Our Blog No 9

Our blog Log 9From Monday 21st FebruaryAfter a drive around Kings Park and walk to the war memorial in the park which commands a wonderful view of the Swan River and city of Perth we went to the airport and collected Celia my sister and Janets mum who flew in from the UK.We then had a lovely dinner at Char Char Bull in Fremantle meeting up with several of Janets friends.On Tuesday we had

Further ‘Down Under’

Thursday 24th today we are off on our special holiday so Graham was up at about 6.15 to prepare Sweetie for her rest period. I followed as soon as the alarm went off at 6.30am. There were a few other people about but generally most people were still asleep so we had to be as quiet as possible although when you are putting a caravan away its practically impossible not to

Day 90 Paihia to Auckland

I took quite a psychological risk last night. I had verified on Friday night that when people played the DVD in Cap’n Bob’s common room it now really hurt my shoulder even if the piece didn’t have drums. I’d finally gone out on Friday and begged them to turn it off and they had.Anyhow I decided to write a little note and put it on the DVD explaining the situation. I did and I signed it and

Nepal. Kathmandu. Boudhnath and Pashupatinath

November 14On this day I was to have a guided excursion to Boudhnath and Pashupatinath the price of it was included into the cost of the trip. There was a guide for me and a car with driver. This day was the last day before the trek so I was rather excited if not very. It was warm in Kathmandu during all my stay. The sun shone most of the time but in the evenings when I went to the hotels

Erdbeben Panne Arbeit Studium Umbuchung

NewsNewsNews. Es ist mal wieder an der Zeit was von uns hoeren zu lassen und es ist auch wieder einiges passiert. Von dem was Neuseeland im moment Kopf stehen laesst habt ihr vermutlich in den Nachrichten etwas mitbekommen. In der Region Canterburry hat sich ein Erdbeben mit verheerenden Schaeden ereignet. Die Opferzahl steigt taeglich und im Ferneshen laeuft nichts anderes mehr. Das Erdbeben

Getting Ready to Go Home

This may be my last entry before we leave to head home. I have posted pictures from my Grandson Angelo’s or as he calls himself Angelo Jofus first haircut his third birthday Granddaughter Lincoln’s sewing creation and also pictures of the friends I have made at the Baha’i’ Center here on Guam. Angelo’s haircut was quite the ordeal. He didn’t quite know how to feel about it. He certainly

Deadly Indeed

There are sources of information I inclined to accept with minimal questioning.  I do not have time to examine everything in excruciating detail, and like most people, use intellectual short cuts to get through the day.  If it comes from Clinical Infectious Diseases or the NEJM, I am inclined to accept the conclusions without a great deal of analysis, especially for non-infectious disease articles.  Infectious disease publications I have to read more closely; its part of passing as an expert.

Outside of medicine, I am predisposed to accepting at face value many of the articles in Skeptic and Skeptical Inquirer. They are trusted sources.  Some topics, like haunted house or Big Foot investigations, I barely skim. After all these years, I doubt there will be any new insights into the subject.  Other topics, depending on my interest, I may read more carefully.

I  often read longer articles  many times.  First a quick skim to see if it offers anything of interest.  If it does, then I may read it carefully.

This months Skeptical Inquirer had an article called  Seven Deadly Medical Hypotheses by Reynold Spector.  Just seeing the title and knowing the magazine, I was primed to accept the content at face value.  I enjoy a well reasoned, thoughtful rant. I relish a clever diatribe, even if I do not agree with the topic.   So I gave it a quick skim.  I was discomfited.  My first gut check was ick.  But I was uncertain why.  So I read it slowly and carefully, and still ick.  But why?There is a degree of self absorption in being a blogger.  I can write about what I want any way I want (I remain amazed at how much I can get away with).  The process of writing about a topic helps me clarify in my own mind issues with articles.

The author of 7, as I shall refer to the article,  has over 200 published articles, is a former executive vice president in charge of drug development at Merck and oversaw the development of 15 drugs and vaccines.  I am nobody from nowhere who just takes care of infected patients for a living.  He wins the argument from authority; I am the E. coli evaluating the human.  Oh well,  this is more an exercise for me to enlighten myself; you are the innocent bystander.

Overall the tone of 7 ? It reminded me of the Health Ranger at NaturalNews.com. Really.  Lots of dramatic statements, no qualifiers, no buts, no subtlety, no nuance.  To me, what marks good medical writing is an understanding that there is far more grey than black and white and that generally people are doing the best they can within numerous limitations  One of the many characteristics of the Health Ranger is hyperbole without nuance.  The Health Ranger has a belief system and sees the medical industrial complex through that lens; information is used to support a predetermined conclusion.  Health Ranger is a bombastic style that is both self assured and self referential.

Let us see what 7 has to say. It begins

A chronic scandal plagues the medical and nutritional literature: much of what is published is erroneous, pseudoscientific, or worse.

I’ll grant the first.  I am an Ioannidis convert.  The second seems hyperbole and exaggeration. Pseudoscientific?  Like homeopathy, psi and astrology?  Sorry The author is 17 words in and he has lost me.  I already question his veracity and judgement.  I read the literature. Hundreds of papers a month. I know the literature, and Sir, it is not pseudoscientific.  Suboptimal, often, but not pseudoscientific.  The third?  What could be worse than pseudoscientific?  Oh yeah.  Wakefields Lancet article.  But fraud  is a very rare exception in the over 20 million references on Pubmed.  The author’s opening salvo strikes me as someone more interested in polemic than truth. If done with verve and panache, and above all wit, I like a good polemic. Pomposity with hyperbole, not so much, and calling the medical literature erroneous, pseudoscientific, or worse leans towards the latter.

Two major factors account for a large proportion of this problem.  First, many medical and nutritional hypothesis are ill-conceived.

Are they?  Over 20 million references in Pubmed.  A few, perhaps, were ill conceived before they are tested. Say, measles vaccine induced gastroenteritis causing autism?  Not even that.  If approached honestly and competently, it would be a long shot, but you never knows unless you look.   That is what a great deal of medical research is about: looking around to see if an etiology or intervention or medication will be effective.  Most ideas, I would guess, go nowhere.

Second, the methods used are often epistemologically unsound.

Got me there.  What is epistemologically unsound?  Even after looking epistemologically up on the interwebs, I am uncertain what it means.   I expect the comments will school me on the meaning of epistemologically unsound. I guess that is why I am a lowly clinician.

Moreover, the same unsound methods are often repeated multiple times on the same tired hypotheses with the same incorrect results.

Isn’t that three major factors?  Or is that the unsound epistemological I cannot understand?  I shouldn’t quibble about counting, but I feel a rising tide of ridicule and scorn, and I am not one to hold it back.

I am not even done with the first paragraph, and the author has epistemologically lost me. Maybe there is good reason to be unsettled with the article.   And in the first five sentences, there are four references, all to works by the author, to justify the position.  I tend to prefer external references in my literature; the hyperbolic self-validation is what I expect from the Health Ranger and his ilk.  But again, who am I to question (1)?

… there is an epidemic of published studies that do not follow the principles of sound medical science- the principles demanded by the US Food and Drug Administration for the licensure and sale of medications.

Well, most studies are preliminary and exploratory.  The rigor demanded by the FDA is the final step in a long process starting with basic principles and, perhaps, epidemiology.  I can’t imagine we should jump to huge randomized, placebo controlled trials for every therapy and to answer every question.  Seems a wee bit excessive to me. Start small and build.  The downside is that there will be dead ends and false conclusions.  The upside is that in the end, a close approximation of Truth will be determined.

The resulting “findings” of such misleading or erroneous studies are often hyped by the news media on the day they are reported or published without any additional, careful analysis.

Hyped “findings”?  Nothing like that in the first two paragraphs of the this essay. Nope.  Nothing to see there but a well reasoned, careful, nuanced prologue for the body of the  essay.  “I” am always “mistrustful” of people who use “quotes” as a form of “sarcasm” when sarcasm is not used for good “effect” like “humor” because it otherwise comes across as “supercilious”.

Now I am starting to understand my discomfiture. Still, that’s just the first two paragraphs.  The body will better, right?

The author then proceeds to the background of how to do a good study: generate a plausible, testable hypothesis and test it.  He uses the Scandinavian Simvastatin Survival Study as an example of medicine done right (a Merck product if you care) and bemoans that not every study meets this high standard.

Too many published studies fail to adhere to these high scientific standards and lead to faulty, and even dangerous, conclusions.

Which is true and to my mind understandable, since there are not the resources to do perfect studies of every hypothesis.   Not every car is a Lexus, not every restaurant has a Michelin three star rating. You can’t always get what you want (2).  The issue to my mind is not that there are suboptimal studies; they are often used to find search for hypothesis that can be tested in better trials.  A large part of research is flailing about looking for something interesting to investigate in further detail.  Not everyone has the resources to test everything using the ‘hypothetical/deductive method” to answer all out questions, like the FDA demands.  Although this is not always the preferred method of generating ideas to test.  I don’t need quotes to cast aspersions on the validity of information or generate guilt by association.  I have learned a thing or two from reading the Health Ranger.

I wonder how many suboptimal studies it required to get to the point of the Scandinavian Simvastatin Survival Study?  The concepts to be tested did not appear from the void, fully formed.  The author does not, as will be seen, pay attention to the history and context of the evolution of medical ideas.

