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The risks of CAM: How much do we know?

Working in pharmacies where supplements are sold alongside traditional (over-the-counter) medications, I’m regularly astonished at the different perceptions consumers can have about the relative efficacy and safety of different types of products. Once, speaking with a customer about a medical condition she wanted to treat, I indicated that there were no effective non-prescription therapies — she needed to see a physician for access to an effective treatment by prescription — and I gestured behind the counter. “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!” Suggesting that my patients with heart disease or HIV had a somewhat different perspective, I tried (unsuccessfully) to talk her out of a questionable-looking supplement (Hint: avoid anything from a company with a P.O. box as a mailing address.) This appeal to nature, combined with a perception that natural products are safe, and conventional drugs are unsafe, is pervasive.

One of the responses regularly tossed at health professionals who argue for higher regulatory standards for supplements, CAM, and other natural health products is that conventional medicine kills, and prescription drugs are its preferred weapon. In contrast, they argue, supplements are safe. Any credible health professional will agree that conventional medicine can cause harms. David Gorski has examined SBM and patient safety before. The number of preventable adverse events from medical treatments is far too high. And even the idiosyncratic events — freak accidents, basically — mean we must always consider the rare but possible harms of the therapies we use. But as Harriet Hall has pointed out, we cannot look at drug harms in isolation: the variable perpetually ignored by critics of mainstream medicine is the benefits associated with those drugs, which can make the risks seem quite acceptable.  Both expected benefits and possible harms need to be incorporated into our decision-making process.

When it comes to drug (or supplement) safety monitoring, causality assessment is the evaluation of the odds that a particular treatment is associated with a particular adverse event. A single adverse event may have characteristics that suggest the relationship to a treatment is highly probable. But because correlation may well not equal causation, data are usually rolled up an analyzed in aggregate, by national and world-wide agencies to help identify the rare but serious adverse events. What this means is, if data are not collected, we have an incomplete picture of a product’s adverse event profile. Yet when it comes to supplements, good data on safety and efficacy are often lacking.

How Safe is the ‘Alternative’?

One of the recurrent themes of science-based medicine is that any medical intervention that can plausibly cause physiological benefit can also plausibly cause physiological harm.
— Steven Novella, Vitamin E and Stroke

Despite the widespread perception that supplements are safe, some do have undesirable biological and pharmacological activity. There is no inherent safety to any product, natural or not. There is both anecdotal and more systematically-captured information to suggest harms can be associated with supplements. So how do we gather good data to inform decision making?

The primary challenge we face when evaluating the risk profile of supplements is the lack of good quality clinical trial evidence. When these data do exist, studies are typically of short duration with small sample sizes. Without clinical trials that systematically measure and report adverse events, there’s no harms profile, and the “Side Effects” section of the monograph stays nice and short. In contrast to supplements, new drugs undergo extensive clinical trials and adverse events are actively monitored, collated, and eventually are summarized in the product monograph. It should surprise no-one that the list of adverse events is longer, when you actually go out an systematically look for them.

As regulators worldwide generally don’t require any meaningful pre-sale testing of supplements for safety or efficacy, there’s typically little data available when any product becomes marketed. (Some regulators will approved products based on a history of “traditional use”, which offers little insight into a products safety profile, as that data have never been systematically collected.) Instead, regulators worldwide (e.g., Canada and the USA) rely almost entirely passive surveillance to monitor the safety of marketed products.

Passive surveillance depends on the spontaneous reporting of adverse events from health professionals, alternative medicine purveyors, manufacturers, and even consumers directly. Passive surveillance is the key method of collecting safety data on drugs and supplements once they have been licensed for sale.

