Marlborough Wine Festival

Saturday the 12thMaybe just once someone will call me 'Sir' without adding 'You're making a scene.' Homer SimpsonI had bought tickets for us to attend the Marlborough Wine Festival. It is held in Blenheim in a valley that more than doubles the size of Napa in CA and is wall to wall with vineyards.

The Land Down Under

Do you ever get that feeling first thing in the morning like youre completely lost and have no bearing on the world around you Mostly its dark but there seems to be a faint glow of green. A strange sound comes from outside probably what woke me up in the first place. Sounds like sounds like sounds like an orangutan laughing. Cant be where the heck am I Now there seems to be s

Dunedin

Our last day in a NZ port starts with a gray day as we board the historic Taieri Gorge train right on the dock. After loading a full train of 12 cars with 400 plus cruise passengers we sip our champagne as the train proceeds along beautiful Otago Harbor across causeways to the Scottish heritage city of Dunedin Gaelic for Edinborough. Stopping briefly at the picturesque Victorian railway stati

Hanoi

Hanoi is in Northern Vietnam so the weather was somewhat cooler that the rest of our trip. Not cold by any means but more comfortable. We started our day at the Ho Chi Minh mausoleum. It is located in the center of Ba nh Square which is the place where Ho Chi Minh read the Declaration of Independence on September 2 1945 establishing the Democratic Republic of Vietnam. Ho Chi Minh wanted

Brisbane

Brisbane is just like any other city around the world. It has no distinct features to make it stand out from the rest. Wasn't even a beach in walking distance. Spent more time in book shops than walking around the city. I did walk in the botanical gardens which was a nice walk but that was about it. It felt like a place where you can work and then go out and play in the evening but the drinks ar

Christchurch to Kaikoura to Picton

Thursday Feb 10thOf all the things about me that could frighten you you worry about my driving UnknownWell actually over here one might worry about my driving. Driving on the left can be a little bit of a challenge. Having done it for a month two years ago I was pleasantly surprised how quickly it came back. There is a big Keep Left sticker on the dash of the rent a car so that hel

Travel by Bus

Lets see. A lot has happened and a lot has changed the past few weeks. I was in Santiago Chile for almost 2 weeks. Its a great city. It felt like home here. Even after just a few days here I felt like a local. The train was easy to follow great neighborhoods to visit and great food to eat. Of course I have been counting my pennies since I started my travel so I try to eatin instead. The

Motorway madness and the road to Northland

12 February 2011 The sunrise was stunning and I wanted to stay but we hadn't booked another night in Raglan. I think we were both more than a little sad to be moving on but if we were to head North we needed to move this morning. We had been lucky enough at Solspace to have access to a fridge so the cool box or 'chilly bin' as they call them here had been redundant for a few days. This necess

Train from Wuhan to Kunming

I was initially concerned about domestic travel during the Spring Festival season so much so that I was considering going to Taiwan or sticking closer to Wuhan. I saw some terrifying photos in news articles and read stories about people getting stranded for days. However I went myself to the train ticket office early in the morning nine days before the train I wanted and all options hardsoft

We Came to the Land of Kiwis The HOT North

Efter en lang nat i Sydney lufthavn og en knap saa lang flyvetur var vi nu i NZ. D Vi blev kun med noed og naeppe lukket gennem paskontrollen og havde ogsaa lidt problemer med at faa Melanies taske gennem security den kom igennem scanneren 5 gange foer vi fik lov til at gaa. Vi tog ind til Auckland City hvor vi fandt vores hostel ogsaa var der doemt afslapning. Vi blev dog alligevel sat for

Abel Tasman National Park le bijou des parcs nationaux

Nous voici donc attaquant la route avec notre Mazda prte tout cap sur lOUEST Objectif Abel Tasman National Park via Nelson une petite ville sur la route plaque locan. Distance 194 km. Lieu choisi pour le repos des guerriers Motueka. La premire grande trace au volant de la nouvelle voiture a t parfaite belle journe belles routes beaux paysages conduite agr

A Wicked Adventure in the East

Den 4. Januar tog vi afsked med Pink house samt alle beboerne med undtagelse af en Hugo for han var saa heldig at skulle joine os paa vores sidste roadtrip i OZ. Han saa frem til en forrygende tur med 2 skoerre danskere. DVi fandt nemt ud af Sydney ret overraskende eftersom vi havde haft store kvaler med at finde ud af de mindre byer i omraadet. Vi drog mod nord og planen var at komme helt t

Cathedral Gorge

Cathedral Gorge is located in a long narrow valley where erosion has carved dramatic and unique patterns in the soft bentonite clay. Trails abound for exploring the cavelike formations and cathedrallike spires. Miller Point a scenic overlook just north of the park entrance on U.S. 93 offers excellent views of the scenic canyon. Shaded picnic areas and a treeshaded campground area are open al

Vaccine Council of Vaccination

Non-overlapping magesteria. I always loathed that concept, as if one aspect of culture could be separate from, and not answerable to, reality. However, there might be something to the concept, as there certainly appears to be two approaches to medicine, and they are non-overlapping. I am not certain the two approaches are even in the same universe.

One approach to medicine is reality-based, where understanding of the world is seen though the lens of science, and as the science  evolves, so does the understanding of reality. What characterizes this approach is, in part,  an understanding of cognitive errors and logical fallacies and the insight of understanding that these cognitive errors and fallacies apply to themselves as much as they apply to others. Skeptics and science-based medicine (SBM) practitioners attempt to live in this magisteria.

The other approach is opinion-based, where reality is fixed and objective data ignored or warped to fit preconceived notions as to how the world should be.  Cognitive errors and logical fallacies are the foundation of this world view, and its practitioners behave as if these concepts do not apply to them. This is the not so magisteria of much of alt-med.

It is two world views that do not, and cannot, talk to each other since neither one understands the language of the other. I, for example, cannot understand  arguments based on information that has been repeatedly disproved yet still promulgated as fact.  The creationist viewpoint is an example of arguments using information years after the information has been discredited. I cannot wrap my head around deliberately misusing information that runs contrary to my current understanding of how the world works. I have a respect for, and a fidelity to, the truth.

A far better description of this dichotomy is to be found in The Panic Virus by Seth Mnookin.  As I write this I am about a quarter of the way through the book and I cannot recommend it enough.

The  International Medical Council on Vaccination, with the probably not intentionally ironic motto “Critical Thinking for a Critical Dilemma,” released a position paper entitled Vaccines: Get the Full Story Doctors, Nurses and Scientists on Protecting Your Child and Yourself (direct download link here) with 83 signatories with various initials after their names (conveniently listed here). 83 seems like a lot at first, but the numbers are not that impressive.

After all, there are 800,000 physicians in the US; so that represents 0.006% of physicians,  about .0004% of PhD’s (out of about 2.5 million) and .00017% of nurses (out of 2.9 million).  Not a ringing majority of the medical industrial complex; a fringe on the medical surrey.

They note at the beginning “MD, DO, MB, MBBCh all indicate a doctor of medicine. ND indicates a medically trained and licensed doctor in some areas. FNP indicates a family nurse practitioner,” leaving out an explanation of DC. I suppose even the International Medical Council on Vaccination feels that DC’s are not really doctors, and do not want to call attention to the fact.  I always think of comic books when I think of DC.  I was never a Marvel guy as a kid.

Of course these are all courageous mavericks, including a brain surgeon with a Galileo-like understanding of The Truth (big T) and are fighting against a corrupt and blind authority who are protecting their turf at the expense of you and your children. As an aside, I often find it odd when Galileo is used as an example. I just realized his first name is Galileo.  In that respect he was like Cher or the Donald.  Galileo was a man of science oppressed by the irrational and superstitious.  Today,  he (Galileo, not the Donald)  is used by the irrational and the superstitious who say the are being oppressed by science.  So 1984.