The author then proceeds to his 7 deadly hypotheses. Well, one deadly,  6 not so much.  But guilt by association is a game played by the author of 7 as well.

1) the investigator does not need a specific hypothesis and/or can use an inadequate method to test hypothesis.

He uses the example of epidemiology generated by case-control and cohort studies (the kind of studies that lead to the simvastatin study) and the effects of hormone replacement therapy.  He points out that these epidemiologic studies, for a variety of reasons, can lead to erroneous conclusions. Fine.  The other option?  With no preliminary studies jump straight to a huge trial?  And sometimes epidemiology can lead to important results: that a certain water pump is the epicenter of cholera or that chimney sweeps have more testicular cancer. Or that lowering cholesterol is associated with a decrease in vascular deaths.

Epidemiology is part of a continuum of understanding and evolution of medical knowledge.  But strawmen are easier to burn than recognizing the stuttering, somewhat chaotic progress of medical knowledge.  If proving a point is more important than understanding complexity, this is how you argue.

He then proceeds to genome-wide association studies (GWAS) that have been a disappointment for  elucidating genetic causes of heart disease and Alzheimer’s. The author considers GWAS a failure.  I suppose if you have a narrow perspective, yes it has been a failure. So far.  Huge amounts of information about the genome have been generated, and I am always a fan of knowledge for knowledge sake.  In the world of infectious diseases, there are single gene polymorphisms in the immune system that can increase or decrease a patients risk for a variety of infections.  Is it of clinical relevance yet? No.  Is it interesting? Oh, yes.  Will it lead to a new treatments and diagnostic interventions in the future? Who knows. But trying new ideas may fail but still  lead to insights that may lead to better interventions. I would wonder what secondary advances in technology and understanding were accomplished as a results of the GWAS studies.

It is like complaining that the Apollo program only put 12 people on the moon so the program is a bust since we are not going to the moon for vacation.  Here is a dirty little secret from a mere clinician.  I learn far more from failure than I ever have from success.  “The most exciting phrase to hear in science, the one that heralds new discoveries, is not ‘Eureka!’ (I’ve found it!), but ‘That’s funny…’ -Isaac Asimov.”  If you are a clinician, it is not ‘That’s funny,’ but ‘Oh shit’ that really drives change and knowledge.

2) If women replace these missing hormones post menopausally with HRT, they will remain “youthful” and not suffer from heart disease, dementia, vaginal dryness, hot flashes, and fractured bones.

I remember the late ’80′s,  a time that was the heyday of HRT, when I was in my internal residency training and discussing the issues at length not only in clinic, but with my mother.  I remember discussing the epidemiologic data and the worries of cancer.  The author states that

…based on these  (biased) studies, false claims were made the HRT protected against cardiovascular disease and dementia.

As if we knew it was false at the time. It was the best guess based on the data, and epidemiology can give insights that can be later confirmed  by better studies.  He also says

“the proponents…ignored the well-documented fact that estrogen is a carcinogen that causes breast cancer that can kill women” and that “HRT caused a 25% increase in breast cancer.”

I do not know where the author was practicing, but I remember talking with patients (I know, flawed memory) and my mother about the relative risks of cancer and fracture from HRT.  And 25%. Increase.  That’s bad.

What was the study?  On “16 608, patients, there were  more invasive breast cancers compared with placebo (385 cases [0.42% per year] vs 293 cases  [0.34% per year]…and the estrogen group had higher mortality (25 deaths [0.03% per year] vs 12 deaths [0.01% per year].”

That is bad.  Equally bad was the way the author presented the data, the same author who complains in the opening paragraphs about complex data being presented as looking “superficially adequate to the unsophisticated reader,” but I know when someone is presenting information in an manipulating manner designed to blow smoke out a usually inaccessible area.

In a section worthy of the Vaccine Council or Dr. Mercola, it sounds like people deliberately ignored cancer risk to push estrogen to kill women.  Someone mention hype?  I know it is important to make a point, but those who were investigating HRT and prescribing it, as I did once upon a time, were doing it carefully and with knowledge that there could be risks.

Information does not exist in a vacuum.  When talking with my patients and Mom in the late 1980′s, I basically said, based on the odds, how do you want to live your life?

Lifetime risk is a useful way to estimate and compare the risk of various conditions. Hip fractures, Colles’ fractures, and coronary heart disease, and breast and endometrial cancers are important conditions in postmenopausal women that might be influenced by the use of hormone replacement therapy. We used population-based data to estimate a woman’s lifetime risk of suffering a hip, Colles’, or vertebral fracture and her risk of dying of coronary heart disease. A 50-year-old white woman has a 16% risk of suffering a hip fracture, a 15% risk of suffering a Colles’ fracture, and a 32% risk of suffering a vertebral fracture during her remaining lifetime. These risks exceed her risk of developing breast or endometrial cancer. She has a 31% risk of dying of coronary heart disease, which is about 10 times greater than her risk of dying of hip fractures or breast cancer. These lifetime risks provide a useful description of the comparative risks of conditions that might be influenced by postmenopausal hormone therapy.

That was the kind of information and conversations about HRT I was having with patients in my clinic as I completed my residency, the years the author was at Merck developing drugs.  Many patients were far more worried about the disability and pain of fractures than they were of breast cancer.

In continued hyperbole that is totally disconnected from what I remember, he calls HRT a “flagrant example of the harm done by straying from the principles of hypothetical/deductive approach and sound clinical science.”

Really?  Did this guy ever take care of patients?  Has he ever had to make decisions based on incomplete information?  We are only into number two of seven and he last lost me with the hysteria.  I wonder how he would suggest exploring the effects of waning estrogen on the health of women?  Jump straight to a large trial?  Do no preliminary work?  Ignore any potential leads?  What is the alternative to the incremental, and sometimes erroneous, results of medical understanding?  How about fluoride and tooth decay?  So many insights start with a guess and a little epidemiology. Sometimes it pans out, sometimes it doesn’t.  But you do not know unless you try.

3)  if small dosages of vitamins are good for humans, very large doses would be better for everyone.

He then notes the studies that show the hypothesis was wrong.  But this was only known after the fact, after the studies,  and perhaps using vitamins like drugs would have beneficial effects.

Then the odd summary: ” megavitamin therapy tested in properly controlled trials either does nothing or is harmful (except in a few well defined exceptions).”

So it does nothing except when it does.  And how would we know the well defined exceptions unless we did the trials?

He goes from complaining about the science to complaining about the regulatory and commercial issues of megavitamins, changing arguments in midstream.  Is it the science or how the science is used?  Two different issues.

This is getting tedious, even for me.  I will soldier on, although the re re re reading 7 is increasingly painful. The closer I read it, the greater the errors and manipulations; a Mandelbrot set of manipulative medical writing.  Soon I will find the indefinite articles and pronouns suspect.  I try to skim the Health Ranger for a few chuckles; that is not why I read SI. And when is their swimsuit issue?  Oh. Wrong SI.

4) Screening tests beyond the standard medical examination are necessary for identifying disease and the risk of disease in apparently healthy, asymptomatic adults.

I will leave this issue to the more knowledgeable hands of Dr. Gorski.  His argument seems to be based on the 20:20 vision of hindsight, which is apparently the primary argument in all seven cases.  We thought screening would be effective,  studies showed it wasn’t, so the hypothesis was flawed and we should not have suggested screening or done the studies.

The author does not show in this, or other examples, why the ideas were wrong in the context of time the ideas were first offered. It is only viewed through the all powerful retrospectoscope that the author finds his deadly hypothesis. It is ever so easy to predict the past.

He also seems to argue that since our understanding of the ramifications of screening are not perfect, they are suspect, referencing himself for issues with PSA and mammograms (1).  The author argues in part that since our understanding is imperfect, it is a deadly hypothesis. I have always been comfortable with making decisions based on incomplete information, as that is the only kind of clinical information we ever have, save for the results of the occasional autopsy.  The perfect always being the enemy of the good.

He also complains about genetic screening. He notes that few people with high risk genes will develop disease and they can’t do anything about it, so why bother?  I wonder if the author has had much direct patient care.  What  most patients dislike is uncertainty about the why of their disease and most prefer as much understanding and certainty about their health as they can gather.  That is why they bother. And todays why bother may be tomorrows critical insight.  I have discussed how the show Connections made an impact on my view of the serendipity underlying advances. It may not be cost effective or useful currently,  the author does note that for some patients (breast cancer) it may have utility. Again, it is a deadly hypothesis except when it isn’t. So much sound and fury.

But how do you know until after you have done all the studies and see what works and what doesn’t?  His argument still seems to be since in some patients genetic testing has been shown to be of no utility, in the past they should not have done the work to show it is not useful. Except where it is.  Sort of like going back in time to kill Hitler as a child because he was found to be evil in the future, even though you could not tell that the babe in the crib was going to be the source of Goodwin’s law. And far worse.

Circular argument much?

I do not get the impression the author is one for thinking outside the box.  Usually new ideas lead nowhere, but again, you never know unless you try. Nothing ventured, nothing gained vrs nothing ventured, nothing lost.  It is often not the results of studies that are the issue, but how they are portrayed in the media, as noted by the author, and, probably not intentionally, his entire article is a superb example of just that concept.  Maybe 7 is really meta.

5) Manipulating one’s nutrition can prevent cancer.

As he says,  “In retrospect,  this hypothesis does not seem plausible.”