However, passive surveillance is an imperfect means of collecting safety data. It is much more effective at identifying rare and infrequent adverse events (e.g., liver toxicity) than incremental increases in the risks of common medical conditions (e.g., heart attacks). While the true denominator cannot be know with certainty, it’s generally accepted that only a fraction of adverse events are identified, and only a fraction of these are actually reported.  Despite these limitations, the Institute for Safe Medication Practices reports that in 2009, the FDA received 19,551 reports of patient deaths associated with drug therapy.  Is this the smoking gun that Big Pharma is killing us? Not quite. Causation has not been established, and even then, we need to consider harms in the context of the benefits a therapy may offer. The system isn’t perfect, but it is producing data that may be helpful for decision making, and understanding the evolving risk profile of licensed products.

Despite their widespread use, surveillance of supplements reveals generally few adverse events. It could be that many products lack meaningful pharmacologic activity — either positive or negative. An adverse event is probably less likely in drugs without any meaningful beneficial effects. But beyond efficacy, there are several other factors, unique to supplement use, that may contribute to even less frequent adverse event reporting. These were identified in a series of qualitative semi-structured interviews conducted by Rishma Walji in 2010, and summarized in the paper Consumers of Natural Health Products: natural born pharmacovigilantes?:

  • Consumers believe supplements are safe, because they are “natural.” Therefore they’re less likely to associate adverse events with supplement use.
  • Supplements don’t require a prescription. No health professional may be involved in monitoring response to therapy, who might be able to identify adverse events as part of a monitoring plan.
  • Because consumers may not involve health professionals in their decisions to take a supplement, they may feel obliged to deal with it on their own, and not involve health professionals. Perceptions about how their health professional will react to their use of supplements may come into play.
  • Consumers may not know how to manage and adverse event, and who to report an adverse event to. They didn’t get it from a doctor, so they don’t report the outcome to a doctor.
  • Even if they do contemplate reporting an adverse event, the process can be complex, especially for consumers.
  • Users may have a distrust of “conventional” medicine which drove their initial use of the product. When adverse events were identified, there were reluctant to consult “conventional” health care providers for assistance.
  • Some surveyed stated a fear of losing access to supplements, driving a reluctance to report adverse events.

From my own practice, I’d add few additional factors to the list. Supplements are commonly used for short durations, and for self-limiting conditions, in comparison to prescription drugs that may be used chronically. Prescription drug manufacturers are required by law to report to regulators any actual or potential adverse events that they learn of. This requirement was recently implemented in the USA for supplement manufacturers — however, contact information may not yet appear on supplement labels.

Disappointingly, consumers surveyed reported a preference to discuss adverse with health food store personnel, family or friends, which appears to be a factor of both comfort and convenience. Enablers to reporting adverse events included knowledge and importance of adverse event reporting, and personal comfort with their health care provider.

Real World Harms

People often ask “what’s the harm” of supplements and other forms of alternative medicine. This question can be answered, if incompletely. Considering the numerous case reports of harm helps us understand patterns, look at causality, and guide the safe use of these products. A recent case series of adverse events supports some of the observations that Walji made in her paper, and expands on the possible consequence of CAM use. The paper, Adverse events associated with the use of complementary and alternative medicine in children, is from Lim et al., and appears in the Archives of Disease in Childhood.

Monthly surveillance reports of CAM-associated adverse events in Australian children were collated over a three year period. This active surveillance program (pediatricians are asked monthly to report any rare disorders that have been observed) followed adverse event reports with detailed questionnaires, evaluating causality, severity, and whether the adverse event was potentially related to a failure to use “conventional” therapy. The program identified 39 adverse events, with 64% considered severe, life threatening, or fatal. Thirty cases (77%) were considered to be related to CAM, and 17 cases (44%) were felt to be due to a failure to use conventional medicine. Four deaths were documented, all attributed to a failure to use conventional medicine in favour of CAM. One of the deaths, from seizure, was attributed to a decision to use CAM rather than drugs, with the aim of avoiding the side effects of drugs.

