Another clean kill by chelation

Somehow this one passed under my radar four years ago. However, the there's a reason for this. First, I wasn't blogging then and thus wasn't paying as close attention to alternative medicine. Also, apparently, the State of Oregon didn't know about it until 16 months after the fact, which was still before I started blogging. In any case, behold the sad case of Sandy Boylan:

Sandy Boylan was a contagiously cheerful woman whose hobby was handing out bouquets of homegrown flowers. But in the summer of 2003, she was scared.

The 53-year-old B&B owner from Dallas, Ore., had been told by her naturopathic physician that she had dangerously high levels of mercury, lead, cadmium and nickel. She believed those metals caused the aches and pains she'd long suffered--the ones that had confounded traditional doctors for years.

On Aug. 13, 2003, Boylan visited the naturopath who had made the diagnosis--Donald McBride of the Salem Naturopathic Clinic. McBride was giving Boylan a controversial course of treatment in his office called chelation therapy (see "Curing Jamie Handley," WW, Oct. 12, 2005), where amino acids are administered intravenously to suck metals out of the blood.

This is how alternative medicine often sucks in the unwary, by promising cures to vague complaints that conventional medicine often doesn't do too well managing. Sometimes it's nothing more than what we sometimes call the "diseases of living," where some people suffer more aches an pains getting older than most. Sometimes it is pain whose cause is not readily traceable. Whatever the reason, such complaints often drive patients to alternative practitioners. As long as the alternative remedies involve things like massage, relaxation, or other therapies that may or may not be effective but that at least do not cause harm, this may not be such a horrible thing. However, that's not what happened in this case. In this case, the therapy recommended was chelation therapy, and chelation therapy has the potential for serious risks:

But chelation also withdraws metals the body needs, including calcium, which can lead to heart failure. Hooked up to the IV, Boylan collapsed and blacked out. She was taken to Salem Memorial Hospital, where she died that day of cardiac arrhythmia due to low calcium resulting from chelation therapy, according to a report by the state Medical Examiner.

This is, of course, as good a time as any to reiterate that there is only one real indication for chelation therapy, and that is to treat cases of heavy metal poisoning documented by appropriate laboratory work and clinical symptomatology. Using to treat autism, coronary artery disease, cancer, or vague pains such as Mrs. Boylan had, is not evidence-based and can be quackery, depending on the circumstances. Of course, I have to wonder how on earth such an obvious clean kill due to quackery escaped the attention of the Oregon Board of Naturopathic Medicine for 16 months. Conventional practitioners have to report deaths immediately. Perhaps it's because she died in the hospital, but if I were the physician taking care of her when she died, I would have called the coroner to report it as a suspicious death.

But here's the kicker. Because Dr. McBride is a naturopath, he is not required to carry malpractice insurance, as physicians are. Consequently, when he was sued by Sandy Boylan's husband, there was less for him to settle for:

On May 4, 2007, Sandy Boylan's husband, Clint, signed an out-of-court settlement ending a malpractice and wrongful-death suit against McBride. Family members declined to say how much McBride agreed to pay, except to note it was far less than the $1 million they sought in the lawsuit filed Feb. 28, 2005, at Marion County Circuit Court. Naturopaths aren't required to carry malpractice insurance. And McBride, who signed the settlement April 27, declined to comment.

Even worse the Oregon State Naturopathic Board of Examiners did not strip McBride of his license to practice:

The board determined it was McBride's negligence that killed Boylan but let him keep his license with some limits on his Salem practice. Citing state confidentiality laws, Walsh declined to comment on the decision.

But the fact that McBride could again do chelation therapy astonishes and angers Boylan's family.

"My mom is no longer here because of negligence," says Eli Boylan, one of Sandy Boylan's four adult sons. Knowing McBride is still practicing, he says, makes the loss "more difficult to swallow."

Absolutely astonishing. Of course, I guess I can't be too hard on a "naturopathic" state medical board. Apparently, Oregon's Board has learned from their fellow "allopathic" state boards. For example, nearly two years later, Dr. Roy Kerry, the DAN! doctor who killed a five-year-old autistic boy with chelation therapy in Pennsylvania, is apparently still practicing. His state medical board is "investigating." Apparently, the Oregon State Naturopathic Board of Examiners has also learned how to do slaps on the wrist for doctors who should be stripped of their license as well. For killing Mrs. Boylan and for prescribing medicines that naturopaths aren't allowed to prescribe, as well as "dangerously excessive" doses of narcotics, this is all the penalty that Dr. McBride will suffer from the board:

  • An $8,250 fine
  • No IV chelation therapy for three years
  • Complete education on chelation therapy
  • No IV treatment for three years
  • No prescribing opiates for one year
  • Continuing education on approved substances
  • Keep prescription pads in triplicate
  • Allow board staff access to his office

As rare as it is for this to happen, words fail me. However, they apparently do not fail supporters of such non-evidence-based medicine. They've shown up in the comments of the news story in abundance, trumpeting the same old canards.

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What really scares me about the strength of naturopaths and the schools for them (of which there are many in and around Portland), is that I know more about plant medicines, than some of the licensed practitioners they produce. I have had some fairly extensive discussions about a few plants and their pros and cons, with several licensed naturopaths. Only one, out of about a dozen, was aware of some of the potentialy serious contraindictions, when certain plants are used in conjunction with over the counter and some prescription drugs. The most obvious was OSHA root, which if mixed with psuedoephidrine can cause heartattacks. If it's mixed with anything containing dextromethorphan, it's like getting another dose.

