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
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
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
Harvard Medical School Adviser: How to winterize skin? – Detroit Free Press
Harvard Medical School Adviser: How to winterize skin? Detroit Free Press This lack of moisture can be caused by frequent bathing, use of harsh soaps, aging or certain medical conditions. Winter poses a special problem. ... |
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.
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.
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.
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.
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.
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:
- Strategic Objective 1: Advance Research on Mind and Body Interventions, Practices, and Disciplines
- Strategic Objective 2: Advance Research on CAM Natural Products
- Strategic Objective 3: Increase Understanding of “Real-World” Patterns and Outcomes of CAM Use and Its Integration Into Health Care and Health Promotion
- Strategic Objective 4: Improve the Capacity of the Field To Carry Out Rigorous Research
- Strategic Objective 5: Develop and Disseminate Objective, Evidence-Based Information on CAM Interventions
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!
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.
Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes
NB: This is a partial posting; I was up all night ‘on-call’ and too tired to continue. I’ll post the rest of the essay over the weekend, when this note will disappear.
Review
This is the fourth and final part of a series-within-a-series* inspired by statistician Steve Simon. Professor Simon had challenged the view, held by several bloggers here at SBM, that Evidence-Based Medicine (EBM) has been mostly inadequate to the task of reaching definitive conclusions about highly implausible medical claims. In Part I, I reiterated a fundamental problem with EBM, reflected in its Levels of Evidence scheme, that although it correctly recognizes basic science and other pre-clinical evidence as insufficient bases for introducing novel treatments into practice, it fails to acknowledge that they are necessary bases. I explained the difference between “plausibility” and “knowing the mechanism.”
I showed, with several examples, that in the EBM lexicon the word “evidence” refers almost exclusively to the results of clinical trials: thus, when faced with equivocal or no clinical trials of some highly implausible claim, EBM practitioners typically declare that there is “not enough evidence” to either accept or reject the claim and call for more trials—although in many cases there is abundant evidence, other than clinical trials, that conclusively refutes the claim. I rejected Prof. Simon’s assertion that we at SBM want to “give (EBM) a new label,” making the point that we only want it to live up to its current label by considering all the evidence. I doubted Prof. Simon’s contention that “people within EBM (are) working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”
In Part II I responded to the widely held assertion, also held by Prof. Simon, that there is “societal value in testing (highly implausible) therapies that are in wide use.” I made it clear that I don’t oppose simple tests of basic claims, such as the Emily Rosa experiment, but I noted that EBM reviewers, including those employed by the Cochrane Collaboration, typically ignore such tests. I wrote that I oppose large efficacy trials and public funding of such trials. I argued that the popularity gambit has resulted in human subjects being exposed to dangerous and unethical trials, and I quoted language from ethics treatises specifically contradicting the assertion that popularity justifies such trials. Finally, I showed that the alleged popularity of most “CAM” methods—as irrelevant as it may be to the question of human studies ethics—has been greatly exaggerated.
In Part III I continued to argue against trials of implausible methods. I didn’t share Prof. Simon’s optimism, expressed in another post on his blog, that “research can help limit the fraction of CAM expenditures that are inappropriate.” I argued that whatever evidence there is suggests otherwise. I argued that if existing science is sufficient to reject a method, as is the case for much of “CAM,” then the research has already been done, and the task of EBM is to explain this kind of evidence—not to pretend that the jury is still out. I argued, furthermore, that efficacy trials of highly implausible, ineffective methods inevitably yield equivocal, rather than merely disconfirming results, and that this leads to an endless cycle of further (equivocal) trials. I offered parapsychology as a longstanding example of such an “an immortal field of fruitless inquiry: a pathological science.”
I promised that in this final part of the series I would mention a few more points about Cochrane Reviews of highly implausible methods, and even report some reasons for slight optimism. Finally, I promised to respond briefly to this comment by Prof. Simon:
…how can we invoke scientific plausibility in a world where intelligent people differ strongly on what is plausible and what is not? Finally, is there a legitimate Bayesian way to incorporate information about scientific plausibility into a Cochrane Collaboration systematic overview(?)
Cochrane Reviews
The ongoing theme is that Cochrane Reviews ignore key ‘external’ evidence, by which I mean all evidence other than what might be found in randomized, controlled trials (RCTs). I’ve previously alluded to the 2002 Cochrane Review of “Chelation Therapy for Atherosclerotic Cardiovascular Disease,” which concluded,
At present, there is insufficient evidence to decide on the effectiveness or ineffectiveness of chelation therapy in improving clinical outcomes of people with atherosclerotic cardiovascular disease.
Elsewhere we have shown that the evidence against such effectiveness is substantial, far exceeding the evidence against Laetrile for cancer or against bilateral ligation of the internal mammary arteries for coronary disease, two long-since discredited methods that no biomedical researcher in his right mind would consider resurrecting for further trials. Oops, make that almost no biomedical researcher.
Quips aside, my reason for bringing up the chelation review again is as follows. The review acknowledges that there have been RCTs, involving about 250 subjects, which
…showed no significant difference in the following outcomes: direct or indirect measurement of disease severity and subjective measures of improvement.
That those findings weren’t sufficient reasons for the Cochrane reviewers to judge chelation ineffective was apparently due first to their having ignored the abundant non-RCT evidence, and second to their having been intrigued by a single, tiny RCT that reported a positive outcome:
One of the studies, which included only 10 participants, was interrupted prematurely, because of an apparent treatment effect. However, relevant data were not available in the report and have been requested from the authors.
I had to chuckle when I read that passage, because I know a lot about that study and its authors. If you look here and scroll down to “Olszewer (1988),” you will know, too. I wonder if the Cochrane Reviewers ever got a straight story from the authors. There hasn’t been an update of that review, so whether they did or not is anyone’s guess.
I’m sorry to say that I haven’t been able to get a copy of that review in its entirety, so my comments apply only to the abstract. I have recently obtained a few other complete reviews, of which two are worth mentioning. A 2008 review of “Touch therapies for pain relief in adults” looked at Healing Touch, Therapeutic Touch, and Reiki. It doesn’t mention the Emily Rosa experiment. Its conclusion is what we’ve come to expect:
Touch therapies may have a modest effect in pain relief. More studies on HT and Reiki in relieving pain are needed. More studies including children are also required to evaluate the effect of touch on children.
In this review we are told why it is that not touching is called “touch”:
Touch Therapies are so-called as it is believed that the practitioners have touched the clients’ energy ?eld.
For readers who are unfamiliar with such practices, which consist of waving one’s hands over a “client” (you really have to see it to believe it), the review continues:
It is believed this effect occurs by exerting energy to restore, energize, and balance the energy ?eld disturbances using hands-on or hands-off techniques (Eden 1993). The underlying concept is that sickness and disease arise from imbalances in the vital energy ?eld. However, the existence of the energy ?eld of the human body has not been proven scienti?cally and thus the effect of such therapies, which are believed to exert an effect on one’s energy ?eld, is controversial and lies in doubt.
Indeed. The following passages are not to be read in detail, other than by the masochistic. Their purpose is to demonstrate the elaborate wheel spinning that EBM treatments of such fanciful methods inevitably involve. The perseveration of statistics, as if they can support the house of cards that is the basis for the technique, will, I hope, ruffle Prof. Simon’s own energy field:
Types of touch therapies
The effects of different kinds of Touch Therapies were examined (Comparison 3). It appears that all three types of Touch Therapy, HT, TT and Reiki, may decrease pain to a certain extent. Substantial heterogeneity exists among the HT group and TT group. The HT group (163 participants) had an I2 of 76% and a P value= 0.04 (Chi-square) and the TT group (686 participants) had an I2 of 70% and a P value < 0.00001 (Chi-square). The results for both the TT and the HT group indicate that there is signi?cant heterogeneity and that the effects were positive. There were two studies in HT included in the analyses (Cook 2004; Post-White 2003). The pooled results showed that participants exposed to HT had, on average, 0.71 units less pain, however, this was not statistically signi?cant (95% CI: -2.27 to 0.86). The pooled estimates of TT suggested a statistically signi?cant result of 0.81 units (95% CI: -1.19 to -0.43) less pain in the exposed group. Nonsigni?cant heterogeneity was detected in the Reiki group (116 participants) which consisted of three studies (Dressen 1998; Olson 2003; Tsang 2007) with an I2 of 7% and a P value = 0.34 (Chi-square). The pooled estimates of the results for Reiki reported a statistically signi?cant effect. Participants exposed to Reiki had an average of 1.24 (95% CI: -2.06 to -0.42) less pain.
Experience of practitioner
The experience of the practitioner on the effects of touch therapies was also analyzed. This helped to explore whether a less experienced touch practitioner would result in less effect and an experienced touch practitioner would result in an increased effect. Subgroup analyses were thus performed. There are usually four levels of training in HT, TT and Reiki, level I, II, III and a master level or teacher level. Studies were divided into subgroups according to the level of training. Due to a small number of studies having reported the experience of touch practitioners, studies were divided into two groups, level I and II , and level III or above, rather than four groups. Four studies were included in the subgroup of less experienced practitioners (212 participants) (Blank?eld 2001; Cook 2004; Frank 2003; Redner 1991). An I2 of 2% and a P value = 0.38 (Chi-square) was found. In the subgroup of more experienced practitioners (116 participants), three studies were included (Dressen 1998; Olson 2003; Tsang 2007) and an I2 of 7% and a P value = 0.34 (Chi-square) was found. No signi?cant heterogeneity was detected in the two subgroups. Participants in the subgroup of less experienced practitioners had, on average, 0.47 units (95% CI: -0.73 to -0.22) less pain. More experienced practitioners yielded higher contribution, having on average of 1.24 units reduction in pain intensity (95% CI: -2.63 to -0.23) (Comparison 4). Minor non-signi?cant heterogeneity existed in both the experienced and less-experienced group. This might suggest that any heterogeneity calculated in other subgroups was owing to the difference in the experience of the practitioners. However, only a small number of identi?ed studies were included in this subgroup and the apparent small heterogeneity may be owing to the low power of the chi-square test or due to having a small numbers of studies (Higgins 2005), it would not be appropriate to make conclusions about the existence of heterogeneity at this stage with the current results.
Dose-response analyses
Dose-response analyses were also conducted to investigate if there was any difference in effect due to differences in duration of treatment. The study with the shortest session had the session lasting for ?ve minutes while studies with the longest session lasted for ninety minutes. The number of treatment sessions ranged from a single session to ten sessions. Data regarding the duration and number of treatment sessions were pooled. Data were analyzed in terms of total duration of treatment (duration of a single session multiplied by the number of treatment sessions). Three hundred and ninety six participants exposed to touch for less than an hour had an average of 1.16 units (95% CI: -1.85 to -0.47) less pain; 239 participants exposed to touch for more than one hour but less than two hours had an average of 0.75 units (95% CI: -1.81 to 0.31) less pain, but this was insigni?cant; 255 participants exposed to touch for between two to three hours had an average of 0.47 units (95% CI: -1.09, 0.14) less pain; 116 participants exposed for over three hours to touch therapies had an average of 1.57 units less pain (95% CI: -2.38 to -0.76). No dose-response relationship can be gained as yet from this information (Comparison 7).