The authors make the following observations on CAM use and adverse events:

  • Reporting can be complicated because information on the product may not be available.
  • Products can be contaminated or adulterated with therapeutic, undisclosed drugs, complicating evaluations of causality.
  • Because CAM products are perceived as safe, they may not be stored properly in the home.
  • CAM use may be accompanied by dietary advice that is dangerous, and not based on good evidence. Two of the fatalities associated with CAM occurred in children on marked dietary restrictions prescribed by a CAM practitioner.

It’s a small case series, and we know neither the actual numerator or denominator. Still the severity of some of the reactions is concerning, and the author’s comments point to additional factors that may influence the incidence of adverse events reported.

Information is Beautiful … But Incomplete

As a pharmacist, I constantly need to contextualize data directly for patients, translating trial results into more understandable figures like numbers needed to treat and numbers needed to harm.  I’m always searching for better ways of communicating the understanding of risks and benefit. Information is Beautiful is one of my favourite blogs, as the authors highlight innovative and effective ways of graphically presenting data. So I was initially excited about their attempt to summarize the data for supplements — click on the image to view the data on the IiB website:

Clicking each bubble will link you to the supporting clinical data. But there’s a crucial element missing in their presentation: harms. You cannot evaluate the value of a treatment based on efficacy alone. For example, selenium is ranked very highly for colorectal cancer prevention based on this study. Not only is there evidence to the contrary, selenium consumption is associated with a significant increase in the risk of type 2 diabetes. The risks actually seem more compelling and relevant than the potential benefits. Or look at red yeast rice, another supplement rated highly. While RYR does seem effective, is less effective and more dangerous than drugs derived from it. I like the IiB visual approach, but it fails in communicating meaningful data on risk and benefit, both of which are essential for decision-making.

Supporting Science-Based Decision Making

Whether one is considering a “conventional” drug or a supplement, the questions we should be asking are the same:

  • What benefits can I expect given my own condition? What data exist to support this? How much more effective is this treatment than a placebo?
  • What harms with this treatment have been documented? Has the product been studied extensively enough to understand the potential risk profile?
  • In how many patients has this product been studied? How closely do they match my situation?
  • What alternatives exist, and what are their risk-benefit profiles? What are the risks of no treatment at all?
  • What are the economic consequences of the treatment strategy I decide upon? How much “bang for the buck” should I expect?

Conclusion

Any active treatment can have harms, yet robust safety data can be hard to come by for supplements and natural health products, painting a skewed picture of their risks and benefits.  Our passive system of collecting safety information isn’t likely to remedy this situation. While regulators may have created different standards for supplements and CAM, permitting sale in the absence of good safety and efficacy data, our decision-making should make no such exceptions.  Evaluating what we know about efficacy and safety, and what we don’t know, and the limitations of both, are critical to science-based decision making.

References

Lim A, Cranswick N, & South M (2010). Adverse events associated with the use of complementary and alternative medicine in children. Archives of disease in childhood PMID: 21178176

Walji, R., Boon, H., Barnes, J., Austin, Z., Welsh, S., & Baker, G. (2010). Consumers of natural health products: natural-born pharmacovigilantes? BMC Complementary and Alternative Medicine, 10 (1) DOI: 10.1186/1472-6882-10-8

Posted in: Herbs & Supplements, Pharmaceuticals

Leave a Comment (33) ↓

33 thoughts on “The risks of CAM: How much do we know?

  1. ConspicuousCarl says:

    An HIV patient walks into a pharmacy and declares, “I want something natural!” The pharmacist says, “You’ve already GOT something natural.”

    (ha)

  2. threelittlepigs says:

    I hear it all the time-its natural, its fine. My sister in law gives her 2yr and 4yr old melatonin every night. I asked her if she was concerned about it and she said, “no its natural it can’t hurt them.” I have several other friends who give all kinds of supplements to their kids and they basically say the same thing.

    Side note: I would love an article about melatonin. I do know lots and lots of people who use it regularly. From what I have seen it does seem safe.

