Properties of #2 Fuel Oil

Posted on by

Does anyone know a website that could tell me how long it takes #2 home heating oil to evaporate if spilled on concrete (less than a gallon) and how slippery it would be on concrete?

Obama Snr. in Immigration Files: No Son of Mine

Posted on by

by Clifford F. Thies

The latest proof of President Obama's qualification as a "natural born citizen" reminds us of the sad reality that the issue just kind of touches and yet misses by miles. I am speaking of his coping with his abandonment by his natural father and his rejection of his mother.

Along with the release of a photocopy of his "long form" certificate of live birth, we have the release of his father's immigration file.

In the birth certificate, filed on August 8, 1961, his mother says that her child, who is named Barack Hussein Obama II, was born on August 4th. She also states that the father of her son is Barack Hussein Obama, an African, who is 25 years old, and a student.

In the immigration file, we find out that the Barack Hussein Obama "Sr." variously claims to be married to two women, one back in Keyna and another in Hawaii, or to not be married at all, to have and to not have children, but never to have Barack Hussein Obama II as a child, and to have and to not have worked in the United States.

As Pamela Geller at Atlas Shrugs Atlas Shrugs points out:

Stanley Ann Dunham could not have been so savvy as to know that BHO I was a Muslim polygamist. Yet clearly, Barack Hussein Obama Sr., was never divorced from his first wife in Kenya.

The Immigration and Naturalization Service suspected that the elder Obama’s marriage to Dunham was a sham, arranged strictly to secure immigration status for him. Despite the fact that BHO I had married Dunham, the government wasn’t buying it: An INS official wrote in 1961 that the agency should “make sure an investigation is conducted as to the bona-fide of the marriage.”

Specifically, in a certificate dated June 6, 1963, seeking an extension of his student visa, Obama "Sr." fails to mention his marital status, the name or names of any spouses, and the name or names of any children. He then signs the form certifying to the government of the United States that it is correct and complete.

In a certificate dated August 17, 1962, the Kenyan indicates that he is married, although he does not indicate the name or names of the women to whom he is married, and he lists one child, viz., Roy Obama, the President's half-brother.

In a certificate dated August 31, 1961, the Kenyan indicates that he is married, naming his spouse as Ann S. Dunham of Hawaii, after marking over whatever he first put into the box, and - voila! - not mentioning the names of any children. Going by the certificate of live birth, this was about four weeks after the birth of Barack Hussein Obama II.

Eventually, immigration rejected extension of the Kenyan's student visa. Barack Hussein Obama II would be raised first by his mother, during which time a decent Indonesian man who married his mother acted for a time as a stepfather. Later he was raised by his maternal grandparents.

You might think, based on his the races of his natural parents and on his upbringing, that he might consider himself biracial. But, no, as we all know, he claimed only to be black on his 2010 census form. As we all known, in Chicago, he attended a white-hating, Afro-centric church. As we all know, he reflexively blames the white person in any high profile altercation involving a white person and a black person.

As we here at LR discussed during the election campaign of 2008, this is just so obvious from a reading of his book, Dreams from my Father. Our President is working through some issues. In a country where most children, nowadays, are not raised in homes headed by their father, he is not so unusual. It is really such a sad predicament for our country and for so many of our children.

Singer Sheryl Crow: Obama "has Muslim ties"

Posted on by

Obama killing Osama okay cause he's Black

From Politico:

"The first thing I thought was, I felt the same way everyone else did, mixed emotions about the fact that we killed someone. ... We know that killing is not right. In this particular instance, we have such an association with this person for having dealt us such a heinous blow. So, you know, mixed emotions of finally justice has been served and, secondly, we've just killed somebody…"

“It’s just fascinating that we have a black man, who has Muslim ties with his father, even though he’s a Christian, it’s amazing how far our country has come, that that’s the man who took down Osama bin Laden. It makes you feel very patriotic.”

H/t Photo - Breitbart. Weasel Z...

Red One-Piece Swimsuits

Posted on by

Red one-piece swimsuits are no longer reserved for Baywatch / lifeguards.  Make an impact on the beach and check out these variations:

The relatively modest Plunging Halter Maillot by Anthropologie is available for $178. It’s out of my price range but still an interesting take on the Baywatch look. The high cut leg elongates the gams and de-accentuates thunder thighs, and the wrap creates/highlights an hourglass shape.

Plunging Halter Maillot - photo courtesy of Anthropologie

Since when did Victoria’s Secret swimsuits get so expensive?? They were usually the affordable go-to for swimwear. Just saying. This Carmen Marc Valvo – Retro One piece, $167, is super sexy with that neckline. The ruching hides that tummy but the leg… if you have slim hips it will look great but for those with shapelier hips/thighs, it might highlight the very area you want to mask.

Carmen Marc Valvo Retro one-piece - photo courtesy of Victoria's Secret

La Blanca’s Sweetheart One Piece ($122) is simple and sweet.

La Blanca sweetheart one-piece - photo courtesy of South Moon Under

Win! The most affordable clocking in at $88, is j.crew’s ruched and knotted twist front tank.  The removable halter strap, the universally complimentary sweetheart neckline and a normal cut on the leg makes this the overall winner for me.

j.crew ruched and knotted twist front tank - photo courtesy of j.crew

I think this is what inspired this my new obsession with red swimsuits. So cute and retro!

Photo courtesy of Cherry Blossom Girl

Moon Tahiti eBook

Posted on by

The 7th edition of Moon Tahiti is now available electronically worldwide in an Amazon.com Kindle edition and from Barnesandnoble.com as a NOOK eBook.

Glorious April

Posted on by
Razorbills now on eggs!

Guillemots galore

Monday 25th April comments:

Its still all go on the islands, as the fine weather continues (we’ve yet to be closed due to poor weather in April!), good numbers of visitors are visiting us and the breeding seabirds are settling day by day.

The month has brought some exceptional weather, with high temperatures and plenty of flat calm seas. However we went through a spell of thick fog late last week, but the sunshine has returned and everyone is happy once again!