Phew! (‘Dose-response analyses’ ?). At the end of the monograph are the first author’s acknowledgements:
I would like to thank Dr Yan-Kit Cheung, who is my Reiki teacher and an expert in complementary and alternative medicine, in giving me valuable advice in conducting this review…Last but not least, I would like to express my gratitude to Miss Wan-Choi Patsy Lee who brought me to Reiki. Without her, I would know nothing about Reiki and would not be enlightened by this precious gift.
I don’t know who should be more embarrassed: Cochrane, for having asked a devout believer to pass judgment on the sacred object of her belief, or me, for having stumbled upon her supplication.
…
*The Prior Probability, Bayesian vs. Frequentist Inference, and EBM Series:
1. Homeopathy and Evidence-Based Medicine: Back to the Future Part V
2. Prior Probability: The Dirty Little Secret of “Evidence-Based Alternative Medicine”
3. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued
4. Prior Probability: the Dirty Little Secret of “Evidence-Based Alternative Medicine”—Continued Again
5. Yes, Jacqueline: EBM ought to be Synonymous with SBM
6. The 2nd Yale Research Symposium on Complementary and Integrative Medicine. Part II
7. H. Pylori, Plausibility, and Greek Tragedy: the Quirky Case of Dr. John Lykoudis
10. Of SBM and EBM Redux. Part I: Does EBM Undervalue Basic Science and Overvalue RCTs?
11. Of SBM and EBM Redux. Part II: Is it a Good Idea to test Highly Implausible Health Claims?
12. Of SBM and EBM Redux. Part III: Parapsychology is the Role Model for “CAM” Research
13. Of SBM and EBM Redux. Part IV: More Cochrane and a little Bayes
Complementary and alternative medicine in hospice care
A number of news outlets (e.g. Bloomberg Business Week, MSN.Com, US News, etc) have recently reported that use of complementary and alternative therapies (CAT) is widespread in hospice care facilities. This is based on a report from the Centers for Disease Control, Complementary and Alternative Therapies in Hospice: The National Home and Hospice Care Survey, Untied States, 2007. According to most news reports, about 42% of hospice care providers offer some kind of CAT.
I was initially inclined to find this a little worrisome. In my own field of veterinary medicine, advocates of alternative therapies are prominent among the organizers of the nascent hospice care movement. And while I am strongly supportive of better and more available veterinary hospice care, the involvement of CAM advocates raises the concern that animals at the end of their life might receive ineffective palliative care, or be denied the benefits of conventional treatments by some CAM providers, who often characterize “allopathic” treatments as “unnatural” and harmful.
In practice, I have seen this happen to patients with terminal diseases. I will never forget a Rottweiler dog I diagnosed with osteosarcoma, a very painful bone cancer, whose owner was convinced that homeopathy was adequate to control his pain and refused to use NSAIDs because of her conviction they were “toxic.” I have also seen my patients denied euthanasia even in the face of great suffering because so-called “animal communicators” claimed the pet was “not ready to leave” and had expressed a desire to remain with their owner as long as possible.
Perhaps these experiences have made me overly sensitive on this subject, but I saw these recent news reports and pictured people at the end of their lives being similarly denied effective palliative care or subjected to pointless therapies like homeopathy and “energy medicine,” or even more worrisome treatments like chiropractic or herbal remedies with real risks. However, a little digging into the details suggests that the headlines are a bit misleading, and these fears are probably unfounded.
As always, when trying to assess how popular alternative medical therapies are, the tricky issue arises of defining “alternative.” In this study, the authors referenced the MedlinePlus definition:
Complementary and alternative medicine (CAM) is the term for medical products and practices that are not part of standard care. Standard care is what medical doctors, doctors of osteopathy and allied health professionals, such as registered nurses and physical therapists, practice. Alternative medicine means treatments that you use instead of standard ones. Complementary medicine means nonstandard treatments that you use along with standard ones. Examples of CAM therapies are acupuncture, chiropractic and herbal medicines.
Personally, I prefer Dr. Novella’s definition:
CAM is a political/ideological entity, not a scientific one. It is an artificial category created for the purpose of promoting a diverse set of dubious, untested, or fraudulent health practices. It is an excellent example of the (successful) use of language as a propaganda tool.
In any case, in order to measure the popularity of something, one has to define it in some way, and in the past assessments of how popular or widespread CAM use is have created misleading impressions due to dodgy definitions. For example, the 2007 National Health Interview Survey (discussed in detail here) reported 30% of Americans to be regular CAM users. A closer look at the details of the survey, however, showed that very little of this self-reported usage involved the application of the usual dubious CAM approaches (e.g. acupuncture, chiropractic, homeopathy, various herbal traditions, etc) to treat specific medical problems. Much of this supposed CAM usage involved the non-medical application of massage, yoga, tai chi, prayer, and so on to provide psychological comfort or facilitate relaxation.
Of course, if one argues that massage, yoga, or even prayer are effective in reducing the objective signs or disease, or even bringing about a cure, then one could argue these are forms of alternative medicine. But such methods are mostly employed to provide comfort and help patients cope with their illness, and as such they can be valuable and legitimate interventions. This does not make them medical therapies, however, alternative or otherwise.
The hospice care survey suffers from the same kind of problematic definition for “complementary and alternative.” According to the report’s technical notes, providers of hospice care were asked first to choose all the services they offered from a list, and “Complementary and Alternative Medicine (CAM)” was one of the choices. Those that indicated they offered CAM were then asked to indicate “Which of these complementary and alternative medicine therapies does this agency use?”
Here is the list:
- Acupuncture
- Aromatherapy
- Art therapy
- Guided imagery or relaxation
- Massage
- Music therapy
- Pet therapy
- Supportive group therapy
- Therapeutic touch (a westernized version of reiki)
- TENS (Transcutaneous Electrical Nerve Stimulation)
- Other
Personally, I see little on this list that I would classify as CAM. Acupuncture, certainly, along with therapeutic touch (like reiki) and aromatherapy. But most of the rest, unless specifically marketed as treatments for disease, seem more like benign, pleasurable activities designed to provide comfort, relaxation, and enjoyable stimulation. As a veterinarian, I work with a lot of pet therapy dogs, and I have yet to run across a handler of one who thought they were practicing alternative medicine! (Though I suppose there might be some such folks out there). And TENS is a perfectly conventional intervention, often somewhat disingenuously confused with acupuncture.
The most popular of the “true” CAM therapies offered was therapeutic touch, available at 48.3% of facilities. Aromatherapy was offered by 39.7% of hospice providers. I cannot even find a number for acupuncture in the report. And by far the most popular “alternative” therapies offered were massage (71.7%), group therapy (69%), music therapy (62.2%), and pet therapy (58.6%).
The report also indicates that only 8.6% of patients discharged from a hospice facility that offered CATs actually received one of these therapies. So even under such a loose definition of alternative, there is no evidence that large numbers of hospice patients are receiving alternative medical treatments.
It wouldn’t surprise me if we begin to see advocates of alternative medicine proclaiming that this report shows CAM is widely available, popular, and even indispensible in hospice care. The 2007 National Health Interview Survey results were frequently used this way to create the impression that CAM is becoming mainstream and that resistance to it is the province of extremists and ultimately futile. The details of both surveys, however, indicate that even with aggressive expansion of the definition of CAM to include conventional therapies such as TENS and non-medical interventions like pet therapy, CAM is not truly as popular ubiquitous as its proponents claim.
There is little objectionable from a science-based medicine perspective in most of the therapies hospice care providers are offering, according to this study. I enjoy a good massage, relaxing music, and the company of a friendly dog as much as anyone. And those elements that are truly nonsense, such as therapeutic touch and aromatherapy, are unlikely to do harm or replace appropriate conventional therapies, and they seem in any case not to be especially popular with patients even when they are available. So regardless of what PR use is made of this study, it does not suggest that human hospice care is becoming predominantly the domain of CAM providers, as I might have feared. I only hope the same will be true of veterinary hospice care as that becomes, hopefully, more commonplace.
Dr. Mehmet Oz completes his journey to the Dark Side
A couple of weeks ago, both Steve Novella and I criticized Dr. Mehmet Oz (a.k.a. “America’s doctor”) for not only hosting a man I consider to be a major supporter of quackery, but going far beyond that to defend and promote him. After that, I considered Dr. Oz to be a lost cause, with nothing to excuse him for his having embraced a man whose website is a wretched hive of scum and quackery almost as wretched as NaturalNews.com (in my opinion, of course). Unfortunately, apparently Dr. Oz’s defense of Dr. Mercola was only the beginning of the end of whatever minimal credibility Dr. Oz had left as a practitioner of evidence-based medicine.
This week, Dr. Oz put the final nails in the coffin of his credibility as a practitioner of science-based medicine. I realize that some would argue that he did that long ago. Fair enough. However, I always held out some hope that he might stop mixing pseudoscience like reiki with science. Then he embraced Dr. Joseph Mercola. Strike one! Unfortunately, strikes two and three followed over the last week or so.
Dr. Oz embraces the “bait and switch” of alternative medicine.
One message that we’ve been trying to get SBM readers to understand is that much of what falls under the rubric of “alternative” medicine, “complementary and alternative medicine” (CAM), and “integrative medicine” (IM) is in reality a fairly obvious “bait and switch,” as Steve Novella put it so well. The bait consists of various modalities that naturally fall into the bailiwick of science-based medicine (SBM)–or at least should. These modalities include diet, exercise, relaxation. Indeed, it irritates me to no end when various apologists and advocates for CAM claim that science-based physicians don’t recognize the importance of diet and exercise or how they can have a profound effect on health, in particular on diseases like type II diabetes. I ranted about this not long ago when i wrote about the woo of raw “living food” diets, in which “living food” advocates claim that it requires extreme raw vegan diets to “cure” diabetes. Diet and exercise are every bit a part of science-based medicine; yet CAMsters appropriate them as being somehow “alternative,” the better to bring in the real woo along with them. The pitch is, in essence, that diet and exercise clearly work and are “alternative.” Therefore there must be something to other forms of “alternative” medicine. That’s the “switch” in the bait and switch. Nowhere is this switch better demonstrated than in a segment from The Dr. Oz Show last week called Dr. Oz’s Holistic Health Overhaul.