  3. Neal W. says:

    What’s the psychology behind appeals to nature? Is it just misinformation, is there a cognitive bias at work, or what?

  4. S.C. former shruggie says:

    Melatonin is one of several natural products I used in my credulous Philosphy student days, on recommendation of woo-friendly friends.

    It was pretty awful. I don’t know how common side effects are. I just did a google search and found only pages insisting it had absolutely none or that they were exceedingly rare and completely devoid of details.

    In my experience, melatonin caused rapid heart rate and hammering headache. It did help me fall asleep. At first. Then my insomnia got worse. Why? I probably shouldn’t speculate without a proper body of scientific studies, but… maybe my own melatonin production was reduced to maintain normal levels?

    Anyway, that’s my n=1 anecdote. Rapid heart rate. Hammering headache. It stops working after the first few days. And I have yet to see any statements online or in any scientific or quackademic articles outlining possible side-effects.

  5. CarolM says:

    I too would appreciate an article on Melatonin. I was going to comment that I am off all supps since I started reading SBM, but this is one I still rely on a couple times a week due to try to get a full nights sleep.

    But I am 61 – it’s being given to kids? That is just wrong.

  6. Joe says:

    “Consumer Reports” (Sept. 2010) lists “supplements” that are thought to be dangerous http://www.consumerreports.org/health/natural-health/dietary-supplements/supplement-side-effects/index.htm Yet they remain on the market because the FDA has not yet banned them.

  7. Josie says:

    As Scott pointed out the “it’s natural so it can’t hurt them” mentality can be turned around to also say that it also doesn’t do any good…

    Aside from the obvious natural doesn’t necessarily mean nice…does she give them a Uranium sandbox to play in as well? It’s natural…

    i also like the joke about the HIV positive person wanting something natural :)

  8. DTR says:

    I’d also like to see an article on melatonin. Our son (age 6) has been on melatonin as prescribed for months in an attempt to shift his circadian rhythm. He had been falling asleep between 11:00 and midnight regularly and not getting good sleep at night. It works – he falls asleep within 1 hour of taking it, but he still doesn’t stay asleep. He has never complained about any of the effects mentioned by S.C. former shruggie (granted, he’s only 6, but a 6 year old should be able to articulate that he’s got a headache).

    @CarolM – do you have any data to support your belief that giving this to kids is wrong?

  9. DTR,

    Do you have any data to support your belief that giving sleeping pills to children is safe and effective?

  10. Harriet Hall says:

    The Natural Medicines Comprehensive Database rates melatonin as LIKELY SAFE …when used orally or parenterally and appropriately, for short periods up to 2 months. For children, it rates melatonin as POSSIBLY UNSAFE, with concerns about gonadal development. In pregnancy, it rates it POSSIBLY UNSAFE and recommends against using it. It also provides a long list of drug interactions.

  11. Just a funny bit of trivia. The melatonin sold in supplements is “natural” it is a synthetic. “Natural” melatonin would made from animal pineal gland and is apparently unsafe due to risk of viral contamination.

  12. S.C. former shruggie says:

    There are two obvious complications to my n=1 anecdote.

    I could be the odd one out who has rare complications.

    The product could be contaminated with goodness knows what. I did buy it a CAM outlet.

  13. That should be “the melatonin sold in supplement is NOT “natural”. Makes a difference.

  14. Jeff says:

    I disagree that supplements are taken mainly for a specific condition. I think most people take supplements on an ongoing basis to stay healthy. Mr. Gavura makes two good points concerning adverse event reporting. They apply to both supplements and drugs:

    1. Not all adverse events get reported. According to U.S. Pharmacist, substantial underreporting of adverse drug events is suspected:
    http://www.uspharmacist.com/content/d/feature/c/20262/

    2. Correlation does not equal causation. Someone with a serious medical condition could mistakenly assume symptoms are caused by a supplement or drug. The FDA always makes this point when releasing AER numbers.