The whole crux of almost every one of his arguments. Repeat after me. In retrospect. In retrospect. In retrospect.  In retrospect everything is clear.  I have had MD after my name for 27 years, and I remember the uncertainty and interest in all his 7 mostly not so deadly hypotheses.  In the beginning, it was not so clear as he makes it out to be.  The past is easy to predict.

6)  Personalized medicine will greatly advance medical care.

His argument is the same: it hasn’t worked except where it has.

“Personalized medicine has only been shown to be cost effective in a few well defined situations.”

How did we find these well defined situations?  Doing a ton of studies that show benefit in some cases and none in others.

I think the solution to this problem is being able to see the future and know in advance which research ideas will bear fruit and which will be a bust.  Precognition is apparently the only solution. Miss Cleo may be available to help review research proposals, I understand that her readin’ is free.

7) cancer chemotherapy has been a major medical advance.

Of course, in some cases it has been extremely effective, but the war on cancer has not been what it was promised.  Again it seems his argument is the same hindsight argument:  when cancer therapy has been effective, it is great, and when it is not so good, we should not have done the work to show that wasn’t effective.   Again, I leave the details to Dr. Gorski should he choose to cover the topic.

And of course the author doesn’t have a dog in the fight (and there are those quotes, so commonly used by the dispassionate):

“When one dispassionately weighs the minimal prolongation of ‘good’ life in patients with metastatic cancer versus the very distressing side effects of chemotherapy with ‘targeted’ drugs, the case is close.”

I’m convinced,  He is dispassionate.  And Jenny isn’t anti-vax, just pro-safe vaccine. Here is my hypothesis to be tested.  Anyone who argues they are dispassionate isn’t. They are fooling themselves and trying to fool others with their alleged practice of arei’mnu.  Me? I am never dispassionate; although sometimes I do not care, but there is a difference.

Some of his conclusions are reasonable: we need to do our science as best as we can.

The author argues that all these errors and  expenditures of his 7 mostly no so deadly hypotheses could have “been avoided if the hypothetical/deductive method had been applied rigorously.”  I am not convinced, since most of his arguments are based after the fact.  I would be far more impressed if, by using only the hypothetical/deductive approach (no epidemiology, no early studies, no preliminary clinical data, no basic science) if he would predict 7 hypotheses that warrant jumping straight to large, randomized, placebo controlled clinical trials so beloved by the FDA. The Randi prize awaits.

We all need that god like perfection and prescience, unlike those

“guilty of perpetuating worthless practices include “scientists” who repeatedly employ flawed methods and then publish them, government agencies who fund such practices, editors of journals that publish pseudoscience, the USDA and NCI bodies that perpetuate unscientific regimens…”

My. God.  The Health Ranger was right.  The conspiracy has incorporated itself into every aspect of the Medical-Industrial  complex.  A different conspiracy than the one we get from the woo world, but  everyone is involved.

Putting scientists in quotes. A very Health Ranger thing to do.  I don’t suppose he is referring to the “scientists” at Merck who repeatedly employed flawed methods and then published them.

“Approximately 250 documents were relevant to our review. For the publication of clinical trials, documents were found describing Merck employees working either independently or in collaboration with medical publishing companies to prepare manuscripts and subsequently recruiting external, academically affiliated investigators to be authors. Recruited authors were frequently placed in the first and second positions of the authorship list. For the publication of scientific review papers, documents were found describing Merck marketing employees developing plans for manuscripts, contracting with medical publishing companies to ghostwrite manuscripts, and recruiting external, academically affiliated investigators to be authors. Recruited authors were commonly the sole author on the manuscript and offered honoraria for their participation…

This case-study review of industry documents demonstrates that clinical trial manuscripts related to rofecoxib were authored by sponsor employees but often attributed first authorship to academically affiliated investigators who did not always disclose industry financial support. Review manuscripts were often prepared by unacknowledged authors and subsequently attributed authorship to academically affiliated investigators who often did not disclose industry financial support.”

I see people doing the best they can with the tools at hand.  Mostly honest people (I say mostly not knowing what their IRS forms show), working within many limitations, to advance medical understanding.  They do not deserve quotes applied to their work or the title of pseudoscience.  Not everyone is able to achieve the peerless, perfect knowledge bestowed on  a Professor of Medicine and Merck Vice President.

We need “honest” corporations.  Ironic from a former Merck executive;  casting the first stone and all that. I do not need quotes to show my snotty superiority.  We need better regulation of “unsafe and unproven products.”  Like Merck’s Vioxx?.   Ohhh, snap. The Merck shots are cheap shots,  I know. But they made me laugh, and above all I like to make me laugh. It is all about me.

Like the Health Ranger, I see someone with a bee in their bonnet, selectively and histrionically arguing in circles, hoping that if the same cognitive errors and circular reasoning are repeated they will be believed as fact.  I am not enthusiastic about the conclusions and arguments used, being significantly more flawed than the research he rails against. It is not far in style and content from being in the Natural News.  Science, at least,  is ultimately self correcting.  This article, probably not so much.

Of course, I am nobody from nowhere. Not a professor or scientist or a vice president.  I am a clinician and citizen who has to trust his sources of information.  I was raised to judge a man by the company he keeps.  When the NEJM published garbage on acupuncture, my trust in the Journal fell a notch.  The Lancet has always had a reputation of being flaky, it is part of the British charm and I have never held it against them; I just factor it in when reading a paper.  The Annals of Internal Medicine has been untrustworthy for years. Clinical Infectious Diseases remains unsullied.  Now the Skeptical Enquirer (sic) has slipped a bit as well.  7 was primarily deadly for my confidence in its editors. Oh well, at least I can still trust the material published by DC.

Rationalizations

(1)  Crislip et. al.  I said it here before, so it must be right.

(2) And if you try sometime you find/You get what you need.

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Supreme Court Saves Nation’s Immunization Program

The Supreme Court of the United States made a ruling the other day that has profound implications for the health of millions of children. Since October 12, 2010, The Court has been quietly deliberating the case of Bruesewitz v. Wyeth, inc. The case centers on Russell and Robalee Bruesewitz’s allegation that their 18 year old daughter, Hannah, was irreversibly injured by a DTP vaccine she received when she was 6 months old. What is important about this case is not the allegation itself (I will discuss its merits, or lack thereof, in a moment), but the ramifications the ruling has for the future of childhood immunization in this country. The Supreme Court’s ruling against the Bruesewitz’s and in favor of the U.S. vaccination program was the right one, and safeguards our children from the irrationality of the anti-vaccine movement. Some important background is necessary here to understand why this is so.

Prior to the development of effective vaccines, diphtheria, tetanus, and pertussis were common diseases, terrifyingly familiar to all parents. Death records from Massachusetts during the latter half of the 1800’s indicate that diphtheria caused 3-10% of all deaths. In the first part of the 20th century, these dreaded organisms still caused illness in hundreds of thousands of people each year in the United States. These are devastating diseases which, if not resulting in death, often produced severe and permanent damage to those afflicted. In the 1920’s, vaccines against each of these scourges were finally developed, and in the mid 1940’s the combined DTP vaccine was introduced. The vaccines were so effective that cases of these deadly infections were practically eliminated. Today, few parents know the terror once routinely wrought by these pathogens.


Despite the effectiveness of the original DTP vaccine, it did frequently produce reactions in the children who received it. Fever (and fever seizures in those genetically predisposed), irritability, and sometimes frightening hyporesponsive episodes were seen. The side effects of the DTP vaccine were attributable to its pertussis component. The vaccine was produced using the whole pertussis organism in an attenuated state so that it could not cause the disease itself. Utilizing the whole organism, however, exposed the child to a large number of proteins, some of which were responsible for the fever and other side effects the vaccine produced. These deleterious reactions certainly paled in comparison to the dangers of the diseases themselves. Nonetheless, as the diseases prevented by the vaccine disappeared, parents began to take more seriously these annoying and often frightening reactions. Because some of these reactions were so frightening, including febrile, or fever seizures, many people began to believe the vaccine was responsible for more serious side effects, including brain damage and even death. As outlined in an earlier SBM post, the side effects of the original “whole cell” DTP vaccine (DTwP) were not, however, life-threatening and produced no long-term problems in those receiving it. In 2006, a retrospective case-control cohort study of more than 2 million children concluded there was no increased risk of developing encephalopathy following administration of the original DTwP vaccine1. But when encephalopathy or a new onset seizure disorder occurred in temporal association with the receipt of the DTwP vaccine, causation was often ascribed to it.

It was the escalating, yet unfounded fears surrounding the original DTwP vaccine that led to the emergence of the modern-day anti-vaccine movement in this country. In 1982, the shockumentary “Vaccine Roulette” appeared on a local NBC TV affiliate. It purported to show the child victims of the DTwP vaccine, housed in a dark and dismal chronic care facility, damaged by doctors and forgotten by society. The show awakened the nation to the alleged dangers of this vaccine, and the fear quickly spread like wild fire. Fear of the DTwP vaccine and of vaccines in general enveloped the nation, and lawsuits against vaccine manufacturers over a host of alleged reactions rained down upon the courts. This torrent of legal action threatened the future of the vaccination program in this country. While in 1979 there was only 1 DTP-related lawsuit, by 1986 there were 255, with a total of over $3 billion sought by claimants. This clearly was not sustainable for the vaccine industry, and in fact manufacturers went out of business. In 1967 there were 26 US manufacturers of vaccines. By 1980 this number had dropped to 15, and by 1986 there were only 3 companies still making vaccines in this country. Vaccine prices skyrocketed, and manufacturers found it difficult to obtain liability insurance.