At the beginning of part 1 of this segment, Dr. Oz appears on stage and announces his “holistic health overhaul.” What strikes me is that what Dr. Oz is supposedly “overhauling” is based on people who feel run down, who lack energy, who feel older than they are, symptoms virtually all of us feel at one time or another to one degree or another. (How is one supposed to know if one feels his or her age, anyway?) Right from the start, Dr. Oz promises that he can make you feel younger and better, all within 28 days. To do this, he immediately introduces a yoga instructor named Yogi Cameron Alborzian, who pontificates about spirituality, yoga, and how he became a yogi. As is typical for such practitioners, there are many softly lit and fuzzy shots of Yogi Cameron doing yoga poses in beautiful, natural surroundings (of course!) interspersed with shots of him talking about “mind-body” connections and how he asks his clients what they’re feeling.
In part 2, Patricia from New Jersey is introduced. Patricia is a stay-at-home mother of four boys, who describes herself as feeling “toxic, tired, and stressed-out.” Patricia’s biggest problem, according to her, is that she’s a self-admitted “junk food junkie” who doesn’t exercise. She also complains of sluggishness, feeling “hung over,” and wiped out. In response to her complaints, Yogi Cameron and Dr. Oz show Patricia her health risks, pointing out that her body mass index qualifies her as obese and that her waist size suggests that most of her fat is in her abdomen, which is known to be a risk factor for type II diabetes and a variety of other health problems. Basically, the problem is laid out. It’s (mostly) science-based. Unfortunately, the solution is a mixture of woo and science-based diet and lifestyle changes. That’s the bait. Enter Dr. Oz and Yogi Cameron and his “holistic health overhaul” in part 3 and part 4. Here’s where the switch comes in.
First, let me show why the woo that flows is not a surprise at all by referring you to Yogi Cameron’s own website and a promotional video for a book he’s written:
We learn that Yogi Cameron was a fashion model for several years and even was cast in what looks like the video for Madonna’s song Express Yourself. (He’s the buff, sweaty, half-naked worker seduced by Madonna near the end of the video.) Also on his website, Yogi Cameron opines about Ayruvedic medicine, referring to it as the “science of life”:
Before Western medicine, before homeopathic medicine, and before even traditional Chinese medicine, there was Ayurveda. This is an ancient system of healing created by sages in India over five thousand years ago. While yoga was developed as a science for the practitioner to bring balance and control to the mind, Ayurveda is a sister science developed for the practitioner to bring balance to the body.
Western medicine tends to treat a patient’s symptoms with different pills and medications without any attention to healing the cause of a disease that is feeding the symptom. It is like weeding a garden without taking out the roots; the weeds just grow back. Ayurveda works to define the cause of the patient’s symptoms and to treat the body with various methods for the sake of restoring balance to the system as a whole. These methods include eating in a way appropriate to one’s constitution, taking herbal supplements and remedies, and receiving treatments such as oil massage. Effective use of Ayurveda can help to alleviate digestive problems, allergies, insomnia, asthma, obesity, migraines, and many other bodily complaints.
The ancient sages who developed Ayurveda many centuries ago observed that our bodies are formed by three fundamental energy types or doshas. The first (Pitta) is responsible for metabolizing for the sake of processing oxygen and perpetuating life. The second (Kapha) forms our bodies, which serves as a container so that life can exist as matter. The third (Vata) shifts matter’s position in space through the act of motion.
And this is how Yogi Cameron treats his clients’ problems:
Through other Ayurvedic treatments such as Pancha Karma we also clean the inside of the body. Cleaning the inside of our system is fundamental to our wellbeing and without such cleanings we can never experience complete health and vitality, youth and vigor. When the inside of the body is clean we experience young skin and vibrate energy on the outside.
For those of you who don’t know what Pancha Karma is, it the name for five actions that make up an Ayruvedic method to purify the body. There are three stages of treatment. First, there is the pretreatment, which consists of oil therapy, massage, and something called formentation therapy. This part actually doesn’t sound too bad. Whether it cures anything or not, who knows? However, having your body oiled up and massage can’t be all bad. The formentation therapy is basically heat, either steam from herbs, sitting under the sun, or using warm blankets. Of course, this latter treatment, depending on what it is used for, is a perfectly fine science-based treatment. Be that as it may it’s the next part of the Pancha Karma that is supposed to do the purification. This consists of Nasya (nasal therapy), Vamana (emesis or vomiting), Virechana (purging) and two kinds of Vasti (therapeutic enema), Nirooha Vasti and Sneha Vasti.
Enemas? What is it with enemas? Truly, enemas seem to be the woo that knows no national or ethnic boundaries, the quackery that is truly world-wide. Fortunately, there does appear to be an alteration to this ancient art of purging in America:
Originally, this phase consisted of five practices: nasal cleansing, enemas, laxatives, emesis (vomiting), and blood-letting. Although the five practices are followed in India, the practice of emesis and blood-letting is omitted in North America.
I suppose we should be grateful for small favors in that the bloodletting is left out by our very North American woo-meisters. Dr. Oz then reveals the “switch,” describing week 1 of this plan as “detox.” For his part, Yogi Cameron helpfully chimes in that his methods “burn off toxins.” Dr. Oz then immediately asks Yogi Cameron about tongue examination. Now, there’s one thing you need to know about tongue examination. When an Ayruvedic practitioner or a practitioner of traditional Chinese medicine talks about tongue examination, he is not referring to the sorts of things I learned in medical school about tongue examinations, where we look for turgor, moistness, plaques, and a variety of other physical findings that can be indicative of disease. No, the Ayruvedic art of tongue diagnosis is very much like reflexology in that various organs are claimed to map to various parts of the tongue:
To be fair, some of the tongue diagnoses actually do agree with science-based medicine, for example, a yellow tongue being indicative of jaundice. However, someone with jaundice will also usually have yellow visibile in their sclerae, which are probably more sensitive. In reality, the Ayruvedic tongue diagnoses that match science-based medicine diagnoses are actually a classic case of being right for all the wrong reasons, and most of them are wrong, wrong, wrong, particularly the mapping of various organs to different parts of the tongue. Not that that stops Yogi Cameron from proclaiming that the “head is represented by the tip of the tongue.”
I will admit that there is one mildly amusing part of this entire segment. Yogi Cameron has a rather strong disagreement about the amount of sex people should have. Yogi thinks that people shouldn’t have sex too much; Dr. Oz is apparently a randy little bugger and thinks people should have sex all the time, the thought of which is an image I don’t want in my head. Be that as it may, one thing that strikes me about this argument is that it appears to be vitalistic in nature. Yogi Cameron claims you shouldn’t have too much sex because it’s about “conserving energy,” in essence implying that sex somehow saps your life energy. This is not unlike various pre-scientific beliefs that semen is the equivalent of life energy, which is why men shouldn’t have sex before battle, athletic contests, or anything that’s likely to require a large energy expenditure.
At this point, the “bait and switch” is complete. Dr. Oz had presented the story of a typical middle class mother who works hard, doesn’t eat right, is a bit obese, and as a consequence of her lack of exercise, her work, and her poor diet feels run down all the time. A perfectly fine science-based solution to her problems would involve a change in diet to something healthier, cutting out the junk food, and adding regular exercise (all things that I myself have a lot of problem managing to do, truth be told). Instead, what Dr. Oz and his guest Yogi Cameron present is an improved diet, plus yoga, plus woo that includes tongue diagnosis, “detox,” and “Nasya lite” (given that all Yogi Cameron had Patricia do was to place some Ghee in her nose, rather than shooting water in and out of it). At least he spared her the purging and enemas, but I bet if Patricia had come to Yogi Cameron’s center those would have been part of the mix. But there’s enough there, even the classic favorite of apologists for Ayruveda and traditional Chinese medicine, the appeal to ancient wisdom, the claim that, if people have been doing this for thousands of years, there must be something to it, they must know something we don’t.
Strike two!
To mix baseball and Star Wars metaphors (hmmm, light sabers instead of bats?), Dr. Oz has two strikes against him now, but is his journey to the Dark Side complete? He’s certainly controlled his message, but has he fully released his woo? Unfortunately, Tuesday’s episode this weeks demonstrates that Dr. Oz has truly become the master of woo.
Dr. Oz: Falling for faith healing
To abuse my Star Wars metaphors yet again, if Dr. Oz’s featuring of Yogi Cameron on an episode of his show last week was the equivalent of Anakin Skywalker slaughtering a tribe of Tusken raiders for having tortured and killed his mother Shmi, Tuesday’s episode was Anakin cum Darth Vader hitting the Jedi temple with a bunch of storm troopers and slaughtering all the younglings. Either that, or it was Anakin cutting off Mace Windu’s hand, allowing Emperor Palpatine the opening he needed to kill Windu. Take your pick. In other words, Dr. Oz’s credulous treatment of faith healing definitively marks the point of no return, the point at which Dr. Oz’s journey to the Dark Side is now complete. All he needs is a Darth Vader mask. Or maybe a mask of Samuel Hahnemann. Or something.
The reason Tuesday’s episode definitively marks a point of no return for Dr. Oz when it comes to his support for quackery is because he has apparently decided to follow his TV mentor Oprah Winfrey’s example in realizing that faith healing sells. Of course, Dr. Oz, as popular as he is, is not as well established as Oprah. Whereas Oprah got John of God, complete with his “psychic surgery,” Dr. Oz gets a second tier faith healer. He gets Dr. Issam Nemeh. Of course, Dr. Oz is a surgeon; so maybe he is less easily taken in by parlor tricks in which tiny superficial incisions are made. Or maybe not. Just being a physician does not guarantee not being taken in by faith healing nonsense, as we’ve seen many times. In any case, Dr. Nemeh must be very grateful to Dr. Oz, because when you look at his website, you’ll be greeted with a message:
Welcome Dr. Oz Viewers!
Dr. Nemeh has received an overwhelming response from the viewers of the Dr. Oz show. Medical office appointments with Dr. Nemeh are already filled for the next four months.
To add your name to the cancelation list, send an email with your name, phone number, and reason for treatment to appointments@drnemeh.com.
But how did Dr. Nemeh get so popular suddenly? Behold the power of Dr. Oz and his segment on Tuesday’s show entitled, Is this man a faith healer?
If you recall my discussion of Oprah Winfrey’s utterly credulous treatment of John of God, you might wonder if Dr. Oz did any better than Oprah’s staff and Oprah herself. Going in, I actually expected that Dr. Oz’s segment about Dr. Nemeh would be harder for me to deconstruct. Indeed, I expected it to be much harder to deconstruct. Dr. Oz is, after all, a cardiothoracic surgeon. Also, in the preview for the episode featuring Dr. Nemeh, there was a clip showing Dr. Oz with small pile of charts saying that he had asked to be allowed to examine the medical records of some of Dr. Nemeh’s patients. Given that and given that Dr. Nemeh is a physician himself, I figured that, between the two of them, Drs. Oz and Nemeh would be able to cherry pick cases that would appear truly convincing and thus be very difficult to refute. When that happened, I feared I’d be reduced to saying that single anecdotes are not convincing, which, while true, is a relatively hard sell to lay readers without medical training. Even some physicians remain unsatisfied by such an explanation, and it’s not hard to figure out why. Fortunately for me (and unfortunately for Drs. Nemeh and Oz), I needn’t have worried. You’ll see what I mean in a minute.