    Even so it is useful to look at actual AER figures supplied by the FDA. We can compare serious adverse event reports for supplements and drugs during the year 2008. This was the last year for which the FDA publicly released the AER numbers for supplements. 2008 was also a year during which mandatory reporting of serious adverse event was required by supplement manufacturers. The numbers make clear what a strong safety record supplements have compared to drugs:

    Serious supplement adverse event reports received by the FDA for 2008: 672
    Serious drug adverse event reports received by the FDA for 2008: 320,000

    Since the passage of DSHEA in 1994, only one supplement, ephedra, has ever been banned by the FDA because of adverse events. The experience with ephedra shows how quickly any real problems are recognized by the medical profession and publicized by the news media and the FDA. The recently-passed Food Safety Law gives the FDA mandatory recall authority over all food products (including supplements), so any harmful products can quickly be taken off the market.

    For those interested, LEF magazine had a good article on melatonin:
    http://www.lef.org/magazine/mag2008/aug2008_Beyond-Sleep-New-Medical-Applications-for-Melatonin_01.htm

  15. Bogeymama says:

    Great post Scott!

    Regarding melatonin in 2 and 4 year olds – how is that necessary at their ages? I doubt that this was advice from a parenting book.

    Good sleep requires good sleep habits. At their age, these kids are going to associate going to sleep with taking a pill, so unless she stops soon, these kids will NEVER be able to get to sleep on their own. Maybe she should try skipping the pills altogether, and adopting a more “natural” approach like bathtime, snack, story-time, hugs & kisses, then lights out.

    It amazes me how people stuff themselves with supplements, and think it’s natural. Nothing is natural about taking anything, and this is how I put it to my patients. If you’re not getting it in your food, you’re using it as a drug, and you need to think of it as a drug. Amazingly, this wins alot of people over.

  16. Joe says:

    Jeff on 20 Jan 2011 at 1:27 pm continues to ignore many basic facts. It is very difficult for the FDA to gather enough information to ban a drug. He notes that it was easy to see that ephedra was more dangerous than warranted by its benefits; while overlooking the fact that Big Suppla fought the ban in court and Congress for ten years. Even then, Big Suppla sued to have the ban reversed.

    I linked (above, on 20 Jan 2011 at 12:05 pm) to a list of supplements that are still on the market despite FDA warnings because, according to some manufacturers, they have not yet been banned. That is hardly a recommendation for the safety of supplements.

    Jeff also ignores the fact that many supplements are safe because they are no more therapeutic than lettuce.

    Finally, Jeff thinks that most supplements are taken by people who want to stay healthy. Maybe so, but where is the evidence that they do that? Echinacea is still a big seller despite good evidence that it does not maintain health.

    As for melatonin, it is good to see that Jeff is keeping-up with the latest medical literature … Wait, is that “Life Extension” magazine that he has cited? …

  17. DTR says:

    @Alison Cummins,
    No, I don’t have any data, just trust in our pediatrician who prescribed it based on the recommendation of a sleep study on him. Naive? Maybe, but as a non-physician, my choice is between trust in my physician and making my own decisions based on a University of Google education. Look, I’m not trying to pick a fight with CarolM, I’d just like to know if there’s any data behind her opinion on the subject.

    @Harriet Hall,
    This is consistent with how it was prescribed for our son – 2 months to try to shift his sleep time. His sleep study follow-up is soon, so we’ll see how he does off the melatonin.

    @Bogeymama,
    It’s hard to imagine how we could have been more habitualistic about the bedtime routine. I’m not a fan of drugging my kids, but going to sleep late, getting up early for school, and going through the day in a daze wasn’t working.

  18. Jay Gold says:

    It’s happened to me that I wanted to buy something in a store and someone on staff bad-mouthed the product, as you bad-mouthed the “questionable-looking supplement”. My response: “You’re the ones who sell it!” If you’re going to work in a pharmacy that sells questionable things, your credibility in steering customers away from them naturally will be suspect.