With the future of our vaccination program at risk, Congress passed the National Childhood Vaccine Injury Act (NCVIA) in 1986 and established the National Vaccine Injury Compensation Program (NVICP). Funded by an excise tax on each vaccine component administered, the NVICP was designed as a no-fault, expedited process to compensate families who claim their child has suffered a vaccine-related injury. No proof of causation is necessary to be eligible for compensation. A child simply has to have a documented problem that occurred in the specified time frame following a vaccination, and that problem has to be on the table of problems recognized by the NVICP as potential vaccine adverse events. Cases are reviewed by a Special Master, who makes a determination based on minimal evidence, with the primary goal being a prompt resolution. If a claim is successful, compensation is granted for medical, rehabilitation, counseling, special education, and vocational training expenses, and $250,000 when the claimed outcome is death. Patients may accept the ruling or take their case through the usual tort process by suing the manufacturer. However, a major aspect of this process, and the one which saved the vaccine program from total collapse in the 1980s, is the significant liability protection granted to the vaccine manufacturers. Before suing a vaccine manufacturer, a claimant must first go through the NVICP process, or the so called “Vaccine Court”. But if a parent rejects an NVICP ruling and decides to sue in court, the vaccine manufacturer is immune from liability, assuming they have complied with all regulatory requirements and have not committed outright fraud or other crimes in the manufacture of the vaccine. Most importantly, the NCVIA stipulates that,

No vaccine manufacturer shall be liable in a civil action for damages arising from a vaccine-related injury or death associated with the administration of a vaccine after October 1, 1988, if the injury or death resulted from side effects that were unavoidable even though the vaccine was properly prepared and was accompanied by proper directions and warnings.

Setting aside for the moment the fact that there is no evidence the DTwP vaccine can cause any of the adverse events listed in the original table, the statement above gets to the heart of the Supreme Court’s ruling. Specifically, the ruling centered around the words “unavoidable” and “even though” in the above excerpt. In April 1992, when Hannah Bruesewitz received the vaccine that allegedly injured her, her diagnosis “residual seizure disorder” had just been removed from the NVICP vaccine injury table. Her claim was denied by the Special Master, although she was still awarded $127,000 for legal fees. The family rejected this decision, and instead brought the case against Wyeth (which had acquired Lederle) to Pennsylvania state court. The Breusewitz’s asserted that the vaccine was defective, that the manufacturer knew it could cause harm, and that they had knowledge of a safer vaccine but failed to develop or use it. The Pennsylvania court rejected this claim, citing that such design-defect claims were preempted by the Vaccine Act. The case then ended up in The Supreme Court which finally, this past Tuesday, upheld the intent of the NVICP to protect the vaccine supply by preventing lawsuits based on design-defect claims. The Supreme Court’s opinion, delivered by Justice Antonin Scalia, interpreted the word “unavoidable” as written in the Vaccine Act, to apply to the specific vaccine administered to a claimant, and not to other hypothetical, alternate vaccines that might or might not be more or less safe and effectve. Justice Scalia argued that the use of the words “even though” in the excerpt above implies that the unavoidability referred to in the Act applies to the specific vaccine that was administered, and not to some other potential vaccine. In other words, the Breusewitz’s claim that their daughter’s condition was avoidable because a safer alternative vaccine could have been given was ruled to be a misreading of the Vaccine Act’s intent. The Opinion asserts that exclusion of design defects from the Act was intentional. The fact that the NCVIA and the FDA spell out in detail the manufacturing method and the warnings and directions that must be provided by a vaccine manufacturer, while making no mention of vaccine design requirements is a clear indication that such an exclusion was intentional. It was the Court’s opinion that any other reading of The Act would require very difficult determinations of relative vaccine safety and efficacy. Justice Scalia points out that these determinations are rightly the domain of the FDA and National Vaccine Program experts, and not the courts.

The Supreme Court’s ruling in this case was a huge victory for the health and well-being of our Nation’s children, and the Court should be applauded for its good sense and clarity on the issue. Undoubtedly, those who eschew rationality and oppose vaccines will find fault with the ruling, and cling to the mantra of conspiracy and collusion. Sadly, the fear and misinformation spawned from the DTwP-era lives on today. As technology improved, a version of the vaccine containing an “acellular” pertussis component did eventually become feasible. The DTaP vaccine, as it was called, was introduced in 1996 and nearly eliminated reactions to the vaccine. But the damage was done. As the media and a splintered cadre of like-minded conspiracy and anti-establishment groups took up arms against vaccines in general, a new anti-vaccinationism took hold. We’ve since been through the Wakefield crisis, the thimerosal debacle, and many other dangerous vaccine myths, nourished along by the media and the anti-vaccine cartel. The consequence of this spreading fear is an increasing distrust of vaccines, and the development of pockets of underimmunization around the country. We are now seeing outbreaks of completely preventable childhood disease, and children have died as a result. This was an important ruling, but we have a long way to go before we can bring rationality to the public discussion and understanding of vaccines in this country.

1Pediatr Infect Dis J. 2006;25:768-773

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Dr. Oz, you’re not helping diabetics

Dr. Mehmet Oz is one of America’s most influential doctors.  Just ask him.  He has a TV show and everything.  And in the past, much of his advice had been practical and mundane, the same advice you might hear from your own (perhaps less charismatic) physician.  But lately, he’s been giving out frankly bizarre medical opinions.  Not all of Oz’s recommendations are over-the-top strange, but even some of his less-bizarre stuff is hyperbolic to the point of being—in my opinion—deceptive.  Let’s explore one example close to my heart, diabetes.  As an internist, one of my most important tasks is the prevention and treatment of diabetes.  I know something about it.  As a heart surgeon, Dr. Oz deals with one of the most serious complications of diabetes, coronary heard disease, so he must know a bit about it as well.

So I was a bit surprised to learn from his website that I’ve  been going after diabetes the wrong way.  Unknown to me is the “prevention powerhouse” of coffee and vinegar.  He recommends heavy consumption of these miracle foods to prevent diabetes and to help the liver and cholesterol, whatever that means.  Reading this, two questions come to mind (a few more, really, but two that we will focus on): is this plausible, and is this true?

There are a few epidemiologic studies that support the idea that coffee consumption is in some way associated with diabetes risk.  (For a bit of background on different types of studies, see here and here.)  There are a few bits of basic science that could explain this relationship, if it turns out to be causal.  But these large studies simply show relationships.  They have found that people who drink more coffee (regular or decaf) were less likely to develop diabetes during the study period.  Most of these studies tried to control for confounding variables (for example, caloric intake) but none of these truly shows cause and effects.

The two biggest potential problems here are recall bias and confounding variables.  Do people reliably report the data we ask them to?  We aren’t directly measuring it, so this is critical.  Do coffee drinkers simply have smaller appetites?  Or other habits that reduce the risk of diabetes?  These studies give us an interesting starting point.  The next step to look for actual cause and effect would be a randomized controlled trial (which obviously could not be double-blind), that takes non-diabetics and randomly has half drink coffee and half abstain, and follows them over a several year period.   The idea that coffee can affect blood glucose metabolism and the development of diabetes is not nuts, but the available data don’t allow us to go any further than that.

The data support the plausibility of the question of coffee and diabetes, but not the truth of the statement.   But let’s pretend it is true.  The next questions are are how much risk reduction is there, and at what cost?

We know that some drugs and proper diet and regular exercise reduce the risk of diabetes.  How do these interventions compare with coffee or vinegar?  Is one of them 100 times more potent than the other?  One thousand?  One fifth?  And what are the hazards of caffeine consumption?  Not that great in general (and lessened by drinking decaf), but even small amounts of caffeine can cause significant acid reflux, sleep problems, heart palpitations, headaches.

What Dr. Oz is suggesting is using an unproven drug (coffee or dilute acetic acid) that isn’t needed.  We have safe, effective ways to prevent diabetes.  Our biggest failure is in providing people with the education, health care, and other tools to follow through.

References

Salazar-Martinez E, Willett WC, Ascherio A, Manson JE, Leitzmann MF, Stampfer MJ, & Hu FB (2004). Coffee consumption and risk for type 2 diabetes mellitus. Annals of internal medicine, 140 (1), 1-8 PMID: 14706966

VANDAM, R., & FESKENS, E. (2002). Coffee consumption and risk of type 2 diabetes mellitus The Lancet, 360 (9344), 1477-1478 DOI: 10.1016/S0140-6736(02)11436-X

Tuomilehto, J. (2004). Coffee Consumption and Risk of Type 2 Diabetes Mellitus Among Middle-aged Finnish Men and Women JAMA: The Journal of the American Medical Association, 291 (10), 1213-1219 DOI: 10.1001/jama.291.10.1213

van Dam, R. (2006). Coffee, Caffeine, and Risk of Type 2 Diabetes: A prospective cohort study in younger and middle-aged U.S. women Diabetes Care, 29 (2), 398-403 DOI:10.2337/diacare.29.02.06.dc05-1512

Pereira MA, Parker ED, & Folsom AR (2006). Coffee consumption and risk of type 2 diabetes mellitus: an 11-year prospective study of 28 812 postmenopausal women. Archives of internal medicine, 166 (12), 1311-6 PMID: 16801515

Dam, R., Dekker, J., Nijpels, G., Stehouwer, C., Bouter, L., & Heine, R. (2004). Coffee consumption and incidence of impaired fasting glucose, impaired glucose tolerance, and type 2 diabetes: the Hoorn Study Diabetologia, 47 (12), 2152-2159 DOI: 10.1007/s00125-004-1573-6


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The Hidden Cancer Cure

Last week David Gorski wrote a excellent post about why we have not yet cured cancer. It turns out, cancer is a category of many individual diseases that are very challenging to treat. We have made steady progress, and many people with cancer can now be cured – but we have not discovered the one cure for all cancer. I personally am not convinced that we will discover a single cure for all cancer, at least not with any extrapolation of current technology. But if we continue to make progress as we are cancer will become an increasingly treatable and even curable type of disease.