I prefer to quote  Arthur Schopenhauer:

All antivaccination “truth” passes through three stages. First, it is based upon feelings instead of reality. Second, it is opposed by the rationally inclined. Third, the more complete the information that falsifies it, the more vehemently it is embraced as self-evident.

Or something like that; I am using Bing for my search engine.

Then, without referencing any primary literature, the Vaccine Council of Vaccination proceeds with their Critical Thinking for a Critical Dilemma and where are sarcasm html tags when you need them:

These are some of the diseases that have documented associations with vaccines.

A laundry list follows.  Are any of the diseases on list been shown to be CAUSED by vaccines.  Nope.  Association is not causation, although the decline in pirates is not only associated with global heating, it is the cause of global heating. Or is it the contrariwise, for if it was so, it might be; and if it were so, it would be; but as it isn’t, it ain’t. That’s logic. Praise be to the Flying Spaghetti monster!

The list is interesting. I quasi-randomly picked sudden infant death syndrome (SIDS) to Pubmed, since that is the scariest one on the list. In my reality based understanding there is an association:

AIMS: To conduct a meta-analysis examining the relationship between immunization and SIDS.

METHODS: Nine case-controls studies were identified examining this association, of which four adjusted for potential confounders.

RESULTS: The summary odds ratio (OR) in the univariate analysis suggested that immunisations were protective, but the presence of heterogeneity makes it difficult to combine these studies. The summary OR for the studies reporting multivariate ORs was 0.54 (95% CI=0.39-0.76) with no evidence of heterogeneity.

CONCLUSIONS: Immunisations are associated with a halving of the risk of SIDS. There are biological reasons why this association may be causal, but other factors, such as the healthy vaccinee effect, may be important. Immunisations should be part of the SIDS prevention campaigns.

Cancer is also on the list. Again, there is an association. The HPV vaccine is used to  decrease risk of  cervical cancer and the hepatits B vaccine to decrease the risk for hepatocellular carcinoma. Of course, I am assuming that the Vaccine Council of Vaccination means a beneficial  association, but that is not stated explicitly. I was surprised to find the Vaccine Council of Vaccination trumpeting the benefits of vaccination and oh wait, I misunderstand. They imply vaccines cause SIDS and cancer. That’s different. The data to support the assertion? None that I can find. Maybe the Vaccine Council of Vaccination motto should really be, “I reject your reality and substitute my own” Or maybe, “There is no reality but what we make for ourselves.” Sara Connor almost had it right.

Autoimmune and allergic diseases?  Data?  Nope.

If you generate a list of diseases, unreferenced and unsupported by the literature, that you attribute to vaccines, what could be more worrisome and frightening than

And many, many more.

Not just one many, but two. Two many’s!!! If you Google “many” and “vaccine,” there are over 16 million hits!!! If you Google “many, many more”  and “vaccine” you get a quarter of a million hits. That is an incredible association between vaccines and many, many more. That is the kind of compelling arguments that I find convincing. No more vaccinations for me and mine!

They follow with another list, this time of vaccine side effects. After the first list I am not so confident of the rigor used to generate the document.  I will never say that vaccines are 100% safe. Nothing is. Life, as I understand it, is about relative risks. Seat belts and air bags kill people every year. I still want my car equipped with both.  Nothing is perfect, and it is an issue of the relative risk. An accident without seat belts is far more likely to cause morbidity and mortality.

Life without vaccines is likely to have more potential morbidity and mortality  with 250,000 kids injured each year in car accidents, approximately 2,000 die from their injuries. Your best bet, if you really want to prevent vaccine associated injury, is to not let people drive their kids to the doctors.

Few aspects of medicine offer as much benefit for as little risk as vaccination.  But people do not remember the plagues of the past and pay little attention to the outbreaks of the present unless it directly affects them and theirs.  I understand that.  Who cares if children are dying of pertussis in California, of measles in Africa, and paralyzed by polio in Nigeria?

Every anti-vax is an island entire of itself;
…no childs’s death diminishes me,
because I am uninvolved in mankind.
And therefore never send to know for whom
the bell tolls; it is none my concern.

~ John Donne.

or something like that.  Again, my searches are not working quite right.

Fainting a side effect?  Sure.

Kidney failure requiring dialysis.  They say that these side effects are “documented in medical literature and/or in package inserts.”  but I can’t find the reference that a vaccine side effect is renal failure.  Maybe it is this underwhelming reference, but given the lack of documentation, it is hard to know. It is probably there somewhere, since the Vaccine Council of Vaccination would not make up data.

More worrisome is “Many common diagnoses given for hospital admissions,” which, when combined with ‘vaccine’, results in 3,350,000 Google hits, although which package insert and which reference in the medical literature  is hard to precisely narrow down.

I am shocked they did not mention that vaccines are associated with hip fractures.  Really. 3% of children get a fracture each year and most are vaccinated.  The Amish, who do not get vaccinated, have less fractures. Coincidence?  I think not.  Maybe I should write for the Vaccine Council of Vaccination.

Then the Vaccine Council of Vaccination says “Autism is associated with vaccines” and point to Fourteenstudies.org, which Dr. Gorski, Dr. Novella, I have discussed before. The approach of 14 studies can be summarized in one ‘critique’: “We gave this study our highest score because it appears to actually show that MMR contributes to higher autism rates.”

If a study agrees with their position, that defines  a good study.  The bass ackwards approach to the medical literature, but telling nonetheless.  It is the world were belief determines the facts. But I am not swayed by such incisive analysis as “What is it with Eric Fombonne and Pediatrics?” and “Fombonne again,”  linking him to a paper he is not an author of.  Still.  I pointed out the mistake years ago.  Seriously, if you are going use guilt by association, at least get your association correct.

The Vaccine Council of Vaccination continues with “Drug companies, insurance companies and the medical system get rich when you get sick.”

The first and third do make money when you are ill, but the second?  Then why do they spend so much time denying coverage?  It is an opinion that seems removed from reality.

The issue is not that vaccines have almost eradicated numerous childhood diseases for which I could make a healthy living if they existed.  The issue is “Vaccine side effects can make you sick for the rest of your life. Conveniently, there are many drugs to treat the side effects caused by vaccines.”  The odd idea that most medical problems are due to “the zeal to eliminate a short list of relatively benign microbes, we have traded temporary illnesses for pervasive, life?long diseases, disorders, dysfunctions and disabilities.”

All the  “many many more” and the “many common diagnoses given for hospital admissions” that result from vaccines.

Nothing specific, ominous appearing, unsupported by data, and feeding into the peculiar paranoid conspiracy  train of thought so common in parts of the world.  I have to confess, I have little appreciation of the conspiratorial mind-set.  As best I can tell,  life is dominated by inadvertent stupidity and randomness mixed with a dollop of greed; one does not need to invoke the Trilateral commission or Big Pharma machinations, although they have machinated enough over the years to earn our distrust.

And, as the data would suggest, most physicians who give childhood vaccines break even.

For hoots and giggles, I Googled  random names of the list  and 6 of 7 are selling products online of an “alternative” nature: books, tapes, DVDs, etc.  I do not know if the names of the signatories are the same people I found who are shilling on the net. Still, later in the paper they bemoan the conflicts of interest of  Dr’s Offit and Gerberding and pediatricians:

…the average U.S. 10?doctor pediatric group has over $100,000 of vaccine inventory in their office to sell. These doctors make money from office visits and from giving your children vaccines, and also from follow up office visits for assessing reactions.

For 250 workdays a year, that is  40 dollars a day, or 5 dollars an hour, before taxes and expenses,  of inventory they have to sell off on their patients.  Less than the minimum wage. Yeah. That’s the way to get rich, selling vaccines, not peddling material on the internet.