On the seabird front, most birds are now on eggs including the latest additions of Razorbill, Black-headed Gull and Ringed Plover. In fact, having had Shags on eggs since 23rd March, we’ll probably be boasting chicks very soon! However, as expected, we’re waiting for the Terns to settle (but not until early May) whilst Kittiwakes have yet to lay (which will probably happen in the next day or two).

On the migration front, we’ve had up to 23 Little Terns (earlier than normal) during the evening roost whilst another Hooded Crow and the lingering Mediterranean Gull have been noticeable highlights.

Off the Beaten Path

Posted on by

post thumbnail

Stan Diamond was an educator for most of his working life. But, it was his explorations and travels of the world that made his style of teaching unique. Now retired, he has begun to document his experiences – leading others down exciting paths they may not have chosen without his inspiration to guide them.

© Gretchen for TravelBlogs, 2011. |
Off the Beaten Path |
No comment |

Post categories: Blogs
Post tags: , , , , , , ,

Cochrane is Starting to ‘Get’ SBM!

Posted on by

This essay is the latest in the series indexed at the bottom.* It follows several (nos. 10-14) that responded to a critique by statistician Stephen Simon, who had taken issue with our asserting an important distinction between Science-Based Medicine (SBM) and Evidence-Based Medicine (EBM). (Dr. Gorski also posted a response to Dr. Simon’s critique). A quick-if-incomplete Review can be found here.

One of Dr. Simon’s points was this:

I am as harshly critical of the hierarchy of evidence as anyone. I see this as something that will self-correct over time, and I see people within EBM working both formally and informally to replace the rigid hierarchy with something that places each research study in context. I’m staying with EBM because I believe that people who practice EBM thoughtfully do consider mechanisms carefully. That includes the Cochrane Collaboration.

To which I responded:

We don’t see much evidence that people at the highest levels of EBM, eg, Sackett’s Center for EBM or Cochrane, are “working both formally and informally to replace the rigid hierarchy with something that places each research study in context.”

Hallafrickin’loo-ya

Well, perhaps I shouldn’t have been so quick to quip—or perhaps that was exactly what the doctor ordered, as will become clear—because on March 5th, nearly four months after writing those words, I received this email from Karianne Hammerstrøm, the Trials Search Coordinator and Managing Editor for The Campbell Collaboration, which lists Cochrane as one of its partners and which, together with the Norwegian Knowledge Centre for the Health Services, is a source of systematic reviews:

I just wanted you to let you know that I have been playing around with the same thoughts as you express in the EBM/SBM Redux series; having come across related problems in other reviews and finding the laetrile review by chance – as well as following the SBM blog (strangely enough I corresponded with Dr. Ernst concerning laetrile the day before you posted your correspondence with him – he must be getting tired of these e-mails!). For this reason a colleague and I wrote a letter to Cochrane, a letter which they have, to my surprise, accepted as an editorial and which will be published in mid March, I believe (The SBM blog is duly credited). Just wanted to let you know, and also that the response from Cochrane has been overwhelmingly positive.

Thanks for a very interesting, entertaining and educating blog!

Well, with no small sense of self-satisfaction I thanked her and forwarded her email to the other authors here, who got a kick out of it, but then I kinda forgot about it until trusty SBM commenter Peter Moran posted a link to the promised editorial. Lo and behold, woodja look at the very first sentence! Its citation is the post in which I’d dismissed Dr. Simon’s assertion about Cochrane placing research studies in context, and in which I reported my correspondence with Dr. Ernst regarding the Cochrane Laetrile review. But yes, I may have been a bit too facile in my dismissal of Prof. Simon’s contention, because it’s clear from the editorial and its ‘feedback’ that others, even among Cochrane reviewers themselves, have been similarly bothered. The problem, elsewhere dubbed EBM’s ‘scientific blind spot,’ nevertheless remains the rule rather than the exception. Two of the three feedback letters that are available as of this writing, moreover, don’t fully grasp the point.

Those of you who’ve been following this series know that I’ve already mentioned an exception to the EBM scientific blind spot at Cochrane, regarding its Laetrile review. It’s found not in the review itself, but in the form of Feedback from another Cochrane reviewer, who made arguments similar to my own. Today I’ll discuss another exception, the best that I’ve found so far, and for the second time today I’ll tip my hat to Scandinavians.

Intercessory Prayer

A 2009 revision of “Intercessory prayer for the alleviation of ill health” begins as follows:

This revised version of the review has been prepared in response to feedback and to re?ect new methods in the conduct and presentation of Cochrane reviews.

There are interesting changes in this revision, some of them having to do with what we’ve been talking about. Let’s go right to the punch line. The first sentence is old hat; the second is nearly revolutionary for EBM:

Authors’ conclusions

These ?ndings are equivocal and, although some of the results of individual studies suggest a positive effect of intercessory prayer, the majority do not and the evidence does not support a recommendation either in favour or against the use of intercessory prayer. We are not convinced that further trials of this intervention should be undertaken and would prefer to see any resources available for such a trial used to investigate other questions in health care.

Wow! Previous iterations of this review, spanning about a decade, had made the customary call for “further study.” What changed? Don’t get too excited, even though I’ve been goading you: what the authors left unstated were their reasons, intuitive though they might have been, for not being “convinced that further trials should be undertaken.” That, I suppose, would’ve been just too dicey.

Before discussing what actually changed, let me explain a couple of key features of this review. First, the authors take pains to acknowledge but, er, distance themselves from religious implications:

How the intervention might work

The mechanism(s) by which prayer might work is unknown and hypotheses about this will depend to a large extent on religious beliefs. This review seeks to answer the question of effect not mechanism and it does not seek to answer the question of whether any effects of prayer con?rm or refute the existence of God…

…the results of this review will be of interest to those who are involved with the ‘debate about God’ – both religious believers and atheists – but these results cannot directly stand as ‘proof ’ or ‘disproof ’ of the existence of God…We do not, therefore, seek to pose or answer any questions about the existence of God with this review.