It boggles my mind that these folks are licensed to prescribe so many different drugs. While a lot of "naturopathic" medicines are a crock of whooy, some plant medicines can be very powerful. They can certainly be very dangerous when mixed with pharmacueticals, or even other plant medicines.

Thats horrible. The fact that they get away with it is mind boggling.
How dumbarse is that 'Worn Out Women syndrome'? It's what we call in the real world as the natural aging process.

That is truly insane.

What qualifications exactly does a "Naturopathic Physician" in Oregon (or the US generally) have, Orac?

If it is a Naturopathy only training ("ND" or similar), what bunch of raving lunatics decided these idiots should be allowed to put in IVs, or prescribe opiates??! The idea of letting some herbal quack dole out opiates boggles the mind.

And if the person has a proper medical licence as well, shouldn't the state medical board revoke it?

I had heard people in the Pacific NW were a bit tree-hugging Alt-loopy, but this is going it some.

By Mad Scientist PhD (not verified) on 05 Jun 2007 #permalink

Mad Scientist PhD -

In OR, they get the equivalent education to that of a nurse practitioner, but it is an entirely separate license, from that of any medical professional. You will probably love to hear that one must acquire a PHD in naturopathic medicine to get licensed. And yes, they do call themselves doctors - quite legally. A lot of insurance companies will reimburse for their services too - which really irks me. An insurance company I was looking into, won't cover smoking cessation or psychiatric meds, but they would pay for me to see a naturopath, they'll cover scripts for homeopathic remedies (minus the copay) and even reimburse part of the cost for "nutritional supplements."

DuWayne, I live in another of the states that licenses naturopaths, and, as out your way, the move was based on lobbying rather than science or need or any such niceties. Here is what I just posted to the WW, don't know if it will end up on the page there:

MDs are not afraid of NDs as competitors. Some of us in health care ARE concerned about the rise of unscientific pseudomedicine, pretend or delusional medicine. Some of what NDs do falls in these categories. I have been watching with dismay as naturopaths get licensed in several states to be primary care "physicians." They say that they know when to refer to medical doctors, but they very often delude themselves about this. The biggest danger of NDs is that they do not know what they do not know, and they do not know THAT they do not know.

Diagnosis and treatment have to be plausible in medicine, based on the knowledge of the physical world. (Such knowledge is the great legacy of humanity.) Yet naturopaths are trained to be experts in such things as applied kinesiology, qi/chi, homeopathy. Each of these can take years of complex study, but none of them has been scientifically demonstrated, nor are they plausible.

Homeopathy, with its serial dilutions and succussions guaranteeing that almost all the "remedies" have none of the original substance in the diluent AT ALL, simply makes no sense. For it to have any activity in the body, we would have to assume the suspension of the unchangeable workings of nature. Physics and chemistry - not the bodies of knowledge, but the actual processes themselves - preclude homeopathy's principles. No appeal to "science used to think the earth was flat" or "Einstein made Newton obsolete" will support the delusions of homeopathy. The earth was never flat, hydrogen will never change its atomic weight, and Newton is not obsolete, just incomplete for describing the very small or the very fast.

For many centuries, bleeding and purging were used as therapy. They were based on principles of the four humours, and the need to balance them. A huge, complex body of diagnosis and treament based on this humoral notion was developed. When medicine grew up and became increasingly scientific, bleeding to balance humours became obsolete.

Medical care should be based on the real world, and treatments should be chosen on safety and efficacy. Sometimes medical treatment is noxious. Surgery hurts, some (by no means all) cancer chemotherapy sickens and damages. We continue to add to human knowledge and improve medical care.

Many of the comments here have mentioned iatrogenic deaths, but only as an odd pseudomath equation. The deficits of medicine are treated as a quantity that somehow bolsters the validity of naturopathy. The fallacy is obvious.

Much of medical education is clinical. Before one has an MD degree they have done extensive and complex clinical work. And that is just the beginning. Medicine is grounded in science, therefore continuously changing. MDs are constantly learning and quite dependent on one another and the rest of the professionals in health care.

If NDs want to become part of modern health care, they must earn the legitimacy. They must increase their focus on scientific, evidence based diagnosis and care, promote scientific research (not bias-driven outcome studies like the Bristol, UK, survey of customer satisfaction among repeat users of homeopathy), and discard those "modalities" that are plain nonsense. How does one reconcile modern pharmacology with homeopathy with traditional Chinese medicine anyway? They cannot all be correct, they contradict one another, and the last two contradict, in many particulars, nature.

Urk, I didn't mean to be so long-winded...

(Applauds Skeptyk)

I am absolutely shocked. Never mind license revocation, how about criminal charges for manslaughter and obstruction of justice? How much do you want to bet the woo-woos try top class this case as a iatrogenic death because the subject died in the ER?

Here in the UK, we've just had a naturopath quoted in the national press talking about "detoxifying" oneself of radio frequency emissions from mobile phones.

There's so much stupid there I don't know where to begin.

I had some problems with commenting earlier, hope this time it'll get thru. I wonder how it looks in other countries. In Poland few weeks ago some woman lost conciousness while on chelation IV and died shortly afterwards. Chelation was supposed to cure her from arteriosclerosis. No information yet as to any official inquiries taking place.

Thanks for the post, Orac. In the UK, we've also got a prominent media nutritionist advocating chelation as a valuable naturopathic treatment (I've just blogged about that - and this story).

your following comments are exactly the reason why people seek out naturo paths

"This is how alternative medicine often sucks in the unwary, by promising cures to vague complaints that conventional medicine often doesn't do too well managing

Whatever the reason, such complaints often drive patients to alternative practitioners".