This topic also brings up a meme that has been around for a long time – the notion that scientists have already cured cancer but the cure is being suppressed by the powers that be, to protect cancer as a source of income. In the comments to David’s article, Zuvrick writes:

So we can find a cure. It has probably happened multiple times. But nobody wants to cure cancer. Too many researchers earn a living seeking a cure by remaining inside a narrow, restricted channel of dogma. Their institutions get grant money and survive from the funding. Big Pharma makes big bucks selling chemotherapy drugs, surgeons remove tumors and various radiation devices employ radiologists and firms making these machines. MRI and CT scans would not be needed for cancer if Rife technology were available today.

I have heard or read some version of this claim since before I entered medical school.  Superficially it may sound like profound wisdom (cynicism is a cheap way to sound wise) – but the idea collapses under the slightest bit of logical scrutiny.

First, as David thoroughly pointed out, the claim is implausible. Cancer is a complex set of diseases that defy sincere attempts at a cure. Those who promote the notion of the hidden cure often simultaneously promote wacky pseudoscientific treatments that they claim work – and Zuvrick is no exception. He believes that Royal Rife cured cancer 70 years ago. Rife was essentially a copycat of Albert Abrams who promoted his radio frequency devices. The concept is to use radio waves to alter the vibrations of cells in the body. This is pure nonsense. Here is a quick summary from Stephen Barret:

One of Abrams’s many imitators was Royal Raymond Rife (1888-1971), an American who claimed that cancer was caused by bacteria. During the 1920s, he claimed to have developed a powerful microscope that could detect living microbes by the color of auras emitted by their vibratory rates. His Rife Frequency Generator allegedly generates radio waves with precisely the same frequency, causing the offending bacteria to shatter in the same manner as a crystal glass breaks in response to the voice of an opera singer. The American Cancer Society has pointed out that although sound waves can produce vibrations that break glass, radio waves at the power level emitted a Rife generator do not have sufficient energy to destroy bacteria.

But let’s explore the logic of the hidden cure a bit further. Given that cancer is such a complex set of diseases, there is a vast and evolving science exploring the causes and behavior of cancers. This research takes place in numerous labs around the world. A cure for cancer would likely emerge from a collaboration among many researchers, in different labs and institutions, and even in different countries. Even if one lab made a significant breakthrough, it would be the capstone on top of a large body of research that was available to the entire community (and in fact the public). It would be impossible to keep other researchers from replicating the final steps that lead to a cure.

Often the hidden cure conspiracy idea is framed around the claim that a pharmaceutical company would hide such a cure to protect their profits from other cancer drugs. This claim fails not only for the reason above but for a separate practical reason. It would take about 100 millions dollars of research (if not more) to prove that a drug was actually a cure for one type of cancer (let alone all types of cancer). Why would a pharmaceutical company spend that kind of research money on a drug they know they have no intention of marketing, just so that they can suppress it? Also – where would they do such research? How could they get past all the regulatory hurdles to perform human research without revealing what they are doing?

Often those who claim that “they” are hiding a cure for cancer have only a vague notion of who “they” are. They generally have an image of the “medical establishment” as monolithic, but nothing could be further from the truth. The medical establishment is composed of universities, professional organizations, journals, regulatory agencies, researchers, funding agencies, and countless individuals – all with differing incentives and perspectives. The idea that they would all be in on a massive conspiracy to hide perhaps the greatest cure known to mankind is beyond absurd.

For those who think the profit motive is sufficient explanation, not all of the people and institutions named are for profit. And what about countries with socialized medicine who could dramatically reduce their health care costs if a cancer cure were found? Is Canada, the UK, all of the European Union, in fact, in on the conspiracy to protect American cancer treatment profits? It’s as if hidden cure conspiracy theorists forget that there are other countries in the world.

Hidden cancer cure conspiracies also are premised on a simplistic notion of how medicine and medical research progresses. The practice of medicine is constantly evolving in a process of creative destruction. New technologies render older ones obsolete. Resources ebb and flow to diseases as they emerge and are reduced or cured. There used to be entire hospitals dedicated to the chronic treatment of tuberculosis – and now, after antibiotics, those hospitals have been repurposed. Researchers, specialists, hospital space, and other resources shift over time to where they are needed.

If a cure for cancer were discovered it would not be as disruptive as is claimed by the conspiracy theorists. It would take years if not decades of research to explore how effective the treatment was for every type, grade, and stage of cancer. We could not assume that it cured all cancer even if it cured one type. And what about people who did not respond to the treatment, or could not tolerate it for some reason? (One might assume a 100% effective and side effect free cure for all cancer, but this gets progressively more unlikely.) Further, any real breakthrough cure would likely tell us something profound about the nature of cancer itself, and this would spawn entire research programs.

Research funding and researchers themselves would shift their focus where it was needed. Some might shift their skills to other diseases entirely, and perhaps fewer doctors and researchers would go into cancer research if a cure were already found. As with any other significant medical advance, the medical infrastructure would adapt.

Conspiracy theorists also tend to ignore the huge incentive to find a cure. For the researchers involved, it would mean fame, fortune, Nobel prizes and an enduring legacy within the halls of medicine. It is safe to say that it is every cancer researcher’s dream to be part of the team that finds the cure for cancer (or at least as big a breakthrough as is plausible).

The institution would also gain fame and prestige, which translates into more donations, better applicants, and also part ownership of any patents. A company that discovered the cure for cancer would make billions, even if it meant it would make existing drugs obsolete. Patents on drugs are finite, so companies are always looking for new drugs anyway. And imagine the public relations boon for the company that cured cancer – their name would forever be “Pharmaceutical Company – We Cured Cancer!” Even if the new treatment could not be patented, it would still be an enduring profit stream for the original company to market it – it would become their Tylenol, only bigger.

And of course the health care systems around the world would rejoice at the potential reduction in health care costs, which are now threatening to cripple the system. Doctors, hospitals, researchers – pretty much everyone, is making less money than they were a couple decades ago because of rising health care costs. The system is now being threatened by further cuts and restrictions to tame rising costs. A significant reduction in overall costs, by curing an expensive disease, would ease the pressure on the entire system, and free up resources for other diseases.

Finally, there is the human element. A hidden cure would require individual people to know that a cure for cancer is available but to deny this cure to dying patients in order to protect their or someone else’s profit. There may be people in the world who are that callous and evil, but think of all the people who would have to be that evil, over years or decades, to maintain a hidden cure. These are people who also have loved-ones who are likely to get cancer at some point in their lives, and who themselves are at risk for cancer. I would not casually assume that the medical establishment is full with such cartoonish maniacal villains.

Conclusion

The grand conspiracy of the hidden cancer cure is a meme that I wish would go away, but for some reason persists. It is like an urban legend – it appeals to some ill-formed fear or anxiety produced by the complexity of modern society. It gives a focus to these anxieties, and gives the illusion of control. No one wants to feel as if they are being deceived, and so assuming there is a conspiracy feels like a good way to avoid being duped. But ironically it is the conspiracy theorists who are being duped, or who are doing the deceiving.

The notion of a hidden cure is also dependent on seeing institutions with which one is not personally familiar as faceless and monolithic organizations, comprised of obedient drones. But these institutions are made of people – ordinary people with flaws and feelings and families just like everyone else.

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Diet Supplements or Nutritional Supplements: A Ruse by Any Other Name is Still a Ruse

I was surprised to get this e-mail from a reader:

Surely, Dr. Hall, the public mania for nutritional supplements is baseless. All the alleged nutrients in supplements are contained in the food we eat. And what governmental agency has oversight responsibility regarding the production of these so-call nutritional supplements? Even if one believes that such pills have value, how can the consumer be assured that the product actually contains what the label signifies? I have yet to find a comment on this subject on your otherwise informative website.

My co-bloggers and I have addressed these issues repeatedly. Peter Lipson covered DSHEA (The Diet Supplement Health and Education Act) nicely. It’s all been said before, but perhaps it needs to be said again; and maybe by writing this post I can make it easier for new readers to find the information.

Food, Medicine, or Something In Between?

The FDA regulates foods and has been instrumental in improving the safety of our food supply. It regulates prescription and over-the-counter medications, requiring evidence of effectiveness and safety before marketing. Surveys have shown that most people falsely assume these protections extend to everything on the shelves including diet supplements, but they don’t.

Under the 1994 Diet Supplement Health and Education Act (DSHEA), a variety of products such as vitamins, minerals, herbs and botanicals, amino acids, enzymes, organ tissues, and hormones can evade the usual controls if they are sold as diet supplements. Under the DSHEA, the manufacturer doesn’t have to prove to the FDA that a product is safe and effective; it is up to the FDA to prove that it isn’t safe, and until recently there was no systematic method of reporting adverse effects (required reporting is still limited to serious effects like death).