They observe that there are “several challenges” in performing such trials, naming “contamination” (people outside of the study likely to be praying for the same patients) and “blinding” (when the putative agent of the effect is an omniscient being). However, assert the authors,

…these are theological questions, and this review proceeds on scienti?c principles in that it is a widely held belief that intercessory prayer is bene?cial for those who are unwell because God directs the outcome of those for whom prayers are offered differently from those for whom it is not. As noted above, we are not seeking to assess whether God is or is not the agent of action for prayer but, by using the same study designs used to test other interventions in healthcare we will assess the effects of the intervention. For this reason we also exclude from consideration such theological considerations as the injunction “Do not put the Lord your God to the test” (Deuteronomy 6:16) or questions as to whether God generally veils his presence from observation: in the words of the philosopher GF Hegel, “God does not offer himself for observation” (Hegel 2008).

Given their determination to measure “effect not mechanism” and to exclude theological considerations, it seems paradoxical that the authors chose to exclude “distant healing” (DH) studies that “may have included an element of prayer but did not specifically involve personal, focused, committed and organised intercessory prayer on behalf of another alone.” Thus they excluded one of the most famous, purportedly ‘positive’ studies in the field, which had recruited 40 “Healers” with

…an average of 17 years of experience and [who] had previously treated an average of 106 patients at a distance. Practitioners included healers from Christian, Jewish, Buddhist, Native American, and shamanic traditions as well as graduates of secular schools of bioenergetic and meditative healing.

Those ‘healers’ were told “to ‘direct an intention for health and well-being’ to the subject.” Thus, even though there was a religious theme to the choice of ‘healers,’ the imagined ‘mechanism’ of healing was decidedly psychokinetic—it was linear rather than angular, or non-stop rather than 1-stop, if you catch my drift. This was in keeping with the interests of the most important co-author, the late Elisabeth Targ, previously mentioned here.

That’s why the Cochrane authors excluded it and similar DH studies, but c’mon: an influential group of ‘CAM’ enthusiasts, including Targ, Larry Dossey, Victor Sierpina (Distinguished Teaching Professor at the University of Texas Medical School), Mehmet Oz (heh), Marilyn Schlitz (a former member of the NCCAM advisory council), naturopath Leanna Standish (also a former member of the NCCAM advisory council and the Director of Research at the Bastyr University AIDS Research Center), Andrew Weil, Kenneth Pelletier, James Gordon (Chairman of the White House Commission on Complementary and Alternative Medicine Policy), Jeanne Achterberg (who, together with Dossey and Gordon, chaired the “Mind-Body” panel of the 1992 “Workshop on Alternative Medicine,” whose report has debased medicine and medical research for nearly two decades), and many more fairly gush over the potential of ‘nonlocal healing.’ There’s a lotta research money wasted there, so it’s too bad that Cochrane hasn’t offered the same conclusion about the non-stop version of DH that it now has about the layover kind.

I also wonder if the reviewers would have included Targ’s study if that particular exclusion had not held, because Targ was later revealed to have rigged her study to yield “positive” results. She did this after the fact but before the publication, by “data dredging.” I’ve come to expect Cochrane reviewers to remain blissfully ignorant of such departures from polite methodology. Consider their ingenuous response to the Olszewer paper in the chelation review. In this “intercessory prayer” (IP) review are examples that needn’t require the reviewers to venture from the papers themselves. The review characterizes the most famous early ‘positive’ study, Byrd 1988, as double-blinded. That, presumably, follows from this statement in Byrd’s Methods section:

Patients were randomly assigned (using a computer-generated list) either to receive or not to receive intercessory prayer. The patients, the staff and doctors in the [coronary care] unit, and I remained “blinded”, throughout the study. As a precaution against biasing the study, the patients were not contacted again.

Well, OK, but consider this statement in the very next paragraph (emphasis added):

The patients’ first name, diagnosis, and general condition, along with pertinent updates in their condition, were given to the intercessors.

It seems that someone with access to that coronary care unit (CCU) musta not been blinded, and could easily have revealed subject allocation to the subjects themselves and to others. Just sayin’.

The review is ambivalent about the Byrd Score, a composite “severity” score that Byrd devised ostensibly to deal with the problem of multiple outcomes. Here are the results of those outcomes:

Byrd Table 2

Hmmm. The difference that jumps out at you is the incidence of congestive heart failure (CHF). All other differences reported to have achieved statistical significance—use of diuretics, intubation/ventilation, pneumonia, antibiotics, and even cardiopulmonary arrest—likely followed from CHF or from a common antecedent. Since such key outcomes as mortality and duration of CCU and hospital stay were no different between the two groups (surprising given the poor prognosis of CHF, especially 23 years ago), it seems reasonable to discount the CHF difference as either spurious or, as the Cochrane authors correctly acknowledged, due to chance in the context of multiple outcomes.

Not acknowledged by the reviewers were other curious findings in Byrd’s table: if 14 subjects in the control group suffered cardiopulmonary arrest—which involves a blood pressure of approximately zero—how could only 7 subjects in that group have experienced systolic blood pressures below 90? How could only 3 subjects in the IP group have suffered cardiopulmonary arrest—the final common pathway of dying, other than for the special category of ‘brain death’—when more than 4 times that many (13) actually died? Oh yeah, and dead people also have blood pressures below 90, except, apparently, several in each of the groups reported here. I dunno about you, but I’d like to think that any reasonably intelligent physician or scientist would look at that table for a couple of minutes and conclude, “Nope. Nuthin’ goin’ on there.”

The Cochrane reviewers included a study of “retroactive intercessory prayer.” Yup, it means what you’re afraid it means, your double-take notwithstanding. I am not making this up: Check it out. ;-)

All right, you must be thinking, so far I’ve shown you nothing but reasons to be more pessimistic than ever about Cochrane ‘CAM’ Reviews. Next they’ll be declaring that there is not enough evidence either in favour or against the use of exorcisms for demonic possessions, f’crissakes. But remember, the very same reviewers who went for time travel also politely called for a halt in intercessory prayer trials, so something must have swayed them.