Oddly, neither the paper nor the website have a Conflict of Interest (COI) Statement that I can find.  I wonder if the Vaccine Council of Vaccination are in the palms of big Alt.  Who knows how much money  the Vaccine Council of Vaccination are paid by homeopathic preparation  and supplement manufacturers?  Who knows how many thousands of dollars of herbs, supplements, homeopathic products, books and videos the members of Vaccine Council of Vaccination has stocked away to sell for a profit over the internet. It is probably nothing, since I am sure the signatories are not in for the money, but for the benefit of their patients, but with no COI, no transparency,  it is impossible to say.   In the pursuit of openness, I have two ebooks for sale on my website, but really, I am using this as an opportunity to shill for myself in the guise of openness. Or am I?

The Vaccine Council of Vaccination  then notes “Many doctors and healthcare practitioners do not get vaccinated and do not vaccinate their children” and declare that HCW’s do not get vaccinated because they know all the dangers of vaccination. More often it is laziness and inconvenience that prevents HCW’s from vaccination although there is a subset who sign manifestos whose reasons appears to be a profound and pervasive misunderstanding about vaccinations efficacy and safety.

There are the mavericks  who question the status quo, who notice plate tectonics, or that the gravity of the visible  mass  of the universe is insufficient to hold everything together or that  ulcers are caused by bacteria.  Mankind owes a debt of gratitude to those who have extended our knowledge and understanding against the dogma of the day.

Then there are those who publicize cold fusion*, perpetual motion, and water powered cars. The same world view that also writes

“Vaccines are the backbone of the medical system. Without vaccines, healthcare costs would go down because we would have a healthier overall society. We have exchanged chicken pox for autism, flu for asthma, ear infections for diabetes. The list goes on and on. In the zeal to eliminate a short list of relatively benign microbes, we have traded temporary illnesses for pervasive, lifelong diseases, disorders, dysfunctions and disabilities.”

The words are there.  I understand each word individually.  When strung together they are, when compared against the last 100 years of advances in infectious diseases and medicine, gibberish. That paragraph is as divorced from medicine as I understand it  as anything I have ever encountered.  I feel like I am reading

a tale/Told by an idiot, full of sound and fury, Signifying nothing.

Unfortunately, the preceding paragraph was not written by “a poor player/That struts and frets his hour upon the stage/And then is heard no more”

Anti-vax is probably forever.

The Vaccine Council of Vaccination continues with “If U.S. children receive all doses of all vaccines, they are injected with up to 35 shots that contain 113 different kinds of disease particles, 59 different chemicals, four types of animal cells/DNA, human DNA from aborted fetal tissue and human albumin.”
Well, vaccines are evidently a step up from Taco Bell beef.

As discussed, vaccines are nothing compared to the volume of particles the child receives from the real diseases.  Biochemistry is not the strong point of those who are against vaccines.  As usual they point to the presence of formaldehyde, ignoring that the concentration in the vaccine is less than the body makes as part of normal biochemistry in the course of a day.  The net effect of the concentration gradient should be to remove formaldehyde from the blood and into the vaccine.  But in the upside down world of homeopathy, promulgated by some of the signatories, the less the chemical, the stronger it becomes.

And gelatin.  Vaccines have gelatin. The horror, the horror.  I always knew Jello was bad. Not as dangerous as dihydrogen monoxide, a major ingredient in all vaccines that kills 4000 Americans a year, 20% of them children.   And it is in our vaccines.  Think about the children.  Come on. Gelatin? Really? Really?

The Vaccine Council of Vaccinations  wind down by emphasizing you do have the right to refuse vaccination, and that doing so is a shameful, embarrassing, repellant act, which is why, I suppose, they say “Vaccination decisions are between you and your spouse/partner. No one else needs to know. It is not the business of your family members, your neighbors, or your in-laws.”  Or am I reading it wrong?

They conclude with a combination of advice on how to avoid vaccinations and how wonderful  infections are compared to vaccines:

Babies are born with powerful, natural defenses. If this were not so, all would die shortly after birth. Enormous cascades of complex immune processes start with the first cry. This needs to occur naturally, without the interruption caused by the injections of toxic substances.

Learn about the “vaccine preventable”  diseases. Your children will never come in contact with most of them and if they do, nearly all healthy and unvaccinated children recover uneventfully, with long term immunity. Health cannot come through a needle.

Tell that to UNICEF :

Almost 40 per cent of all under-five deaths occur during the neonatal period, the first month of life, from a variety of complications. Of these  neonatal deaths, around 26 per cent, accounting for 10 per cent of all under-five deaths, are caused by severe infections. A significant proportion of these infections is caused by pneumonia and sepsis (a serious blood-borne bacterial infection that is also treated with antibiotics).

Around 2 million children under five die from pneumonia each year‚ around 1 in 5 deaths globally. In addition, up to 1 million more infants die from severe infections including pneumonia, during the neonatal period. Despite progress since the 1980s, diarrhoeal diseases account for 17 per cent of under-five deaths. Malaria, measles and AIDS, taken together, are responsible for 15 per cent of child deaths.”

The industrialized West, having routed, at least locally, three of the four hoursemen of the apocolapse (War, Famine, Pollution (Pestilence having retired in 1936 following the discovery of penicillin)),  has developed  many interventions, including vaccines, that have resulted in a decrease in childhood infectious diseases, not a one discovered or implemented by the practitioners touted in this manifesto “a naturopathic doctor, a pediatric chiropractor, a doctor of oriental medicine, or a homeopathic doctor.”

I do not want to return to the bad old days when

For example, in 1900, 21,064 smallpox cases were reported, and 894 patients died. In 1920, 469,924 measles cases were reported, and 7575 patients died; 147,991 diphtheria cases were reported, and 13,170 patients died. In 1922, 107,473 pertussis cases were reported, and 5099 patients died.

Those who cannot remember the past are condemned to be against vaccination.

~ George Santayana

The Vaccine Council of Vaccination bids you remember

Learn about the vaccine preventable  diseases. Your children will never come in contact with most of them” and “Understand that your child can be vaccinated and still contract the illness you are wishing to prevent.

Which is it? They will be exposed or they won’t.   I know.  A foolish consistency is the hobgoblin of little minds.

They finish, with a not so subtle reminder that they take Visa, Mastercard and cash, but not Blue Cross:

“Know that healthcare is something you pay for; sick care is covered by insurance. Your insurance will pay for drugs and vaccines.

Budget accordingly to stay healthy. Your life depends on it.”

The Vaccine Council of Vaccination concludes not with  primary references,  but links to more web sites.

The Vaccine Council of Vaccination is the group who wanted to debate vaccines. Besides the fact that I am a lousy debater, having lost every substantive discussion with my wife, how can  one debate the Vaccine Council of Vaccination?  My assumption is that those who hold opinions that are contrary to mine are not bad people. I presume good intentions and, since the Road to Hell is paved with frozen door-to-door salesmen,  I need not fret about ultimate consequences of their intent, although the Vaccine Council of Vaccination strains my credulity.   I always feel like I am constrained by the truth as best I understand it, and a fidelity to reality is a handicap in any argument.   It would be like debating the nature of the moon with Wallace. Bad example.  He had objective data to support his position, unlike the Vaccine Council of Vaccination.

Non-overlapping indeed.

===

* Dude.  You know who you are.  Don’t fill the thread with cold fusion commentary again.  It is not the point of the entry. Thanks in advance for understanding.

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CAM on campus: Black History Month

I emerge from the haze of board exams and residency interviews to blog about a recent development on campus that disappointed me, involving a university celebration of Black History Month.

To provide context, I must tell you that my medical school campus has the university hospital for a poor city full of immigrants and racial minorities. White citizens make up about a quarter of the city population. I am extremely proud of our faculty and students who strive to serve our surrounding community. Some of these efforts are based, predictably, in medical care. This care is provided not just by working in the hospital and clinic, but also by promoting health and prevention through community health fairs and mobile outreach programs. Other efforts are aimed at helping local kids get to college and into health-related careers. Establishing a physician workforce that represents a diversity of racial, ethnic, and cultural backgrounds is considered an important step in reducing racial disparities in health care access and outcomes (e.g., 1, 2), and that mission is embraced wholeheartedly at my institution. (An anecdotal example of the diversity in our school and hospital: it is neither rare nor surprising for me to look around a random gathering and realize that I am the only pale, American-born man in attendance.) Therefore, one might expect my university’s celebration of Black History Month to be kind of a big deal.

