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Red Yeast Rice and Cholesterol

While much of CAM is ridiculous or implausible, herbal remedies are an exception. Plants produce pharmacologically active substances; in fact, the science of pharmacology grew out of herbalism. Some herbal remedies have not been scientifically tested, but others have been tested and are clearly effective. Nevertheless, these are seldom if ever the best choice for treatment.

One natural remedy stands out. Red yeast rice has been tested and has been shown to lower cholesterol as well as a statin drug. That’s hardly surprising when you realize that it contains the exact same ingredient as the pharmaceutical drug lovastatin.

Only it doesn’t any more.

Origin

Red yeast rice has been widely used in Asian cuisines as a coloring agent and taste enhancer. It has been used in traditional Chinese medicine for centuries for indigestion, diarrhea, blood circulation, and spleen and stomach health.

Preparation

It is prepared by fermenting rice with the yeast Monascus purpureus. It contains eight mevinic acids (statins), mainly lovastatin or monacolin K. It also contains sterols and other components. Its overall cholesterol-lowering effect may be due to a combination of several of its constituents. In manufacturing it for use as a supplement, temperature and growing conditions are carefully controlled to increase the concentration of mevinic acids. These products are not the same as the red yeast rice sold in Chinese grocery stores.

Safety concerns

The safety of red yeast rice has not been established. The Natural Medicines Comprehensive Database only gives it a “possibly safe” rating. Since it contains lovastatin, it can be expected to have the same side effects as the prescription drug. Patients on statins are monitored for liver, muscle, and kidney damage; sellers of red yeast rice do not usually inform their customers of those risks. There are also a number of interactions with other drugs and dietary supplements. And eating grapefruit can affect blood levels of lovastatin.

Regulatory actions

When does a food cross the line to become a drug? Red yeast rice was marketed in the US as a dietary supplement, Cholestin. The FDA banned it in 1998, saying that since it contained lovastatin it was an unapproved drug. In 1999, a federal judge overruled the FDA, saying it could be sold as a food supplement. In 2000 a Circuit Court of Appeals said that ruling was in error and restored the FDA’s ability to regulate Cholestin as a drug. The FDA then sent warning letters to several companies, and the product disappeared from the market for a few years.

The manufacturers’ response

Red yeast rice products gradually reappeared on the market. Around 30 brands are now available. Most of them got around the FDA restriction by eliminating the monacolin content and by careful labeling and advertising that does not claim to lower cholesterol. In 2007, the FDA sent warning letters to two companies whose products still contained monacolins; the products were withdrawn. Red yeast rice products are still widely sold in the US and products containing lovastatin are still readily available from other countries.

Pharmanex continues to sell a product under the name Cholestin, but it no longer contains lovastatin.  They say:

Cholestin® is a breakthrough all-natural solution for individuals concerned with maintaining cholesterol levels already in the normal range.

Cholestin’s proprietary blend contains polymethoxylated flavones extracted from citrus fruits, geraniol and the essential fatty acids EPA and DHA found in marine lipids. Each individual constituent has been shown to control existing normal cholesterol levels in the body and promote overall cardiovascular health. Only Pharmanex’s new Cholestin® offers this unique blend of scientifically-tested constituents for effective cholesterol management.

Pharmanex sells Cholestin for around a dollar a pill. Theprice of lovastatin varies from 29 cents to $1.71 per pill 

CAM recommendations

Dr. Andrew Weil recommends red rice yeast extracts, saying they are by far the most effective natural supplement for lowering cholesterol and claiming that they are less likely to cause side effects than prescription statins. 

Dr. Oz says red yeast rice is a statin that will lower your cholesterol by 30 points.

Dr. Mercola says red yeast rice is a statin and all statins should be avoided.

Natural News recommends it but notes that supplements currently sold in the US don’t contain any of the active ingredient.

Many websites have outdated and false information.

Other herbal remedies

My general objections to herbal medicines are these:

  • When tested, isolated active ingredients tend to work at least as well as the whole plant derivative.
  • Although herbalists claim that the other components in their remedies act synergistically, that has seldom been substantiated, and the other ingredients might just as well be expected to do harm or to decrease the effect of the active ingredient. 
  • Most herbal products have not been adequately tested to ensure safety.
  • Herbal products on the market vary in dosage and purity. There is no guarantee that you will get what the label says.
  • Products may contain contaminants. Products have been found to contain everything from toxins to insect parts and even prescription drugs.

I see no good reason to prefer St. John’s wort to a prescription antidepressant. On a practical basis, I can understand that some people might prefer it because it is less expensive and can be acquired without a visit to a doctor with all the inconvenience and cost that entails. But I think their health would be better served by being diagnosed and regularly monitored by a medical doctor and by taking a pure antidepressant in a controlled dosage.

Conclusion

Red yeast rice containing lovastatin is effective in lowering cholesterol, but brands currently sold in the US contain no lovastatin. It’s ironic that one of the few proven CAM treatments was effective only because it contained a drug available by prescription. And that they continue to recommend it after the lovastatin was removed. Even if a lovastatin-containing red yeast product can be obtained, concerns remain about purity and safety. It would be hard to justify recommending it over a pharmaceutical statin.

 
 

Posted in: Herbs & Supplements

Leave a Comment (176) ↓

176 thoughts on “Red Yeast Rice and Cholesterol

  1. Old_skeptic says:

    Consumer Lab tested several brands of red yeast products sold in the United States in 2011. Some contained lovastatin in significant amounts. Some didn’t. Some companies are following the law and producing supplements that are legal but worthless. Others are violating the law and producing supplements that are illegal but effective.

    You have to pay to get their report, but it might be worth it.

    The same report also notes that several of the tested red yeast rice products contained citrinin, a potential kidney toxin produced by the yeast. I think this is an important point. Even if all red yeast rice products still contained lovastatin, they would be less desirable than statin drugs, in my opinion, because of the poorer control over their manufacturing.

  2. I contend that statins are one of the top ten discoveries of modern medical science. Not only do they decrease LDLs and inflammation, but they also stabilize atherosclerotic plaques and actually decrease their size. If anybody isn’t familiar with statins, re-read that sentence. They fight cardiovascular disease on so many levels.

    Any CAM practitioner who recommends against statins is directly contributing to the death of their patients. Honestly, I don’t see how people like Joe Mercola can maintain their medical license in spite of recommendations that are diametrically opposed to the current standard of care. Jann, do you know? Is it because he isn’t directly treating patients?

    -

    In other news, in our area there is a chiropractor who has gone off the deep end. He started trying to treat autism with hyperbaric ROOM AIR (not just oxygen!) He started appearing on local TV as a “chiropractic neurologist,” and claims to treat diabetes, Hashimoto’s, etc. He may have had a slap on the wrist by the chiropractic board. Then, strangely, he started rapping (yes, you read that correctly) about chiropractic, and apparently he performs chiropractic raps at chiropractor conventions. In other words, he’s conventional chiropractic scum.

  3. nybgrus says:

    To illustrate the issue with “shruggies” and CAM…

    during my family practice rotation we had our weekly meeting with the head of the rotation and were discussing cholesteral therapies. The question of RYR was raised and the quick consensus around the room was “RYR is a CAM that works well. I don’t know much about it and would be a bit skeptical of recommending it to a patient, but if they are using it then I don’t see any reason to advise them against it.”

    I commented that the MOA was that the yeast actually produced lovastatin and that it was entirely akin to taking a highly adulterated form of Lipitor with unknown amounts of both intended and unintended active ingredients and would thus recommend patients not take it (same as for any other herbal supplement).

    I was roundly met with amazement at how I know “so many different things” and everyone now suddenly felt like they were better equipped to manage a patient with RYR and advise them appropriately – including counseling them to stop or switch to a regulated pharmaceutical.

    The point being that even our attendings are poorly informed as to exactly what is up with all this stuff, and the default is to be a shruggie about it. Once I educated them on exactly what is going on with RYR that changed palpably.

  4. mousethatroared says:

    Funny, Some people (including myself) think twice before buying poorly regulated imported toys or pet food, but some of those same folks think nothing of consuming poorly regulated imported or domestic supplements or giving them to their child (or pets).

    Probably because we haven’t had any major news worthy supplement manufacturing errors as has happened with pet foods and toys.

  5. mousethatroared says:

    I just wanted to mention how much I’ve enjoyed reading your articles lately, HH. Not only are they very readable/understandable to a non-science person such as myself, but they well organized, concise, entertaining and….well catchy.

    Very nice hook – “Only it doesn’t anymore.”

  6. Old_skeptic says:

    NCCAM has a fact sheet on red yeast rice on their Web site. They just published it a month ago. http://nccam.nih.gov/health/redyeastrice

  7. ConspicuousCarl says:

    Here is a [free] article with a few key findings from the Consumer Lab tests:

    http://www.medpagetoday.com/Cardiology/Dyslipidemia/22973

    It looks like the statin levels per pill range from the low range of prescription levels down to almost nothing. And on top of that, some had a possibly-toxic substance (but they don’t say how close it is to being harmful).

  8. Jimmylegs says:

    I just saw a new(er?) episode of Dr. Oz today and he had Dr. Weil on there talking about his better health stuff and his anti-cancer super meal (because you want the super version and not the regular one I guess). And Dr. Oz mentioned RYR but I assume is unaware of the fact that all RYR in the US should not have the lovastatin therefore is useless.