The first segment begins, as usual, with Dr. Oz introducing the topic. In this case, Dr. Oz breathlessly proclaims this to be a show “unlike any other we have done before” and describes how he has been “fascinated” by “this doctor in Cleveland.” We’re then shown several people in the audience who claim to have been healed by Dr. Nemeh, who is described as a doctor who doesn’t use drugs or procedures but “heals with his hands.” Dr. Nemeh, we’re told, uses a “high tech form of acupuncture” in his office and the laying on of hands and the use of spirit in churches and meeting halls, all to “heal.” During this voiceover, we’re treated to images of Dr. Nemeh in action, including a paralyzed patient who claims that he’s noticed some movement in his feet since Dr. Nemeh started treating him, a woman who implied that she had her vision restored, and a woman who claims that her multiple sclerosis is gone. Dr. Oz’s chief medical correspondent, Dr. Michael Roizen, tells us that he definitely believes “there’s something here,” and Dr. Nemeh himself proclaims that his goal is to “bridge the gap between science and spirituality.” Certainly, there is a receptive audience among Dr. Oz’s studio audience, as Dr. Oz cites a poll of his audience, which reveals that 86% of them believe in the power of faith to heal.
It’s in this segment when Dr. Oz shows Dr. Nemeh’s stack of medical records. Quite frankly, to me it looks like a pretty darned small stack. Be that as it may, Dr. Oz tells the audience that he’s had his medical staff investigate the cases and that he personally has discussed them with Dr. Roizen. That’s when the interview with Dr. Nemeh begins. Dr. Nemeh, it turns out, is a trained anesthesiologist who in addition to his faith healing activities sees patients at his office in Rocky River (a suburb of Cleveland). As the interview progressed, it became clear that Dr. Nemeh used a lot of different “alternative medicine” modalities in addition to his “electroacupuncture” (which is, of course, not really acupuncture at all, but transcutaneous electrical nerve stimulation, or TENS) and prayer services. Dr. Nemeh, of course, is also represented not just as the Brave Maverick Doctor but as the reviled Brave Maverick Doctor, with even his family disapproving of what he is doing. I can sympathize–with Dr. Nemeh’s family. If one of my siblings were a faith healer, I’d be pretty disapproving and embarrassed too.
In the next part of the segment, Dr. Oz tells the audience to judge for themselves whether Dr. Nemeh is a faith healer on the basis of the patients of Dr. Nemeh’s whose story he will tell. Of course, as an academic surgeon (which Dr. Oz was for a long time before turning to woo and, given that he is still a professor of surgery at Columbia University, technically still is even though he long ago abandoned science in favor of nonsense), Dr. Oz should know that single anecdotes say at best little or nothing and at worst mislead. The plural of “anecdote,” as we say, is not “data.” Yet anecdotes are what he provides–and then only two of them. No science. No statistics. No real detailed case reports. Not even a mention of scientific studies to be presented along with the human interest anecdotes, other than late in the segment, when he mentions the infamous intercessory prayer study that failed to find that prayer works in helping cardiac patients heal after their surgery. All we see are testimonials and utterly unconvincing cherry picked clinical test results.
First up is a woman named Cathy. Cathy is presented as having a mass in her left lung and states that she was “so sick” that she was coughing up blood. A CT scan is presented, which does show a worrisome mass in the lower lobe of the left lung. We are not informed whether Cathy is a smoker, which would have made me even more worried if I were Cathy’s physician. In any case, Cathy describes a two hour visit with Dr. Nemeh, who, she reports, used acupuncture, “infra-ray light” (whatever that is; probably she meant “infrared” light), and prayer to treat her, after which her breathing got much better. Later, a PET scan was ordered, and–miracle of miracles!–the mass was gone. The problem with this anecdote, as regular readers of this blog can probably spot right away, is that there was no tissue diagnosis. In the story, it is implied that the mass was some sort of horrible lung tumor. Yet her doctor violated the cardinal rule of oncology: He never got a tissue diagnosis; it’s unclear if he even tried.
Whatever Cathy’s pulmonologist did or didn’t do, that mass could have had any number of nonmalignant explanations, including tuberculosis, sarcoidosis, focal pneumonia, or fungal infection, to name a few. Whatever it was, if the Cathy’s physician thought it was cancer, he should have gotten a core needle biopsy. Indeed, reading between the lines, I wonder if Cathy’s doctor really thought the mass was cancer. The fact that he ordered a PET scan implied that he thought it might be (although infection can light up on PET as well), but his failure to obtain a biopsy expeditiously implies that he either wasn’t very sure or that he doubted that the mass was cancer.
All in all, it’s a somewhat confusing case, but there is no evidence whatsoever other than the post hoc ergo propter hoc fallacy that, just because Cathy got better after seeing Dr. Nemeh, it must have been Dr. Nemeh’s woo that cured her. To be fair, Dr. Oz points out the possibility that the mass might have been infectious in nature, but in reality to me he didn’t sound as though he really believed that. In fact, he came across more as playing Devil’s advocate than anything else. Unfortunately, Cathy’s doctor (Dr. Kelly) was not particularly skeptical and served up a custom-made quote that Dr. Oz read on the air, completing the picture of faith healing having cured Cathy.
Next up is a woman named Dr. Patricia Kane, who is introduced as having been diagnosed with idiopathic pulmonary fibrosis (IPF) in 1995, when she was told that she probably had less than five years to live. IPF is a disease in which the lungs develop scar tissue for reasons we don’t understand (hence the label of “idiopathic”), gradually decreasing air exchange. In Dr. Kane’s case, we are informed that she underwent a biopsy that confirmed the diagnosis. We are not really informed whether Dr. Kane has gotten better, but, as you might expect, idiopathic pulmonary fibrosis is a disease with a highly variable rate of progression that can range from a very rapid scarring of the lung with concomitant loss of lung function to slow progression that takes many years or even to long periods of time (years) with no detectable progression. Overall, the five year survival is reported to be between 30% and 50%, with this caveat:
Keep in mind that researchers have noted a considerable variation in these life expectancies based on the factors that were mentioned previously.
We are not told whether Dr. Kane had any of the factors associated with a less malignant course for IPF. I’m left to conclude that she is almost certainly a woman who is fortunate enough to be an “outlier” on the survival curve. Like all such patients who are lucky enough to be outliers and who chose “alternative” medicine, Dr. Kane underwent conventional therapy and Dr. Nemeh’s quackery, after which she did better than predicted and–of course!–attributed her much better than expected outcome to the faith healing. Again, Dr. Oz plays the “skeptic” a little bit (but only a very little bit) by challenging Dr. Kane gently with the possibility that the diagnosis was mistaken, which, while most definitely a possibility, was not the only possibility. More likely is the possibility that, as I mentioned before, Dr. Kane is fortunate enough to be an outlier.
Dr. Oz finishes this segment by interviewing Dr. Jeffrey Redinger. Remember him? He’s the same physician who was taken in by John of God, and he lays down the same sort of barrage of credulous nonsense that he did when he commented on John of God for Oprah Winfrey:
What I think at this point is that we are just not physical beings, we are also spiritual beings, physical beings need oxygen and spiritual beings need love. One research questioned I believe is whether there is a connection between love and healing? That is something that modern science is begining to tiptoe into.
Finally, in the next segment (which, unfortunately, does not appear to be on Dr. Oz’s website), we’re treated to what has to be one of the most pathetic faith healings I’ve ever seen. A woman named Mary Beth is brought up on stage. After she states that she has lower back problems that she attributes to arthritis, Dr. Nemeh does his thing. The best Mary Beth could come up with was that she felt “a little” better afterward. I don’t know about those of you who saw this episode, but I was so not impressed by this “healing” at all. Indeed, I was left scratching my head and thinking, “This is the best Dr. Nemeh could come up with?” You know that if Dr. Nemeh could come up with better cases, he would have brought them with him to Dr. Oz’s studio. For instance, where’s the paralyzed patient who said he was getting some motion back? Why wasn’t his case featured? What about the woman who claims her MS is gone? Why wasn’t she featured? It makes me wonder if the evidence for these patients’ claims is even weaker than the evidence for the “healing” of Dr. Kane or Cathy. Not that any of this stops Dr. Nemeh from proclaiming:
You don’t have to be religious, you don’t have to have faith, you can be an Atheist, what matters is we were talking before about one very important principle, the love that we have. Because the heart of God himself is Love. No you don’t have to have any faith to be healed.
Imagine how relieved I am to hear this. Strike three! Or dip Dr. Oz in a lake of lava and slap a black metal respirator suit on him, whichever metaphor you prefer. Dr. Oz is done.
I often wonder how a man as obviously intelligent and well-trained as a surgeon as Dr. Oz can fall for such utter tripe. In his case, I suspect that it’s become more about the fame, the money, and the image that has developed as “America’s doctor.” Whatever the reason, Dr. Oz’s journey to the Dark Side is complete. When Dr. Oz left Oprah, he was but the learner. Now he is the master. The master of woo. Yes, yes, I know the analogy is flawed in that it inappropriately likens Oprah to being one of the good guys (i.e., Obi-Wan Kenobi), but I just love that line.
Unfortunately, it’s not just Dr. Oz, though, who suffers from a profound lack of skepticism and critical thinking when it comes to medicine. It’s all too many physicians. After all, Cathy’s doctor apparently believed that she had been the beneficiary of some sort of miraculous healing solely on the basis of the thinnest of thin evidence. And he is a pulmonologist! This should serve as a reminder to us physicians that, unless we apply skepticism, science, and critical thinking to our practices, we are just as prone as anyone else to confusing correlation with causation, the post hoc ergo propter hoc fallacy, and, above all, an over-reliance on our own personal experience and anecdotes. Indeed, from my perspective, it is the over-reliance on personal experience and anecdotes that is most prone to leading physicians astray, and physicians have to learn how not to confuse “my clinical experience” with science. Instead of educating about this pitfall, Dr. Oz, sadly, has apparently tried to capitalize on it to promote faith healing and other forms of quackery. In my opinion of course.
Also in my opinion, I’ll try to find different metaphors next time.
The Safety Checklist
During my recent stint covering the Neuro ICU I noticed for the first time a checklist posted above each patient bed. The checklist covered the steps to undergo whenever performing an invasive procedure on the patient. I was glad to see that the checklist phenomenon had penetrated my hospital, although the implementation of safety checklists is far from complete.
A recent study published in the BMJ offers support for the efficacy of using checklists to reduce complications and improve patient outcomes. This is a retrospective study looking at mortality and length of stay in Michigan area ICUs, comparing those that had implemented the Michigan Keystone ICU project (including a safety checklist for the placement of central lines) with local ICUs that had not implemented the project. They found a 10% decrease in overall mortality, but the results were not significant for length of stay. Because this was a retrospective study it was not designed to prove cause and effect, but it is highly suggestive of the efficacy of implementing such checklists.