So far the FDA has only managed to ban one substance, ephedra, and it took the death of a prominent sports figure and considerable skirmishing with the courts to accomplish that. Independent lab tests of diet supplements have found a high rate of contamination (with things like heavy metals and prescription drugs) and dosages wildly varying from the label. A striking example was Gary Null’s recent poisoning with vitamin D from one of his own products which contained 1000 times the intended amount.

The FDA has issued rules on good manufacturing practices, but standardization is not required and it remains to be seen whether the new rules will effectively improve product quality.

Rational Supplementation

It makes sense to supplement the diet with essential nutrients if the food in the diet is deficient in those nutrients or if the patient is not able to absorb nutrients normally. There are specific situations where that applies, such as providing folic acid to women to prevent birth defects or providing vitamins and minerals to bariatric surgery patients whose digestive functions are compromised. There are FDA-approved sources of nutrients for indications like these.

It is commonly claimed that “food is medicine” but there are very few situations where the evidence shows that specific nutrients are useful as medicine. Niacin for treatment of hyperlipidemia comes to mind.

The following (taken from a supplement website) are not rational reasons for supplements and are not supported by evidence:

  • We can’t get all the nutrients we need from food.
  • Supplements boost the immune system.
  • Supplements help get rid of toxins.
  • Even if you feel well, your health will only be optimal if you take supplements.

The Big Lie

DSHEA is based on a fiction. It prohibits claims that diet supplements prevent or treat any disease and only allows structure/function claims alleging that they “support” health in various ways. DSHEA is a stealth weapon that allows the sale of unproven medicines just as long as you pretend they are not medicines. It allows the sale of products that are not intended to prevent or treat disease so people can buy them with the intent of preventing or treating diseases. People don’t buy St. John’s wort to correct a deficiency of SJW in their diet or in their bloodstream; they don’t buy it to “support” brain function; they buy it to treat depression. People don’t buy glucosamine to “support joint health” but to treat their arthritis pain. People don’t buy saw palmetto to “support prostate health” or correct a saw palmetto deficiency, but to relieve symptoms of benign prostatic hyperplasia or to prevent prostate cancer. The FDA’s “Quack Miranda warnings” are routinely ignored even by those few who actually read the fine print.

DHEA (dehydroepiandrosterone) is a hormone that was once approved by the FDA as a prescription drug; then it was taken off the market because the FDA decided it was unsafe. Now it’s available as a diet supplement without a prescription. When the FDA later saw evidence that DHEA was effective for a rare adrenal condition, they re-approved it with orphan drug status. Now the people with that rare disease, and only those with that disease, can get a prescription for the drug, while their perfect healthy neighbor can buy it at any health food store. Does that make any sense at all?

Advocates of CAM complain about “Big Pharma.” What about “Big Supplement” (“Big Suppla”?)? The diet supplement industry is a very profitable multibillion dollar industry that was able to lobby effectively to get the DSHEA passed. BP generates huge profits but it also saves lives. BS (double entendre intentional) has generated huge profits for its investors but hasn’t produced any measurable health benefits to those who use its products.

Yes, Some of Them Work

Some of them do work, but do they work better than prescription alternatives or FDA-approved over-the-counter products with more trustworthy, regulated sources? Are they as safe? They are admittedly cheaper and more convenient than prescription drugs, but is there any other reason to prefer them? One argument is that they are safer, but it isn’t safe to assume that—not until proper large-scale studies are done. Just think of all the prescription drugs that appeared to be safe until careful post-marketing surveillance revealed unexpected problems.

What are the chances that a diet supplement picked at random will turn out to be safe and effective when proper studies are done? Not high. Promising drugs that pharmaceutical companies submit to clinical trials only have about a 5% chance of making it to the market. A few years ago, I went through all the entries in the Natural Medicines Comprehensive Database and tabulated their effectiveness ratings.  Only 5% were rated “effective” and almost all of those were vitamins, minerals, and medicines that are also available as prescription or over-the-counter products approved by the FDA.

There are many products on the diet supplement market that combine multiple ingredients in a kitchen-sink mixture that has no rationale and has not undergone any testing. Maybe the ingredients act synergistically; maybe they interfere with each other. How would we know? Taking such products is a crap-shoot and is like being a guinea pig in an uncontrolled experiment. Many supplement mixtures are sold by multilevel marketing programs and improve health only to the extent that they improve the health of the promoters’ wallets.

Supplements can also harm. Kava has been associated with fatal liver damage. An herbal weight-loss remedy caused kidney failure in dozens of women in Belgium. One fifth of Ayurvedic remedies have unacceptable levels of arsenic, lead and mercury. Most trials of antioxidant vitamin supplements have shown that patients taking them either do no better or do worse than those taking placebos. Vitamin A supplementation increases the risk of fractures in post-menopausal women.

Conclusions

  • As my correspondent put it, “the public mania for nutritional supplements is baseless.”
  • In general, all our nutritional needs can be supplied by an adequate diet.
  • Supplements are beneficial for a few specific evidence-based indications; otherwise, they offer no benefits and may even be risky.
  • Diet supplements are not medicines, but are being used as medicines.
  • DSHEA should be repealed.

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Naturopathy and science

Naturopathy has been a recurrent topic on this blog. The reasons should be obvious. Although homeopathy is the one woo to rule them all in the U.K. and much of Europe, here in the U.S. homeopathy is not nearly as big a deal. Arguably, some flavor of naturopathy is the second most prevalent “alternative medical system” here, after chiropractic of course, and perhaps duking it out with traditional Chinese medicine, although naturopathy does embrace TCM as part of the armamentarium of dubious medical systems that it uses. In any case, some sixteen states and five Canadian provinces license naturopaths in some form, and in some states naturopaths are fighting for–and in some cases winning–the power to prescribe certain real pharmaceutical medications and order real medical tests. For instance, in California, naturopaths can order laboratory tests and X-rays, which reminds me of a conversation I had with a mammographer from California at TAM last summer. He told me a tale of the dilemma he had when naturopaths and other “alt-med” practitioners ordered tests at his facilities. Specifically, the dilemma came about because he doubted that the naturopath knew what to do with the results. Meanwhile, in Oregon, naturopaths can prescribe certain types of pharmaceutical drugs (as opposed to the usual supplements, herbs, or homeopathic remedies they normally prescribe). Meanwhile, moves are under way to expand the prescribing privileges of naturopaths in Canada, as Ontario (which is, remember, just across the Detroit River, less than two and a half miles as the crow flies from my cancer center—a truly frightening thought to me).

Unfortunately, naturopathy is a hodge-podge of mostly unscientific treatment modalities based on vitalism and other prescientific notions of disease. As a result, typical naturopaths are more than happy in essence to “pick one from column A and one from column B” when it comes to pseudoscience, mixing and matching treatments including traditional Chinese medicine, homeopathy, herbalism, Ayurvedic medicine, applied kinesiology, anthroposophical medicine, reflexology, craniosacral therapy, Bowen Technique, and pretty much any other form of unscientific or prescientific medicine that you can imagine. Despite their affinity for non-science-based medical systems, naturopaths crave the imprimatur of science. As a result, they desperately try to represent what they do as being science-based, and they’ve even set up research institutes, much like the departments, divisions, and institutes devoted to “complementary and alternative medicine” (CAM) that have cropped up on the campuses of legitimate medical schools and academic medical centers like so many weeds poking through the cracks in the edifice of science-based medicine. Naturopaths also really, really don’t like it when they encounter criticism that their “discipline” is not science-based. Indeed, the president of the American Association of Naturopathic Physicians, Carl Hangee-Bauer, ND, LAc (he’s an acupuncturist, too!), wrote a revealing post on the official AANP blog entitled Science and Naturopathic Medicine.

Science. You keep using that word. I do not think it means what you think it means.

The President of the AANP takes umbrage

Apparently criticisms of naturopathy as unscientific have started to penetrate even the reality distortion field of the AANP, because Carl Hangee-Bauer has noticed them, and he’s not happy. Oh, no, he’s not happy at all. First, he begins by enumerating his bona fides as a science-loving geek, in order to prove to readers just how dedicated he is to science. These bona fides include a love of marine biology and a mention of how much he originally wanted to become a marine biologist. (Hey, I loved The Undersea World of Jacques Cousteau when I was a kid, too, you know.) Hangee-Bauer then discusses how he “took every course in biology, chemistry, physics, etc.” that he could in school and in college majored in biology, with dual minors in physics and chemistry. Then, somehow, while he was in the U.S. Army, he developed an interest in medicine as a Medical Service Corps officer, and that led him to naturopathy. Personally, this story leads me to ask: What happened to Hangee-Bauer? How could someone who was so interested in science go so far off the rails? Whatever happened, Hangee-Bauer’s narrative leads up to this lament about nasty bloggers like us:

I tell you this to let you know that I am no stranger to science. I still find it fascinating and appreciate the many ways it helps us understand the workings of nature and the world, helping us separate what appears to be the truth of things from reality. Studying naturopathic medicine, and especially acupuncture, presented me with many challenges, and I learned along the way that our medicine, as well as all other systems of medicine, are really a combination of science and art. When we work with our patients, we draw from both in order to stimulate the vis and provide well-rounded care to our patients.