Here is the announcement for our university-sponsored celebration of Black History Month. The title of the speech that kicks off the celebration is “Holistic Medicine – Ancient Africans to African-Americans.” The next event is a screening of a video called “Hidden Dangers in Kids’ Meals: Genetically Engineered Foods.” Clearly the celebration is being used to address health concerns in the black community, which seems entirely appropriate for a medical university. However, as regular blog readers have already predicted, I found myself getting increasingly upset about the particular topics chosen to meet this worthy goal.

I am upset not simply because my skeptical hackles raise at the term “holistic medicine,” but because I feel that here is an example of CAM ideology marring an opportunity for meaningful service. The most charitable word I can use for the topics listed is “controversial.” Airing of controversial views can certainly be appropriate in a university setting, but not if and when the goal is supporting the health of a historically disenfranchised part of our community.

Guest speaker on “holistic medicine”

Local physician Kevin Holder, MD gave a talk titled, “Holistic Medicine – Ancient Africans to African-Americans.” I am sad that my clinical duties prevented me from attending the talk. I will refrain from speculating on its content, but one might infer what Dr. Holder means by “holistic medicine” from the website of his Center for Preventive Medicine, particularly the “Our Philosophy” and “Our Team” pages.

From the standpoint of understanding the history and current prevalence of unconventional health beliefs in African and African-American communities, I can appreciate this topic as germaine to Black History Month even if I would disagree with Dr. Holder as to the medical value of those beliefs. It is a shame I missed the event, because it might have been a great opportunity to have a discussion about the appropriateness of incorporating pre-(non-)scientific philosophies into a modern medical practice. It is a fascinating question: where should we draw the line between hard-nosed adherence to science-based medicine and pragmatic appeals to a community with strongly held traditions? Perhaps the celebration organizers had in mind to foster such a debate.

The cranky skeptic in me cannot help speculating, however, that it was explicit sympathy for CAM in the planning committee that resulted in the scheduling of both Dr. Holder and the subsequent, much less defensible event.

Screening of an anti-GM food movie

The next event is a screening of “Hidden Dangers in Kids’ Meals: Genetically Engineered Foods” by anti-GM (genetically modified) food activist Jeffrey Smith. Here can be found the 24-minute video for the brave, and below is an outline for everyone else:

  • Ominous music opens the video, and scattered throughout are gripping quotes like “I don’t want to sell my children’s future for a handful of magic beans.”
  • Descriptions of how the industry controls research programs and regulatory bodies (I do not know to what extent this is true) are plentiful, along with stories of individuals being pressured or even expelled if they ask the wrong questions or voice the wrong opinions. An analogy is made to tobacco companies spinning science about cigarettes.
  • Frequently cited experiments document the horrible effects of a particular GM food on a group of laboratory animals. Interestingly, there seems to be no consistent pattern in the particular adverse effects cited; it sounds like GM foods can cause just about any pathology.
  • Anecdotes are also offered about adverse effects in farm animals, ranging from the mysterious death of twelve cows in Germany to “The cows didn’t care for it” in Iowa.
  • Broad claims are made for the effect of food on behavior. An unidentified study apparently showed that “25% of tantrums in 3-year-olds [were] due to additives or colorings in their food.” A Wisconsin school that instituted sweeping changes in its lunch offerings and cafeteria environment reported a resulting improvement in student behavior and attention. Neither of these dramatic examples, of course, specifically involved GM foods. But the audience gets the message that healthy food is better than processed junk, and presumably they can make the connection from there.
  • Another example of this implicit yet bold assumption—that GM food is associated with all manner of ills—is the closing statement that begins, “With the rise in obesity and diabetes…” and ends with concerns about GM food.
  • At one point the video creator Jeffrey Smith, to his credit, speaks carefully about not being over-confident about conclusions based on a single, small experiment in animals. He says it “would be irresponsible,” however, not to proceed cautiously until better studies are done. The audience is left to take his word that better studies than these have indeed not been done.

The most detailed, science-y part of the video involves the implications of an article published in Nature Biotechnology titled “Assessing the survival of transgenic plant DNA in the human gastrointestinal tract.” Jeffrey Smith describes how transgenes were shown to jump from GM soy to bacterial flora in the human gut. He expresses concerns about transfer of antibiotic resistance genes, pesticide production genes, promoters that might insert themselves anywhere in the new genome… It all sounds pretty scary until you read the abstract of the Nature paper, which ends with “we conclude that gene transfer did not occur during the feeding experiment.” Reading the full article in order to judge the researchers’ conclusion versus Jeffrey’s opposite interpretation is left as an exercise for the blog reader.

Finally, for those who like a good “Quack Miranda Warning,” the one at the end of the video (at 8:40 here) is amusing.

A scathing critique of Jeffrey Smith’s claims and use of evidence can be found here, at a site that appears to have been founded by a couple of food science professors fed up by this guy. I do not have the time and patience to wade through it, but suffice to say that the creator of the video “Hidden Dangers in Kids’ Meals” looks an awful lot like a crank to me. The link to Dr. Gorski’s favorite Health Ranger, Mike Adams, on Jeffrey Smith’s home page increases my suspicion. I welcome any comments by blog readers better versed in this field or with this individual.

The purpose of screening the Jeffrey Smith video for Black History Month eludes me. Only a handful of the activists, experts, parents, and innocent children depicted had much melanin in their skin. But more importantly, I do not think we support a marginalized community by promoting fear of greedy corporations and complicit government. Raise your hand if you think a conspiracy theory about food is what black Americans really need right now.

Honoring Black History Month by serving black Americans

For my university, a public celebration of Black History Month is not simply an exercise in honoring diversity. Our school and hospital are prominent institutions in a city of many black children who could benefit greatly from inspiration and guidance. I applaud the goal of using the celebration to spotlight the health of Black Americans, which by many metrics lags deplorably behind the health of other racial groups in this country. A particularly salient problem is the high rate of obesity in this population, making all the more potentially valuable a program to promote healthy lifestyle and diet.

I wish, however, that this intention had found a different execution than holistic medicine and anti-GM hysteria. Here is an alternative: how about featuring First Lady Michelle Obama’s “Let’s Move!” initiative? She is focused on urban children’s health, though her concerns are more about access to fresh produce and safe playgrounds rather than exposure to GM foods. Our mayor Cory Booker recently kicked off the Let’s Move! campaign in this city and is using Facebook to lose weight himself. The messages from this campaign could have been tailored to black youth (include yoga for exercise if you want some CAM) and used as part of the Black History Month celebration instead of the dubious health messages we are sending now. Even better than the non-magical, non-paranoid character of the Let’s Move! campaign: its national and local leaders are terrific black American role models. (Of course, I appreciate that it would be very difficult to secure either of these high-profile individuals for a guest appearance. But I bet there are other folks in our city working on this problem…)

Americans, whether African- or any other kind, deserve from their medical universities the truth as best as we know it. We can do better than this misguided, misleading, fear-mongering video.

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The Flu Vaccine and Narcolepsy

Last year it was reported that there was a possible increase in narcolepsy, a sleep disorder characterized by excessive sleepiness, in children who had received the Pandemrix brand of H1N1 flu vaccine in Sweden, Finland, and Iceland. However a review of the data did not find a convincing connection, although concluded there was insufficient data at present and recommended further surveillance. A narcolepsy task force was formed in Finland, and now we have their preliminary report.