    As a side note about the anti-cancer meal I thought it would be some vague an obscure foods it make it seem plausible. But to my suprise it wasn’t, all it was is really a standard red pasta sauce with capers in it. Cut tomato, olive oil, black olives, garlic, basil, tuna, and capers. So why do we have cancer? That is pretty standard food we all eat regularly (except capers and olives for me). So sad that people will believe without question that the meal will have anti-cancer properties. Oh and it’s not just one it’s all cancer, because you know… all cancer is totally the same.

  9. Red Yeast Rice (Hong Qu Mi in Chinese Pinyin) isn’t in most Chinese Herbal Materia Medica texts. It was mainly used a s a food coloring agent, though had a small reputation as helping with digestion (a handfull of rice itself is sometimes added to bitter or harsh decoctions to act as a buffer). I carried it in my Chinese herbal pharmacy for years. My goal was to carry every legally available TCM herb and make them accessible to “responsible adults” without making drug claims for them. I sold it by the pound, about $10/lb, and only sold about 10 lbs/year; I discontinued it about a year ago. The Chinese herb importer I got it from no longer stocks it as well.
    The TCM industry reported that they couldn’t import and market an extract standardized for lovastatin, just the whole herb. I still get a little torqued when I see Red Yeast Rice extract capsules on the shelf at Safeway, etc. There’s very little logic, level playing field, or consistent law enforcement in CAM.
    I prefer to buy bulk Chinese herbs from a top supplier who carefully heat-dries them and uses and air-tight double-bag system with nitrogen injected between the two bags. This takes care of the live insect problem, something I encountered in virtually every TCM herb pharmacy I interned in. I bought the Red Yeast Rice from a secondary supplier in a ‘normal’ cheap plastic bag (sometimes these have intentional holes in them to release moisture or allow fumigation). Live moths developed from tiny larvae in the bag. Of course, having a Chinese moth infestation in my pharmacy is unacceptable (the smaller, hard bugs that can bore through plastic and hard roots are another story). Out went the Red Yeast Rice (sealed in thicker bags, then frozen for a few days first). New stock was immediately rebagged and frozen. The customers were advised to not eat it raw, but to boil it first. I found no credible information about dosage. These factors don’t combine into a good sales pitch, thus it’s discontinuation.
    My libertarian-leaning attitude of “provide legal access for responsble adults who know what they are looking for” continues to be challenged by reality. For example, the rarely used Magnetite (Ci Shi) in a TCM pharmacy had a sales spike when a product called Magneurol was heavily promoted as an ESP pill. I didn’t mind reducing the sales of Magneurol, but grew concerned about iron toxicity and the deluded delusions of my customers…

  10. Janet Camp says:

    @Jimmylegs

    Well, I eat the capers and the olives as well, and I don’t have cancer yet–so there, it must be true! You, of course, are doomed. :-)

    ——–

    Co-incidentally, I have talked with three people while on my road trip who have been told by an MD to either lower their cholesterol through (gasp!) DIET, or to start a statin drug. All three have refused to consider “taking a pill”, yet have little intent of doing much about their diets. Two mentioned that they would look for something “alternative” and one mentioned red yeast rice. I will send her this post–and thanks because I didn’t know the history of this product and had a vague idea that it was one of those that, at least sort of, worked. Rather amusingly, I have been calling this stuff red rice yeast–I though it was made from “red” rice I guess. 0_0

  11. Zetetic says:

    @ mousethatroared:

    “Probably because we haven’t had any major news worthy supplement manufacturing errors as has happened with pet foods and toys.”

    That’s because NOBODY HAS REALLY BEEN WATCHING the supplement manufacturing industry for far too long!

  12. BKsea says:

    “Each individual constituent has been shown to control existing normal cholesterol levels”

    What does this mean? They gave the pills to people with normal cholesterol levels and afterward they still had normal cholesterol levels? Yikes!

  13. Jimmylegs says:

    @BKsea:

    It’s fine when drugs are used to maintain normal levels, but I would like to see the research the company did to come to this conclusion. What were their diets during the trial? Was there a follow up after the trial? How long was the trial? Size?

    I assume you are saying they used an drug on normal people and they stayed in normal levels, meaning it did not work. Please let me know if I read that wrong cause it seems a little vague to me.

    A lot of questions and I’m afraid there are very few answers, if any. I doubt any research by Pharmanex (Nu Skin) even exist seeing that it is more or less a multi-level marketing company (read: pyramid scheme) so that is a red flag in my opinion.

  14. windriven says:

    @SkepticalHealth

    So why aren’t statins available OTC?

    Yes, there are rare but potentially very serious side effects. Isn’t that why god made IFUs (package inserts)?

    There are very good reasons for some drugs to be available only by prescription; antibiotics leap to mind. But many others could and should be available OTC – as they are in a variety of foreign countries.

    How many hours of scarce and expensive physician time was spent asking Ms. Jones about her heartburn while proton pump inhibitors (prilosec et al) were prescription drugs? Now they’re readily available in every drug store and supermarket.

  15. Harriet Hall says:

    There have been proposals to make statins an OTC drug. The FDA ruled against it. This editorial in NEJM explains why: http://www.nejm.org/doi/full/10.1056/NEJMp058025

    Basically, statins treat a condition that patients can’t self-diagnose; patients have no way of self-monitoring response, and they might be getting inadequate treatment or ignoring other risk factors for CVD; they can’t self-diagnose adverse effects like liver disease; and the prescription statins recommend monitoring liver function tests at regular intervals; and the drugs have not been proven safe for special populations like pregnant women (and they might be taken by women not yet aware they were pregnant).

  16. windriven says:

    @Dr. Hall

    With all due respect, suggestions of hypercholestorlemia are easy enough for a person of reasonable intelligence to spot. I am not suggesting though that people should self diagnose – though I would argue that is their right if they choose to be stupid. I am suggesting that once diagnosis is confirmed, the dosage titrated and side effects ruled out, that patients not troop back to their physician every 6 months to get a new prescription.

    I was prescribed a statin in the past (on the grounds that normal cholesterol is good but low cholesterol is better) and the biannual kabuki was a 10 minute visit that consisted of ‘hi howya doing, what’s your daughter up to?, been dove hunting yet this season?’ and out the door with a new scrip; a pleasant exchange but a waste of valuable resources on both sides of the equation.

    “and the drugs have not been proven safe for special populations like pregnant women (and they might be taken by women not yet aware they were pregnant).” And seeing one’s physician every 6 months for a scrip renewal impacts this exactly how?

  17. Harriet Hall says:

    @windriven,
    “Suggestions of hypercholesterolemia are easy enough for a person of reasonable intelligence to spot.”
    Really? What do you mean by that? Most people who have elevated cholesterol levels aren’t usually aware of it until a blood test is done. And a titrated dose may not remain titrated, and side effects can’t be “ruled out.” Some of them can develop even after long usage. The fact that you apparently didn’t appreciate that underscores the value of consulting a doctor.

    Now you are moving the goalposts. First you suggested statins should be available OTC and now you’re saying refills should not require a visit to a doctor, which is an entirely different matter. By the way, in my experience doctors usually write prescriptions for a year’s refills, not just 6 months.

    There is value to a doctor’s appointment that may not be readily apparent to a patient: the entire risk status can be re-evaluated, other factors can be addressed that may have impact on the need for statins or the dosage, the doctor can ask about symptoms that the patient might not have connected to the drug, liver function can be monitored, and the doctor may have new information that might affect dosage, target numbers, or special populations. Just one example: one specific statin was recently found to interact with a certain BP med, and doctors were switching their patients to a different statin. Admittedly, pregnancy could be covered by a package insert warning, but new concerns can’t be foreseen.

    The UK has an intermediate solution: a behind-the-counter option where a prescription is not required but a consultation with a pharmacist is.

    FDA policies are certainly open to question; but as they currently stand, statins don’t meet the criteria they are using for designating a drug OTC. They have good reasons, but reasonable people may have other reasons to disagree with their decision.

  18. Jimmylegs says:

    @windriven:

    Ahhh hypercholesterolemia is not easy to spot as it is asymptomatic, so we require blood tests to diagnose it. Also if you are arguing the point that easy to spot/diagnose conditions should not require prescriptions or renewals of, is a horrible position. What about hypothyroidism, after it’s diagnosed should the patient never require blood work or a new dosage ever again? What about depression, should they never be reevaluated to increase, lower, or even stop taking their drug (or switch due to ineffectiveness/side effects)?

    The answers to all, including hypercholesterolemia, is no (kind of a double negative here): patients need to be reevaluated for their conditions. I understand if you may think this is stretching it but how do you justify that disease vs others in terms of “one and done?”

    Also your biannual visits may be like that, but others may have more intense evaluations with their doctor drilling them with questions to be thorough.

  19. windriven says:

    “What do you mean by that? Most people who have elevated cholesterol levels aren’t usually aware of it until a blood test is done. ”

    Screening tests are available everywhere from shopping malls to drug stores. Anyone with modest interest in their health has the opportunity to screen for cholesterol, high blood pressure, receive influenza vaccines, etc.

    “What do you mean by that? Most people who have elevated cholesterol levels aren’t usually aware of it until a blood test is done. ”

    And this was exactly my point: using valuable physician time for routine prescription review is unconscionable in a nation that spends nearly twice that spent per capita by other industrial nations with, at least by gross measures, nothing to show for it. No moving of goal posts involved.