You are focusing on these people's 'complaints'. and doctors ignore these 'complaints' and people get tired of their doctor not listening! These are not complaints, they are health concerns! symptoms and conditions that people dont take seriously.

You post "Sometimes it's nothing more than what we sometimes call the "diseases of living," where some people suffer more aches an pains getting older than most". When your symptoms start interfering with your ability to live life like everyone else can, you want answers! Doctors have decided that if it isnt life threatening that they should just tell you to deal with it or that you are making too much out of it. Everyone else tells you that if you cant do what they can do and dont have the endurance that they have that you are being lazy and not trying. Your employer tells you that if you cant work the crazy hours they expect of everyone else that you have a poor work ethic and are not devoted to the company and you should be fired. Gee so why are people seeking alternative care? They want answers, they want someone to listen and they want someone who doesnt keep tellling them that their lack of performance isnt just because they are horrible, excuse making, lazy people.

Chelation therapy is very risky, you'd have a lot more credibility with people on the subject if you'd stop toeing the same lines that the doctors use on patients when the doctors dont know what to do about something. Everyone in the medical fields need to get together and share information and more testing needs to be done. But they wont do the testing because if it's not life threatening, you're not worth their time.

Quote DuWayne "In OR, they [NDs] get the equivalent education to that of a nurse practitioner ..."

That is seriously incorrect:
http://www.naturowatch.org/

Even their claim that they get the same basic science education as health pros is nonsense.

Sorry- NDs are equivalent in education to astrologers who graduate from accredited schools of astrology, and those astrologers who don't.

Doctors have decided that if it isnt life threatening that they should just tell you to deal with it or that you are making too much out of it.

Well, this pretty much convinces me that lori has never talked to a doctor before.

They want answers, they want someone to listen and they want someone who doesnt keep tellling them that their lack of performance isnt just because they are horrible, excuse making, lazy people.

Sometimes it is their lack of performance. Doctors tell people all the time that they should eat more fruits and vegetables, and exercise more often. Few people listen. As for other times, I certainly don't know what you're talking about. I've never seen the attitude you describe in a doctor except when there's poor diet and laziness involved.

Chelation therapy is very risky, you'd have a lot more credibility with people on the subject if you'd stop toeing the same lines that the doctors use on patients when the doctors dont know what to do about something. Everyone in the medical fields need to get together and share information and more testing needs to be done. But they wont do the testing because if it's not life threatening, you're not worth their time.

Do you even know what the debate is about? This is about woos recklessly using a potentially life-threatening procedure without controls or accountability. This is about woos who use a potentially life-threatening procedure under protocols that prohibit learning anything from the results.

Most of all, I'm completely baffled about where you get this idea that doctors only care about life-threatening conditions. Where do you think over-the-counter medications for the sniffles, insomnia, headaches, gas, and so forth come from?

Lori, the term "complaint" is being used by Orac in the medical sense. It does not mean whining, it means the symptoms for which one is seeking medical care. Orac was explicitly NOT judgmental or dismissive of these symptoms.

Sometimes we cannot find a cause for some symptoms, but, of course, neither can a naturopath in the vast majority of cases. Naturopaths, far from having the "holistic" perspective they advertise, tend to fad diagnoses (which they reach with faulty or vague diagnostic criteria) and fad treatments. Candidiasis, heavy metal poisoning, adrenal fatigue...fashions change. Colonics are so yesterday, IV chelators and vitamins are the latest thing (actually, like much of alt-med, they are old medical treatments that have either been discredited - found unsafe and/or useless, or are being used inappropriately).

As advanced and complex as medicine is, it is still young, there is much we do not know and much we cannot treat. Sometimes there are no good answers. To think that pseudomedicine has the answers would be delusional.

wow lori...as a doctor-to-be i can assure you that we dont follow the credo "if it's not life threatening, you're not worth [our] time..." its not in our oath i promise. what orac means about doctors not doing well in treating these vague complaints is just that...pain medications (approved by FDA and studied) does not work. so what will work? i have a potion here that i made in my basement of all natural herbs that will help. do i sense incredulity? my potion went under the same rigorous investigation as any natural remedy. so why do you believe the naturopath and not a stranger? because they went through some institutional process? sorry to say, but their remedies are not shown to work in a clinical study. when docs send you home with no answers, its likely that there isnt an answer, except the likely placebo effect of alternative medicine. we try to treat the cause of the pain...sure a massage will feel good, but is that what gets rid of the pain? see what i mean?

By natural born skeptic (not verified) on 06 Jun 2007 #permalink

Skeptyk is correct. The term "complaint" is a medical term. It is neutral and means nothing more than the reason that a patient is seeking medical care. Usually it's called the "chief complaint."

I did not state that I have not been to a doctor. Why you all come off making wild statements? it hardly furthers discussion. I quite understand the palcebo effect of medications. I am frequently intolerant of medications and so I take nothing unless absolutely necessary. I do not feel that naturopaths are better than doctors, but I do feel they are better listeners. My ND is a former MD, so I have no worries about her skills. I do worry about other people who buy into the rather strange methods used by some NDs. I'm not a fan of kinesotherapy. As for you all who say doctors don't disregard non serious symptoms, yes they do. If you keep going back saying you have a problem with joint pain and they do an exray and dont see anything, they just dismiss your concerns. they tell you to come back in two weeks, they do a blood test for the basics, tell you it came back just fine, and then tell you to go see a shrink. I've had chronic joint pain since I was 8 years old and have never had a doctor go into any effort in finding the cause. Yes maybe sometimes a doctor cannot find a cause, but No doctor has ever told me they could not find a cause, they told me that since it wasnt a big deal that I should just learn to deal with it. Well I have learned to deal with it, I just figure that as science progresses, eventually they are going to figure something out and I don't like being treated like a hypochondriac for bringing it up every couple of years hoping there is something new out there.