Feedback

The answer seems to be found in two Feedback letters. The second is identified only as having been written by “Chris Jackson, anaesthetist.” I don’t know where he or she is from, but I’m guessing he’s what we in the U.S. call an ‘anesthesiologist.’ That’s what I am! Chris, you make me proud. This letter apparently jolted the Cochrane reviewers into noticing that a study they’d included for years, the infamous Cha Intercessory Prayer for IVF study, was, well, infamous enough to finally exclude (in 2009). Jackson also wrote that “RCTs of prayer are meaningless…There’s a lot of pseudoscience being done in this area,” which the reviewers, alas, didn’t buy.

The first Feedback letter is much longer, more adamant and less polite, and—what a kick!—written by other Cochrane reviewers. It begins with condemnation:

This review is riddled by serious flaws such as lack of critical appraisal of the included trials and findings, lack of a necessary discussion of the relevant sources of bias, and undue interference of theological reasoning.

It ends with a call for banishment:

This review does not live up to the scientific standards one can reasonably expect of a Cochrane review. The review as currently published should be withdrawn from the Cochrane Library, not least because it suggests that all scientific studies are meaningless, as we will never know whether one or more gods intervened in our carefully planned experiments.

The authors of this letter are identified as Karsten Juhl Jørgensen, Asbjørn Hrobjartsson and Peter C. Gøtzsche, from the Nordic Cochrane Centre, Rigshospitalet Dept. 3343, Copenhagen, Denmark. The cognoscenti among you might recognize Hrobjartsson and Gøtzsche as the authors of several reviews questioning the ‘power of the placebo,’ a topic that they’ve also reviewed for Cochrane.

I’m happy to report that I needn’t quote any more excerpts from that Feedback letter, even though you can’t read it without paying for the full review, because there’s an even better source. Jørgensen and colleagues turned their letter into a full article that you can read online in the aptly-named Journal of Negative Results in Biomedicine: “Divine Intervention? A Cochrane review on intercessory prayer gone beyond science and reason.” They make several of the points made above and elsewhere in this series (citing Bayes, for example), and many more, because unlike your semi-faithful blogger they were not too impatient to slog through the tedious religious formulations in the Cochrane IP review.

I suspect that it was this article and its associated Feedback letter that led the Cochrane IP reviewers to reverse their previous call for further studies, even if they failed to heed most of the arguments made by Jørgensen et al. Unfortunately, you would only know the last point if you had access to the full Cochrane review, where the exchange is found.

This post is already way too long, so I’ll end by telling you the most amusing example. By now I’m sure you either know or suspect that the “retroactive intercessory prayer” study included in the Cochrane IP review was a joke that the Cochrane reviewers didn’t get. The Danes explained this both in their article and in their Feedback letter, even providing a reference to a subsequent letter by the “retroactive” author in which he pretty much cops to the joke. The Cochrane reviewers, notwithstanding, responded:

Comments made about the Christmas issue of the BMJ and the Leibovici 2001 study in particular are not fully accurate. Several articles in the late December issues of the BMJ are written with humour and some in pure spoof. Most are not. They may be written with humour and have an odd perspective, but are, nevertheless, interesting and well thought out research. The Leibovici 2001 was not in jest. It is a rather serious paper, intended as a challenge.

Yikers.

…………

*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

8. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 1

9. Evidence-Based Medicine, Human Studies Ethics, and the ‘Gonzalez Regimen’: a Disappointing Editorial in the Journal of Clinical Oncology Part 2

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

14. Of SBM and EBM Redux. Part IV, Continued: More Cochrane and a little Bayes

15. Cochrane is Starting to ‘Get’ SBM!

Facebook Google Buzz Digg LinkedIn StumbleUpon LiveJournal Share

Do calcium supplements cause heart attacks?

Posted on by

Calcium is good for us, right? Milk products are great sources of calcium, and we’re told to emphasize milk products in our diets. Don’t (or can’t) eat enough dairy? Calcium supplements are very popular, especially among women seeking to minimize their risk of osteoporosis. Osteoporosis prevention and treatment guidelines recommend calcium and vitamin D as an important measure in preserving bone density and reducing the risk of fractures. For those who don’t like dairy products, even products like orange juice and Vitamin Water are fortified with calcium. The general perception seemed to be that calcium consumption was a good thing – the more, the better. Until recently.

In a pattern similar to that I described with folic acid, there’s new safety signals from trials with calcium supplements that are raising concerns. Two studies published in the past two years suggest that calcium supplements are associated with an significantly increased risk of heart attacks. Could the risks of calcium supplements outweigh any benefits they offer?

Why Calcium? Osteoporosis

Osteoporosis is a progressive bone condition of reduced bone mass and deterioration of bone tissue, and a correlating increase in fracture risk. 80% of those diagnosed are women. Hips and spines are the most common fracture locations, but they can appear in any bone, and osteoporosis makes fractures more likely. In postmenopausal women over the age of 50, the lifetime risk of a vertebral fracture is about one in three, and one in five for a hip fracture. Because they are so common, hip and vertebral fractures cause considerable aggregate and individual morbidity and mortality. So prevention and treatment are major health issues.

The initial strategy to preventing and managing osteoporosis is ensuring adequate calcium and vitamin D dietary intake, as both influence bone density. Calcium intake influences overall calcium balance: adequate vitamin D and calcium ensure calcium balance is positive. This occurs at about 1000mg per day in premenopausal women, and 1500mg per day in postmenopausal women not taking estrogen. The North American Menopause Society’s (NAMS) 2006 osteoporosis guidelines recommends [PDF] adequate calcium and vitamin D for all postmenopausal women, regardless of osteoporosis risk factors. The guidelines note that requirements increase with age owing to reduced absorption, and recommending adequate intake (preferably via diet) as the preferred sources. The 2010 Canadian guidelines [PDF] are similar, recommending 1200mg of calcium (diet and supplements) and vitamin D for all individuals over the age of 50. The Institute of Medicine recently updated its calcium and vitamin D guidelines (pdf) as well. It concluded with the caution that the consumption of levels beyond those recommended have not been shown to offer additional health benefits, and may in fact be linked to other health problems.

