destruction at the hands of government!

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