    1. Scott Gavura says:

      Jay Gold:

      If you’re going to work in a pharmacy that sells questionable things, your credibility in steering customers away from them naturally will be suspect.

      As a part-time or casual pharmacist working in a retail pharmacy, I have no impact on what’s put on the store shelves, and my compensation doesn’t change either way. In general most patients appreciate an unbiased evaluation of what the science says. The bigger challenge is reassuring someone they don’t need to buy anything, when that’s specifically what they came into the pharmacy to do.

  19. Bogeymama,

    I know one kid who’s been very difficult from birth (a non-difficult sibling serves as a control) and went through years of psychological testing before being prescribed Ritalin (if it was childhood bipolar instead of ODD/ADD then Ritalin would have been a big mistake).

    Once taking Ritalin, suddenly going to sleep at nine and waking up at six (exactly like the control sibling) seemed normal. (The previous pattern had been to stay up reading/ playing/ singing all night, then to stay up being difficult all day.) I can relate to this: sometimes I take Dexedrine, which I absolutely adore (temporarily, until it makes me so irritable I can’t talk to anyone). I am fully awake in the daytime and fully asleep at night. I don’t actually have problems sleeping, it’s just that, somehow, being asleep and being awake are more different when I’m on speed. It feels really good. (Until it doesn’t.)

    We don’t know what DTR’s son’s issues are or are not. Maybe they could be addressed with fresh air, exercise, routine and clear direction. Maybe DTR’s son has multiple developmental issues — and siblings who respond in the usual way to the plentiful fresh air, exercise, routine and clear direction available in the DTR household. We don’t know that. Telling someone that being a stricter parent will fix everything before knowing what’s going on is not smart.

  20. norrisL says:

    Why do people so often seem yo assume that natural equals safe?

    “Back there?!” she pointed. “That’s where you keep the stuff that kills people! I want something natural!”

    When people start mentioning natural therapies and their supposed safety in my veterinary surgery, I point out to them that taipan venom is natural.

    The Inland Taipan of Australia is, in terms of number of mice that can be killed by one bite, or for that matter number of people that can be killed by one bite, is the most deadly land snake on Earth. Fortunately for us here on the east coast of Australia, if you want to be bitten by an Inland Taipan, you need to travel to central Australia, find a taipan and aggravate it.

    Stuart

  21. Bogeymama says:

    Easy there Allison, I should have been more specific – I was not commenting on DTR’s son, I was commenting on threelittlepig’s sister-in-law, hence my phrase “Regarding melatonin in 2 and 4 year olds – how is that necessary at their ages?” (not a 6 year old, as DTR’s son is)

    I am not opposed to melatonin in children when prescribed like DTR, and find myself even recommending it on occasion for children who – possibly due to meds they are taking – have poor sleep habits. I, like Harriet, have consulted the Natual Medicines Database for safety info and know the concerns about gonadal development warrant caution in children. As long as the melatonin use is physician-monitored, I am quite OK with it.

    Also, I ALWAYS recommend non-medicinal treatments for any issue as first-line before heading to any exogenous treatments. And for all children with sleep issues, assessing their sleep hygeine and habits is step #1. All too often, it is lack of a proper routine that gets kids into sleep troubles. I speak not from the perspective as a sleep expert, or parenting expert, but as a health care provider. Isn’t that what people want from us? Not to always throw a pill at something? Sorry if I offended.

  22. BKsea says:

    To echo norrisL above, I like to point out that whatever “natural” chemical you find in the plant did not evolve to make humans more healthy. More likely, it evolved to kill whatever tries to eat the plant. Now open wide!

  23. Draal says:

    (Some regulators will approved products based on a history of “traditional use”, which offers little insight into a products safety profile, as that data have never been systematically collected.)