Thus it has become an increasing concern to me when I read articles and blogs on the Internet blasting naturopathic medicine for being “unscientific.” These frequently polemic articles, while professing to come from scientific logic, to my eye are biased misrepresentations of the truth. They often lambast our profession and philosophy as unscientific, yet I have yet to see any one of them provide a critical analysis of research done by naturopathic physicians and researchers. It is sad that science can be used in these political ways.

It’s very hard for me not to point out that in Hangee-Bauer’s case science has apparently not been particularly successful in helping him to separate “what appears to be the truth of things from reality.” He is, after all, an acupuncturist and naturopath. It’s also apparent from the website of Hangee-Bauer’s practice, which treats all manner of ailments, as listed here on this page. Out of curiosity, I started clicking around on the conditions for which Hangee-Bauer provided links. For example, naturopaths frequently claim to be able to treat allergies (whether you have them or not!); so I gravitated to the page on allergies first. After a description about how “allopathic” medicine treats allergies by blocking histamine, having the patient avoid the allergen, and desensitization, we then see this passage:

Let’s look briefly at an example of TCM treatment for allergies. John presented with acute allergy symptoms of one-month’s duration which included sneezing, runny nose with lots of watery phlegm, extreme fatigue and occasional loose stools. After taking his history and doing an examination, his acupuncturist assessed his condition according to TCM as Wei Qi Deficiency resulting from a weakness of the Lung and Spleen. In addition to general recommendations for his condition, John was given Minor Blue Dragon formula which has decongestant properties for those with copious clear phlegm, as well as Astra 8, an herbal formula designed to tonify the Lung and Spleen Qi. He was also told to minimize or avoid dairy products and excessively sweet or spicy foods. As John’s condition improved, he and his acupuncturist developed a plan to strengthen his immune system in preparation for next year’s allergy season. This plan included replacing coffee with green tea, which is rich in catechins which exert anti-allergy effects, as well as taking quercetin, a bioflavonoid which has been shown to stabilize mast cells thus slowing the release of histamine and other chemicals related to allergic symptoms.

One wonders what “science” supports the vitalistic prescientific notion that allergies are due to “Wei Qi Deficiency” or detonification of “Lung and Spleen Qi” requiring “tonifying” (whatever that is). In all fairness, however, I will give Hangee-Bauer credit for one thing: on the same page, he actually states that applied kinesiology “may be of no value in testing for an allergy.” Imagine my relief, except that he should have said “is of no value whatsoever” for diagnosing allergies. That relief is also tempered by Hangee-Bauer’s suggesting that “strengthening the immune system” in an allergy would be a good thing in preparation for next year’s allergy season. Given that allergies are due to an excessive histamine response to a particular kind of antigen, “strengthening the immune system” might well make it worse. Of course, “strengthening the immune system” is a meaningless phrase, as we’ve pointed out many times before, but apparently, for all his love of science, Hangee-Bauer hasn’t figured that out.

But let’s move on. Elsewhere on the web page, Hangee-Bauer’s practice recommends breast thermography as an adjunct to mammography. I was shocked. No, I wasn’t shocked that he recommended thermography, as thermography is very popular among the “alternative medicine” set. Rather I was shocked and relieved that Hangee-Bauer apparently still recommends mammography. Even so, his website parrots scientifically unsupported claims common among CAM practitioners that thermography can find cancer ten years before breast cancer is identified by other methods (claims of the sort that I wrote about recently), and that it should be done at least once a year to screen for breast cancer. Amusingly, there was then this claim:

Finally, licensed acupuncturists can use thermography to detect slight temperature variations which reflect disturbances in the flow of Qi and blood, which can result in pain and dysfunction. Concrete evidence that acupuncture therapy actually restores blood flow and normalizes disrupted temperature patterns has been proven by thermographic studies.

I would so love to see the scientific studies demonstrating that thermography can detect disturbances in the flow of qi and how acupuncture restores it and blood flow. Surely there must be such studies; Hangee-Bauer, after all, claims that he is all about science and just bristles with outrage at the commentary of bloggers who correctly castigate much of naturopathy for being unscientific. What he does is based on science, isn’t it? So show it! What is the science demonstrating that thermography can detect disturbances in the flow of qi?

These are but a couple of examples that stood out of unproven treatments modalities and scientifically–shall we say?–”debatable” statements that I found on Carl Hangee-Bauer’s web page. I encourage SBM readers to check out other examples, such as the pages on tips for lung health (complete with recommendations for regular acupuncture sessions to “increase your resistance to both viruses and allergens”), treating springtime allergies, naturopathic “detoxification” (it’s always about those evil “toxins,” isn’t it?), and, of course, treatment of heavy metal poisoning. You know, whenever I see the term “heavy metal poisoning,” I can’t help but think of Ozzy Osbourne being the way he is as a result of 40 years of heavy metal poisoning. Oh, wait. It was the alcohol and illicit drugs. And perhaps the heavy metal poisoning.

But I digress.

Perhaps the most bizarre bit of ostensibly “science-based” recommendations to be found on Hangee-Bauer’s website is something called biotherapeutic drainage. I must admit, I had never heard of biotherapeutic drainage before. It turns out that if you Google the term “biotherapeutic drainage,” you’ll find that naturopaths appear to love this particular treatment modality. But what is it? Erika Horowitz, one of Bangee-Bauer’s naturopath partners, describes it thusly:

Detoxification is a big part of naturopathic theory and practice.

I can’t help but interrupt right here and say: No kidding! Too bad these “toxins” are as fantastical as the “science” that naturopaths invoke to support “detoxification.” Horowitz then continues:

Helping the body eliminate toxins safely and effectively can play an important role in improving health and preventing disease. One of the most useful detoxification therapies I use in my practice is the use of UNDA numbers, which are unique combinations of liquid homeopathic formulas founded on the theories of Chinese medicine, homeopathy, and anthroposophy.

Wow. Apparently one woo isn’t enough; so Horowitz combines three. It’s hard for me not to imitate a commercial and say something like, “Biotherapeutic drainage. It’s three, three, three woos in one!” Oh, wait. I just did. In any case, I had never heard of UNDA numbers before, which means I’m definitely learning something while writing this post. Unfortunately what I’m learning is that, even though I’ve been at this several years now, I still haven’t learned all the forms of unscientific medicine and treatments that exist out there. I can still be surprised, and UNDA surprised me. Apparently, it’s this:

UNDA numbers consist of homeopathically prepared low-dose combinations of plants and minerals. The plants possess specific characteristics as to how they affect an organ or organ system; some may have a stimulating effect, whereas others will calm or sedate an organ’s functions. The minerals in the compounds affect how the cells carry out chemical reactions that are necessary to efficiently begin the detoxification process. So the plants guide the remedy to the appropriate organ system (be it digestive, cardiovascular, or respiratory) and the minerals help change the cells’ biochemical function. These remedies help the body detoxify by helping cells work more efficiently and eliminate waste effectively, and by improving how our organs of elimination work.

UNDA numbers treat both acute ailments and chronic disease, addressing symptoms but more importantly concentrating on the reason that the body is manifesting the symptoms in the first place. The remedies are nontoxic, won’t interfere with other allopathic or holistic medications, and have a gentle yet deep-acting effect.

If they’re homeopathic, then I can’t really argue with two out of the three claims made for UNDA numbers. They certainly must be nontoxic and I’m sure they don’t interfere with other medications. Speaking of homeopathy…

One huge reason (among many) that naturopathy can’t be scientific

After this detour to Hangee-Bauer’s website, where we can find ample evidence suggesting that, when the rubber hits the road (or the patients hit the exam rooms) his dedication to science-based medicine is not nearly as strong as he proclaims in his message to the AANP, let’s move on to the single most glaring reason why naturopathy can’t be scientific. It begins when Hangee-Bauer lionizes Joseph Pizzorno, a prominent naturopath on the faculty at Bastyr University, arguably the most influential school of naturopathic medicine in North America, as having spent the past 25 years trying to use science to increase the credibility of naturopathy. Now I’ll give Pizzorno credit. For example, he did recognize as quackery Hulda Clark’s “parasite”-zapping “syncrometer,” which is a lot better than a lot of proponents of “natural medicine” have ever done.

On the other hand…

Pizzorno is currently the President Emeritus of Bastyr University, having been its founding President. Presumably he is still involved in Bastyr University, but until 2000 he was the one running its day-to-day operations right from the very beginning. Hangee-Bauer lauds Pizzorno as being a visionary in terms of trying to make naturopathy science-based, but there’s one problem with that view. Pizzorno’s school embraces homeopathy uncritically. It is, after all, a school of naturopathy, and there is are few forms of woo that naturopathy doesn’t embrace uncritically. Indeed, Bastyr not only embraces homeopathy, but requires its students to study it. Don’t believe me? Let’s start by looking at Bastyr University itself. Here is what the Bastyr University website says about homeopathy. First, it describes homeopathy as “natural” and “nontoxic” (the latter of which is hard to argue with, given that homeopathy is nothing more than water). It goes beyond that, though. Bastyr also offers homeopathy services in its clinics. As you may know, one of my favorite litmus tests for any CAM advocate’s connection with science and reality is how he reacts to homeopathy. If he embraces it, then I know that any protestations of being “science-based” are utter piffle. Bastyr University embraces homeopathy, just as naturopathy in general does.