They conclude that the evidence suggests there is a connection:

Based on the preliminary analyses, the risk of falling ill with narcolepsy among those vaccinated in the 4-19 years age group was 9-fold in comparison to those unvaccinated in the same age group. This increase was most pronounced among those 5–15 years of age. No cases were observed among those under 4 years of age. Also, no increase in cases of narcolepsy or signs of vaccination impacting risk of falling ill with narcolepsy was observed among those above 19 years of age.

The World Health Organization (WHO) has reviewed these results and concluded:

WHO’s Global Advisory Committee on Vaccine Safety (GACVS) reviewed this data by telephone conference on 4 February 2011. GACVS agrees that further investigation is warranted concerning narcolepsy and vaccination against influenza (H1N1) 2009 with Pandemrix and other pandemic H1N1 vaccines. An increased risk of narcolepsy has not been observed in association with the use of any vaccines whether against influenza or other diseases in the past. Even at this stage, it does not appear that narcolepsy following vaccination against pandemic influenza is a general worldwide phenomenon and this complicates interpretation of the findings in Finland.

I agree with the WHO, who is basically saying that these results are intriguing, but are problematic and should be considered preliminary. They then follow with – more research is needed. Epidemiology is a complex endeavor, and there are lots of wrinkles to this data. The increased risk of narcolepsy was only seen within a certain age range. In Iceland (but not Sweden or Finland) the increase in narcolepsy was also seen in those who were not vaccinated. And further, other countries (47 in total) that also used the Pandemrix vaccine have seen no increase in narcolepsy, including Norway, the UK, Germany, and Canada.

Overall we have a very inconsistent pattern. The vaccine does not appear to be a consistent or unique risk factor for narcolepsy in these populations. The task force concludes from this that there must be another factor or factors that is combining with the vaccine to increase the risk. This is logically possible, but until this factor X is identified it remains speculation.

Narcolepsy is a neurological disorder characterized by excessive daytime sleepiness (narcoleptics sleep all night and all day), cataplexy (a tendency to lose muscle tone and collapse in response to stress), hypnagogia (hallucinations associated with a fusion of the dream state and the waking state, so-called waking dreams), and sleep paralysis (being paralyzed upon awaking from sleep). There is a strong genetic predisposition for narcolepsy. In fact it is only seen with a certain genetic type known as the (HLA) DQB1*0602 genotype.

All of the individuals who developed narcolepsy following the Pandemrix vaccine have the narcolepsy HLA type. Therefore there is the possibility that the vaccine only increases risk within this genetic populations, perhaps combined with other gene variants. Perhaps something else is also triggering the increase in Iceland, but not Finland and Sweden, to explain the rise in narcolepsy there in the unvaccinated.

Another possibility is that there is one or more confounding factors leading to the increase in narcolepsy, and the vaccines are a correlating but not causative factor.

Such is the nature of epidemiology, or observational studies. Variables are not controlled for and confounding factors are always a possibility. That does not mean that observational data is not useful or cannot be definitive – but it requires careful, thoughtful, and thorough collection and analysis of data from multiple different angles. The data we have so far from Finland is very preliminary, and generates more questions than answers. There is certainly sufficient cause for caution and further analysis. But at this point I would not be surprised by any particular outcome, since the data can be interpreted in many ways.

Conclusion

While there is an intriguing correlation between the Pandemrix vaccine and narcolepsy, this correlation is inconsistent – it is isolated to a few countries and to one age group and there is a rise in narcolepsy in Iceland not correlated to the vaccine. Further the cases identified so far are restricted to those with a known genetic predisposition to narcolepsy. This could mean that this population is susceptible to some factor in the vaccine, but it could also mean that they are susceptible to some other trigger, or perhaps were destined to get narcolepsy and the apparent increase in entirely an artifact of observation and reporting.

I agree with the WHO that this data should be considered preliminary – which means it is worthy of further monitoring and research, but we are not able to make any firm conclusions at this time.  I would not be surprised if it turns out to be a real effect of the Pandemrix vaccine. Vaccines are not without risk, although over the decades the risks have proven to be very small and vastly outweighed by the benefits. Obviously it would be hugely useful to identify which ingredient was the culprit and exactly how it triggered narcolepsy in this population. But I would also not be surprised if this turns out to be entirely a red herring. Such is the nature of observational data.

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Ear Infections: To Treat or Not to Treat

Ear infections used to be a devastating problem. In 1932, acute otitis media (AOM) and its suppurative complications accounted for 27% of all pediatric admissions to Bellevue Hospital. Since the introduction of antibiotics, it has become a much less serious problem. For decades it was taken for granted that all children with AOM should be given antibiotics, not only to treat the disease itself but to prevent complications like mastoiditis and meningitis.

In the 1980s, that consensus began to change. We realized that as many as 80% of uncomplicated ear infections resolve without treatment in 3 days. Many infections are caused by viruses that don’t respond to antibiotics. Overuse of antibiotics leads to the emergence of resistant strains of bacteria. Antibiotics cause side effects. A new strategy of watchful waiting was developed.

Current Medical Guidelines

In 2004, the American Academy of Pediatrics (AAP) and the American Academy of Family Physicians (AAFP) collaborated to issue evidence-based guidelines based on a review of the published evidence

Something was lost in the transmission: the guidelines have been over-simplified and misrepresented, so it’s useful to look at what they actually said. There were six parts:

1. Criteria were specified for accurate diagnosis.

  • History of acute onset of signs and symptoms
  • Presence of middle ear effusion (ear drum bulging, lack of mobility, air-fluid level)
  • Signs and symptoms of middle ear inflammation: Either red ear drum or ear pain interfering with normal activity or sleep

They stressed that AOM must be distinguished from otitis media with effusion (OME). OME is more common, occurs with the common cold, can be a precursor or a consequence of AOM, and is not an indication for antibiotic treatment.

2. Pain should be treated regardless of whether antibiotics are used.

3A. Observation without antibiotics is an option for a child with uncomplicated AOM.

  • Limited to otherwise healthy children and stratified by age
    • 6 mo to 2 years with non-severe illness and uncertain diagnosis
    • 2 and older without severe symptoms or with uncertain diagnosis.
    • All children under 6 mo should be treated.
  • Parents must have ready means of communicating with clinician.
  • A system must be in place to re-evaluate the child. Strategies include a parent-initiated visit and/or phone contact for worsening condition or no improvement at 48 to 72 hours, a scheduled follow-up appointment in 48 to 72 hours, routine follow-up phone contact, or use of a safety-net antibiotic prescription to be filled if illness does not improve in 48 to 72 hours.

3B. Amoxicillin is the treatment of choice

4. Reassess in 48-72 hours.

  • If AOM is confirmed in a patient being observed, start antibiotics.
  • If patient is already on an antibiotic and symptoms persist, change it.

5. Encourage prevention

  • Modify the modifiable risk factors: limit attendance at child care centers, breastfeed for 6 months, avoid supine bottle feeding and bottle propping, and avoid exposure to passive tobacco smoke.
  • Influenza vaccine is 30% effective in reducing the incidence of AOM.
  • Pneumococcal vaccine provides a 6% reduction.

6. No recommendations for CAM. They reviewed alternative medicine treatments and found no evidence to support them.

Alternative Medicine

Alternative medicine often misrepresents the facts: for instance, one homeopathic website says

Recent medical studies have shown that giving antibiotics does not effect [sic] the course of ear infections at all.

CAM offers a smorgasbord of options for treating ear infections, but none of them are supported by any credible scientific evidence. Here are a few examples:

  • Jay Gordon, MD recommends herbal and homeopathic remedies.
  • Joseph Mercola, DO warns that antibiotics are harmful, ineffective, and unnecessary. He recommends garlic ear drops, putting breast milk in the ear canal, and onion poultices.
  • Natural News recommends chiropractic; essential oils; herbal remedies including Echinacea, goldenseal, olive leaf and St. John’s wort; and eliminating dairy.
  • Andrew Weil, MD recommends cranial osteopathy and eliminating dairy products.
  • Many chiropractors claim to treat ear infections with upper cervical adjustments to promote drainage of the ear and support immune function. Ear-related claims are particularly common in that profession because D.D. Palmer, founder of chiropractic, claimed to have been originally inspired by a case of curing deafness with a neck “adjustment.”
  • An acupuncture website recommends needling TH 5, GB 41, GB 20, TH 17 and GB 2.
  • A homeopathic website offers to treat the whole child instead of just treating ear infections. They consider the child’s personality, likes and dislikes, and other factors; then choose the right homeopathic remedy to strengthen the health of the child. They claim that their treatment will make everything in the patient’s life get better.