    Humph. I’m still in favor of GRAS (generally regarded as safe) exemptions for a number of things including Saccharomyces cerevisiae. If I had to deal with that, I’d never be able to submit research grants for my projects.

  24. # BKseaon “To echo norrisL above, I like to point out that whatever “natural” chemical you find in the plant did not evolve to make humans more healthy.”

    Well this depends…rice, wheat, many fruits and vegetables have “evolved” via human selection and manipulation to provide more nutritional value. Of course we can ask the question “who’s manipulating who?”

    This is only an aside, not really relevant to naturalness and safety.

  25. threelittlepigs says:

    The pediatrician suggested that my SIL try melatonin with the 4yr old because she was having nightmares. I don’t think the ped meant for her to still be giving it to her 9mos later or for her to also be giving it to the 2yr old. If the ped had prescribed a sleeping pill, I know she wouldn’t be giving it to the sibling and she would probably be asking how long she was supposed to give it to the 4yr old-not endlessly. But, because it is natural, she thinks it is safe. Another friend was told to try melatonin for her son with autism. Not only does she give it to him, she also gives it to her other kids. Another friend has a child with special needs who takes melatonin along with a bunch of other medications. She gives the sibling melatonin, but would never dream of giving the meds. All three really believe that, because it is natural, it is safe for anything. All three got the recommendation for melatonin from a dr originally, but they are not really using it as directed by the dr.

    I also find it so interesting that the people who describe themselves as “natrual” do the most interventions. My mom is the most natural person I know, and she would never describe herself that way. If she gets sick, she goes to bed, gargles with salt water, drinks hot tea, etc. If she is sick enough she would go to a dr, but she doesn’t seek relief from normal symptoms. She wouldn’t go to a pharmacy for something natural. My “natural” friends have a supplement for everything. One doesn’t give her kids ibprofren for a fever, she gives some supplement-and brags about it like it makes her a more enlightened parent. No drugs for her kid. Who knows what the safety is with the supplement-at least you know the side effects with ibprofren. I am not sure when “natural” came to mean what it appearantly means now.

  26. A colleague once made an effort to collect reports of potential harm associated with alternative therapies, including herbs, vitamins, and supplements. I add to this on an ongoing basis as new reports come out. It is by no means coprehensive, representative, or in any sense a truly scientific assessmentof CAM risks. It does, however, provide at least some response to the question “What’s the Harm?” so I find it useful for that purpose.

    http://www.skeptvet.com/index.php?p=1_21_What-s-The-Harm-

  27. Bogeymama says:

    threelittlepigs: “I am not sure when “natural” came to mean what it appearantly means now”. “I also find it so interesting that the people who describe themselves as “natrual” do the most interventions”.

    So true. And it sounds like your Mom is a common-sense-kind of lady. Hopefully you and she can rub off on your SIL a little. I, too, have a SIL that dabbles heavily in woo – and once called me narrow-minded for not helping her promote “Youth Juice”. Caused quite a rift. We’re fine now, but she soon realized that not too many people were willing to spend $150 for a 2 week supply of juice for their family. She spread testimonials about how everyone on her side of the family have all been able to get off their meds, including asthma stuff. Needless to say, that didn’t last long either after her son ended up with a severe asthma attack. She never acknowledged the error of her ways, she simply stopped bringing it up, and nobody asks her about it anymore.

    It’s too bad there isn’t a better way to measure the harm – much of which comes from abandoning proper treatments for woo.

  28. ebohlman says:

    re “traditional use”: One of the problems is that oftentimes the “traditional use” of a substance, in terms of dosage, frequency and indications, bears little to no resemblance to the use for which the substance is sold. For example, ephedra has been used for a long time—as a tea used occasionally to relieve bronchospasm. But the consumers of ephedra supplements were taking it as pills, daily, for “energy” or weight loss. There’s no reason to believe that the safety profile should be the same for such wildly different usage patterns.