The effectiveness of calcium and vitamin D for the prevention and treatment of osteoporosis has been studied in both observational and prospective clinical trials. Wile there are data to demonstrate that calcium and vitamin D can prevent bone loss, the data on fracture prevention are much less convincing, with some trials showing no effect. Beyond density effects, calcium is also associated with generally positive effects on muscle strength, balance, and the risk of falls. So for most men and women with (or at risk of) osteoporosis, calcium and vitamin D are standard treatments. Given dietary intake in those at greater risk of osteoporosis may be below recommended levels, supplements are often used to meet recommended amounts.

The Safety Signals

Prior studies of calcium supplements have pointed to a possible relationship between calcium supplementation and cardiovascular events. Bolland et al specifically examined the relationship of calcium with the risk of heart attacks and cardiovascular events in a 2010 BMJ meta-analysis. It included all RCTs of calcium supplements (?500 mg/day), with a study size of 100 or more participants, an average age over 40, and a duration of more than one year. Trials that included vitamin D as an intervention were excluded. 15 trials were identified: some with patient-level data, and some with trial level data. Analyses of both sets of data identified a significant increase in heart attacks in those randomized to calcium supplements. The trial-level analysis show a hazard ratio (pdf) of 1.27 with a 95% confidence interval of 1.01 to 1.59 (p=0.038). The patient level analysis revealed a similar hazard ratio for myocardial infarction of 1.31 (95% confidence interval 1.02 to 1.67, p=0.035). Overall, the analysis suggests that calcium supplements increase the relative risk of myocardial infarction by about 30%. Reassuringly, there were no statistically significant increases in the risk of stroke, death, or the composite endpoint of MI+stroke+death in either analysis. Based on the patient-level data, the authors estimated that treating 69 people with calcium for five years will cause one additional heart attack. The authors suggested that in light of calcium’s unimpressive efficacy against fractures, that calcium’s role in osteoporosis prevention and treatment should be reevaluated.

Time to stop the calcium? As noted above, the data to support the use of calcium supplements alone to prevent fractures are, on balance, unimpressive. And there are possible models for how calcium could be causing these harms: vascular calcification is a potential (though not proven) consequence that might be more likely in the elderly patients. However, given calcification can take years, and harms appear shortly after dosing starts, it could be a due to effects on carotid plaque thickness, leading to aortic calcificiation, and subsequent cardiovascular events. (Reid describes potential mechanisms for these harms in a2010 paper in Clinical Endocrinology.)

What happened after this paper was released? There were criticisms of the endpoints, and the fact the composite endpoint was not significant. Concerns were also raised that the trials included were not designed with cardiovascular endpoints – a valid criticism. And many pointed to the fact the studies excluded vitamin D, contrary to treatment guidelines and common use. Now the same group has done a new analysis, incorporating vitamin D. Bolland and associates followed up their calcium-only therapy with a study of calcium + vitamin D. They used the Women’s Health Initiative (WHI) dataset to answer the vitamin D question, added in some other studies, and redid their meta-analysis.

The WHI was a massive 15-year trial of over 161,000 women that sought to answer a number of questions about women’s health. The most well known components were the hormone therapy trials which changed our understanding of the risks and benefits of hormone treatments. The calcium and vitamin D study was a component of the WHI which randomized 36,282 postmenopausal women aged 50-79 into two groups. One group received 1,000 mg of calcium carbonate and 400 UI of vitamin D once daily, the other, placebos. Interesting in the design was that 54% of women were already taking calcium, and 47% were already taking vitamin D, and they were allowed to continue with their therapy, even after randomization. This meant that actual calcium and vitamin D doses women consumed varied from zero to substantially more than the intervention dose. The clinical question the study sought to answer was to understand the effects on fracture risk and the prevention of colorectal cancer — and the results were disappointing: no effects on colorectal cancer, and insignificant effects on fractures (though in a subgroup analysis of compliant patients, significant reductions in hip fractures were noted.)

Bolland sought to analyze the WHI data for cardiovascular effects, and then add these data into the previous meta-analysis. In the over 16,000 women not taking their own calcium and vitamin D, there was a significant increase (hazard ratio 1.22) in myocardial infarction noted in the group randomized to calcium and vitamin D (p=0.04, 95% CI 1.00 to 1.50). Similarly, significant effects were also noted in other composite endpoints. In contrast, women taking their own calcium and vitamin D didn’t show any changes in their cardiovascular risk when randomized to calcium and vitamin D. In addition, no relationship was found between calcium dose and risk of cardiovascular events.

The authors then pooled their own WHI analysis with two other studies of calcium and vitamin D where trial-level data for cardiovascular events were available: In total, over 20,000 participants could be studied. In this pooled analysis, calcium and vitamin D were associated with a significant increases in myocardial infarction (relative risk 1.21), stroke (RR 1.20) and a composite endpoint of both (RR 1.16).

Finally the authors combined the trial level data from their calcium-only meta-analysis with their trial level calcium plus vitamin D data:, resulting in a pool of over 28,000 patients across nine trials. In this analysis, there was risk increase of 1.24 (95% confidence interval 1.07-1.45, P=0.004) for myocardial infarction and 1.15 for the combined endpoint (1.03-1.27, P=0.009).

Difficult to interpret? Yep. The lack of effect of “personal” use of calcium on endpoints, and the lack of dose response, means this isn’t case closed for the clinical question. But the persistent and significant correlation between randomization to calcium, with or without vitamin D, and myocardial infarction, does concern me. There are a number of additional criticisms outlined in the editorial that accompanied the Bolland WHI analysis, and the keen reader is referred there for more.