As for the definition of complaint, I can tell you it has a negative connotation no matter how much it is supposed to be a neutral medical term.

And as for massage, obviously you've never been to an LMT that knows how to find the muscles that are spasming on you and get them to calm down. Most LMTs arent very good at anything but a relaxing massage, but some, especially those to specialize in neuromuscular techniques really know what they are doing. I went to 5 LMTs before I found someone who knew what they were doing.

I understand that the chief subject of the article is the dangerousness of chelation but the rest of it is just ND bashing. it's hardly going off topic to explain why people find lack of satisfaction with their MDs and go to an ND. I go to BOTH, i know which is good at which and I have a healthy dose of skepticism when it comes to silly superstitious types of cures.

If you MDs were willing to listen as to why some people find disatisfaction with MDs, then you would never be the type of MD that people find disfaction in, you'd be the type of MD that has to say no because they already have too many patients. A friend of mine has an MD like that, that she loves. The doctor has to fend off new patients because she's so in demand. This doctor never says "come back in 2 weeks if it's not better". She runs the tests, does some research on her own, consults with other doctors and is honest with her patients. And now that my insurance has changed and covers her, i'm switchiing over to see her. Maybe you all shouldn't treat everyone who's disatisified with their doctor as a sucker. And for the record, i've tried out more than 5 different primary care doctors and they were all the types that just wanted to hand me the latest pharmecuticals without any testing. I hardly see any difference between that and an ND who just wants to hand out supplements.

I agree fully with what Lori is saying. The tragic death of this woman (Sandy Boylan-- she has a name) is simply being used here as a launching pad to bash naturopaths, chelation -- virtually anything else even remotely associated with "woo"

The discussion about this one anecdotal death, however tragic, fails to analyze the underlying reasons and scientific data as to why sensible people are turning away from conventional health care.

Reason No. 1: Prescription drugs cause 106,000 deaths in USA each year. (See, Lazarou, JAMA 1998)

Reason No. 2: Altogether, conventional doctors and hospitals cause about 225,000 deaths in the US each year. (Source)

This data is peer-reviewed in the Journal of the American Medical Association.

If you are saddened and/or outraged about what happened to Ms. Boylan -- I hear you. I agree with you.

But, how saddened and outraged are you at the death of 225,000 patients each year by medical professionals, who obviously should know better?

By Ky Sanderson (not verified) on 06 Jun 2007 #permalink

Joe -

I couldn't find a link relevant to Oregon's licensure or any of the schools in OR. I was basing that statement on what I have been told by the naturopaths I know, what the schools themselves claim and the fact that a friend of mine, who was a nurse practitioner going into school for naturopathy, didn't have nearly as many classes to take. As such, I could be entirely mistaken. I am certainly not terribly sympathetic to them.

By getting chelation, she might as well have been getting "experimental stem cell therapy" from some clinic in Tijuana. Someone who knew better screwed her over for money and she ended up dead. To compare that to some person dying from a reaction to a conventional drug is inane.

I just wonder if JB Handley, founder of Generation Rescue and apologist of all things quack, would take his child back to this guy who killed the poor woman.

By Apples and Oranges (not verified) on 06 Jun 2007 #permalink

But, how saddened and outraged are you at the death of 225,000 patients each year by medical professionals, who obviously should know better?

Why do you think people keep cracking down on malpractice?

It's questions like yours that demonstrate a profound ignorance of the issues: Evidence-based medicine works in clinical trials. It's not perfect, but it works more often than anything woos can come up with (placebo rate or worse). An additional thing you fail to recognize is the difference between scientific and infrastructural issues. EBM works well enough under ideal conditions, but if it's poorly handled by bureaucracy, incompetent doctors, it can indeed kill. Don't blame the medicine when you should blame the bureaucracy or the incompetence.

The problem with naturopathy and other woo is that they aren't held to the rigorous standards evidence-based medicine is, both scientifically and bureaucratically. It's given a free pass. All bad things that happen are given free excuses by the practitioners and even the patients: "Oh, well, it doesn't work for me. On to the next woo."

If you don't have good evidence a procedure works, and you're not conducting a carefully controlled study, it's malpractice.

If you want my view on the whole malpractice subject change, here it is. Just make sure you keep your ability to comprehend analogies turned on.

Nice response, Bronze Dog. Ky's comments are an old tried-and-true altie trope designed to distract attention away from the incident at hand. You nailed it: This is the difference between a scientific issue and an infrastructure issue. It's a systems problem that requires a systems-based method to address it, perhaps like the methods used by the airline industry to keep accident rates so low. It says little or nothing about the validity of the actual treatments s.

Moreover, it's a matter of illness as well. EBM-based therapies are effective against serious diseases, but that means that patients receiving them in hospitals tend to be sick and thus more vulnerable to infrastructure problems that result in medication errors. In addition, these analyses tend to look more at correlation, specifically deaths associated with medication errors. They do not do a very good job of looking at whether the medication errors were the primary cause of the death.

None of this is to say that there isn't a problem; It's merely to point out that woos who bring up this old trope are confusing apples and oranges. They're basically using the old red herring fallacy.

Ky Sanderson -

Yes, lots of people die, using EBM. Of course, a much larger number of people use EBM than use woo. And even among those who use woo, many of them will go to an EBM doctor when it's serious. Too, many naturopaths (unfortunately, not nearly enough) will encourage their patients to see a EBM doctor, for serious or lifethreatening complaints - or if the patient has a bad reaction to the treatment they get from the naturopath.