Difficulty of diagnosis

Parents suspect their child has an ear infection when they notice irritability, pulling at the ear, and fever. These symptoms may be due to other causes, some of them serious, so a diagnosis by a doctor is essential. Anyone who has attempted to examine the ears of a struggling 2-year-old realizes that diagnosis is not a straightforward, black-and-white procedure. Many clinicians are not skilled in pneumatic otoscopy and tympanometry and they may have to rely on the appearance of the tympanic membrane (TM) through a simple otoscope. The ear canal is narrow and the view often obstructed by wax. The TM can be red because the child is crying. It can be a difficult judgment call to say whether the TM is bulging or dull, especially when you can only see part of it. When a doctor sees a sick child with an unexplained fever, it is tempting to call it AOM and have an answer and an excuse to “do something” (give antibiotics) when the diagnosis is not really so clear.

New Studies

Critics have suggested that the studies the recommendations were based on had limitations such as biases in patient selection, varying diagnostic criteria, and suboptimal antibiotic regimens. Two new studies have re-assessed antibiotic treatment using strict diagnostic criteria and optimum antibiotic regimens.

On January 13, 2011 The New England Journal of Medicine published two very similar high-quality studies done in Pittsburgh and Finland. Neither was funded by Big Pharma or any other commercial entities. Both addressed acute otitis media in very young children (6-23 months and 6-35 months respectively). Both were randomized double-blind studies. Both used stringent diagnostic criteria, with examiners who were skilled otoscopists. Both used amoxicillin/clavulanate rather than amoxicillin alone, since the evidence now indicates it is the most effective treatment.

Both studies found that antibiotics were clearly superior to placebo. The Finnish study calculated an NNT of 3.8 (the number of children that must be treated for one to benefit). It found that the benefit was the same regardless of the severity of the illness. Diarrhea and diaper rash were more common in those getting antibiotics. One patient in the placebo group developed mastoiditis. No increase in colonization by antibiotic-resistant bacteria was found.

An accompanying editorial stresses that the key to the optimal management of acute otitis media remains the accuracy of the diagnosis.

Conclusion

It is now clear that young children with a certain diagnosis of AOM recover more quickly with antibiotic treatment. The benefits of antibiotic treatment must be balanced against the development of resistant strains and the recognized side effects of antibiotics. Watchful waiting is only appropriate for patients over 6 months old when the diagnosis is uncertain. The new studies suggest that severity of illness should not be a criterion for deciding which children to treat, but that the emphasis should be on accurate diagnosis. I’m guessing that these two new studies will lead to revised guidelines.

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The NCCAM Strategic Plan 2011-2015: The Good, The Bad, and The Ugly

As hard as it is to believe, it’s been nearly a year since Steve Novella, Kimball Atwood, and I were invited to meet with the director of the National Center for Complementary and Alternative Medicine (NCCAM), Dr. Josephine Briggs. Depending upon the day, sometimes it seems like just yesterday; sometimes it seems like ancient history. For more details, read Steve’s account of our visit, but the CliffsNotes version is that we had a pleasant conversation in which we discussed our objections to how NCCAM funds dubious science and advocacy of complementary and alternative medicine (CAM). When we left the NIH campus, our impression was that Dr. Briggs is well-meaning and dedicated to increasing the scientific rigor of NCCAM studies but doesn’t understand the depths of pseudoscience that constitute much of what passes for CAM. We were also somewhat optimistic that we had at least managed to communicate some of our most pressing practical concerns, chief among which is the anti-vaccine bent of so much of CAM and how we hoped that NCCAM would at least combat some of that on its website.

Looking at the NCCAM website, I see no evidence that there has been any move to combat the anti-vaccine tendencies of CAM by posting pro-vaccination pieces or articles refuting common anti-vaccine misinformation. Of all the topics we discussed, it was clearest that everyone, including Dr. Briggs, agreed that the NCCAM can’t be perceived as supporting anti-vaccine viewpoints, and although it doesn’t explicitly do so, neither does it do much to combat the anti-vaccine viewpoints so ingrained in CAM. As far as I’m concerned, I’m with Kimball in asserting that NCCAM’s silence on the matter is in effect tacit approval of anti-vaccine viewpoints. Be that as it may, not long afterward, Dr. Briggs revealed that she had met with homeopaths around the same time she had met with us, suggesting that we were simply brought in so that she could say she had met with “both sides.” Later, she gave a talk to the 25th Anniversary Convention of the American Association of Naturopathic Physicians (AANP), which is truly a bastion of pseudoscience.

In other words, I couldn’t help but get the sinking feeling that we had been played. Not that we weren’t mildly suspicious when we traveled to Bethesda, but from our perspective we really didn’t have a choice: if we were serious about our mission to promote science-based medicine, Dr. Briggs’ was truly an offer we could not refuse. We had to go. Period. I can’t speak for Steve or Kimball, but I was excited to go as well. Never in my wildest dreams had it occurred to me that the director of NCCAM would even notice what we were writing, much less take it seriously enough to invite us out for a visit. I bring all this up because last week NCCAM did something that might provide an indication of whether it’s changed, whether Dr. Briggs has truly embraced the idea that rigorous science should infuse NCCAM and all that it does, let the chips fall where they may. Last week, NCCAM released its five year strategic plan for 2011 to 2015.

Truly, it’s a case of The Good, The Bad, and The Ugly.

The Good (more accurately: The Least Bad)

Let’s start by listing the goals of the NCCAM Strategic Plan 2011-2015:

  • GOAL 1: Advance the science and practice of symptom management.
  • GOAL 2: Develop effective, practical, personalized strategies for promoting health and well-being.
  • GOAL 3: Enable better evidence-based decision making regarding CAM use and its integration into health care and health promotion.

To accomplish these goals, NCCAM proposes five Strategic Objectives:

As much as I detest NCCAM as a political tool foisted upon the NIH by quackery-friendly legislators, in particular Senator Tom Harkin (D-IA), even I have to admit that there is some good in NCCAM’s strategic plan, specifically Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research. If you’re a scientist, arguing against improving the capacity to do rigorous science is akin to arguing against mom and apple pie; no serious scientist would do it. Of course, implicit in this NCCAM objective is an admission that the CAM research NCCAM has tended to fund in the past has not been very good, and, worse, it is very telling that NCCAM should even find it necessary to make improving the quality of its funded research a strategic objective. After all, improving the the capacity of a field to carry out rigorous research should be part of the mission of every NIH institute and center, so much so that it should almost go without saying. Unfortunately, how NCCAM proposes to go about improving the scientific rigor of its work isn’t exactly the way it should go about improving the scientific rigor of its work. For example, one key method proposed by NCCAM is to “support a variety of high-quality research training and career development opportunities to increase the number, quality, and diversity of CAM researchers”:

A successful and robust CAM research enterprise must draw from two sources of well-trained, skilled, and experienced talent: CAM practitioners expert in their respective disciplines and biomedical/behavioral scientists expert in cutting-edge scientific methods. CAM practitioners are the key holders of knowledge related to the potential application of CAM interventions and disciplines. NCCAM has always recognized the need for research training and career development efforts targeted specifically toward this diverse community. Over the years the Center has developed a number of programs aimed at enhancing CAM practitioners’ abilities to critically evaluate biomedical literature, participate in clinical research, and, in some cases, seek advanced training and career development opportunities for careers in the field of CAM and integrative medicine research.