Evaluation

Is it possible that calcium supplements can be causing harms that could outweigh their benefits? Yes, but the evidence isn’t clear enough to give an definitive answer. These data need to be factored into individual evaluations of diet as well as risk factors for cardiovascular disease and osteoporosis. I’d like to see these findings validated by other groups, as both meta-analyses came from the same group of researchers. The meta-analysis can be a very useful tool, but it’s not without its own limitations, as is often pointed out by the contributors to this blog. Interestingly, a 2010 meta-analysis, from a different group of authors, and using a different methodology, has come to a different evaluation of calcium. So the question remains an open one. More data may help refine our estimates of number needed to treat, and number needed to harm, to inform treatment decisions. And it should help guide advice for younger, premenopausal women, as well as men. So until more data emerges, my tentative recommendations to consumers are as follows:

  • Calcium supplementation has been associated with increased risks of cardiovascular events like heart attacks. Until there is more evidence to confirm or refute this association, it’s prudent to be cautious when taking calcium supplements.
  • No harms have been shown from calcium consumption via dietary sources. Efforts should be made to first meet dietary requirements through food products, before considering supplements.
  • Routine supplementation, in the absence of a dietary deficiency, is not necessary or advisable.
  • Calcium supplements may still be advisable for those with low dietary intakes, or those at risk of or being treated for osteoporosis. The risk-benefit assessment for calcium supplements needs to consider risk factors for both osteoporosis and for cardiovascular disease.
  • Vitamin D supplements are advisable for most people, and are recommended for the prevention and treatment of osteoporosis. The suggested doses of calcium and vitamin D may vary based on diet, medical conditions, and other considerations. Sources for target doses could include the IOM or recent osteoporosis guidelines (Canada) (USA).

Conclusion

The emerging safety data on calcium may yet become another cautionary tale about the unexpected and undesirable outcomes of targeted supplements. Until more evidence emerges, the safety of calcium supplements will continue to be questioned and debated. But that’s science-based practice: Data can be conflicting, messy, and difficult to interpret. There is always the possibility of unintended consequences when we make therapeutic decisions, and only by rigorously evaluating what we’re doing can we continue to improve the way we prevent and treat disease.

References
Bolland MJ, Avenell A, Baron JA, Grey A, MacLennan GS, Gamble GD, & Reid IR (2010). Effect of calcium supplements on risk of myocardial infarction and cardiovascular events: meta-analysis. BMJ (Clinical research ed.), 341 PMID: 20671013

Bolland, M., Grey, A., Avenell, A., Gamble, G., & Reid, I. (2011). Calcium supplements with or without vitamin D and risk of cardiovascular events: reanalysis of the Women’s Health Initiative limited access dataset and meta-analysis BMJ, 342 (apr19 1) DOI: 10.1136/bmj.d2040

Facebook Google Buzz Digg LinkedIn StumbleUpon LiveJournal Share

Dr. Oz on alternative medicine: Bread and circuses

Posted on by

NOTE: Dr. Novella has written up a detailed description of his experiences on The Dr. Oz Show. Please read it. Also note that the online video for Dr. Novella’s appearance is now available:

  1. Controversial Medicine: Alternative Health, Part 1
  2. Controversial Medicine: Alternative Health, Part 2
  3. Controversial Medicine: Alternative Health, Part 3

When I first learned that our fearless leader and partner in crime for this blog, Dr. Steve Novella, Yale neurologist, blogger, and host of the popular skeptical podcast the Skeptics’ Guide to the Universe was going to be on The Dr. Oz Show, I was concerned. After all, this is the same physician who had in essence given up science-based medicine in favor of media stardom based on the promotion of alternative medicine. Of late Dr. Oz has been getting worse, too, promoting pseudoscience and what can only be described, in my opinion, as quackery. The snake oil that Dr. Oz has promoted over the last several months includes Dr. Joe Mercola, one of the biggest promoters of “alternative” health, whom Dr. Oz first had on his show about a year ago and then defiantly defended in a return appearance in early 2011, to be followed by a rapid one-two punch in which Dr. Oz had an ayurvedic yogi named Cameron Alborzian, who promoted highly dubious medicine, including “tongue diagnosis,” to be followed a few days later by something I would never, even in my most cynical assessment of Dr. Oz, expected, namely the appearance of faith healer Issam Nemeh on his show. ext Dr. Oz endorsed a diet that he once eschewed as quackery and then, to top it all off, invited psychic John Edward onto his show, asking Is talking to the dead a new kind of therapy? All of these offenses contributed to the reasons why in 2011 the James Randi Educational Foundation awarded him the The Media Pigasus Award for the second year in a row.

So right from the start I wasn’t very optimistic about how this whole thing would turn out. Fortunately, however, I was pleasantly surprised. Steve managed to hold his own in a completely hostile environment, with Dr. Oz asking him “Have you stopped beating your wife?”-style questions, with only minor stumbles. At one point, he even managed to hand Dr. Oz his posterior. Alas, I doubt it will make any difference to Dr. Oz’s viewers, but we can always hope to change a few minds. I also realize that, however a big deal being on Dr. Oz’s show was to Steve and many members of the skeptical movement (especially supporters of SBM), to Dr. Oz it was just one segment in one episode of one season of a daily talk show made up of well close to 150 episodes. Not to detract from Steve’s achievement at all (it’s truly amazing that he managed to get on the show and do as well as he did, given how the deck was stacked against him), but to us this is big; to Dr. Oz it’s just another episode. It’s entertainment. As giddy and anxious as we at SBM have been the last two weeks, we have to keep things in perspective.

So what happened?

As I watched the beginning of the segment, my experience having watched several episodes of Dr. Oz’s show led me to look for the not-so-subtle signs of the story that Dr. Oz and his producers intended to portray. In a television show like Dr. Oz’s, you always have to look for the story, and the story is revealed by how the issue being discussed is framed. I didn’t have long to wait. One thing I thought as I watched the opening minutes of this episode of Dr. Oz’s show is that that watching Oz really reminded me of was Kevin Trudeau, whose strategey for spreading snake oil was implicit in the title of his book, Natural Cures “They” Don’t Want You to Know About. The message is the same as Dr. Oz’s. It’s you (as in Dr. Oz’s audience or Kevin Trudeau’s readers) against the establishment. The Man is trying to keep you down and keep you from The Truth (a.k.a. “natural cures” that don’t rely on big pharma)! So, what are you, sheeple? Or are you among the enlightened, like Dr. Oz and his viewers? Why is your doctor afraid of alternative medicine? (Yes, that was the title of the segment.) It’s an appeal both to the appeal of outsider status and to the vanity of Dr. Oz’s audience. His audience is encouraged to feel not just like a maverick, bucking the system, but to feel superior than everyone else, “empowered” to “fight the power.” Right from the start, Dr. Oz frames the issue of “alternative medicine” as the little guy versus dogmatic physicians, as “taking control” from undefined outside forces. In doing so, he paints himself as the champion of the little person, willing to risk everything to tell his audience The Truth. It’s a load of fetid dingos’ kidneys of course. Dr. Oz is fabulously wealthy and famous in a large part because he’s embraced alternative medicine and found a way to preach it to the masses, all wrapped up in a lovely bit of framing:

Today I’m taking on a controversial issue in medicine that has everything to do with helping you take control of your health. There are a lot of doctors, including me, who are putting their reputations on the line because we’re using alternative therapies in our traditional practices. But many doctors claim that these therapies are nothing more than junk science and may even be dangerous. Your doctor could be one of them. Why are they so afraid of alternative medicine? Should you be too?