Yeah, I am saddened and even occasionally outraged, when the case is obvious gross negligence, at the number of people who die from EBM. But I am also damned glad that I don't have to depend on quacks when the chips are down. I am damned glad that I have EBM doctors, who will do everything in their power to keep me alive in case of an accident, or if I end up with a terminal disease. Why? Because my odds of surviving or at least achieving the best quality if life possible, drastically increase with EBM doctors.

Bronze Dog,

Listen up, Twerp. The Lazarou paper has nothing to say about medical malpractice. Did you even read it?

It says that FDA-approved drugs at the "proper" doses still kill 106,000 patients a year. It is not "mal"practice -- it is standard practice that is killing all these people.

If, in your mind, that is an acceptable level of "collateral" damage, because, on the whole, these drugs reduce much more suffering, than they cause, that would be a valid argument -- one that you didn't make.

Orac, I'm surprised at how blinded you are at this topic.

1 death from woo gets a full post, 225,000 yearly deaths from conventional medicine gets ... scorn?

Are you intellectually honest on this topic?

I'm fully against woo. I haven't ever been to a naturopath, nor have undergone chelation therapy, nor would I before exhaustive research on the particular issue and numerous second and third opinions from credentialed professionals. Woo doesn't work and doesn't impress me.

None of this, however, mitigates the sad fact that conventional medicine, including regularly prescribed FDA-approved medicine, causes substantial death. I noticed that you and Bronze Dog ignored the peer-review literature I cited.

Final point: Recently the NY Times had an article on declining breast cancer rates.

If cancer rates are falling, this is no doubt, great news.

But, look at the cause -- women stopped taking cancer causing hormone replacement therapy.

In other words, the prescribed drugs were causing cancer. Purely, iatrogenic death. What women would trade unpleasant menopause for fatal breast cancer?

I gather as a cancer researcher, this would concern you.

Can we expect a similarly hostile post about any of the women killed by breast cancer, due to this conventional medicine?

By Ky Sanderson (not verified) on 06 Jun 2007 #permalink

It says that FDA-approved drugs at the "proper" doses still kill 106,000 patients a year. It is not "mal"practice -- it is standard practice that is killing all these people.

Yes, virtually any effective treatment carries some risk. And the drugs used to treat the most painful or life-threatening illnesses frequently carry substantial risk. What evidence-based medicine is about is quantifying those risks, making sure that physicians and patients are aware of them, and that the judgement that the benefits of a treatment outweigh the risks is made on a sound basis.

Often overlooked is that the body's own "natural" defenses against disease--immune reactions, inflammation, etc.--also carry hazards. Many deaths occur each year as a result of "side effects" of the body's natural processes directed toward healing disease--deaths from autoimmune diseases, allergic reactions, etc.

Chelation therapy carries substantial risks--risks so great that it is judged acceptable only when there is clear evidence that the patient is likely to suffer substantial harm if untreated as a result of clearly demonstrated heavy metal poisoning.

In other words, the prescribed drugs were causing cancer. Purely, iatrogenic death. What women would trade unpleasant menopause for fatal breast cancer?

If you ask around, you will find that quite a few women would gladly accept a slightly higher risk of dying from breast cancer for a certain relief of severe menopausal symptoms that are destroying their quality of life.

By the way, cancer incidence rates are slippery things, as Orac has commented before. One effect of estrogen is thought to be speeding up the growth of estrogen-sensitive tumors that are already present. So some of this decrease may simply be the postponing of diagnosis of tumors that will crop up later on. Moreover, estrogen-sensitive tumors tend to be the most successfully treated, so the impact on breast cancer mortality rates of this decreased incidence rate could turn out to be quite small.

Yes, virtually any effective treatment carries some risk. And the drugs used to treat the most painful or life-threatening illnesses frequently carry substantial risk.

Very true, and the woo's attitude toward this is typically, "It's not perfect, so let's poo-poo on it unhelpfully. Oh, and we should be immune to any risk-benefit analysis that requires us to show any benefit at all for our alternatives."

Bronze Dog, have you done a doggerel series yet on this particular tripe: "EBM kills x people a year, therefore woo works"? I find this line of argument maddening as it's complete fallacy; as Skeptyk said, the deficits of EBM do not infer that woo works. As expected, the alties on this thread can't seem to get away from this line of argument.

As a 39 year old woman who has breast cancer (and has never taken hormone therapy), I will add that one of the perhaps unintended negative consequences of woo is psychological. Do any of you know how often cancer patients are told by friends and family to skip conventional therapy for woo? Do you know how difficult it is to explain to the True Believer why you are taking poison like chemotherapy instead of (pick one): praying, vitamins, enemas, The Secret, positive thinking, macrobiotics, homeopathy, vegetarianism (was one for ten years, so much for veggies), etc.

I had to spend an hour on the phone with a woman who luckily only had DCIS to convince her to take her tamoxifen because she had heard so many bad things about it from her homeopathic naturalistic friends.

As if it's not bad enough having cancer, us patients have to constantly justify our decisions and even deal with the GUILT that we are sometimes made to feel for being sick. I've had people tell me that my disease is a result of (pick one) anger, water, bad thoughts, secular humanism, bad chi, etc.

There's nothing lower than the vitamin and "remedy" pushers who target the sick. I love shopping at Whole Foods, but get angry every time I see the "natural remedy" aisle and over hyped supplements. When did fresh food and healthy lifestyle get entangled with woo and religion???