    1. Harriet Hall says:

      @windriven,

      “Anyone with modest interest in their health has the opportunity to screen for cholesterol’

      Yes, consumers can have their cholesterol tested, but it’s not a simple matter of “Chol high = take statin.” Consumers don’t have the knowledge and judgment to determine what their level means in the context of all the other cardiovascular risk factors and whether statins are truly indicated, and if so, which ones and what the dosage should be. I gave the example of one statin that interacted with a BP med; I doubt that any consumer is aware of that and would know to switch statins when starting the BP med.

      “No moving of goal posts involved.”

      Yes there was. Your original goalpost was that statins should be OTC, then you moved the goalpost to not requiring a physician visit for refills when a patient is established on a medication.

      “using valuable physician time for routine prescription review”

      I would argue that that is one of the most essential roles of a physician in this era of polypharmacy: routinely checking which prescription and non-prescription meds a patient is taking and reviewing the need for each, possible interactions, etc. Your objection to unnecessary appointments could be answered by providing more liberal refills over a longer time period whenever that is safe and reasonable.

  20. RD says:

    Part of the reason it is challenging to get certain supplement products off of the market is because companies have to ‘prove’ it was their product specifically that caused adverse effects. Companies can always claim that their product was not taken as directed…or blame other items being consumed for adverse effects. How long did it take to get Ephedra banned in the US, even after many serious health and death reports? It is just frustrating that people will gobble up these type of supplements…while eating their Big Mac…and wonder why they can’t afford to ‘eat healthy’ and other effective treatments?
    This would never happen to a drug, because the drugs have to be shown to be safe prior to public use. The side effects would have been found out right away!

  21. mousethatroared says:

    windriven “And this was exactly my point: using valuable physician time for routine prescription review is unconscionable in a nation that spends nearly twice that spent per capita by other industrial nations with, at least by gross measures, nothing to show for it. No moving of goal posts involved.”

    A routine prescription review is a 15 minute appointment, maybe with a blood test that would have to be done regardless. How do you know you aren’t being penny wise and pound foolish? What are the potential costs and amount of time spent in the doctors office or ER from missed side effects, inappropriate drug combinations or missed signs of progressing disease?

    Maybe I missed something, are statins OTC in other countries that have more efficient health care than the U.S.? What is your evidence that OTC statins would, overall, reduce the cost of healthcare?

  22. windriven says:

    @Dr. Hall

    “Your original goalpost was that statins should be OTC”

    No, I asked SkepticalHealth whom I presume to be an MD why statins aren’t OTC. I noted that there were a number of formerly prescription drugs that are now OTC and wondered if statins would fit this profile. I can purchase statins OTC in Mexico and in China. I don’t know about Europe beyond your note that they can be purchased in the UK with a pharmacist’s blessing.

    @mouse
    “A routine prescription review is a 15 minute appointment”
    Perhaps for the physician but not for the patient. Why not have that routine prescription review handled by a PA or skilled nurse practitioner? Why not have annual renewals (apologies to Dr. Hall but in the real world physicians don’t write 1 year prescriptions and if they did I again have to wonder what the magic of a year is, why not 2 or 5 or forever? If we’re going to have a protocol shouldn’t there be a solid rationale on which to base it?).

  23. Harriet Hall says:

    @windriven,

    “No, I asked SkepticalHealth whom I presume to be an MD why statins aren’t OTC”

    Yes, you originally phrased it as a question, but I can only assume that you asked it because you thought it would be a good idea, and you followed it with the assertion that apart from antibiotics, “many other”prescription drugs should be available OTC.

    I would be concerned about quality control for OTC statins obtained from Mexico or China.
    Incidentally, narcotics used to be available OTC. Today, most people think restrictions are a good idea.

    “in the real world physicians don’t write 1 year prescriptions”

    Nonsense! I live in the real world and both my husband and I routinely get prescriptions refillable for 1 year, including my statin prescription.
    As you point out, a 1-year period is arbitrary. There are no studies showing the optimal time for refills, and in the absence of evidence, a year is a convenient guess. It would be very costly to study that question for each of the many prescription drugs or even for the most commonly used ones, and there are other needs calling for our research dollars.

  24. windriven says:

    @ Dr. Hall

    “Nonsense! I live in the real world and both my husband and I routinely get prescriptions refillable for 1 year”

    Dr. Hall, you are a physician and your husband is the husband of a physician (and perhaps a physician himself). While not a physician, I work in the medical industry and through contacts and friendships have a relationship with my primary care physician that allows many things to be handled with an e-mail or a phone call. But that is not the experience of many people. Many people have to book appointments weeks in advance, sit in waiting rooms long after their appointment time has come and gone, and never get year long prescriptions. Many people don’t have the luxury of shopping primary care physicians to find one that adheres to scientific values and isn’t a douche, a quack, or a serial malpracticer (or?). In point of fact while I can generally get a prescription with a phone call, I’ve never had a 12 month prescription for anything.

    “but I can only assume that you asked it because you thought it would be a good idea”

    I asked it because I thought it might be a good idea. I’m still not convinced that it isn’t – at least within the scope of something like the UK model of OTC w/ a pharmacist consult. But I’m more interested in the larger issue of intelligently allocating scarce medical resources to achieve the greatest good for the most people (and hopefully at a cost more in line with other industrialized nations) than I am in the vagaries of statin prescriptions. Statin prescription practices need to be critically examined just like other allocations.

    “There are no studies showing the optimal time for refills, and in the absence of evidence, a year is a convenient guess.”

    You say 12 months, another physician says three. Where does clinical judgment stop and whim begin? Isn’t it just as reasonable to have a frank discussion with the patient about potential side effects and their warning signs and send them on their way to purchase statins OTC with the take-home that any signs of muscle weakness etc. necessitate an immediate call to the physician’s office?

  25. mousethatroared says:

    hmmm, I’m a regular nobody patient and all of my chronic condition prescriptions are for a year. For the albuterol and Flonase, I’ve gotten extensions past a year with a call to the office script refill line. The synthroid, they get testy if I don’t come in for a TSH test after a year.

    i don’t take (need) statins, though, so I can’t say there.

    I’d also note that doctor’s ask every visit if you need any prescription refills. So, if one is at the doctor for a cough, sore foot, etc, one can ask for neededrefills then.

  26. mousethatroared says:

    Windriven “Perhaps for the physician but not for the patient. Why not have that routine prescription review handled by a PA or skilled nurse practitioner? Why not have annual renewals (apologies to Dr. Hall but in the real world physicians don’t write 1 year prescriptions and if they did I again have to wonder what the magic of a year is, why not 2 or 5 or forever? If we’re going to have a protocol shouldn’t there be a solid rationale on which to base it?).”

    I don’t understand your point. Of course a 15 minute appointment takes more time for the patient, but your argument was scare doctor resources, not patient convenience. Nurse Practitioners do presently write and refill prescriptions, what has that have to do with making statins (or similar medications) OTC.

  27. weing says:

    With the coming patient satisfaction requirements as quality indicators, maybe a 1 year prescription for Vicodin will become common? Getting back to statins. The requirement for routine LFT monitoring has been dropped. So, I don’t have a problem prescribing statins for a year, as long as the patient’s LDL is at goal. http://www.fda.gov/Drugs/DrugSafety/ucm293101.htm

  28. Harriet Hall says:

    @windriven,

    “Isn’t it just as reasonable to have a frank discussion with the patient about potential side effects and their warning signs and send them on their way to purchase statins OTC with the take-home that any signs of muscle weakness etc. necessitate an immediate call to the physician’s office?”

    No. I have tried to explain why that would not be in the patient’s best interests. Apparently you don’t know enough about the complexities to understand what I meant. I agree with the FDA that making statins available OTC is not a good idea.

    I strongly encourage the use of PAs and nurse clinicians and I am in complete agreement with you about the need to better allocate scarce resources. But I don’t think increasing the availability of drugs OTC is the answer.

    If you think I get better treatment and longer refills because I am a physician, you are wrong. I get my medical care through the military system and they are regimented to treat everyone the same. Half the time they don’t even know I’m a doctor. The nurse calls my name as “Mrs. Hall” and they usually assume I’m a dependent wife. I have had to wait for appointments and have sat in the military pharmacy awaiting my turn for as long as 5 hours. I don’t get to choose a physician but am assigned one arbitrarily. I’m being followed in the cardiology clinic, but have never seen a cardiologist: my appointments there have been with PAs and nurse practitioners. I have never had any special treatment because of my rank or my profession, except once when they offered me the chief of anesthesiology instead of the nurse anesthetist; I chose the nurse.

  29. mousethatroared says:

    weing “With the coming patient satisfaction requirements as quality indicators, maybe a 1 year prescription for Vicodin will become common?”