The checklist trend represents a culture change within medicine – and a good one. This change received its greatest boost with the publication of The Checklist Manifesto by Dr. Atul Gawande. He presents a compelling case for the need and efficacy of using checklists in order to minimize error.
He argues that historically medicine has had a culture of quality control through individual excellence and training. This culture still pervades medicine. Each year, for example, I have to go through a long list of safety and other training – the standard response of the powers that be is to institute a new training and certification program for each new regulation or identified safety issue. Training is good, but increasingly there is recognition that it is not adequate.
The problem, Dr. Gawande points out, is that there are areas of our complex civilization that are too complex for mere humans to adequately master. Or you can look at it from the perspective of minimizing error. Training to deal with a complex system can only minimize error to a certain degree. There are inherent human limitations of memory, attention, and consistency that mean that error will be inevitable. In situations where minor mental errors can have catastrophic consequences (like flying planes or performing major surgery) relying on training alone is folly. In such situations the implementation of a simple checklist can significantly reduce error far below what training alone can. It is a lot easier to remember to follow the checklist than to remember each item on the checklist.
There is no question that medicine is a high stakes and complex game. While I am a strong advocate of science-based medicine, we have to recognize its limitations. The opportunities for catastrophic error in medicine are enormous – from prescribing the wrong medication or dose, to forgetting important steps in a complex procedure, to removing the wrong limb. Even minor errors or oversights can have extreme consequences.
In medicine the overarching consideration of any intervention is risk vs benefit. We only use interventions that have potential benefit that is greater than the potential risk (while also understanding that our information is probability-based and imperfect). Often our knowledge is based upon clinical trials which are highly controlled, and therefore do not have the same risk of error that is likely to exist when implemented in the “real” world outside of a clinical trial. In any case minimizing error is key to minimizing risk and optimizing the risk-benefit ratio of medical interventions.
It seems that we have pushed the limits of training. Medicine has become highly technical, specialized, and complex. While extensive training is necessary, it is no longer sufficient to minimize risk. We are now entering the age of the checklist. This is a simple procedure that can significantly improve human performance. The latest study is further evidence in support of this. A 10% reduction in mortality is highly significant.
A related phenomenon, in my opinion, is the movement toward a team approach to patient care, especially in highly complex cases. There is increasing recognition that group intelligence can vastly outperform individual intelligence, and that a group can be smarter than even its smartest member. Complex or high risk cases can benefit from a team of experts, especially with a variety of specialties, collaborating on care. This is nothing new in medicine – tumor boards and multi-disciplinary clinics have been around for decades. But there is movement toward greater reliance on teams than on individual experts.
This is related to the checklist phenomenon in that both trends represent a movement away from over-reliance on the individual and training to minimize error and maximize performance. Both recognize the crushing complexity of modern medicine, and the need to be humble before this complexity.
To broaden the context further, I think these phenomena represent increasing recognition that we need to pay attention in medicine to how our knowledge is implemented, not just to the acquisition of greater knowledge. Pushing the limits of medical knowledge is, of course, incredibly important. But we also have to pay attention to how that knowledge is disseminated, how it is received by the public, how it affects regulation, and how it is implemented by systems and by individuals. We also need better understanding of these processes – we need increased medical meta-knowledge. We need to learn how to deal with this vast body of scientific information we are rapidly accumulating.
Overdiagnosis
Dr. H. Gilbert Welch has written a new book Over-diagnosed: Making People Sick in the Pursuit of Health, with co-authors Lisa Schwartz and Steven Woloshin. It identifies a serious problem, debunks medical misconceptions and contains words of wisdom.
We are healthier, but we are increasingly being told we are sick. We are labeled with diagnoses that may not mean anything to our health. People used to go to the doctor when they were sick, and diagnoses were based on symptoms. Today diagnoses are increasingly made on the basis of detected abnormalities in people who have no symptoms and might never have developed them. Overdiagnosis constitutes one of the biggest problems in modern medicine. Welch explains why and calls for a new paradigm to correct the problem.
Where to draw the line? FDR had a BP of 200/100 at the time of his re-election in 1944 and subsequently died of a stroke with a BP of 300/190. At that time, elevated BP was not commonly recognized as a problem requiring treatment. Then studies showed that the higher the BP, the greater the risk, and now everyone diagnosed with HBP is treated. That has undoubtedly saved many lives; but for someone with only a mild elevation, the risk of heart attacks and strokes is smaller and the risk of complications from treatment becomes less acceptable. So where do you draw the line and start treatment? When the limit of 160 systolic was dropped to 140, the new definition instantly turned 13 million people with “normal” BP into patients with hypertension. Not all of those new patients were better off with treatment. Welch gives the example of an 82 year old man who was treated for mild HBP at a level where the number needed to treat for one person to benefit (NNT) was 20; he passed out from medication side effects and declined further treatment.
Changing the Rules: We’ve changed the diagnostic thresholds for many diseases, so that people who were previously classified as normal are now diagnosed with diabetes, high cholesterol and osteoporosis. Dropping the threshold of fasting blood sugar from 140 to 126 instantly created 1.6 million new diabetics, diabetics who were less likely to develop symptoms and complications and were less likely to benefit from treatment. He tells about one of his patients who was put on blood sugar-lowering medication because of the new rules and passed out while driving and broke his neck because the medication brought his blood sugar too low.
Osteoporosis: here are the numbers for treatment of decreased bone density:
- Winners (treatment saved them from a fracture): 5%
- Treated for naught (had a fracture anyway, despite treatment): 44%
- Losers (treated but never would have had a fracture without treatment): 51%
Seeing too much: New technology allows us to detect abnormalities that would never have caused harm. In people without back pain, over 50% have bulging discs on MRI; 10% of asymptomatic people have gallstones on ultrasound. In patients without symptoms, what’s the value of knowing about these findings? In people with symptoms, such findings may lead to a false diagnosis.
10% of the general population and 7% of people under the age of 50 have findings of stroke on MRI. Whole body CT scanning finds abnormalities in 86% of asymptomatic people. The higher the resolution of your testing method, the more anomalies you will detect; but how many of them are important to know about? How will finding them affect health outcomes?
Prostate cancer: the harder you look, the more you find, and the smaller the cancers you detect, most of which would never have hurt the patient. Welch estimates that for every prostate cancer death avoided by screening, between 30 and 100 patients are harmed by unnecessary treatment.
In breast cancer, for every death prevented by mammography, 2 to 10 women are overdiagnosed and treated unnecessarily, 5 to 15 are diagnosed earlier without any effect on final outcome, 250-500 will have a false alarm and half of these will be biopsied. 999 out of 1000 women do not benefit from mammography. A study in Norway showed that screening resulted in 22% more diagnoses of invasive cancer; apparently some invasive breast cancers in the unscreened group had spontaneously regressed.
Other cancers: In an autopsy study, researchers determined that almost everyone has small thyroid cancers; so many that they could be considered “normal” findings. The US Preventive Services Task Force (USPSTF) recommended against screening for thyroid cancer, since it increases the diagnosis rate without affecting the death rate, and increases morbidity from unnecessary surgery and other treatments.
There is overdiagnosis of melanoma and lung cancer. For colon cancer and cervical cancer there is overdiagnosis of precancerous abnormalities.
The good news: We are learning that many, perhaps most, small cancers either regress or never progress. Spontaneous remissions may be far more common that we ever imagined. In one study, 14% of kidney cancers got smaller without any treatment. So we don’t really need to know if any cancer is present: we need to know if a cancer is present that is likely to progress and harm the patient. And so far we have no way of distinguishing which these are.
Incidentalomas are nodules or other unexpected findings noticed on imaging studies, often in body parts adjacent to the area being studied. About half of virtual colonosopies detect abnormalities outside the colon. More than 99% of the time, these are not cancers and not important to know about; but they lead to anxiety, further studies, surgeries, and complications. Protocols are being developed to follow incidentalomas suggestive of kidney and lung cancers over time rather than immediately pursuing diagnosis.
Routine electronic fetal monitoring has minuscule benefits and results in many more C-sections.
Vascular screenings: The Lifeline company and other commercial ventures offer tests direct to the public, tests that the USPSTF doesn’t recommend and that have not been shown to benefit those screened.
Genetic screening. These tests are not done for symptoms, and do not even detect signs of early disease, but just estimate future risks using inadequate data. Welch reminds us that genetics is not destiny and abnormal genes do not equal disease. The predictive value of these tests is small, and we seldom know what to do about the risk after we identify it. Low risk for a condition doesn’t mean you can’t get it, and everyone is at high risk of something.
A paradigm shift is needed, but it will be difficult to achieve for many reasons:
- It is hard to ignore information.
- Most people believe the more information, the better.
- Accepted wisdom and common sense are hard to overturn.
- Most people are convinced that it is always in people’s interest to detect health problems early, even though the data say otherwise.
- There is a common belief that early detection is cost-effective, even though the data show it actually ends up costing more.
- We find it hard to tolerate uncertainty.
- Commercial interests benefit from screening and overdiagnosis.
- Doctors fear being sued if they omit tests.
- Anecdotes about lives saved are emotionally persuasive.
We are easily impressed by anecdotes from people who believe their lives were saved by early detection; but we don’t hear anecdotes from people who were harmed by a diagnosis of a condition that would never have hurt them, mainly because we have no way of knowing which ones they were. I am a case in point: I had a suspicious mammogram and an excisional biopsy that removed a lobular carcinoma in situ. That is not really a cancer, but more like a risk factor for cancer. Did my surgery remove a part of my breast that would have eventually developed invasive cancer and killed me, or did it uselessly remove a harmless chunk of tissue? Did it save my life or just mutilate me? I will never know.
What’s the solution? Maintaining a healthy skepticism about early diagnosis. Informed consent for screening tests, based on accurate information. Resisting over-simplified hype about the benefits of screening. Putting our efforts into prevention (exercise, smoking cessation, healthy diet, etc.) rather than pursuing early detection. Pursuing health without paying too much attention to it and without developing anxieties about it. Welch argues for not even mentioning incidentalomas on imaging reports, but I think radiologists and lawyers would object to that strategy. He says
Severe abnormalities warrant action because net benefit is likely. But the best strategy for mild ones may be to leave well enough alone, otherwise net harm is likely. In fact, it may be better not to look for them in the first place…An overdiagnosed patient cannot benefit from treatment… [but] can only be harmed.
He doesn’t offer prescriptions. He recognizes that different individuals will assess the risk/benefit ratio differently; based on the same data, some will choose to be screened and some won’t. But they deserve accurate information to base their decisions on, and this book offers a lot of good data and thought-provoking analysis.