Trrll writes:

Yes, virtually any effective treatment carries some risk. And the drugs used to treat the most painful or life-threatening illnesses frequently carry substantial risk.

And, in other news, water is still wet.

Look, everyone on the planet knows it, so why say it?

You are dodging the "cumulative risk" phenomenom of prescription drugs, as well as the "cumulative harm" caused by said drugs in aggregate.

The risk of harm from any individual drug given for a particular illness is probably small and well-defined. As long as this is conveyed to the patient to get informed consent, Great.

The problem is that in the aggregate, 106,000 patients are killed by what were described as safe doses of safe drugs. (See Lazarou, JAMA, 1998). This is a meta-analysis, so it can't be ignored (as Orac seems to do).

Does this mean, throw out ALL prescription drug treatments? Of course, not!

What it means, though, is that there is a huge, understated cumulative risk of death from prescription drugs, that traditional MD's are not really conveying to patients. Perhaps, an increasing number patients are starting to "intuit" this problem by their actions such as seeking alternative therapies like chelation.

Bottom line: Before yapping endlessly about the problems of woo (which are many), perhaps Dr. Orac could display his intellectual honesty by acknowledging a "systemic" problem in conventional medicine, based on the findings of Starfield and Lazarou in the peer-review literature.

Of course, this is the equivalent of unbuttering one's own bread, so I doubt it will happen.

By Ky Sanderson (not verified) on 06 Jun 2007 #permalink

The risk of harm from any individual drug given for a particular illness is probably small and well-defined. As long as this is conveyed to the patient to get informed consent, Great.

...

What it means, though, is that there is a huge, understated cumulative risk of death from prescription drugs, that traditional MD's are not really conveying to patients.

OK. So what percentage of those 106k patients died of risks they were not informed of, per the first comment above?

Bottom line: Before yapping endlessly about the problems of woo (which are many), perhaps Dr. Orac could display his intellectual honesty by acknowledging a "systemic" problem in conventional medicine, based on the findings of Starfield and Lazarou in the peer-review literature.

No, bottom line: there's an enormous difference between those who do their best to ensure that their patients get the safest, most effective treatments available, and those who pull out any old crap with no evidence of efficacy or safety whatsoever.

Ky would appear to be one of those disingenuous "I'm not into woo" types who nonetheless is enamored of this particular favorite trope of alties, which, when you get right down to it, really is nothing more than a red herring that says in essence:" EBM causes X number of deaths; therefore woo works" or "EBM causes X number of deaths; therefore it's 'intellectually dishonest' to criticize quacks when they cause deaths administering useless and potentially dangerous treatments if you don't also criticize EBM for its shortcomings." The only real reason for this tactic is to try to "shame" critics of quackery to falsely create a sense of "balance" in their criticism (as if a treatment like chelation therapy for vague complaints were the scientific equivalent of EBM) by labeling them "intellectually dishonest" if they don't

It's a very tiresome and obvious red herring, and repetition doesn't make it any less so. Bottom line: This woman died because a quack treated what was probably a nonexistent illness with a treatment that has no efficacy for anything other than one specific condition but has become in the hands of quacks a "cure-all"--and died as a result.

It should also be noted that the 1998 study was conducted by and for health professionals, and published in a front-line journal. The purpose of such studies is to identify and eliminate causes of harm.

Alties don't do that. For example, when it came to light that chiros were causing strokes by pointless neck-snaps, the chiros denied it for years. Now that they are beginning to acknowledge it, many continue to put their customers at risk.

You are dodging the "cumulative risk" phenomenom of prescription drugs, as well as the "cumulative harm" caused by said drugs in aggregate.
The risk of harm from any individual drug given for a particular illness is probably small and well-defined. As long as this is conveyed to the patient to get informed consent, Great.
The problem is that in the aggregate, 106,000 patients are killed by what were described as safe doses of safe drugs. (See Lazarou, JAMA, 1998). This is a meta-analysis, so it can't be ignored (as Orac seems to do).
Does this mean, throw out ALL prescription drug treatments? Of course, not!
What it means, though, is that there is a huge, understated cumulative risk of death from prescription drugs, that traditional MD's are not really conveying to patients. Perhaps, an increasing number patients are starting to "intuit" this problem by their actions such as seeking alternative therapies like chelation.

I'm not dodging it; I merely didn't bother to comment because I think that it is obvious to virtually everybody that the concept of "cumulative risk" is fundamentally stupid. You multiply any small risk by a large enough number of people or a large enough interval of time, and you can come up with a number big enough to impress anybody who is dumb enough to be impressed by large numbers.

Why should so called "cumulative risk" be meaningful to anybody? When I decide what to do, I'm interested in the risk to me personally, so the multiplier is one. What is relevant to the individual patient is individual risk. Even if you are trying to make some sort of economic argument about the costs to society as a whole, it is a fundamentally stupid way to think about it, because most of those medications are taken to treat or prevent some condition that itself has risks and costs, so a meaningful analysis would have to be on the level of net risk/benefit. Pulling out only the risk of treatment is rhetoric rather than reasoning. The only meaningful point to be made is the trivial one that when a treatment is used by a huge population, even a negligible improvement in individual safety (if it can be made while retaining the full benefits of the treatment) could yield dividends for the society as a whole.

And if talk about nonsensical concepts like "cumulative risk" is really driving some people to seek "alternative" therapies that are hazardous either directly or by virtue of substituting for genuinely effective therapies, the guilt lies squarely with those who throw around these kinds of large-number arguments without making clear their complete lack of relevance relevance to individual treatment choices.