    Similarly, the fact that a substance is a common component of foods and there are no known adverse effects of its consumption as part of the diet does not in any way imply that there won’t be adverse effects from consuming it in amounts much larger than anyone could get from eating. Niacin, for example, is a drug, not a nutrient, when used to lower cholesterol because a) the effect is only present with doses much larger than could be obtained from food and b) the mechanism of action is unrelated to niacin’s nutrient effect (the drug effect isn’t due to increased availability of NAD+ and relatives). Thus it’s neither more “natural” nor safer than other cholesterol-lowering drugs, and needs to get as much scrutiny as them.

    A common statement from supplefantics is “you don’t see lots of people showing up at the emergency rooms because of supplements.” My response to that is “if you’re going to use that standard, then Vioxx was completely safe.” In fact, it took some very rigorous and systematic statistical analysis to discover that Vioxx was associated with increased cardiovascular risk; the risk simply wasn’t detectable by casual observation alone.

  29. tmac57 says:

    ebohlman-

    In fact, it took some very rigorous and systematic statistical analysis to discover that Vioxx was associated with increased cardiovascular risk; the risk simply wasn’t detectable by casual observation alone.

    This is an extremely important point about evaluating the safety of any intervention.Causality is an elusive target.Most people don’t appreciate how complicated it is to sort out all of the confounding factors to get to what actually ’causes’ an effect,either positive or negative.

  30. @Jay Gold:

    If you’re going to work in a pharmacy that sells questionable things, your credibility in steering customers away from them naturally will be suspect.

    That is certainly true; the trouble is that pharmacists often have no control over what is sold in the store. We had a brief discussion of this a few years ago, in the comments after Steve N.’s post on “Airborne.”

  31. “Most people don’t appreciate how complicated it is to sort out all of the confounding factors to get to what actually ’causes’ an effect,either positive or negative.”

    I don’t want to disagree with Scott Gavura’s article or tmac57′s comment. This is just a vent from a patient or layman’s perspective. If you think it’s hard, as a scientist, to get at what the actual causes and effects are, try being the patient trying a new medication or combination of medications for chronic annoyance conditions such as mild asthma, sinusitis, irritable eyes, irritable bowel, skin conditions, headaches/migranes, tendonitis, etc, all those things that don’t have good tests to show objective improvement.

    Try, as a patient, taking into consideration that you may experience an improvement of you symptoms or side effects, or just a coincidental symptom improvement or an unrelated unpleasant physical sensation related to a virus, unrelated allergy, the condition you are being treated for or an unrelated condition. Or you might be experiencing placebo or nocebo. Or you may just be subjectively analyzing your original symptoms differently due to your hopes that the medicine is working. Or you may experience a temporary improvement, then decline in your symptoms, due to the characteristics of the medication or the disease or god only knows what else, because you know, you’re not a doctor.

    Then, just for fun, try finding out that you don’t actually have the condition that you are taking the medication for. “Mr. X, it’s your lucky day, you don’t actually any allergies, but if all the allergy medications I gave you are working for your symptoms, you should just keep taking them”.

    It is a complete pain in the rear. It actually would be nice if you could blame the doctors or the pharmaceutical companies or someone. But, with some exceptions*, generally it’s just the natural of the beast, still frustrating though. For that reason, I completely sympathize with the folks that would like to stay away from medications. Heck, if I could replace the 5 or 6 medications I am taking now with one blissfully side effect free homeopathic placebo, I certainly would.*

    There, glad I got that of my chest.

    *Well, some doctor’s are better than others and pharmaceutical companies…? not my area of expertise.

    **Well I guess I could, but I’m pretty certain I’d feel like heck.

  32. What is your opinion of Vitamin D3 supplements at a dose of 5,000iu? Would anybody like to leave a comment on:-

    http://nigeepoo.blogspot.com/2008/12/vitamin-d.html ?

    Cheers, Nige.

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