I couldn’t help but like this book, since it says many of the same things I have been saying about screening tests , colonoscopy, osteoporosis treatment, PSA tests , not always treating , ultrasound testing , overuse of CT angiograms, genetic testing in general and in specific situations, and the pitfalls of diagnostic tests. It explains complicated concepts like lead-time bias in simple terms and spices the story with patient anecdotes. I found it a bit repetitive but that is probably an asset for driving the message home to a general audience. Both patients and doctors would benefit from reading this book and thinking about the issues it raises.
Dr. Paul Offit appears on The Colbert Report
For a touch of the lighter side, here’s Dr. Paul Offit appearing on The Colbert Report to discuss his new book:
| The Colbert Report | Mon – Thurs 11:30pm / 10:30c | |||
| Paul Offit | ||||
| http://www.colbertnation.com | ||||
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Looks like a win to me. I particularly like how Dr. Offit says that the question of whether vaccines cause autism has been “asked and, fortunately, answered.” Heh. That’s a shot across the bow to J.B. Handley, who, as Steve Novella has pointed out (as have I) is utterly clueless about science and how to interpret the medical literature, as he has demonstrated time and time again with his “14 Studies” nonsense. Of course, anyone who calls Handley out on his ignorance is subject to personal attack. Reporters have felt it. Steve Novella has felt his wrath. So have I. Meanwhile Handley gloats over the decline in confidence in vaccines that his organization Generation Rescue has helped foster.
Fortunately, Colbert appears to get it. I like how Colbert does a faux rejection of one of Dr. Offit’s points by pointing out that he is “ruled by fear.” I particularly like how he mentions Andrew Wakefield, but not by name (rather like Lord Voldemort), and how he asks Dr. Offit a bunch of questions based on talking points the anti-vaccine movement likes to use to frighten parents. No wonder the anti-vaccine collective at Age of Autism is going crazy, having posted (and reposted) numerous attacks old and new on Paul Offit ever since it was announced that he was going to be on The Colbert Report last night, all topped off with one by J.B. Handley himself in which he calls Dr. Offit a “blowhard liar.”
Stay classy, J.B. Stay classy.
Breast implants and anaplastic large cell lymphoma (ALCL): Is there a link?
I must admit that I have a bit of a love-hate relationship with breast implants. On the one hand, as a breast cancer surgeon, I see them as a major benefit to my patients who are unfortunate enough to require mastectomy in order to control their disease. The armamentarium of techniques for reconstructing breasts after mastectomy generally falls into one of two categories, either various form of muscle flaps or breast implants. However, some women are, for various reasons, not eligible for various muscle flap reconstructions. That leaves either breast implants–or nothing. Certainly, some women are perfectly fine with no reconstruction after mastectomy, but many, if not most, women are not. For these women, it would be difficult to overstate how much of a boon to body image and self-esteem reconstruction can be, particularly given how much better at it plastic surgeons have become over the last couple of decades.
On the other hand, breast implants make my life as a breast cancer surgeon more difficult for a variety of reasons. First, they tend to make mammography more difficult by obscuring part of the breast, thus decreasing the sensitivity of mammography. Good mammography facilities can get around this to some extent by using various displacement techniques, but it takes some effort, and it doesn’t completely correct the problems that implants cause for mammographic screening. Moreover, when a woman who has had implants placed for cosmetic reasons comes to see me for a breast mass or an abnormal mammogram, the presence of the implants can complicate treatment decisions. If the abnormality or mass is close to the implant, we worry about rupturing it in the process, particularly if the implant is not below the pectoralis major muscle. Even when the implant is subpectoral, the muscle overlying it frequently ends up being so stretched out that the muscle in essence forms part of the capsule around the implant and ends up being a lot thinner than you might expect. Let me tell you, my anal sphincter tone is always much tighter when operating near an implant, particularly a silicone implant. True, I’m perfectly capable of removing an implant if it’s accidentally ruptured, but such an outcome is not desirable, particularly with silicone implants, where cleaning up the leaking silicone can be difficult.
It doesn’t help that silicone breast implants have been the subject of controversy since the late 1980s and early 1990s, when thousands of women with silicone implants reported a variety of ailments, including autoimmune disease and a variety of other systemic illnesses. These reports led to a rash of lawsuits and, ultimately, the banning of silicone breast implants for general use in 1992. After that, silicone breast implants were only permitted in women requiring breast reconstruction or women enrolled in clinical trials studying breast implants. This ban was partially lifted in 2006, as evidence accumulated that the claims of autoimmune diseases and increased cancer risk due to silicone breast implants were not supported by clinical and scientific evidence and two products made by Allergan Corp. (formerly Inamed Corp.) and Mentor Corp. Not surprisingly, given that the furor over silicone breast implants as a cause of autoimmune and other systemic diseases is based on about as much solid scientific evidence as the antivaccine furor over vaccines as a cause of the “autism epidemic,” there was widespread criticism of this decision. Even now, it is not difficult to find articles about breast implants with titles like Breast Implants: America’s Silent Epidemic and websites like the Humantics Foundation and Toxic Breast Implants . I do note, however, that the number of such sites and articles does appear to be declining and, at least to my impression, seems to have decreased markedly over the last 10 years or so.
Having reviewed the literature and found evidence for a link between silicone breast implants and the systemic diseases attributed to them to be incredibly weak at best, I had little problem with the FDA’s decision. Actually, the only thing I had a problem with at the time, my opinions of how breast implants interfere with breast cancer detection and treatment notwithstanding, is that the FDA was probably being more cautious than the evidence warranted after 14 years.
Was I wrong?
Breast Cancer and anaplastic large cell lymphoma (ALCL): The FDA steps in
I ask this question because last week there was a widely reported story about a warning that the FDA issued regarding breast implants. Indeed, on Wednesday, our press people were circulating copies of the advisory and asking if any of us were available to comment to the press before the evening news deadlines. Unfortunately (or fortunately, depending on your point of view), I was holed up for our NCI site visit rehearsal and thus in essence unavailable. So it was that the national media missed its opportunity to hear me opine my wisdom on the matter to a breathlessly waiting nation. Talk about dodging a proverbial bullet (our nation, that is). Be that as it may, this FDA advisory led to stories in the media like this one by ABC News, FDA Reports Link Between Breast Implants and a Rare Cancer:
The FDA advisory states:
After an intensive review of known cases of a rare form of cancer in breast implant recipients, the Food and Drug Administration says women with implants may have a very small, but increased risk of developing anaplastic large cell lymphoma, or ALCL.
FDA scientists reached that conclusion after examining scientific literature that focused on cases of ALCL in 34 women with breast implants, as well as information from agency reports, international regulatory agencies, scientific experts, and breast implant manufacturers.
But with an estimated five to 10 million breast implant recipients worldwide, agency experts say the known ALCL cases are too few to say conclusively that breast implants cause the disease. FDA believes there are about 60 of these ALCL cases worldwide, though that number is difficult to verify because not all of them were chronicled in scientific publications and some reports may have been duplicated.
This is the sort of epidemiological question that drives physicians and scientists crazy. The reason is quite simple. ALCL is a rare type of non-Hodgkin’s lymphoma (NHL). Indeed, it is classified as a “rare disease,” which for purposes of U.S. policy is defined as affecting less than 200,000 Americans. In actuality, ALCL affects far fewer Americans than that. According to the Surveillance, Epidemiology, and End Results (SEER) Program of the National Cancer Institute (NCI), approximately 1 in 500,000 women is diagnosed with ALCL in the the U.S. every year. ALCL of the breast is even more rare, with 3 in 100 million women per year being diagnosed with the disease. Not surprisingly, that means it’s incredibly hard to get enough patient numbers to make firm conclusions regarding whether the risk of ALCL is truly higher in women with breast implants, and the FDA report, Anaplastic Large Cell Lymphoma (ALCL) In Women with Breast Implants: Preliminary FDA Findings and Analyses, reflects this uncertainty.
Reading the FDA’s report, I was struck by how little there evidence is one way or the other because of the relative rarity of the disease. Basically, the evidence portion of the FDA report concentrates on case studies and the three existing studies that tried to determine whether there is an association between breast implants and ALCL. Given that the report strikes me as being pretty accessible to the lay person, I recommend reading it, because it reveals a careful sifting of the thin gruel of evidence and how the FDA came to its decision to issue this warning. I’ll try to summarize its 21 pages for you and give you my take on the studies used to justify the warning, but go to the full report for details.
Breast implants and ALCL: The evidence
The FDA performed a review of the scientific literature. This included a search of PubMed, Embase, Web of Science, Cambridge Scientific Abstracts (CSA), EBSCO, and BIOSIS for published papers and abstracts about ALCL and breast implants. After duplicates were accounted for, the FDA found that the entire world scientific literature has reports of 34 women with breast implants who were diagnosed with ALCL of the breast. As pointed out above, the number might be as high as 60, as is described in the report:
In a thorough review of scientific literature published from January 1997 through May 2010, the FDA identified 34 unique cases of ALCL in women with breast implants throughout the world. The FDA’s adverse event reporting systems also contain 17 reports of ALCL in women with breast implants. Additional cases have been identified through the FDA’s contact with other regulatory authorities, scientific experts, and breast implant manufacturers. In total, the FDA is aware of approximately 60 case reports of ALCL in women with breast implants worldwide. The exact number is difficult to verify because reports from regulatory agencies and scientific experts often duplicate those found in the scientific literature.
It’s estimated that there are between 5 and 10 million women in the world with breast implants. Given these numbers, the number of women with breast implants who have developed ALCL of the breast is higher than would be expected from SEER data alone. Moreover, another thread of association that is concerning derives from the spatial pattern noticed in these case reports:
Of the 34 cases, the median time from breast implant placement to ALCL diagnosis was 8 years, with a range from 1 year to 23 years. Most patients were diagnosed when they sought medical treatment for implant-related symptoms such as persistent seromas, capsular contractures, or peri-implant masses warranting breast implant revision operations. In each case, lymphoma cells were found in the effusion fluid (seroma) surrounding the implant, in the fibrous capsule, or within a peri-implant mass. Typically, there was no invasion beyond the fibrous capsule into the breast parenchyma.
It should also be noted that it couldn’t be determined whether there was a higher risk of ALCL that could be attributed to silicone versus saline implants, as twenty-four had silicone implants, seven had saline, and the type of implants was unknown. Similarly, there didn’t appear to be a correlation between the indication for implant placement and the risk of ALCL. Of the 34 cases, eleven patients had their implants placed for breast reconstruction, nineteen patients received implants for breast augmentation, and in four cases no reason for placement of the implants was reported.
Unfortunately, these case reports are not particularly illuminating.