All of this sounds very nice, but where the rubber meets the road, what this means is listening to reiki practitioners, acupuncturists, therapeutic touch practitioners, and homeopaths (in other words, believers in unsupported modalities based on magical thinking) when setting priorities, in addition to listening to less unreality-based CAM practitioners, such as herbalists or even chiropractors who stick with musculoskeletal disorders and don’t claim that chiropractic can cure asthma or other unrelated diseases. Using such practitioners to set research priorities and to collaborate with real scientists is what Harriet Hall would call Tooth Fairy science. It’s putting the cart before the horse. Implicit in this strategy is the assumption that there is an actual phenomenon to be studied in modalities like reiki, which, let’s face it, is nothing more than faith healing stripped of its Christian religious background and replaced with Eastern mysticism. If I knew that NCCAM was in actuality trying to determine whether these phenomena exist, rather than “how” they work, perhaps I’d be less critical. Another part of me can’t help but note that trying to suck real scientists into the study of pseudoscience, NCCAM is blatantly trying to cloak various modalities in the mantle of scientific respectability before they deserve to wear it.

Whether I’m being cynical or realistic I leave to the reader to judge. Certainly, given that Objective 3 (Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion) seems custom-designed to develop a case for “integrating” CAM into science-based medicine, rather that determining which modalities actually have some utility supported by science and therefore should cease being “alternative” and become just “medicine.”

Less irritating is Strategic Objective 2: Advance Research on CAM Natural Products. Actually, it’s not so much “good” as least objectionable and even somewhat scientifically defensible. Here are the strategies proposed by NCCAM:

Strategy 2.1: Harness state-of-the-art “omics” and other high-throughput technologies and systems biology approaches of the sciences of pharmacology and pharmacognosy to:

  • Elucidate biological effects, mechanisms of action, and safety profiles of CAM natural products
  • Study interactions of components with each other and with host biology
  • Build a solid biological foundation for translational research needed to carry out clinical studies.

Strategy 2.2: Support translational research to build a solid biological foundation for research on CAM natural products to:

  • Develop and validate sensitive and reliable translational tools to detect and measure mechanistically relevant signatures of biological effect and to measure efficacy and other outcomes
  • Conduct preliminary/early phase studies of safety, toxicity, dosing, adherence, control validation, effect/sample sizes, ADME (absorption, distribution, metabolism, and excretion), and pharmacokinetics
  • Build upon established and proven product integrity policies and processes.

Strategy 2.3: Support targeted large-scale clinical evaluation and intervention studies of carefully selected CAM natural products.

Of course, the reason that I label this as being part of “the good” is because, of all the aspects of CAM, natural products represent the area with the most scientific plausibility. On the other hand, it’s hard not to point out that there is nothing here that natural products pharmacologists haven’t been doing for decades. Nothing. What NCCAM is in essence describing is nothing more than pharmacogonosy, the study of natural products pharmacology. It’s the sort of thing that our very own David Kroll does. It’s the sort of thing that thousands of pharmacologists do every day. Heck, it’s even the sort of thing that a lot of pharmaceutical companies do when they try to isolate drugs from natural products. There are many examples of drugs that have come from natural products, including taxol (Pacific Yew tree); vinca alkaloids (periwinkle plant); related drugs like campothecin, irinotecan, and topotecan (Camptotheca acuminata, a.k.a. Happy tree); and, of course, aspirin. The list is extensive, arguably longer than the list of synthetic drugs.

In fact, what NCCAM is doing here, whether Dr. Briggs realizes it or not, is the classic “bait and switch” that I discussed when kvetching about Dr. Oz’s promotion of various Ayruvedic medicines and “detox” diets. In essence, NCCAM has claimed for itself all of natural products pharmacology as being “CAM.” The difference is that there is a layer of belief slathered on it, specifically the CAM belief that somehow the natural plant is superior to purified components or molecules found to have medicinal value. The assumption is that the mixture of unpurified compounds somehow allows the components in the plant or natural product to be “synergistic.” While this sort of synergy is possible, it is actually pretty implausible, with precious few examples known. Worse, it’s very hard to demonstrate true synergy between only two or three components, much less the hundreds — or even thousands — of components in many plants used in CAM. In reality, for all practical purposes and even when a plant does have an active compound (or active compounds) in it that function as a drug, using whole plant extracts, as most CAM practitioners do, substitutes adulterated active ingredients whose purity and potency can vary wildly for well-characterized, predictable, purified active drug.

Actually, I don’t mind this sort of research so much, as long as it’s testing hypotheses that are supported by sound basic science and preclinical data. Certainly, that’s what NCCAM appears to be trying to do, and if NCCAM can’t be dismantled (as I would prefer), its components absorbed into the appropriate institutes and centers of the NIH, then I suppose this is the sort of research that is least likely to cause harm and might actually produce useful results, far more so than much of the rest of the research that NCCAM funds. However, I continue to question why such research should now be considered “CAM” when natural products research has long been a major area of “conventional research.” After all, the study of natural products and herbs with useful pharmacological activity has been an active area of research in pharmacology since time immemorial. There’s no scientific rationale why such studies should be segregated away as “alternative”; they could and should be evaluated just like any other scientific study. Worse, trying to segregate natural product pharmacology at NCCAM devalues pharmacognosy, and by association with the other woo (see below) also being funded under the rubric of “CAM” makes it look like woo too.

In fact, the entire set of goals set forth by Dr. Briggs in the introduction are a “bait and switch.” Notice how two out of the three of these have nothing to do with CAM. Seriously. Why is it that symptom management is CAM? Take the example of oncology. Considerable research and effort go into trying to develop strategies to minimize the effects of therapy. A whole branch of anesthesiology is devoted to the management of chronic pain. If that’s not “symptom management,” I don’t know what is. So what does CAM bring to the science and practice of symptom management? Very little, I would argue, that can’t be studied outside the context of CAM. Unfortunately, what CAM really does bring to symptom management is pseudoscience and prescientific ideas of how the body works. It brings qi. It brings human energy fields. It brings vitalism. Do we really need to “integrate” nonsense with science in symptom management? Perhaps NCCAM can help us understand placebo effects better, for example, but that is research that can and should be the bailiwick of other NIH institutes and centers.

And don’t get me started on Goal 2, which, similarly, is a province of science-based medicine. One might argue that medicine hasn’t done as good a job of developing personalized strategies to promote health and well-being, but the solution to that problem is to emphasize such strategies more in science-based medicine, not to bring in pseudoscience.

The Bad and The Ugly

Let’s take a look at all the strategic objectives. I only discussed Strategic Objective 2 above, but that’s just because I wanted to discuss the least objectionable objective. Actually, in and of itself, Strategic Objective 2 is not objectionable. After all, natural products pharmacology is something I consider fascinating. So here are the five Strategic Objectives in the NCCAM Strategic Plan 2011-2015. Neither would Objective 4 be objectionable if the science were truly rigorous and subject to analyses of Bayesian prior probability before highly improbable modalities like homeopathy or reiki are tested in human beings.

So let’s look at Strategic Objective 5 (Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions). These sound rather benign, don’t they? I mean, who could argue with disseminating “objective, evidence-based information on CAM interventions,” for example? Certainly not me. And I actually do hope that NCCAM does do that, that it really is serious about it. If so, it would tell people that homeopathy is nothing but water, that there is no evidence that reiki practitioners can manipulate a “universal energy field” to heal, and that there’s no scientifically convincing evidence that practitioners of therapeutic touch practitioners can detect or manipulate human energy fields. Let’s look at the key points NCCAM emphasizes about reiki:

  • People use Reiki to promote overall health and well-being. Reiki is also used by people who are seeking relief from disease-related symptoms and the side effects of conventional medical treatments.
  • Reiki has historically been practiced as a form of self-care. Increasingly, it is also provided by health care professionals in a variety of clinical settings.
  • People do not need a special background to learn how to perform Reiki. Currently, training and certification for Reiki practitioners are not formally regulated.
  • Scientific research is under way to learn more about how Reiki may work, its possible effects on health, and diseases and conditions for which it may be helpful.
  • Tell your health care providers about any complementary and alternative practices you use. Give them a full picture of what you do to manage your health. This will help ensure coordinated and safe care.