    (rant)

    Hah! Because there are not healthier ways to improve patient satisfaction? From a patient here’s a few tips.
    -Don’t hire concentration camp guards to answer your phones and make appointments. (Or give THEM the 1 year prescription for Vicodin)
    -Don’t have the person who leaves snippy notes in the break room saying “We’re not your mother, etc” write the letter that goes out to all new patients.
    - If you give a patient a health history form that takes an hour to fill out, find some way to show that you actually looked at it.
    - If you have a phone system that requires patients to leave a message for test result, refills or to talk to a nurse, makes sure those messages are answered in the time the message states…24 hours usually means 1 day, not 1 week.
    - If your patient is making an effort to be reasonable and polite refrain from rolling your eyes, acting put out, snippy or grumpy. Also refrain from complaining about your staff or the patient’s other doctor(s) to the patient.
    - Get a computer system where you can share records with other doctors in the area so your patients don’t have to spend an hour on the phone and another two hours running around town signing forms and collecting films and lab results.
    - keep your computer testing equipment working…or at least advise staff to struggle with software/hardware problems outside the patient’s sight.
    - Try not to talk to fast.
    - Try not to interrupt more than necessary (yeah, I’ve worked with clients, I understand, sometimes it’s necessary)

    If you are already doing ALL those things, I’m guessing you’d be ahead of the game in “customer” satisfaction surveys. You’d certainly be doing better than the doctor’s offices I’ve been to lately.

    Of course, the endless supply of Vicodin is probably an easier route to customer satisfaction.

    (end rant)

  30. agitato says:

    @mousethatroared

    Excellent rant!

    @Harriet Hall

    Have statins been universally endorsed for primary prevention of coronary heart disease? I thought that this was still controversial.

  31. Harriet Hall says:

    @agitato,

    “Have statins been universally endorsed for primary prevention of coronary heart disease?”

    No. There is evidence that they reduce cardiovascular events and all-cause mortality, but the studies have shortcomings and it is still controversial. See this 2012 Cochrane review:
    http://summaries.cochrane.org/CD004816/statins-for-the-primary-prevention-of-cardiovascular-disease

    Current practice is to use statins selectively for primary prevention in patients who appear to be at high risk when all their risk factors are considered as a whole.

  32. Harriet Hall says:

    @mouse,

    “- If you give a patient a health history form that takes an hour to fill out, find some way to show that you actually looked at it.”

    That made me laugh. It is one of my pet peeves. Especially when the questionnaire repeats the same question on the front and back of the same sheet. Even when the doctor acknowledges part of the questionnaire (“I see you’ve had a hysterectomy.”) he fails to comment on other items that could be important or even red flags.

  33. Scott says:

    - If you give a patient a health history form that takes an hour to fill out, don’t give them the same form next week too.

    FTFY.

  34. windriven says:

    “I have tried to explain why that would not be in the patient’s best interests.”

    Yes, well, 3 months, 12 months, sounds more to me like “because I said so” than an explanation. I’ll spend some time on Pubmed this weekend. Of course I’m probably not smart enough to understand those big words.

  35. Harriet Hall says:

    @windriven,

    “Yes, well, 3 months, 12 months, sounds more to me like “because I said so” than an explanation.”

    The time period is arbitrary and based on professional judgment (informed opinion). I tried to explain why followup at some interval is in the patient’s best interests and OTC availability is not, and I said we have no data to support any specific interval.

  36. windriven says:

    @ Dr. Hall

    “I said we have no data to support any specific interval.”

    Which brings me back to one of my interests and the primary reason that I follow SBM: allocation of medical resources in a way that delivers the biggest bang for the most people at a given expenditure of funds. Prophylaxis, diagnosis and treatment based on solid science seems to me an important component, arguably the most important component for approaching that goal.

    When quacks tout reiki or spinal manipulation or tweedling needles it is absolutely appropriate to ask for proof. When a physician advocates a course of treatment it is also appropriate to ask for proof. Sometimes there isn’t any; apparently that is the case for frequency of patient follow up on a statin regimen. But invocation of clinical judgment doesn’t settle the matter. Clinical judgment is acceptable absent better information – but then the consumer has to evaluate how much faith to place in that clinical judgment – and the consumer rarely has the information to make a truly informed decision.* **

    Medical wisdom changes. Some physicians spend a lot of time and effort keeping up with their field, others not so much. Internists and family practitioners have a particularly difficult task because they have to be up to date on an incredibly broad range of subjects. Clinical judgment and experience are fine attributes, especially in the realm of diagnosis. But they don’t hold a candle to solid scientific evidence when it comes to treatment.

    I don’t know what the rate of rhabdomyolysis or liver damage are with statins. I especially don’t know the odds of either developing after long term use of statins. If I have an opportunity this weekend I’ll try to find out.

    In the event, whether or not statins should or shouldn’t become available OTC isn’t the point. The evaluation of the expenditure of resources versus the good achieved is the point. This very blog has discussed routine mammographies and PSAs in the context of exactly that: how much do we spend to, say, find one cancer? With statin follow-ups how many physician visits per patient per decade yield the best balance between dollars spent and outcomes achieved? If medical care was free or unlimited dollars were available for medical care, or there were in infinite number of physician visits available, none of this would matter. Unfortunately it does matter.

    *One can easily speculate that this is the door through which some people pass on their way to sCAM

    ** Even educated, thoughtful, interested consumers are faced with daunting costs in time and money to gather information on which to base judgments. Many journal articles – even those that issue from tax dollar funded research – are behind paywalls. $30 isn’t much if one can find a silver bullet by the abstract but when it takes 8 or 10 it can run into more than Starbuck’s money.

  37. Harriet Hall says:

    @windriven,

    “it is also appropriate to ask for proof…With statin follow-ups how many physician visits per patient per decade yield the best balance between dollars spent and outcomes achieved?”

    I agree with you. I would love to know that sort of thing, and it’s good to ask those questions and it’s important to do everything possible to increase efficiency and reduce costs of medical care. Meanwhile, we don’t have answers and we still have to write something in that space for the number of refills on the prescription pad. Clinicians are doing the only thing they can do in the absence of science-based guidelines.

    One caveat: if we had a study showing that the best outcomes were in patients given 2 years’ statin refills, it wouldn’t automatically apply to everyone. The subjects in the study would have been selected to rule out confounders and wouldn’t be representative of the patient walking into our office who has 3 other chronic diseases and is on 8 prescription drugs. There might still be reasons for seeing individual patients more often. For instance we might have reason to suspect that an individual was at high risk for liver disease or was on other medications that might affect liver function and we might want to check his liver function tests at more frequent intervals. Medicine is complex, not a black and white cookbook. More studies would reduce guessing but wouldn’t eliminate it.

  38. Jimmylegs says:

    So with this discussion of follow up intervals what is actually being argued here? Is it that it should be shorter? Or that we need to find the best interval with research, which I don’t have the slightest clue as how one would figure that out.

    For the time being it what we have doesn’t seem bad.

  39. nybgrus says:

    @windriven:

    You seem to be focusing on the concept that the only reason for the return to care after 6 or 12 months would be the statin refill script. Perhaps in your case it is. And as you said, there are some crappy docs out there. If the only thing is the statin script, then yeah you’re right. Pretty pointless. However, it is valuable for a patient to follow up with his/her doc regularly. A year is the arbitrary time frame we have for that in general. If your doc won’t write a script for a year well… I dunno what to tell you. When I did family medicine we wrote for a year on meds we figured were good to do so. If a patient needed a script and nothing else, and the clinical judgement was that there was no other reason to see the patient… well, we filled it over the phone! Or even by email, actually. And if a patient came for some other reason outside the scheduled yearly return, we always asked if they needed a refill on anything.

    So your singular experience with which you are trying to paint the whole of medicine an somehow claim that you have a special insight to is old hat. We know this, we do this already. It is how I am being trained. And besides, your initial post and the starting point of discussion was specifically making statins OTC and then generalized to making meds OTC as the solution to this perceived resource wasting problem. The better solution is exactly what I described above.

  40. windriven says:

    @Jimmylegs

    “So with this discussion of follow up intervals what is actually being argued here?”

    Speaking only for myself, it became an inquiry into the relationship between best practices and clinical judgment and how the result impacts costs and outcomes. But it started as a question about why one particular family of drugs isn’t available OTC.

    There have been any number of drugs that began life as prescription drugs. H2 blockers and proton pumps and allergy medications leap to mind. Sometimes physicians argue as Dr. Hall did here that it is in the patients’ best interests to have drugs available by prescription necessitating physician follow up visits.

    Here we drift into an area of relative benefit versus relative cost. There would be fewer traffic fatalities if speed limits were kept below 30 miles per hour, cars were built like battle tanks and only licensed chauffeurs could operate them. But the cost of transportation would be astronomical.

    In America the cost of healthcare is astronomical measured against the cost of care in other industrialized nations. Worse, at least by gross numbers, we don’t have large incremental improvements in outcomes to show for the added expense.

    Life is full of risks and with those risks come potential benefits and potential damages. When you take a statin you are hedging your risk of cardiovascular disease but incurring a risk of (rarely) devastating muscle or liver damage. Having a physician mediate reduces that risk but comes at a cost in both real terms and in terms of opportunity cost because health care is a finite resource. Where do you draw the line?

  41. weing says:

    @windriven,

    Let us know if you find any good studies of optimal patient follow-up. My own approach to refills and f/u varies with the patient. If the patient’s cholesterol is at goal on the current dosage, I don’t have a problem giving refills for a year, especially since quarterly LFT monitoring is no longer required. Again, this is only anecdotal, but I have found that some patients become lackadaisical about adhering to their diet and medication use when they are given refills for a year. It’s as if they feel that if I don’t care enough to monitor them, why should they?

  42. mousethatroared says:

    @agitato – Thanks ;)

    HH – Somehow I thought that a doctor would never ignore another doctor’s health history form…

    Scott – HeHe – if ignoring one form is good, ignoring two forms must be better.