More pertinent to the question of whether naturopathy embraces homeopathy is this answer to a question in Bastyr’s FAQ about homeopathy:

Q. Do all naturopathic physicians use homeopathy?

A. All naturopathic physicians are trained in the use of homeopathy, but not every naturopathic physician will use it as part of their treatment.

Let’s repeat that: All naturopathic physicians are trained in the use of homeopathy.

All. Of. Them.

Consistent with the answer to this question on the Bastyr University FAQ, there’s a lot of homeopathy being taught and practiced at Bastyr. For example, if you look at its curriculum to become a doctor of naturopathic medicine, you’ll rapidly see that Bastyr requires a full year of homeopathy courses spread out over three classes for a total of 8 credit hours. The same is true for Bastyr’s five year track and its combined degree of Doctor of Naturopathic Medicine (ND)/Master of Science in Acupuncture (MSA) or Acupuncture and Oriental Medicine (MSAOM). In addition, Bastyr has a clinical homeopathy department and homeopathy teaching clinic. The department chair is a naturopath and homeopath named Richard Mann, ND.

But it’s not just Bastyr. Taking on Hangee-Bauer’s claims that the AANP is all about the science, let’s take a look at the AANP itself. If you take a look at the official AANP blog and search it for the word “homeopathy, you’ll rapidly see that the largest “professional” organization of naturopaths not only embraces homeopathy but defends it against attacks. Perhaps the best example of the attitude of the AANP towards homeopathy is found in this post from several months ago entitled Getting over it. In it, a naturopath named Christopher Johnson gets all indignant about recent “1023” campaigns that skeptics and proponents of science-based medicine have been using with some success to demonstrate the utter ridiculousness of homeopathy. (Indeed, one such event occurred recently, on February 5.) In response, Johnson writes:

They named their campaign “10:23″, a reference to Avogadro’s number. This number is significant to chemists in that it supposedly sets the limit below which no material elements are likely to be present in a given dilution. Homeopathic remedies are made with solutions far more dilute than Avogadro’s number.

Do these “skeptics” really think the public cares about Avogadro’s number when homeopathy has just significantly improved their toddler’s autism or offered help with any of a vast range of diseases which respond so well to homeopathic (and often not to conventional) treatment?

This is just another tantrum by the clueless wing of the scientific/medical community that can’t understand why the people don’t praise them for their ideological purity and courage, even when the fruits of their scientific labors rot like a brown banana. Note to protestors: maybe they’re just not that into you.

Remember, this is the official blog of the AANP—the organization of which Hangee-Bauer is the current president!—and it’s not just attacking, but rabidly attacking, a valid criticism of homeopathy. This valid criticism is nothing more than pointing out that most homeopathic remedies are diluted far, far more than Avogadro’s number, meaning that it’s highly unlikely (damned near impossible, actually) that a single molecule of the original starting material of the homeopathic remedie remains for dilutions of 12C or greater. When a typical homeopathic dilution is 30C (thirty 100-fold dilutions, or a 1060 dilution), that’s almost 1037-fold greater than Avogadro’s number. The magnitude of this dilution is simply incredible, and the odds against a single molecule remaining are just as incredible.

Particularly amusingly, Johnson likens these 1023 events to the persecution of Galileo in what is arguably one of the most hilariously over-the-top invocations of the “Galileo gambit” I’ve ever seen before. Behold:

These hooligans purport to stand up for scientific principles, while in fact their zealous dogmatism and denial of evidence would make Galileo’s persecutors proud. Score one for book burning and witch trials.

Because a little skeptical activism poking fun at the ridiculousness of the beliefs underlying the pseudoscience of homeopathy in such a way as to point out to nonscientists why it is pseudoscientific nonsense is exactly like putting Galileo under house arrest and burning books and witches. I am thankful for small favors in that Johnson restrained himself from comparing skeptics to Hitler or Nazis. Just barely. (Come on, Mr. Johnson, let it out. Play the Hitler/Nazi card! You know you really, really want to, and you’ll feel much better after you do.)

Science versus naturopathy

So far, all I’ve looked at is Bastyr University and the official blog of the AANP. In fact, though, every school of naturopathy whose curriculum I’ve ever examined includes homeopathy as a requirement, even as the AANP requires and defends homeopathy. It’s no wonder, too. There is actually a North American Board of Naturopathic Examiners, just like medicine’s National Board of Medical Examiners. The NABNE even has a certifying examination, just like real doctors! It’s all science-y and medicine-y, too, with all the trappings of science-based medicine but none of the rigor. This examination, the NPLEX (Naturopathic Physicians Licensing Examinations), which is required for naturopaths to be licensed in the sixteen states and five Canadian provinces that license naturopathic physicians tests naturopaths on homeopathy (emphasis mine):

The current examination, based on these original blueprints, forms the Core Clinical Science Examination now required by every state and province that regulates the practice of naturopathic medicine. The Core Clinical Science Examination is a case-based examination that covers the following topics: diagnosis physical, clinical, lab), diagnostic imaging, botanical medicine, nutrition, physical medicine, homeopathy, counseling, behavioral medicine, health psychology, emergency medicine, medical procedures, public health, pharmacology, and research. Two additional treatment examinations (Minor Surgery and Acupuncture) may also be required for eligibility to become licensed to practice as a naturopathic physician in some jurisdictions.

[…]

The NPLEX Part II – Core Clinical Science Examination is designed to test your knowledge of: diagnosis (physical, clinical, and lab), diagnostic imaging, botanical medicine, nutrition, physical medicine, homeopathy, counseling, behavioral medicine, health psychology, medical procedures, emergency medicine, public health, pharmacology, and research. The examination is comprised of a series of clinical summaries followed by several questions pertaining to each patient’s case. For example, you might be asked to provide a differential diagnosis, to select appropriate lab tests, to prescribe therapies which safely address the patient’s condition, and to respond to acute care emergencies.

I would love to see what questions the NPLEX includes regarding homeopathy. My guess is that the multiple choice questions would be a hoot; that is, if I didn’t know they were completely serious. Unfortunately, as Kimball Atwood points out, no one other than naturopaths really knows what’s on the examination. Indeed, Dr. Atwood observed that naturopaths seem to take great pains not to let scientifically-minded physicians see a copy of an actual NPLEX examination. Be that as it may, homeopathy is but one example of how strongly naturopathy embraces pseudoscience. Be it myofascial analysis, vega testing, traditional Chinese medicine, Ayurveda, germ theory denialism, or even distant healing, there is no nonsense that naturopathy excludes as being too unscientific for it. Yet none of this stops Hangee-Bauer from bragging about how next year at the AANP Convention, it’ll be all about the science:

On August 16, 2011, the Tuesday before the start of the 2011 AANP Convention, the AANP will be sponsoring a scientific summit. While only in the early stages of planning, it promises to be a gathering for the different players in the naturopathic profession to connect and define how the AANP mission, naturopathic research, and evidence-informed health policy can join and result in healthier patients, a more effective health-care system, and a flourishing naturopathic profession. Core discussion points will include articulating policy and practice issues driving our research agenda, where the profession is now and what future possibilities exist, and defining the core research questions relating to safety, effectiveness, and costs.

You might recall that I wrote about last year’s AANP Convention, as did Dr. Atwood, both in the context of lamenting the appearance of Dr. Josephine Briggs, director of the National Center for Complementary and Alternative Medicine (NCCAM) as a speaker. You might also recall that last year’s AANP Convention was chock full of pseudoscience, including (of course) homeopathy, “medical intuitive” scans, emunctorology, “detoxification,” functional medicine, water-only fasting, and many others. If you click around the Naturopathic Physicians Research Institute (NPRI) website a bit (which Hangee-Bauer referenced in his post), you’ll find “research” about chelation therapy for autism and cardiovascular diseases (which is an utterly useless and potentially dangerous intervention) and homeopathy in pediatric care. I do have to thank Hangee-Bauer, however. I’ll keep my eye out for when the AANP announces its speaker list and agenda for its scientific conference on August 16 and the AANP Convention to follow immediately. I’m sure it’ll provide at least one good blog post in a few months.

In the meantime, if I may be so bold, I will make one small suggestion. If Hangee-Bauer is truly serious about making naturopathy science-based, there’s one thing he could do right away to prove it. It would be a simple, powerful, and unequivocal indication of the strength and sincerity of his intent. It’s all Hangee-Bauer has to do as a first step, albeit tiny, to demonstrate that he is not simply mouthing the words in praise of science and proclaiming how much he loves science and wants naturopathy to be based on science. All he has to do is to state that homeopathy is quackery, that it should no longer be considered part of naturopathy, and that he is going to put the weight of the AANP behind removing homeopathy as a required component of training in naturopathy and the examinations used to certify naturopaths. Extra points would be given for correctly stating why homeopathy is nothing but water and how there is no evidence supporting the law of similars as a general principle. If Hangee-Bauer does that, I might start to take his pontificating about the wonders of science and the scientific rigor of naturopathy somewhat seriously. If he can’t do it, then I know it’s a load of hot air.

After Hangee-Bauer deals adopts a science-based approach to homeopathy, then we can talk about purging distance healing, anthroposophy, applied kinesiology, and many of the other bits of pure pseudoscience embraced by naturopaths. However, like infants naturopaths have to creep before they can crawl and crawl before they can walk. Eliminating homeopathy would be that first attempt at creeping. Anyone want to lay any odds on whether or not they’ll take that first creep forward?

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