Pointing out:

Reiki is based on the idea that there is a universal (or source) energy that supports the body’s innate healing abilities. Practitioners seek to access this energy, allowing it to flow to the body and facilitate healing.

Although generally practiced as a form of self-care, Reiki can be received from someone else and may be offered in a variety of health care settings, including medical offices, hospitals, and clinics. It can be practiced on its own or along with other CAM therapies or conventional medical treatments.

I could provide other examples, such as the entry on NCCAM for Ayruvedic medicine. However, perhaps the most instructive example is the entry for homeopathy. A truly science-based assessment of homeopathy would point out that the principles of homeopathy violate multiple well-established laws of physics and chemistry and that, for homeopathy to work, these well-established laws would have to be found not to be just wrong, but spectacularly wrong. It would also point out that, for that to happen, the amount of evidence in support of homeopathy would have to start to approach the level of evidence that tells us that homeopathy can’t work. While NCCAM does concede that homeopathy is “controversial” and that its tenets violate known laws of physics, it does so in a weaselly, wishy-washy way:

Homeopathy is a controversial area of CAM because a number of its key concepts are not consistent with established laws of science (particularly chemistry and physics). Critics think it is implausible that a remedy containing a miniscule amount of an active ingredient (sometimes not a single molecule of the original compound) can have any biological effect—beneficial or otherwise. For these reasons, critics argue that continuing the scientific study of homeopathy is not worthwhile. Others point to observational and anecdotal evidence that homeopathy does work and argue that it should not be rejected just because science has not been able to explain it.

Three of its “key points” about homeopathy are:

  • The principle of similars (or “like cures like”) is a central homeopathic principle. The principle states that a disease can be cured by a substance that produces similar symptoms in healthy people.
  • Most analyses have concluded that there is little evidence to support homeopathy as an effective treatment for any specific condition; although, some studies have reported positive findings.
  • There are challenges in studying homeopathy and controversies regarding the field. This is largely because a number of its key concepts are not consistent with the current understanding of science, particularly chemistry and physics.

Yes, NCCAM presents a classic “tell both sides” false equivalence argument. On the one hand, established laws of science tell us homeopathy can’t work. On the other hand, anecdotal evidence tells us it does work and therefore we should study it. Never mind that the two principles upon which homeopathy is based (“like cures like” and the law of infinitesimals) have no real basis in science, particularly the law of infinitesimals, which states that diluting and succussing a remedy to the point where not a single molecule is likely to remain somehow makes it stronger.

This brings us to the meanest, ugliest, nastiest one, the meanest Strategic Objective of them all, Strategic Objective 1 (Advance Research on Mind and Body Interventions, Practices, and Disciplines). Personally, I find it telling that this is Objective 1 on the list, and NCCAM even lists examples of CAM mind-body interventions:

  • Acupuncture
  • Breath practices
  • Meditation
  • Guided imagery
  • Progressive relaxation
  • Tai chi
  • Yoga
  • Spinal manipulation
  • Massage therapy
  • Feldenkreis method
  • Alexander technique
  • Pilates
  • Hypnosis
  • Trager psychophysical integration
  • Reiki
  • Healing touch
  • Qi gong
  • Craniosacral therapy
  • Reflexology

Here’s the “bait and switch” again. If NCCAM had restricted itself to modalities that, right or wrong, fall under “mind-body” interventions, such as meditation, guided imagery, breathing practices, hypnosis, and the like, I would have had little problem with proposing to study them as a major strategic initiative of NCCAM. Unfortunately, that’s not what NCCAM did. Notice how NCCAM also throws in there all manner of pure quackery, such as reiki, healing touch, craniosacral therapy, and even reflexology. Seriously, reflexology! You know, the idea that every organ and part of the body “maps” to parts of the foot or hand, an idea that is not supported — and, in fact, is contradicted — by what we know about human anatomy and physiology. Placing these forms of quackery next to forms of interventions such as guided imagery that could well turn out to be science-based and useful implies, either wittingly or unwittingly, that “mind-body” interventions already known to be quackery are somehow worthy of study. Also note how NCCAM includes modalities like Tai Chi, yoga, and Pilates in the mix as well. These are, in essence, forms of relatively gentle exercise, at least for most people. (Yes, I realize that some yoga workouts can become quite intense.) What makes them more “mind-body” than other forms of low impact exercise? Finally, I’m really puzzled about the inclusion of massage therapy on this list. No doubt about it, massages feel good, and they are probably even useful for some musculoskeletal disorders, but what makes massage therapy a “mind-body” interaction? It’s a body-body interaction!

In fact, this very list looks to me like a blurring of the line between things that might be true mind-body interventions (meditation, progressive relaxation, guided imagery, etc.) and so-called “energy medicine” (reiki, healing touch or therapeutic touch, acupuncture, and qi gong). In fact, this is intentional, as there is a notice after the list that states, “As used in this plan, mind and body encompasses interventions from the three domains of mind/body medicine, manipulative and body-based practices, and energy medicine.” The problem here is that certain forms of what is called “mind-body” medicine might actually have value, whereas “energy healing” is pure religion or pseudoscience. Yet they are lumped together.

Truly, Strategic Objective 1 is The Bad and The Ugly.

It’s also evidence that neither Dr. Briggs nor the NCCAM leadership understand the problem that is at the heart of CAM. For example, look at this statement from Dr. Briggs in her introduction:

My experience as a physician who has cared for patients struggling with chronic, painful, and debilitating symptoms greatly informs my perspective on our work. When I began medical school, one of my teachers taught that “the secret of care of the patient is in caring for the patient.”* I took these words to heart. Symptoms matter, and few would dispute the fact that modern medicine does not always succeed in alleviating them. Few would also dispute the need for better approaches for encouraging healthy lifestyle choices. These are places in which I believe CAM-inclusive approaches offer promise, and I look forward to exploring the possibilities in the years ahead.

No one, of course, is arguing that symptoms don’t matter, although I note with some amusement that some CAMsters might not be too happy with Dr. Briggs’ emphasis on symptoms given how they like to claim that “Western medicine” treats only the symptoms and CAM treats the “root cause” of disease. Be that as it may, upon reading this, I can’t help but ask: How can “CAM-inclusive” practices offer promise above and beyond science-based medicine in encouraging healthy lifestyle choices, particularly when so much of CAM bases its recommendations on a prescientific understanding of how the body works? You have to know what the body needs before you can encourage healthy choices, and to a large degree we already do know what most American bodies need: More exercise, more fruits and vegetables in their diets, and less fat and calories. To add to that knowledge, we don’t need CAM. We need science-based medicine. More importantly, I would wonder on what evidence, specifically, Dr. Briggs bases her assessment.

Inquiring minds want to know!

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Randi issues a challenge

Lest I be left out of the fun, I can’t help but point out that yesterday the Amazing One himself, James Randi, issued a challenge to manufacturers of homeopathic remedies and retail pharmacies that sell such remedies, in particular large national chains like Walgreens and CVS and large national chains that include pharmacies in their stores, such as Walmart and Target. This was done in conjunction with the 10:23 Challenge, which is designed to demonstrate that homeopathy is nonsense. All over the world, skeptics and supporters of science-based medicine gathered to engage in overdoses of homeopathic medicines in order to demonstrate that there is nothing in them.

As much as I like Randi, unfortunately, I doubt that the prospect of winning $1 million will make much difference to huge companies like Boiron (a French company that manufactures popular homeopathic remedies), Walmart, or Walgreens, but I do like the spirit of the protest, in particular how it drives home a very simply message about homeopathy: There’s nothing in it.

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