Basta. Here's the board order issued to the naturopath responsible for Ms. Boylan's death: http://www.circare.org/pd/mcbride_orders_20060510.pdf

Anybody wanna defend this? And gosh look at the long list of drugs he prescribed. What is it naturopaths are supposed to do again?

Apparently the OR Board of Naturopathic Examiners is brain dead: item # 123 in the OR naturopathic formulary is "EDTA."
http://www.oregon.gov/OBNE/rules/850-060-0225.pdf

There is no drug named "EDTA" - it's an acronym that obfuscates (or conflates) Versenate and Endrate, the calcium disodium and disodium salts of ethylenediamine tetraacetic acid.

Quis custodes custodiet?

Orac write deliberately mischaracterizes an opposing point of view:

1. " EBM causes X number of deaths; therefore woo works"

A strawman lie. I don't think woo works, other than perhaps placebo effect. Where's the evidence that it does work?

2. "EBM causes X number of deaths; therefore it's 'intellectually dishonest' to criticize quacks when they cause deaths administering useless and potentially dangerous treatments if you don't also criticize EBM for its shortcomings."

Better, but still misleading. I'm charging you with intellectual dishonesty because you ignore the peer-reviewed literature demonstrating that EBM causes a statistically significant number of deaths. (See, Lazarou, JAMA 1998; Starfield JAMA, 2000)

My supposition is that 225,000 deaths/year in the US (the third leading death after heart attack and cancer) means that all the loved ones (wives, husbands, sons, daughters, fathers, mothers, friends) of those 225,000 victims are probably a bit more skeptical of conventional medicine, than they otherwise would be.

In addition, this large "market" of people, probably becomes a bit more open to alternative therapies, than they otherwise would be. Perhaps, this explains the growing appeal of woo.

Sandi Boylan, at some point, lost confidence in conventional medicine, and turned to chelation therapy. Tragically, she died.

You are right to point this out, and scrutinize the methods and means of utilizing chelation therapy, as well as the doctor who administered it.

You are intellectually dishonest, though, because you ignore FACTS about conventional therapy -- namely, the staggering amount of deaths dismissed as mere "collateral damage." (Starfield).

A post entitled, "Another clean kill by chelation" is fine, if true.

A post entitled, "Another thousand or so killed by doctors and hospitals" is true, but would take a bit more intellectual honesty than you have to post it.

By Ky Sanderson (not verified) on 07 Jun 2007 #permalink

Ky -

So you want to complain about supposed strawmen arguments, while defending your own? Give me a break. The fact that Orac doesn't talk about deaths caused by EBM, very often, doesn't detract from the point of this post, or show a damn bit of intellectual dishonesty. In case you haven't noticed, one of the major topics of this blog is medical woo, along with lots of other woo.

Also, I question just how statistically significant your argument is. Literally hundreds of millions of people take these drugs every year. It bloody well stands to reason that some folks will have adverse reactions, some fatal. It's tragic and unfortunate, worse still when it happens due to negligence on the part of big pharma.

But most often, I am guessing, it happens due to allergic reactions to safe meds. When I was seven, I was put on Ceclor, an anti-biotic. Turns out I am seriously allergic to it. If I had taken my first dose, just before bedtime, I probably would not have woken up. As it was, it was touch and go in the ER. I broke out in really bad hives, which were also caused swelling in my throat. I got an antihistamine shot in the ER, but they also had to lance some of the hives in my throat so I could breathe.

Allergic reactions in most cases, are not something that can be accounted for before a patient tries a drug, or a class of drug. Unfortunately, this is occasionally fatal.

If you want to find discussions about pharma fatalities and other problems with pharmaceuticals, I highly recommend Abel Pharmboy, at Terra Sigillata. It can even be found in Orac's link sidebar. He welcomes e-mail requesting topics for posting - though he is rather sporadic with posting at times. He does focus more on natural medicines, but seems quite knowledgeable about pharmaceuticals in general. More to the point, his blog is almost entirely focused on pharma and pharmacopia, unlike Orac's.

Just for the record, the term "statistically significant" has a specialized statistical meaning that is frequently misunderstood. It should not be confused with "clinically significant" or "important."

For example, "a statistically significant number of deaths" just means that you can show to a high degree of certainty (conventionally, better than 95%) that the number of deaths is greater than zero.

It is quite possible for the difference between two treatments to be statistically significant but of no practical significance whatsoever.

Quoth Ky Sanderson:

The problem is that in the aggregate, 106,000 patients are killed by what were described as safe doses of safe drugs. (See Lazarou, JAMA, 1998). This is a meta-analysis, so it can't be ignored (as Orac seems to do).

Italics mine. I strongly recommend, Ky, that you read this entry on Junkfood Science, which describes some of the potential pitfalls inherent in meta-analyses:

This technique is frequently used when there are no large, high quality, randomized, double-blind, placebo-controlled clinical trials -- the gold standard -- to prove the validity of a treatment or theory. So a meta-analysis lumps together whatever evidence is available: the good, bad and indifferent. Some studies may show a weak positive statistical association, others report none, and others may even report a negative correlation. It can end up giving the same weight to well-designed studies as poor ones, and create mud. By pooling what are oftentimes weak studies together, it is hoped to create a statistically stronger estimation of an effect.

That's not to say meta-analyses are by definition worthless, but many of them are. Certainly, it does not speak well for your understanding of the scientific literature that you think--or at least claim to think--that meta-analyses are of higher value than other types of study. Besides, it's not as if even the JAMA and NEJM don't publish some highly dubious studies on occasion. And we've all heard of "publication bias." Publication in a respected, peer-reviewed journal is an indication that a study has value, but it is not a guarantee.