Note the “brave maverick doctor” pose. I have no idea if Dr. Oz is aware of this or not, but this is the same pose that quacks who think vaccines cause autism frequently take, that only they are “brave” enough, clever enough, or “open-minded” enough to reject that nasty, reductionistic “Western” science. Dr. Oz then uses the fallacy of argumentum ad populum; i.e., proclaiming that, since alternative medicine has “reached its tipping point” (in his opinion, at least) and people spend $35 billion a year on it in this country, that there must be something to it. It’s a silly argument. Lots of things are very popular; popularity doesn’t equal “scientifically valid.” I do have to admit one thing that made me totally chuckle here. Dr. Oz referred to chiropractic as “chiropractics.” I mean, seriously, Dr. Oz. If you can’t at least get the terminology right about something as commonplace as chiropractic, I find it very hard to take you seriously. Very hard indeed, even more so after he trots out the “superstars of alternative medicine” that he’s showcased on The Dr. Oz Show, including Andrew Weil, Christiane Northrup, Joe Mercola, and Deepak Chopra, to name a few.

Of course, there wouldn’t be any drama if there weren’t any “holdouts,” which is how the argument is framed. It’s very clever. Dr. Oz is the brave, open-minded doctor willing to try things outside the mainstream. Skeptics and proponents of science-based medicine are portrayed as going against the flow, as negative, as “holdouts” against what is portrayed as the inevitable triumph of alternative medicine, when the moon will be in the seventh house and Jupiter will align with Mars. And Dr. Oz is persecuted for it, too. Those nasty skeptics! They’ve portrayed him as having abdicated professional responsibility and gone to the Dark Side. Nasty skeptics!

Dr. Oz’s offense, real or imagined, aside, I’m much less amused by how Dr. Oz panders to his audience. It begins right at the very start of the segment, where Dr. Oz proclaims that you–yes, you!–his viewers (well, maybe not you, as in you who read this blog) “aren’t afraid to test the time-honored traditions of alternative medicine.” That’s because, obviously, if you watch Dr. Oz’s show, you must be a brave maverick, just like him. You’re the brave maverick, and he’s the brave maverick doctor–a perfect combination! If you’re not afraid of alternative medicine, then why should is your doctor? (Yes, Oz actually said that.) All of this was just the introduction, at which point the framing was complete. It’s Oz and his viewers against the world, which leads Oz to the very first question to Steve:

Why are there so many doctors out there–and doctors are our viewers–who don’t like alternative medicine? Why do you not want me to talk about these therapies on the show?

More framing. Notice now that Oz frames alternative medicine as a preference. To Oz and his viewers, doctors who support science-based medicine don’t object to alternative medicine because it is unscientific, because there’s no evidence that most alternative therapies work and a lot of evidence that they don’t, or because it’s a false dichotomy. (Yes, I’m talking about the fact that alternative medicine is by definition medicine that has not been shown to work scientifically or has actually been shown not to work. It can never be repeated too many times in this context that alternative medicine that has been shown to work scientifically ceases to be “alternative” and becomes just “medicine.”) Oh, no, those doctors just don’t like it, as many people don’t like Brussel sprouts, or as some people prefer Coke over Pepsi (or vice-versa). It’s a preference that doctors are trying to impose on their patients, those nasty, reductionist, doctors! Worse, as the language used by Dr. Oz reveals, not only is this opposition to alternative medicine a mere “dislike,” but it’s a “Western” dislike. Yes, Oz kept repeating the term “Western medicine” or “Western science,” another false dichotomy. Good science is good science; it doesn’t matter whether it was done in the “West” or the “East.”

Notice also how Oz takes on the mantle of the victim. It’s not about him talking nonsense about science and medicine, about him promoting quackery (which he has been doing a lot of in 2011). Oh, no! It’s all about skeptics like Steve trying to shut Dr. Oz up! As if we could! It’s a silly argument, obviously custom made to try to portray Dr. Oz’s critics and close-minded, dogmatic, simpletons. In reality, this is a distortion of our position. Nothing could be further from the truth to claim that supporters of SBM don’t want Dr. Oz to talk about these therapies. What we don’t want him to do is to promote them as efficacious when scientific findings indicate that they are not. What we want is a skeptical, science-based assessment of them. Despite the claim by Dr. Oz and his producers that we are “afraid” of alternative health, in actuality we crave an open dialogue based on science, both preclinical and clinical trials, not marketing hype, pseudoscientific claims, and testimonials.

After some minor stumbling, Steve explained very well how the very concept of alternative medicine is an artificial category that exists primarily to produce a double standard that favors modalities that can’t cut it based on science. Unfortunately, as is frequently the case in such “debates,” Steve was paired with a true believer, Dr. Mimi Guarneri, who did exactly what it is that I complain about all the time. She used the classic “bait and switch” of alternative medicine, claiming nutrition, exercise, and the like as “alternative” and then proclaiming them as not being “alternative.” Steve answered that quite well also, but I doubt it got through the audience. Much of the talk was dominated by herbs and supplements, rather than the more bizarre quackery that Dr. Oz has featured on his show in 2011, such as homeopathy, faith healing, and the psychic scammer John Edward. No doubt this is intentional, because herbs and supplements are at least potentially real drugs (impure drugs with highly variable quantities of the active ingredient, but drugs nonetheless). As such, they are the “bait,” used to lure in the credulous, after which the “switch” is made for the real woo, modalities like acupuncture, homeopathy, reiki, and the like.