Given that, perhaps the epidemiology will be more revealing. Except that it isn’t. There are only three studies cited looking at whether there is an association between the presence of breast implants and ALCL of the breast. There were no prospective cohort studies. Indeed, all three studies were in essence retrospective studies. Of these, only one of them was designed to look specifically at a correlation between breast implants and ALCL of the breast, rather than observations of non-Hodgkin’s lymphoma and other cancers in women with breast implants. This study (de Jong et al, 2008) is an individually matched case-control study that mined a nationwide population cancer database from the Netherlands. Since 1971, all reports on cytological and pathological diagnoses generated by every pathology department in the Netherlands have been stored in a central database (PALGA, Pathologisch Anatomisch Landelijk Geautomatiseerd Archief).
Going to show that lymphoma of the breast is a rare entity, between 1990 and 2006, only 429 cases of histologically proven lymphoma of the breast were found, and, of the 389 women eleven had a diagnosis of ALCL. Using these cases as the basis, de Jong et al performed an individually matched case-control study thusly:
Subsequently, we performed an individually matched case-control study, nested in the same cohort of 389 female patients. For each case patient with ALCL in the breast, we attempted to select 3 to 7 controls with other lymphomas in the breast, matched on age at diagnosis (±5 years) and year of diagnosis (±2 years). For all 47 potential controls, we obtained pathology reports. Furthermore, for all cases and controls, we sent a standardized questionnaire to the treating physician to obtain information on medical history, including previous malignancies, staging results, and presence of a breast prosthesis, including mammography results.
Conditional logistic regression analysis was performed to estimate the odds ratio (OR) of ALCL associated with breast prosthesis, using EGRET for Windows, 1999 (CYTEL Inc, Cambridge, Massachusetts).21? The OR was used as a valid risk estimate of relative risk and is therefore referred to as such. An estimate for absolute risk was made based on breast prosthesis sales figures for 1999 to extrapolate the number of women with breast prostheses.
Based on this analysis, de Jong et al estimated the odds ratio of ALCL associated with breast implants to be 18.2 (95% CI 2.1-156.8). What this means is that the odds of having a breast implant were 18.2 times higher in ALCL patients than in the control lymphoma patients. Personally, I have a few problems with this analysis. First, the matching was done on only two criteria, age and year of diagnosis. Although there was no statistically significant difference in age between the groups, there’s no way of knowing if there were any confounding factors that were associated with ALCL of the breast. The numbers are just too small. Consequently, it’s hard to say much about this series except that it is suggestive that there is an elevated risk of ALCL due to breast implants. As the authors themselves say:
Although an 18-fold increased odds for the development of a specific lymphoma in the breast may cause significant concern among women with breast prostheses, it should be realized that the absolute risk remains very low due to the exceedingly rare occurrence of ALCL in the population (estimated incidence at all sites 0.1/100,000 per year).
Which is about one in a million. Even if the estimate made by de Jong et al is accurate, that would put the risk at around 18 in a million.
As for the other two studies, they’re not exactly studies. One (Brinton et al) is a systematic review of the literature looking for evidence of an association between breast implants and cancers at other sites. Brinton et al concluded that breast lymphomas in women with breast implants tend to be associated with the periprosthetic capsule, or in proximity to the implant. Moreover, in the general population, breast lymphomas tend to be a rare entity and most are of B-cell origin. In contrast, breast lymphomas in women with implants tend to be of T-cell origin. The second, Lipworth et al, examined five long term studies of women with breast implants including 43,000 women to assess the risk of lymphoma in these women. This review actually found that there was a slightly decreased risk of lymphoma in women with breast implants, but, as the FDA report noted, it had a at least two weaknesses. First, all the studies began following women more than 35 years before the study, and the entity of ALCL was not defined pathologically until 1985. Second, the number of women studied was inadequate to rule out a rare relationship between breast implants and ALCL.
As you can see, the evidence for a link between ALCL and breast implants is fairly sparse. Of the evidence, de Jong et al is probably the most suggestive, but even it is relatively weak, at least based on numbers alone. However, another piece of evidence comes from the characteristics of implant-associated lymphomas. The FDA report includes a good illustration to show where the lymphoma cells were typically found. In all cases, they were either found in fluid surrounding the implant (it’s not uncommon for implants to have a fluid collection surrounding them) or in the connective tissue capsule that develops around many breast implants:
Add this to the seeming statistical association between breast implants and ALCL, and there might just be something there. It’s not possible to conclude with any degree of certainty that there is such a risk right now; there are simply too few cases and ALCL is too rare, both in the general population and in women with breast implants.
What should be done?
Despite the controversy over the years over breast implants, particularly silicone breast implants, there has been no convincing evidence of a link between systemic diseases, such as autoimmune diseases or cancer. Indeed, since the 1990s, there have been at least a dozen comprehensive systematic reviews looking at a potential link between silicone breast implants and systemic diseases (conveniently listed at Wikipedia), none of which have found convincing evidence for a link. In 2006, Brinton et al found an increased risk of death from lung cancer and suicide in women with implants, but these risks were attributed to increased smoking and psychiatric disorders in women who have implants placed.
This report from the FDA suggests that there might be an increased risk of a rare cancer in women with breast implants, but the numbers are so low that it’s difficult to conclude anything with much certainty, which is why the FDA concludes:
- There is a possible association between breast implants and ALCL.
- At this time, it is not possible to identify a specific type of implant associated with a lower or higher risk of ALCL.
- There is uncertainty about the true cause of ALCL in women with breast implants.
Adding:
Based on available information, it is not possible to confirm with statistical certainty that breast implants cause ALCL. Because ALCL is so rare, even in breast implant patients, a definitive study would need to collect data on hundreds of thousands of women for more than 10 years. Even then, causality may not be conclusively established.
These are reasonable conclusions based on the current state of the evidence, which is inconclusive at best, weak at worst. Given the high degree of uncertainty, what the FDA has done is not entirely unreasonable, although one could argue that it’s a tad alarmist. Basically, the FDA wants clinicians to consider ALCL in women with implants who have persistent seromas (fluid collections) around their implants, recommending that seroma fluid be sent for cytological analysis to rule out lymphoma. In addition, the FDA recommends that any confirmed cases of ALCL associated with implants be reported and is establishing a registry in collaboration with the American Society of Plastic Surgeons to track cases of implant-associated lymphoma. Even this might not be able to detect or confirm a link between implants and ALCL, given the rarity of the disease, but it is a start.
Even accepting the most pessimistic assumption, namely that there really is a significantly elevated risk of ALCL in women with breast implants due to the implants, which has been suggested but not by any means established, this risk, if it exists, should be put into perspective. For example, it should also be noted that, based on what we know, in women who choose implants for reconstruction after breast cancer surgery, the risk of recurrence of their breast cancer is orders of magnitude greater than any theoretical risk of ALCL due to implants. Indeed, in women who have never had cancer and choose implants for breast augmentation, the risk of developing breast cancer is also orders of magnitude higher than of developing ALCL. There is no evidence that implants increase the risk of breast cancer or breast cancer recurrence after breast cancer surgery.
In fact, the most significant risk due to breast implants is not the risk of systemic diseases, such as autoimmune diseases or cancer. Far more significant is the rate of local complications, such as capsular contracture or implant rupture. Due to such complications, many women with implants require reoperation. Indeed, reoperation rates have been estimated to be as low as 3% after seven years to as high as 20% over three years. These are by far the most significant risks due to breast implants.
While I am not a big fan of elective breast augmentation or cosmetic surgery in general (that’s just me, I guess, in that my assessment of the risk-benefit ratio of having a surgeon cut into me to make me better looking probably won’t come down on the side of surgery unless I eer suffer some sort of traumatic injury that leaves me disfigured enough to require reconstructive surgery), if there is informed consent in which the risks of breast augmentation are clearly explained based on science and clinical evidence and not inflated by the addition of claimed risks that are not supported by science, women should be free to choose implants if they so desire. From my perspective as a clinician, more importantly I strongly believe that, for women with breast cancer, implants are an important option to be made available for reconstruction after mastectomy. In particular, given how small the risk would be even if it is confirmed, this new information from the FDA regarding breast implants and ALCL does not change that.
It is all about me.
I was interviewed for Birmingham Skeptics and you can hear the result at
http://brumskeptics.blogspot.com/2011/01/podcast-posting-interview-with-mark.html.
It is bad enough listening to myself as I correct my podcasts, so I have no idea how good the interview is; it was fun at the time. And the picture makes me look fatter than I am. Oh well.
Rambling Musings on Using the Medical Literature
For those who are new to the blog, I am nobody from nowhere. I am a clinician, taking care of patients with infectious diseases at several hospitals in the Portland area. I am not part of an academic center (although we are affiliated with OHSU and have a medicine residency program). I have not done any research since I was a fellow, 20 years ago. I was an excellent example of the Peter Principal; there was no bench experiment that I could not screw up.
My principal weapon in patient care is the medical literature, accessed throughout the day thanks to Google and PubMed. The medical literature is enormous. There are more than 21,000,000 articles referenced on Pubmed, over a million if the search term ‘infection’ is used, with 45,000 last year.
I probably read as much of the ID literature as any specialist. Preparing for my Puscast podcast, I skim several hundred titles every two weeks, usually select around 80 references of interest and read most of them with varying degrees of depth. Yet I am still sipping at a fire hose of information
The old definition of a specialist is someone who knows more and more about less and less until they everything about nothing. I often feel I know less and less about more and more until someday I will know nothing about everything. Yet I am considered knowledgeable by the American Board of Internal Medicine (ABIM), who wasted huge amounts of my time, a serious chunk of my cash, and who have declared, after years of testing, that I am recertified in my specialty. I am still Board Certified, but the nearly pointless exercise has left me certified bored. But I can rant for hours on Bored Certification and how out of touch with the practice of medicine the ABIM is.
My concept of an expert is a combination of experience and understanding of the literature. I used to say mastery of the literature, but no one can master a beast that large; I am just riding on the Great A’Tuin of medical writings. Experience comes with time, and I have read that it takes 10 years to become competent in a field. Whether true or not, it matches my experience. I remember as a resident reading notes on patients I had cared for as an intern, and being appalled with what an ignorant dufus I was. In my first year of practice I had a patient who died of miliary tuberculosis, and the diagnosis was, unfortunately, made at autopsy. It was an atypical manifestation of a rare (in the US) disease. About a decade later the case was presented as an unknown to a visiting professor; I had completely forgotten the case, but I piped up from the audience to pontificate on how this had to be miliary Tb. Afterwards I was shown the chart and nice documentation as to how clueless I had been a decade earlier. When it comes to being a diagnostician, there is not substitute for experience.
When it comes to treatment? That is where I tell the residents that the three most dangerous words in medicine are ‘In. My. Experience.’ You cannot trust experience when deciding on therapy, especially for relatively unusual diseases. Sometimes I will ask a doc why they use a given antibiotic, usually in a situation where it is being used in a way that is, shall we say, old fashioned. Often the response is “I like it”‘ as if the choice of a drug is like choosing a beer.