And at the end of the day, comparing iatrogenic deaths to this case is mixing apples and oranges. How often does it happen that EBM gets a patient who has nothing seriously wrong with her, bar some unexplained aches and twinges, and ends up killing her? Perhaps more to the point, the evidence-based medical establishment acknowledges that things can go wrong. My 14 month-old son recently got prescribed some antibiotics (Amoxicillin) to treat an ear infection, and I was briefed extensively by the pharmacist on how to what detrimental side-effects to be alert for (in particular allergic reactions), and what to do if they manifested. Do you honestly think this McBride guy informed the late Mrs. Boylan that even if the chelation went perfectly (especially if it went perfectly, in fact), there was a risk she might suffer potentially fatal ill-effects from calcium deficiency? Do you think McBride was even aware of this risk himself? I've described McBride's conduct as manslaughter earlier in this thread, and I don't think that's too strong a term. And on top of all that, we get the gentle slap on the wrist imposed by the Oregon State Naturopathic Board of Examiners. Two years from now, McBride will be free to kill someone else, and as far as the Board's concerned, that's adequate. EBM does a significantly better job of policing its own.

Yes, a meta-analysis is a "poor man's" substitute for doing a well designed study with sufficient power to answer the question.

Generally, the need for meta-analysis means one of two things:

1) The existing studies have been very small and inadequate,
and/or
2) The effect size is quite small--perhaps too small to be of much importance at the level of the individual patient.

Even assuming that 225,000 people died solely as the direct result of taking medications at the proper dosage (a point still not proven, given the limitations of the studies cited), the real issue remains one of risk vs benefit.

Naturopathy, chelation for heart disease or autism, homeopathy, chiropractic and the rest of the sorry woo parade have a very low chance of helping the patient. Very low, in the case of homeopathy and chelation for heart disease or autism, having the meaning of "zero".

On the other hand, naturopathy, chiropractic and chelation for heart disease or autism have very real and significant risks associated with them - especially when administered by practitioners "educated" in nonsense (e.g. naturopaths, homeopaths and chiropractors). Homeopathy, since it contains nothing beside water or lactose, is almost completely free of risk (apart from drowning or reaction to lactose).

As a result, even if the risk is low (which is obviously not always the case), the risk:benefit ratio approaches infinity because the benefit is zero (or so close to zero as to be indistinguishable from it). For homeopathy, the ratio is zero risk to zero benefit, and thus is undefined.

Real medicine, on the other hand, has real risks - even the most benign over-the-counter medication has killed people. It also has real - and measurable - benefits. The general practice among conscientious and scientifically-oriented physicians is to balance the risks and benefits for each individual patient in order to obtain the most benefit with the least risk.

Some medications are extremely dangerous (e.g. cancer chemotherapeutics) and cause or contribute to a number of deaths every year. However, even these drugs are valuable because the "downside" risk of not using them is certain death. Many people will choose even a longshot chance of survival over certain death - thus these drugs are used and are considered indispensible.

One of the recurrent canards of the woo-apologists is that medicine is ruining the health of the US (or other Western nations). Rubbish! Every year, like clockwork, the life expectancy goes up a bit, even in the over-medicated, over-fed, and reputedly toxin-riddled US.

I'd find the arguments of the woo-apologists and real-medicine-bashers much more convincing if the life expectancy in the US didn't continue to rise. I'd also like to see the life expectancy of people who depend on "alternative" medicine for their health care.

Prometheus

However, even these drugs are valuable because the "downside" risk of not using them is certain death.

That's one of the big problems with woos who go on about safety: They think that inaction is always safe. Reminds me of an anti-vaxxer we had on here who wouldn't accept anything less than 100% safety for her kids, and yet she drives them to school.

With cancer, 'playing it safe' is one of the most dangerous things you can do.

I wonder if there's any correlation between these altie 'safety' freaks and books promising 'no risk' 'get rich quick schemes'. It's the same mentality: They seriously believe that you can gain without risk.

Instead of taking something with a proven benefit (EBM) and doing everything we can to lower the risks, they insist we take something with no risk and let them spin results until they have the illusion of positive results.

Note on meta-analysis: Someone's JREF sig comes to mind: "A teaspoon of sewage in a barrel full of wine makes a barrel full of sewage." So you really have to be careful about what you include.

Just re-read this thread again after posting a link to it on David Colquhoun's "Improbable Science" blog, and was idly checking out the list of drugs the guy had handed out.

...At which point my jaw was on the floor.

Of course, the judgement says that as an ND the guy shouldn't have handed out these pills... but WTF was the man doing even purporting to treat a patient like "D.E.", who was getting anti-platelet drugs and a cardioselective Beta-blocker??! This sort of combo tends to imply a person w ischaemic heart disease, at least to me.

As Orac alludes to, it makes one very suspicious as to whether "regulation" of NDs/Naturopaths actually provides meaningful safeguards for their customers / patients.
If the regulation is actually to work that way, then the practitioner should only be working "within their area of competence", or some similar phrase. That is how Nurse Practitioner extended prescribing works.

So how could a naturopath treating a person with a serious organic illness (like ischaemic heart disease) at all be "working within their area of competence"?? Does their board really think they are competent to do this? Scary.

The competent thing would be to send said patient straight to a proper cardiologist, or at least an MD. If the "ND" can't work that out, then how exactly can they be viewed as competent? And/Or how can the "Homeopathic State Regulatory Board" be viewed as having any credibility?

"Alternatively" and more cynically, maybe it's just Natural (Naturopathic?) Selection at work.