  43. Jimmylegs says:

    @windriven:

    Ok I think I understand what you are saying. For some drugs that are prescribed for 6-12 month supplies physicians based that on trends. As an anecdote my dad takes medicine for cholesterol and hypothyroidism. He goes in every 6 months or a year (I don’t know the exact times, but it’s not frequent) and when he gets his blood work done his medicine is based on the changes (if no change, it remains the same dosage).

    Now the arguement (if I understand correctly) is why 6 months? Why 12 months? Why not just have it OTC? Well I cannot answer the intervals because 1) I’m not a doctor and 2) I don’t know the methods / reasons for any blood test / testing interval for drug renewal, but the OTC question seems to have been answered.

    Statins are not OTC because they require more than personal judgement on what you need and when you need it. I think you would be hard pressed to find anyone in the world that can give a statin dosage for general populations assuming we have the same cholesterol levels, so we need that blood work at a minimum to get started. So ruling out “time wasted” at a doctor, then going to LabCorp or Quest to get work done will still be there.

    So on the bases of requiring blood work to be done I doubt any statin (unless a new one comes out that is realitively safe and “one dosage fits all”) will be OTC ever.

  44. nybgrus says:

    I actually know a few cardiologists from back before I started med school who said something to the effect that “statins should be put in the water alongside fluoride” because of the amount of good it would to for the population and the risk profile.

    I don’t know that I would go that far. The problem with making statins OTC is exactly what was said above – you have absolutely NO idea if you actually need it. I have a friend who is 4’8″ tall and weigh between 210-230 pounds. She eats poorly, as you may imagine, is in her mid 30′s and has better cholesterol than I do. I am in my late 20′s, 6′ tall, weigh around 185-190 pounds, and in my peak (which is when we both got our cholesterol panels done) I was cycling 3-400 miles per week, running 20-25 miles per week, surfing 3 times a week, and lifting weights 2-3 times per week (obviously, this was before med school started…).

    Any person in their right mind would look at me and assume my cholesterol was fan-friggin-tastic. And look at her and assume it was faaar from so.

    So the harms would not only come from people who need a statin and get side effects but from all those people who don’t need a statin and take one anyways (risk:benefit where benefit is extremely small) and from those who do need a statin but then don’t take it because they assume they don’t need it.

    For the drugs mentioned above there are really obvious indicators when people should take them and the side effect profile is at least as good as a statin. Have an upset stomach? Frequent heartburn? Try a PPI or H2 blocker or Tums. Have runny, itchy eyes and sneeze a lot? Well an anti-histamine makes sense. Have muscle pain? An NSAID seems like a good choice.

    The other aspect is that in each of these commonly OTC ailment/remedy combos the ailment is typically self-resolving and the treatment is typically not taken for years on end. Stomach ache doesn’t go away after a couple of days of OTC? Then follow up with the doc and figure it out. Sinus congestion terrible and won’t go away with a Claritin? F/U. Reflux so bad the PPI doesn’t touch it? Same thing… and of course, if the PPI does work then we would tell you to take it for years anyways.

    Many drugs and supplement are OTC that many here have argued shouldn’t be, so using them as examples is not so valid. My own example of NSAIDs could reasonably argued as such. Especially aspirin and tylenol. But as we all know the NEJM showed us that regular vitamin takers had increased mortality and morbidity…. people who almost certainly had no need for the vitamins and of course what they were taking is probably much more innocuous than a statin.

  45. weing says:

    “and of course, if the PPI does work then we would tell you to take it for years anyways.” I am not so quick to do that. I tell the patient to take it for 2 months and stop. If they have to resume it, I send them for an EGD first to rule out anything more serious. Then, I tell them to take it for years.

  46. nybgrus says:

    excellent point, weing. You are correct – sinister causes need to be ruled out as well. Further demonstrating that OTC is probably an over stocked section of the pharmacy

  47. @nybgrus, I did not read in detail so forgive me if this is unnecessary. UpToDate has a great article on the long term effects of PPIs:

    http://www.uptodate.com/contents/overview-and-comparison-of-the-proton-pump-inhibitors-for-the-treatment-of-acid-related-disorders?source=outline_link&view=text&anchor=H59974871#H59974871

    (I hope that link works.)

  48. (I mean, I didn’t read what you wrote in context about PPIs)

  49. nybgrus says:

    Thanks for the link. It wasn’t anything surprising to me, though it does seem that PPIs are reasonably safe. Of course nothing can be completely benign when taken for an extended period of time.

  50. swithin says:

    @Dr. Hall,
    As a libertarian, I’d love to jump in on the OTC vs. prescription discussion, but I have what I think is a more important question regarding the accuracy of this article. I’m a fan of the SGU, JREF, Dr. Novella in general, and I obviously visit sciencebasedmedicine.org.

    This article states “Only it doesn’t anymore.” That’s what concerns me.
    So that we can have a science-based discussion about this, I’ll include references to my sources of information and will look to you to poke holes in them if you think it’s deserved.

    Background:
    I talked to a doctor about a few years ago that recommended red yeast rice because it contains lovastatin. Knowing that herbal medicine companies aren’t regulated like the pharma companies, I wanted to do some research for the very reasons you discuss in this article.

    Research:
    Like @Old-skeptic, I found that consumerlab.org did what they assert was an independent test on many different red yeast rice brands and found that some did consistently contain the amount of monocolin K (lovastatin) as claimed on the label. That report is at https://www.consumerlab.com/reviews/Red-Yeast-Rice-Supplements-Review/Red_Yeast_Rice but requires an annual subscription to their service. I found one of the higher rated products on Amazon.com and can identify it if you want me to. I’m not sure if you would view listing specific products as inappropriate for this website.

    Likewise, there is an article reviewed by Dr. Agus MD; emeritus professor of U of Penn School of Medicine based on the consumerlab.org research. (See http://www.medpagetoday.com/Cardiology/Dyslipidemia/22973) I don’t know if Dr. Agus really vetted the consumerlab research or just jumped on the bandwagon—this is one of the reasons I’m looking to you, on behalf of sciencebasedmedicine, to weigh in on this.

    Another highly rated (by consumers) red yeast rice brand on Amazon.com lists a certificate on the brand’s website issued by an independent lab (See http://www.aaclabs.com/about/professional) which “seems” legit to me.

    So there are at least two brands, available in the U.S., which claim to have lovastatin as contents, and also claim to have proof of their claimed content (lovastatin) by independent labs.

    Question:
    At this point, I’m wondering if you would consider updating your article based on this new information. If you have contradictory evidence, I’d like to read it. I’m not interested in winning an argument, just getting to the truth.

    I appreciate you taking time to lend your expertise to this website.

  51. weing says:

    @swithin
    Below is the relevant passage from the FDA website. http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/GuidanceDocuments/DietarySupplements/ucm257563.htm See what you can make out of it.

    Can I manufacture and sell a dietary supplement containing a dietary ingredient that was marketed as a food or dietary supplement before it was approved as a drug, licensed as a biologic, or authorized for investigation under an IND?
    Yes, in this situation the dietary ingredient may be used in dietary supplements. In considering whether a substance has been “marketed as a dietary supplement or as a food,” FDA looks for evidence of one of the following:

    Evidence that the substance itself was sold or offered for sale in the U.S. as a dietary supplement, dietary ingredient for use in dietary supplements, or conventional food. For example, a catalog listing a product identified as a “Substance A supplement” would establish the marketing of Substance A as a dietary supplement. Similarly, business records documenting that a substance was offered for sale or sold as an ingredient for use in manufacturing a conventional food would establish the marketing of the substance as a food.

    Evidence that the substance was a component of a food or dietary supplement that was sold or offered for sale in the U.S., and that a manufacturer or distributor of the food or dietary supplement marketed it for the content of the substance by, for example, making claims about the substance or otherwise highlighting its presence in the product.[17] For example, in Pharmanex v. Shalala, the firm marketed lovastatin, a component of its red yeast rice product Cholestin, by promoting the lovastatin content of Cholestin.[18] Merely showing that the substance was present in a food as a component would not be enough to show that the substance was “marketed,” however.

  52. Harriet Hall says:

    @swithin,

    I said “Most of them got around the FDA restriction by eliminating the monacolin content and by careful labeling and advertising that does not claim to lower cholesterol.”

    “Most” doesn’t mean “all.” If any currently available brand contains appreciable amounts of monacolin, much less therapeutic levels of lovastatin, it’s illegal, and it’s only a matter of time until the FDA acts against it.

  53. windriven says:

    @weing

    “Let us know if you find any good studies of optimal patient follow-up”

    I’m sure you know but it bears repeating for other readers who may be new to SBM: I am not a physician. That said, there is an awful lot of material out there on statins but little that I could find that gives follow up recommendations that are both evidence based and specific. The best I found is:

    “Final Conclusions and Recommendations of the National Lipid Association Statin Safety Assessment Task Force” published in the American Journal of Cardiology.

    Unfortunately NLA appears to get a lot of its funding from major pharmaceutical companies so there may be good reason for some caution.

    Conclusions and Recommendations discussed four adverse effects: changes in liver function, muscle disorders, renal disorders and neurological disorders. In discussions of all of these adverse effects clinicians are directed to be vigilant for symptoms (and these are enumerated) and to instruct their patients of symptoms that may warn of adverse effects. Careful evaluation is recommended prior to beginning treatment, for 12 weeks after beginning treatment and after dosage changes. And of course patients with other morbidities and those taking multiple drugs require more careful monitoring. But “routine monitoring of liver function tests is not supported by the available evidence.” Discussions of the other adverse effects similarly do not find available evidence supporting routine labs.