I rely on the literature — such as it is, and limited by my lack of an Ethernet jack in my brain — in deciding the best course of therapy for a patient. The literature is always unsatisfactory. That has always been known. Even with the best studies, there is always the issue of wondering if the literature applies to your patient and their particular co-morbidities, and, perhaps, genetics. As an example, it is becoming evident that the literature on the presentation and treatment of Cryptococcus, which is based on the experience with C. neoformans, is not applicable to C. gattii, a new strain of the fungus in the NW. So how to use a literature that may not be totally relevant to my local conditions? I wing it. It is an educated and experienced winging, but winging it I do.
Given the breadth and depth of the literature, it is nice to have systematic reviews, meta-analysis, and guidelines. As a practicing physician, I find them helpful as they provide an overarching understanding, a conceptual framework, for understanding a disease or a treatment. They are the Reader’s Digest abridged version of a topic, and the references are invaluable. Usually most of the relevant literature is collected in these reviews and make it easier, especially in the era of the Googles and on-line references, to find the original literature.
All three have their flaws, and if you are well versed in a field, you recognize the issues and try and compensate.
As was noted in the recent Archives, the literature to support the recommendations of the Infectious Disease Society America are not necessarily based on the best of evidence. Really? I’m shocked. Next up, water is wet, fire is hot, and the Archives confirms the obvious.
Results In the 41 analyzed guidelines, 4218 individual recommendations were found and tabulated. Fourteen percent of the recommendations were classified as level I, 31% as level II, and 55% as level III evidence. Among class A recommendations (good evidence for support), 23% were level I (1 randomized controlled trial) and 37% were based on expert opinion only (level III). Updated guidelines expanded the absolute number of individual recommendations substantially. However, few were due to a sizable increase in level I evidence; most additional recommendations had level II and III evidence.
Conclusions: More than half of the current recommendations of the IDSA are based on level III evidence only. Until more data from well-designed controlled clinical trials become available, physicians should remain cautious when using current guidelines as the sole source guiding patient care decisions.
Big duh. Anyone who is a specialist understands the weaknesses in all guidelines, but we also understand their importance. When I was a fellow, one of my attending was, and still is, one of the foremost experts in the US on Candida, and anothers areas of expertise is S. aureus infections and endocarditis.
Both have spent a career thinking deeply on their respective areas of expertise. You learn that while no one is perfect, the breadth and depth of their knowledge and experience gives their recommendations extra weight. Who would you want at the controls of your plane in a unexpected and unusual weather conditions? An experienced pilot, or someone who spent a few days on the X-Plane simulator? The same with all the guidelines. When someone with a lifetimes of work in a field helps write a guideline, you pay attention to their expertise. You know the recommendations are not necessarily right, but odds are their opinions are better than mine, just as my opinion is usually better than a hospitalist, as least as far as infections are concerned. With residents, I try make a point of differentiating when my recommendation is no better than the next doc, and when my recommendation is the Truth, big T, and based on the best understanding of the literature at the moment.
This attitude, trusting authority, held by many in medicine, goes against the University of Google approach where a day of searching and a quick misreading of the abstracts renders everyone an expert. I wonder if other fields are plagued with these quick pseudo-experts. Law is, when the accused attempt to defend themselves.
I certainly would be in favor of more money being spent on infectious disease research, and, one hopes, infectious disease doctors. In a perfect world, every disease would be subjected to careful, extensive clinical trials and I would know, for example, the best therapy for invasive Aspergillus pneumonia in a neutropenic leukemia patient. Until that time, I am, in part, going to rely on the guidelines written by those who have spent a career thinking about the diseases I have to treat. To quote Dr Powers,
“Guidelines may provide a starting point for searching for information, but they are not the finish line…Evaluating evidence is about assessing probability,” Dr. Powers commented in a news release. “Perhaps the main point we should take from the studies on quality of evidence is to be wary of falling into the trap of ‘cookbook medicine,’” Dr. Powers continues. “Although the evidence and recommendations in guidelines may change across time, providers will always have a need to know how to think about clinical problems, not just what to think.”
I was struck by a recent Medscape headline:
Cochrane Review Stirs Controversy Over Statins in Primary Prevention
Having been irritated of late by Cochrane reviews in my area of expertise, I clicked the link. The first three paragraphs are
A new Cochrane review has provoked controversy by concluding that there is not enough evidence to recommend the widespread use of statins in the primary prevention of heart disease.
The authors of the new Cochrane meta-analysis, led by Dr Fiona Taylor (London School of Hygiene and Tropical Medicine, UK), issued a press release questioning the benefit of statins in primary prevention and suggesting that the previous data showing benefit may have been biased by industry-funded studies. This has led to headlines in many UK newspapers saying that the drugs are being overused and that millions of people are needlessly exposing themselves to potential side effects.
This has angered researchers who have conducted other large statin meta-analyses, who say the drugs are beneficial, even in the lowest-risk individuals, and their risk of side effects is negligible. They maintain that the Cochrane reviewers have misrepresented the data, which they say could have serious negative consequences for many patients currently taking these agents.
Newsweek and The Atlantic both refer to the Cochrane review as a “study.” A review is not what I would consider a study, usually synonymous with a clinical trial. The use of the term makes it sound like the Cochrane folks were doing a clinical trial, patients being randomized to one treatment or another. My sloppy non scientific poll of people (all people in the medical field, but that is who I have contact with) suggests the no one considers a review of clinical trials to be a study. A review of a novel is not the same as writing a novel.
Sloppy and potentially misleading language from major news outlets. What a surprise.
I have always liked meta-analysis for the same reason I like guidelines: they provide an overarching conceptual framework for understanding a topic. But only a fool would make clinical decisions based upon a meta-analysis. Yet, meta-analysis seem to be creeping to the top of the list of the clinical information rankings to be believed.
There are issues with meta-analysis.
The studies included in a meta-analysis are often of suboptimal quality. Many spend time bemoaning the lack of quality studies they are about to stuff into their study grinder. Then, despite knowing that the input is poor quality, the go ahead and make a sausage. The theory, as I said last week, is that if you collect many individual cow pies into one big pile, the manure transmogrifies into gold. I still think it as a case of GIGO: Garbage In, Garbage Out.
It has always been my understanding that a meta-analysis was used in lieu of a quality clinical trial. Once you had a few high quality studies, you could ignore the conclusions of a meta-analysis.
Evaluations of the validity of the conclusions of meta-analysis have demonstrated that the results of a meta-analysis usually fail to predict the results of future good clinical trials. The JREF million is safe from the Cochrane, I suppose. Their conclusions are no more reliable than the studies they collect and are no more valid than the rest of the medical literature.
We identified 12 large randomized, controlled trials and 19 meta-analyses addressing the same questions. For a total of 40 primary and secondary outcomes, agreement between the meta-analyses and the large clinical trials was only fair (kappa= 0.35; 95 percent confidence interval, 0.06 to 0.64). The positive predictive value of the meta-analyses was 68 percent, and the negative predictive value 67 percent. However, the difference in point estimates between the randomized trials and the meta-analyses was statistically significant for only 5 of the 40 comparisons (12 percent). Furthermore, in each case of disagreement a statistically significant effect of treatment was found by one method, whereas no statistically significant effect was found by the other.
Once there was a quality definitive trial or three, the meta-analysis becomes, I thought, moot. A quality clinical trial trumps the meta. I guess. I am not so certain that is the attitude anymore given the freak-out in the media about Cochrane and statins.
It seems that the producers of meta-analysis have characteristics like the March of Dimes. Polio was conquered, but rather than folding up their tents and stealing away, they continue to march. That may be a good thing too, as there could be a polio resurgence if some anti-vaccine wackaloons have their way.
If there is a definitive trial, rather than declaring the question settled, the new, perhaps higher-quality, study is folded in with the prior studies and a new meta-analysis is generated. But newer studies are diluted by the older, less robust trials, so the more reliable results are lost in the wash. The best drowned in a sea of mediocrity.
For example, I see no need for a meta-analysis on the efficacy of Echinacea. The last several trials, combined with basic science/prior probability, provides sufficient evidence to conclude Echinacea does not work. Good trials win. Ha.
As a practicing specialist, no matter how much I read, I rely in part on guidelines, meta-analyses and systematic reviews as nice overviews to be used as flawed stopgaps awaiting large high quality clinical trials, that, like Godot, may never come.
I have sick patients who need treatment. I need to know what to do. I have to fight the battles with the weapons I have. I have the medical literature and I am not afraid to use it.
The English government cracks down on alternative pet remedies
One cannot play charades forever.
European veterinary groups have long been more skeptical about “alternative” veterinary practices than their American counterparts. For example, the European Board of Veterinary Specialties refuses to grant continuing education credits for non-scientific endeavors attempting to masquerade as a way to improve one’s clinical knowledge, and the practice of veterinary homeopathy is forbidden in Sweden.
Now comes good news (for pets, and pet owners), out of the UK. In an effort to improve animal health and welfare, the Veterinary Medicines Directorate’s (VMD) has targeted “alternative” remedies, which, of course, pose both real and potential dangers to pets. The VMD is the body responsible for the authorization of veterinary medicinal products in the United Kingdom.
Specifically, the VMD is targeting a number of unauthorized products that lack scientific proof of effectiveness, including:
- homeopathic “nosodes” (substances that are the homeopathic equivalent of vaccination, with the notable exception being that they don’t work)
- various herbal products
- “neutraceuticals,” the cleverly coined combination of “nutrition” and “pharmaceutical,” which really aren’t either, a fact which, of course, hasn’t dented their popularity, nor dampened their claims (including improved mental ability in pets)
- Herbal deworming products, which may claim to irritate the bowel and make it less inviting for parasites (an absurd claim)
Giving a pet an ineffective remedy invites direct harm, if a sick animal is treated with an ineffective remedy, as well as indirect harm, if an effective therapy is avoided in favor of the heavily advertised ineffective one.
Director of Operations of the VMD, John FitzGerald, said, “Animal owners have a right to know if a product does what it claims. The products claim to treat diseases which can cause serious welfare problems and in some circumstances kill animals if not properly treated. So in some cases owners are giving remedies to their pets which don’t treat the problem.” British Veterinary Association President Harvey Locke, in support of the VMD, noted, “As veterinary surgeons we rely on the use of safe, effective and quality medicines for the health and welfare of animals under our care – and there must always be sound scientific evidence to back up medicinal claims made by the manufacturer of any product.”
The VMD intends to contact manufacturers of “alternative” products to make sure that they are safe, and provide the claimed benefits. If they don’t (which they won’t), the VMD will make the manufacturers rebrand the products so that consumers will know that the products are not medicinal.
Now one might legitimately ask, “Why don’t the US veterinary authorities and organizations take some action such as this?” Well, in my opinion, veterinary authorities are more interested in getting animals to be treated by veterinarians than they are in the particular remedies that are being used. So far, in the US, it’s been a triumph of economics over science. How long that stance holds up, particularly in light of the legitimate strides at curbing non-scientific practices in other countries, remains to be seen.