    Still, as Conclusions and Recommendations notes, prudent physicians will follow FDA approved prescribing guidelines including periodic follow ups. But, at least from the evidence discussed in this paper and absent significant comorbidities, this has more to do with bureaucratic head-bobbing than quality patient care.

    As to my question to SkepticalHealth about OTC statins, after a few hours of intense reading I still don’t have a strong sense of whether they should or shouldn’t be. The incidence of serious adverse effects is verrrry low but when they occur they can be horrific. These serious adverse effects generally occur where there are other serious comorbidities rather than in otherwise healthy adults – and those with serious comorbidities should be seeing a physician regularly anyway.

    There are a finite number of primary care physician-hours available in any given year. How do we as a society best spend those hours to achieve the biggest bang for the most people? What can we do to leverage those hours; what force multipliers can we use? Where can we eliminate tasks that waste those available hours on non-productive activities?

  54. weing says:

    @windriven,

    It is a rare patient that is just on a statin. Most of them have various comorbidities. I have struggled with the question of optimum follow-up intervals ever since my residency in the early 80s. What I did is adopt what my preceptors did and what my fellow physicians did. That’s how a standard of care is determined anyway. Should something go wrong, I am not an outlier that can be blamed for not following up appropriately. Some of the intervals are based on science but all are based on what the doctors in my community are doing.

  55. windriven says:

    @weing

    “It is a rare patient that is just on a statin.”

    I wonder if this is as true in the general population as it is in your practice? I have quite a number of friends who are on statins on the grounds that low cholesterol is good and lower cholesterol is better. My own former internist had me on Lipitor for several years on the same theory (180 total ~5:1 w/o statins). I took myself off after a while – I don’t like taking drugs without a compelling reason – and my current internist sees no reason for me to resume. But frankly many of my physician friends (mostly anesthesiologists) also subscribe to the prophylactic statin notion regardless of baseline cholesterol.

  56. nybgrus says:

    @windriven:

    You are misinterpreting the intention and purpose of the statin in such cases. There is pretty decent evidence and plenty of plausibility that the curve for morbidity/mortality vs cholesterol not only has an inverse correlation but also does not plateau.

    Meaning that the lower your cholesterol is the better, without some magic number below which there is zero additional benefit.

    By that basis alone some actually argue that statins are always a good risk:benefit.

    I am with the middle ground here that any single risk factor is probably enough to be reasonably certain to tip the balance.

    So being a white male over 40 is a risk factor. Diabetes, family history of CAD or MI under age 50, known CAD or athersclerosis, chronic poorly controlled hypertension, and a few others are risk factors. So pretty much at least half the population at some point meets criteria.

    But that doesn’t mean it shouldn’t be monitored and managed (and titrated to proper dose). Hence, I still think OTC is a stretch… but not that much of a stretch. I could see a good epidemiological study at least potentially demonstrate that the overall risk with very large numbers of uptake was worth the net benefit to society. That would be a tough study to do (to put it mildly) but theoretically possible.

  57. windriven says:

    @nybgrus

    “You are misinterpreting the intention and purpose of the statin in such cases.”

    ?
    No, I don’t think I am misinterpreting it at all. But having no risk factors for CVD (other than my age), no family history of CVD and with statins not having been in widespread use long enough to establish their absolute safety when used daily for, say, 50 years I just don’t see the point. As I mentioned, my former internist in New Orleans was a true believer. My current internist in Portland is … not.

    “Meaning that the lower your cholesterol is the better, without some magic number below which there is zero additional benefit. ”

    Perhaps. Perhaps not. I don’t know that the effects of medically induced long term hypocholesterolemia have been carefully studied.

    In any event, you and I agree that OTC statins is a moot point. If I had to choose today I would probably argue against. But I would also argue that otherwise healthy patients on statins should be followed after the first year or so – if at all – by a PA or RPh* or skilled nurse practitioner.

    I have two reasons for my general philosophical opposition to having physicians personally involved in every detail of care. First, physician time is a limited and extremely valuable resource. I would like to see that resource exploited in the most efficient possible way so as to do the greatest good for the greatest number of people. Second, because physicians as wet-nurses distance people from their responsibility for their own health. It isn’t good for consumers and it isn’t good for physicians (think of how many pointless antibiotic scrips have been written in the past 20 years by physicians because their patients expected/demanded it).

    * It seems to me that ‘lick, stick, count and pour’ is a gross under-utilization of pharmacists.

  58. weing says:

    @windriven,

    ” I don’t know that the effects of medically induced long term hypocholesterolemia have been carefully studied.”

    There are studies of people with PCSK9 loss of function mutations that have extremely low levels of cholesterol that do not show any adverse effects of extremely low levels of cholesterol except that they don’t get atherosclerosis. So, this question is pretty much settled, the lower the better. There are risks to the use of statins as well as benefits. If your Framingham risk is low to begin with, lowering your risk further may not outweigh the risks of the various adverse effects of statins, not even considering the cost of the meds.

  59. nybgrus says:

    I can’t say I know enough – i.e. have sat down and really crunched the numbers if they are even available – as to which way to cut such a thin edge. You do have a risk factor – your age. Is that alone enough to tip the risk/benefit analysis? Maybe, maybe not. If your cholesterol is higher than 170 total, then I would say that is very likely good enough reason.

    And statins have been around – lovastatin specifically – for a long time. Marketed since 1987. And studied very, very heavily.

    And as weing pointed out, there is indeed a fair bit of data to demonstrate that lower is actually better, regardless of how low you actually are. Obviously there are diminishing returns, but nonetheless the evidence is there.

    As for making it a 1 year script, or one that is followed by mid level practitioners… you get no argument from me. And as I said – in my clinics this year we have prescribed for a year plenty of times. And back in my undergrad days I did some work in a heart failure clinic and it was the NP that took care of all that stuff.

    As for your objection to having a physician involved in every bit of care… I also agree. However, the practicality of the situation is more complex than that. Mid level practitioners and a true team mentality for health care is a relatively novel concept and even more novel in implementation. Who is adequately trained and who you can trust is often a legitimate question. An NP who gets good at pattern recognition and succumbs to Dunning-Kruger is quite dangerous… and it is the physician’s license on the line. Not saying NPs are poorly trained – just pointed out that it is actually more complex than just saying “NPs should handle that.”

  60. windriven says:

    @weing and nybgrus

    Sincere thanks to you both. I’ll do a bit more research, then discuss resuming statin therapy with my internist next visit.

    @nybgrus

    “it is the physician’s license on the line.”

    This is more a legal / regulatory issue than a medical one. If we are to rebuild our health care system to offer quality care to all Americans at something closer to the cost of other industrialized nations we will need to address these issues. Tinkering with health insurance a la ACA is necessary but wildly insufficient.

  61. nwtk2007 says:

    @weing, you say that since mice that are genetically purposed to have lower cholesterol have no atherosclerosis, then it is given that higher cholesterol is a cause of atherosclerosis? I have paraphrased but this appears to be the gist of what you have said.

    Isn’t cholesterol a risk factor? and is there any clear evidence that lowering a risk factor lowers the disease?

    I remember about 5 yrs ago a statement issued by the AMA that they were naive in believing that cholesterol caused atherosclerosis since it was high is so many with atherosclerosis. This was in response to studies showing that statins did not actually lower atherosclerosis and in one case there was an actual slight increase when using one particular statin.

    A phD friend of mine working at the UTHSC in Dallas said it was looking like the elevated cholesterol might be a response to something associated with atherosclerosis. He used an analogy I had read related to firemen and fires, that their concentration rises in areas of elevated occurrence of fire. Of course, using the same analogy, lowering the concentration of firemen would not decrease the occurrence of fires.

  62. weing says:

    @nwtk2007,

    “@weing, you say that since mice that are genetically purposed to have lower cholesterol have no atherosclerosis, then it is given that higher cholesterol is a cause of atherosclerosis? I have paraphrased but this appears to be the gist of what you have said.”

    Huh? No. I was talking about PCSK9 loss of function mutations in humans not mice.

  63. nwtk2007 says:

    Oh der. My bad. Not sure where I got that? Any way then, same comment.

  64. weing says:

    @nwtk2007,

    I think your friend was talking about HDL cholesterol. That is a horse of a different color. The studies show that elevated HDL cholesterol is associated with decreased MIs. As far as I know, no studies have shown that raising the HDL cholesterol decreases the incidence of MIs. Only lowering the LDL has been shown to do that. The analogy of firetrucks is frequently used for it. If the firetrucks are just going around and not putting out the fires, or if they are themselves on fire, they don’t do much good.

  65. nwtk2007 says:

    I don’t think so really. I guess what I’m getting at is even though disruption of the function of the pcsk9 entity results in elevated receptors and thus a lowering of blood LDL-C, there is still the question of whether or not this lowered blood LDL-C results in decreased plaque formation or not. Its the same question; does lowering blood cholesterol decrease atherosclerosis of is the decreased atherosclerosis the result of some other thing, not specifically the lowering of cholesterol? Or the reverse, does the cause of atherosclerosis also cause elevated blood levels of LDL-C?

    1. Harriet Hall says:

      Statins have an anti-inflammatory effect as well as lowering cholesterol. The bottom line is that treating patients with statins both lowers their LDL AND reduces their risk of heart attacks and death. We can go ahead and prescribe it without fully understanding exactly how it works.

  66. nybgrus says:

    I genuinely don’t have the time to look it up and reference right now, but there are indeed studies of various populations with various levels of cholesterol that demonstrate decreased athersclerosis and cardiovascular risk. There was also at least one paper some years ago (which I read pre-publication) demonstrating evidence of actual reversal of atherogenic plaques once the TC drops below a certain value (I can’t remember exactly right now, but somewhere in the 70-80 range, so yes, quite low).

    Furthermore there is bench science evidence to demonstrate how LDL gets trapped in the intima of vessels and the oxidization and inflammatory reaction that follows so there is indeed a priori plausibility that it is the increased LDL levels that lead to increased athersclerosis and not just some 3rd communally causal association (similar to how increased blood glucose leads to increased glycosylation – this is something that just happens all the time at a low basal rate so increasing the concentration of the reagents increases the rate).

    The last bit would be a question as to the harm of extremely low levels of LDL or TC. And once again, as weing has pointed out there is evidence that there is very little harm though I will agree that is far from conclusive. However, it can very reasonably be argued that trading the potential harms of low TC for the definitive harms of CVS disease is a good bargain, since if the harms of low TC were even remotely as much as that of CVS disease we would have some evidence of their existence.

    Lastly, I can toss in the evolutionary perspective as to why we would have a propensity for such a deleterious trait as cholesterol that kills us. First, our ancestors rarely had access to regular and significant amounts of food in order to generate a cholesterol level like what we see. But that is rather weak – the bigger part is that cholesterol is useful for a host of hormonal regulation (synthesis pathways) and the “high” levels wouldn’t kill us till LONG after we had procreated repeatedly so there is no particular selective pressure against the trait and at worst neutral selection for the hormone and lipid membrane synthesis aspect. In any event, this part is weak and I haven’t given it too much thought for this, but the point is that there is no evolutionarily compelling reason I can think of that would select against us having such a propensity.

  67. ^Not only that, but as part of their anti-inflammatory mechanism they stabilize and reduce the size of atherosclerotic plaques. They are, quite honestly, a wonder drug.

    @nwtk2007, in case you aren’t following (I don’t mean that in a negative way), we know the following about statins: 1. they lower LDL cholesterol and have favorable effects upon other lipids, 2. they are fantastic anti-inflammatories, 3. they stabilize atherosclerotic plaques, and 4. they decrease the size of atherosclerotic plaques. We also know that decreasing the amount of LDLs leads to a direct decrease in cardiovascular mortality.

    We know these things, and there is basically no debate or question to them. I hope everyone realizes how fantastic those few statements are. Those very same atherosclerotic plaques are the ones that either block arteries or embolize and block arteries further downstream. The fact that we have a medication (that is indeed mostly natural, isolated from fungus or something) that can not only stabilize these plaques, but actually shrink them, is absolutely fantastic. I sometimes think of statins as the second best class of drugs, behind antibiotics.

    Around 20% of your LDLs ultimately (!) come from your diet (trans-fats, saturated fats), and 80% is made by your body. It’s interesting because you can improve your diet, and see a nice drop in your LDLs, but the fact is if you starve yourself of dietary fats your body will compensate by making more LDLs. Of course exercise, etc, can also help reduce LDL levels, but there is a finite limit to what you can achieve by hard work and diet. The other 80% of your LDLs are made by your body. This is where statins (HMG-CoA reductase inhibitors) work, that is, they decrease the LDLs made by your body. Statins are necessary because they can drastically reduce your LDLs, thereby decreasing your chance of dying from cardiovascular causes.

    If anyone ever encourages a patient with hyperlipidemia to quit taking a statin (unless they are having horrible side effects) then they are directly contributing to that patient’s death.

    Note: If you are interested in learning about these things, the first half dozen chapters or so of the book Harriet wrote about a while back, Heart 411, is a great starting point.

    Other note: Any doctors out there, please counsel your nurses on calling patients with results from lipid panels. I’ve had a ridiculous number of extraordinarily healthy friends tell me that they got a call from their PCP’s nurses telling them they had high cholesterol, only to find out they have < 100 LDLs and fantastic HDLs (and of course good triglycerides.) Sigh!

  68. nwtk2007 says:

    Here’s a link to a “summary” of a book about cholesterol “myths”. Some of what you have said is consistent with it and some not. http://www.mnwelldir.org/docs/cardio/cardio8.htm

  69. Nothing I wrote is a myth.

  70. weing says:

    @nwtk2007,
    So, some of it is correct and some of it is crap. You have the power and are armed with the knowledge to decide which is which.

    http://www.sciencebasedmedicine.org/index.php/the-international-network-of-cholesterol-skeptics/

  71. nybgrus says:

    I did a quick skim. Almost stopped reading when I came across:

    Most people survive even a major heart attack, many with few or no symptoms after recovery. What matters is how many die and this is much less than twenty percent.

    Yeah, CHF is not a big deal. Long term sequelae of “minor” heart attacks doesn’t matter. Its only people who die right then and there that count for anything.

    And then I cam across this:

    To cite the Framingham authors: “For each 1 mg/dl drop of cholesterol there was an 11 % increase in coronary and total mortality.”

    Which is doubly funny because at that particular site there was no reference, but in another there was. And the reference right below it was:

    Ravnskov U. Quotation bias in reviews of the diet-heart idea. Journal of Clinical Epidemiology 1995;48:713-719.

    Quotation bias you say?

    The whole abstract from which the Framingham quote was mined:

    From 1951 to 1955 serum cholesterol levels were measured in 1959 men and 2415 women aged between 31 and 65 years who were free of cardiovascular disease (CVD) and cancer. Under age 50 years, cholesterol levels are directly related with 30-year overall and CVD mortality; overall death increases 5% and CVD death 9% for each 10 mg/dL. After age 50 years there is no increased overall mortality with either high or low serum cholesterol levels. There is a direct association between falling cholesterol levels over the first 14 years and mortality over the following 18 years (11% overall and 14% CVD death rate increase per 1 mg/dL per year drop in cholesterol levels). Under age 50 years these data suggest that having a very low cholesterol level improves longevity. After age 50 years the association of mortality with cholesterol values is confounded by people whose cholesterol levels are falling–perhaps due to diseases predisposing to death.

    (Emphasis mine)

    So lets see… under 50 we have a significant decrease in CVD mortality (and presumably morbidity) for decreases in cholesterol. Then, magically at 50 we better crank up the cholesterol in order to continue the protective effects? Even the authors realize this is a stupid assertion and thus we find there must be a confounder (or two) in play here.

    That took me all of 15 minutes to skim and reference. But of course, I wouldn’t be reading such cheesy looking sites proclaiming wild things against the consensus, without references, and consider that a legitimate source of evidence. At least not without doing a little bit of legwork first. You need to up the caliber and quality of your reading material nwtk.

  72. nybgrus says:

    sorry, link to the other site didn’t work:

    http://www.ravnskov.nu/weblit.htm#115

  73. nwtk2007 says:

    nygbrus, I’m really not trying to make a point. I wanted to see your take on it. But it would seem not to be a crystal clear issue.

  74. @nwtk2007, come on man. At least try. Don’t link to a goofy article on a goofy website and then tell a bunch of people who are up to date with the latest science that what they are saying is myth.

    Sigh.

  75. I think nwtk2007 did a great job at exemplifying that chiropractors don’t have even the most basic understanding of the most basic things that are treated in general medicine. This is as basic as pointing to an airplane and identifying the wings. Its interesting that chiropractors spend all that time in school, consider themselves “doctors” (although no one else does), and yet don’t know squat about anything. What a tragic waste of time and money.

    I sat here and wondered why all these CAM fraudsters purposefully obfuscate simple issues. It must be because they are all sidelined because their offerings are useless crap, so in order to sell their snake oil they have to lie about the issues, purposefully confuse people, and then lie directly to them.

  76. Harriet Hall says:

    @nwtk2007,

    ” it would seem not to be a crystal clear issue”

    It is crystal clear to those who understand the science. The waters have been muddied and a manufactroversy created by those who oppose all drug treatments and by so-called cholesterol skeptics who have distorted a grain of truth into a whole edifice of misinterpretations and speculation. See http://www.sciencebasedmedicine.org/index.php/the-international-network-of-cholesterol-skeptics/

  77. weing says:

    “But it would seem not to be a crystal clear issue.”

    Try cleaning your glasses first.

  78. nybgrus says:

    you aren’t trying to make a point? Then why are you posting in the first place?

    That sort of answer is a pretty stock and common one for various pseudoscience apologists (and poor debators in general) as a catch all of the “I’m just asking questions” defense. No matter how you slice it, it is a a sneaky way to slink off and still hold on to some part of one’s original assertion.

    The issue is pretty crystal clear and the tack taken by you and the website you referenced is the same as that creationists and AGW deniers – find an inconsistency, minor hole, or small crappy paper that disagrees with the consensus and focus on that. It’s called a “manufactroversy” in that no reasonable and informed person would think there is a genuine controversy about the underlying principles and salient points.

    Is absolutely everything, down to the tiniest detail, settled about this topic? Of course not. But the framework is pretty solid and well established. The whole of your argument is simply ill informed and at least nominally disingenuous. Not to sound too much like SkepticalHealth ;-p but that does make sense since you use the same tactics to try and defend chiropractic as a valid intervention for back pain.

  79. I do think that this little exchange demonstrates that chiropractors, no matter how science based they claim to want to be, are truly anti-science and anti-medicine. Just another reason why no medical doctor should ever refer a patient and subject them to rank quackery.

    “Oh, you don’t need your statin! LDLs don’t mean anything.”

    … My wife has a friend who just got put on a new diet. It’s a 100% protein diet, consuming less than 500 calories per day. A chiropractor in Houston gave it to her. Wow. What a f-ing idiot.

  80. Haha, I just Google-ed “nwtk2007″ and saw dozens of his posts across the internet over the last 4-5 years. Wow.

    Some of those threads on chirotalk are absolutely hilarious. I do appreciate that a lot of them have realize that their profession is a complete joke and that they shouldn’t wield the title “doctor” and that they know essentially nothing. I just can’t believe how nwtk2007 knows basically nothing about one of the most fundamental aspects of cardiovascular disease. I mean completely clueless. It’s just embarrassing.

  81. @nwtk2007, what exactly do they teach you in chiro school? I saw you’re 37, so it’s not like you passed through before any of this stuff was common knowledge. I just don’t see how you can be so completely devoid of basic knowledge.

  82. BillyJoe says:

    Harriet:

    “The waters have been muddied and a manufactroversy created by those who oppose all drug treatments and by so-called cholesterol skeptics who have distorted a grain of truth into a whole edifice of misinterpretations and speculation. ”

    I love it. :)

  83. nwtk2007 says:

    Your responses are so revealing of your lack of objectivity, don’t you see? I truly just wanted your take on that website. It is obviously on the “crazy” side. Der. But since I am a chiro you just assume I’m trying to make a point? Get over your selves and you might make a difference; in somebody’s life I mean. You are mostly doctors, yes? Disappointed to be sure.

  84. nwtk2007 says:

    Actually I was hoping at least one of you might dicsuss the role of oxidized LDL in atherosclerosis. If I am not mistaken, there was a nobel prize given to a person who suggested that the initial event in plaque formation involved free radicals. I might be wrong about that.

  85. weing says:

    @nwtk2007,

    Oh. You was just joshin’. And I fell for it. Insert icon for: tail between my knees and cheeks flushed with shame. You wanted to discuss the role of oxidized LDL. From what you had posted, that would have been like discussing matrix algebra with someone who didn’t know addition and subtraction. Yes, it plays a role in atherosclerosis. I don’t know of any Nobel prizes for the role of oxidized LDL.

    Here are some references regarding PCSK9 if you’re really interested:
    http://www.hhmi.org/research/investigators/hobbs.html
    http://www.nejm.org/doi/full/10.1056/NEJMoa054013

  86. lol @nwtk2007. Troll harder!

  87. nwtk2007 says:

    Actually Weing, I believe it might have been Murad but his work was centered more on NO and local messengers so I might be wrong. It is interesting however, that is the initial event involves free radical promoted damage, as is also experienced with re-perfusion of ischemic tissues, then the role of cholesterol would have to be questioned. Just say’in.

    Skeptical, whats a troll?

  88. nwtk2007 says:

    Those are really good articles weing. I saw those a few years back. Highly suggestive for sure, but I think the actual role of cholesterol/LDL’s is still misunderstood in that there might eventually be better treatments/preventions than heavy concentration on their reduction.

    I also never found matrix algebra to be of that much use but many of my old prof’s used it in all their applications.

  89. nybgrus says:

    so because reperfusion injury is based on a burst of free radicals in tissues that are ischemic and thus unable to handle it, that calls into question cholesterol’s role in cardiovascular disease? Honestly I am at a loss. That is a complete non-sequiter.

    and “highly suggestive” is basically what science does. It very highly suggests that time-space curvature is real, the relatavistic effects need to be taken into account, and that cholesterol is a significant (though not sole) risk factor for the development of cardiovascular disease. It is also “highly suggestive” that smoking leads to lung cancer. And most evidence demonstrates that the absolute risk increase is somewhere in the 1% range. Perhaps you would also suggest that we are concentrating on smoking cessation much too heavily? Or perhaps you just don’t understand the concept of the law of large numbers and targeting the easiest and safest risk factors first….

  90. weing says:

    “Highly suggestive for sure, but I think the actual role of cholesterol/LDL’s is still misunderstood in that there might eventually be better treatments/preventions than heavy concentration on their reduction.”

    Huh? Picture me scratching my not so luxurious mane. Let us know when we have them. So far this is the only thing that appears to work and that includes LDL-pheresis.

  91. “I’m going to pretend to be interested in the nitty gritty details, but then deny the effectiveness of the whole thing anyway.”

    nwtk2007, despite any claim of yours to be interested in “evidence”-based chiropractic or anything of the sort, the truth is, at your core, you are anti-science. I wonder if the same is true for all chiropractors. After all, does someone “learn” to be a quack, or are they “born” with the “ethical” part of their brain missing?

  92. nwtk2007 says:

    Discussing the depth of the evidence is not denying it. So defensive.

    Skeptical, do you know just how much you sound like a white supremest, intolerant cult/church member?

  93. nwtk2007 says:

    Additionally, even if there is supreme evidence and understanding of cholesterol’s role in heart disease and heart attack, the use of statins for prevention as has been implied in this thread, would seem to be a very highly debated point in the medical arena. http://theunhivedmind.com/wordpress/?p=29647

  94. nwtk2007 says:

    And yes, I am familiar with Barron. Again, can you see error in his analysis of the data he cites?

  95. WilliamLawrenceUtridge says:

    Actually I was hoping at least one of you might dicsuss the role of oxidized LDL in atherosclerosis. If I am not mistaken, there was a nobel prize given to a person who suggested that the initial event in plaque formation involved free radicals. I might be wrong about that.

    You could try my approach – assume that the people making the recommendations, who have generally dedicated their lives to studying the topics at hand, are aware of the complexities of the literature and are not part of a conspiracy to kill large swathes of the population.

    The alternative is to re-enroll in school, focussing on the biochemistry of the oxidation of atherosclerosis, get a Masters, then PhD, then do a post-Doc and at that point you might know enough to answer your questions with a degree of certainty you seem to be asking for. Science is complicated.

    On a somewhat-related note, famed Egyptologist Mark Lehner had his studies funded by the Association for Research and Enlightenment, the foundation that exists to promote the ideas of Edgar Cayce, the sleeping prophet. Lehner went in as an explicit “skeptic” of the mainstream opinion, setting out to defend the lunatic fringe idea that Egypt was the legacy of Atlantis and other such nonsense. After dedicating years of his life to the mainstream ideas on the topic, he shelved his nonsense ideas and became a firm member of the establishment view.

    All this to say – in an empirical area of scholarship, the mainstream view is usually right. The debates that exist between mainstream scholars are usually worth having. Crazy fringe proponents seem to think “mainstream” means “dogmatic” and “stupid”. Really it means “studying, in detail, a topic for a very, very long time to produce supportable conclusions”. Mainstream is the very opposite of stupid, no matter that some people are disappointed because it means there are no aliens, or the pyramids were built by men, or that you can’t pour butter on your cereal every morning. And chances are you won’t understand nitty-gritty detailed research without years of study. So maybe trust the experts.

  96. weing says:

    @nwtk2007,
    After checking out the link you gave, I came to the conclusion that Harriet should change the title to ‘Red Yeast Rice Poisons and Cholesterol’.

  97. nwtk2007 says:

    In other words just shut the heck up they are the doctors and must know what they are talking about? Looking back at the times when that to which you allude was the case and what suggesting the same would have been gives me pause to think about your suggestion.

    At any rate, there is a huge debate as to the use of statins. Its not such a main stream idea, that lowering cholesterol is the end all of heart disease. Take away the promotion by big pharma for the sale of their statin drugs and there you have it.

    As to what you say about mainstream, it is usually true. Take man-caused global warming for example. Or the belief in universal health care by the majority of folks in the world.

  98. Heh, heh. I get called a white supremist, and then I get pointed to a link that is supposed to cast doubt on statins, and the title of the link calls statins “poisons.” nwtk2007, you truly are an idiot. The very fact that someone as ignorant as you can get a “license” to practice “chiropractic” demonstrates what a truly pathetic profession that is. The only debate on the use of statins is by anti-science pseudo-para-medical do-nothings like yourself, who have spent so much money on a completely useless education that actually left them net-negative in medical knowledge and now they are mad at the world.

  99. BTW, I wanted to point out that I “appreciated” your “moving the goal posts.” In your most recent say-nothing post you phrased it as the “end all of heart disease.” No one ever made that claim, but you’ve now been backed into a corner, and instead of admitting that you were wrong and appreciating the fact you had the potential to learn something here, you are now going to move the goal posts and start trying to change the subject.

    It’s actually not interesting that you are not only dishonest professionally, but dishonest personally too.

  100. weing says:

    @nwtk2007,

    Methinks you spend too much time feeding at such “mainstream” websites that you linked to. There has always been debate about statins and pretty much all meds. The goals of therapy have changed several times in the years that I have been in practice. If there were no side effects from statins, then everyone would be on them to lower the risk as much as possible. But such is not the case. The side effects, the law of diminishing returns for the risks and the costs, all make that impractical. That does not mean that chiros have anything better. Until you show us something else that works better than LDL lowering in preventing atherosclerosis, you can rage all you want and it won’t do squat.

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