One thing that cracked me up is that Oz defined alternative medicine rather artificially by dividing it into three categories. Why three? who knows? Perhaps it’s like the Holy Hand Grenade of Antioch, you know, “…then shalt thou count to three, no more, no less. Three shall be the number thou shalt count, and the number of the counting shall be three. Four shalt thou not count, neither count thou two, excepting that thou then proceed to three. Five is right out.” Whatever the reason for choosing the number three, Oz divides alternative medicine into things you can put in your mouth, things that are done to your body, and the “mind-body” connection. For each one of these divisions, Dr. Oz showed a brief video promoting their glories. Particularly irritating and, quite frankly, dishonest, is how Dr. Oz at each point tries to turn around Steve’s statements about how various alternative medical therapies have been studied and found not to work into a straw man in which a distorted version of Steve’s argument is repeated back to him, represented as saying that there aren’t any studies or that there aren’t enough studies. Dr. Oz and Dr. Guarneri then bat that straw man down with gleeful abandon. At one point, Oz even says, “I totally disagree that these have not been studied and some evidence been found to support them.” Of course, “some evidence” has been found to support that most ridiculous of quackeries, homeopathy; one has to look at the totality of evidence to know that not only is homeopathy ridiculous from a basic science standpoint but that the clinical evidence that exists is most consistent with nothing more than placebo effects.

The utter intellectual bankruptcy of this approach was demonstrated when Dr. Oz brought in Catherine Ulbricht, PharmD, MBA[c], chief editor of Natural Standard and editorial board member of Natural Medicine Journal, who touted Natural Standard. One thing I noticed about the journal for which she is on the editorial board is that it is the official journal of the American Association of Naturopathic Physicians (AANP), which is definitely a strike against it right there. (Actually, it’s two strikes.) Naturopathy is a hodge-podge of mostly unscientific treatment modalities based on vitalism and other prescientific notions of disease that fancies itself to be science-based. In fact, as if to emphasize the connection between Dr. Ulbricht and naturopathic quacks, I found in my e-mail box a mass mailing from the AANP touting her appearance on The Dr. Oz Show. Such are the “benefits” of being on the AANP mailing list. Let’s just put it this way. Dr. Ulbricht has published at least one review of homeopathic remedies, specifically Oscillococcinum, in which she concludes that it probably works and that more studies are needed. Amusingly, in the segment that follows Steve’s segment, Dr. Ulbricht even invokes the alt-med cliche of aspirin having been derived from willow bark and being perfectly safe. Of course, natural product pharmacology is in no way “alternative” (more bait and switch), and aspirin is not without risks, sometimes life-threatening.

If there’s one area that Steve managed to score against Dr. Oz in spite of the deck being stacked against him, it’s acupuncture. Steve pointed out that it doesn’t work above and beyond a placebo. As I like to say, it doesn’t matter where you stick the needles and it doesn’t even matter if you stick the needles. The results are the same, and there is a small risk to sticking needles into people’s bodies. Dr. Oz’s reaction is very telling; he says:

There are billions of people around the world who use as the foundation of their healthcare system. It’s the basis of ancient Chinese medicine. I just think it’s very dismissive of you to say because we couldn’t take this idea that exists with a different mindset and squeeze it into the way we think about it in the West then it can’t be possibly effective.

All of which is utter nonsense. First, it’s very arguable whether there are “billions of people” who use acupuncture as the foundation of their health care system. The Chinese, for instance, are actually moving away from traditional Chinese medicine and acupuncture back towards that evil reductionistic “Western” medicine because it works. But even more telling is that Dr. Oz has fallen back on the hoariest of hoary alt-med excuses for not being able generate evidence in favor of their woo: You can’t use “Western science” to study my woo! He even claims that “Western science” can’t understand acupuncture well enough to “know how to study it the way it has to be studied.” It’s special pleading, and it’s pathetic. In fact, Steve’s response was brilliant in that it managed to point out that popularity doesn’t equal efficacy and to liken acupuncture to bloodletting, a comparison that clearly irked the Great and Powerful Oz. Whether Dr. Oz realized it, this was the one part of the show where it can legitimately be said that Steve handed him his posterior, even in spite of everyone being against him. True, Oz would never admit it, but this was the one point in the segment where the mask slipped just a little bit and for a brief moment Dr. Oz looked quite unhappy. After all, he promoted acupuncture, and Steve had just likened it to bloodletting. On the other hand, Oz clearly got what he wanted out of Steve. Steve was fighting a battle based on science, reason, and evidence; Oz was playing to his audience and burnishing the Dr. Oz brand. He got to appear reasonable to his audience by acknowledging criticism while completely controlling the flow, and above all, the language of the discussion. Steve tried to punch his way out of the language box Dr. Oz was constructing and did about as well as anyone could hope to, but always had the last word and always controlled the forum.

It was bread and circuses all around, indeed, so much so that my wife ridiculed the later segments, in which Dr. Oz used huge bottles with huge labels, like “aspirin” as props to help Ulbricht “explain” what his audience should look for in supplements and “natural” remedies. I had never noticed that before, but going back to my past posts on Dr. Oz (particularly the one about Dr. Mercola’s appearance), I had to admit that my wife was spot on in her observation. I even kicked myself for not having noticed it before. Giant props, as if for a children’s show. Simplistic answers. It’s all there.

Finally, there were two very annoying bits in this whole exchange. First, Dr. Oz appropriates the alt-med trope of “individualization” (which in alt-med, really means “making it up as you go along“), even likening his favorite woo to a “bow and arrow” or a “stealth approach” to “hitting what you want to get that works in you” and science-based medicine to a “ballistic missile approach that we have so often become comfortable with.” “Ballistic missile approach”? You mean like Tarceva, Herceptin, Avastin, and other targeted therapies designed to hit very specific molecular targets?

In his “final word” on the topic, Dr. Oz then solidifies the bond with his intended audience. Oz fans, it’s you and him against the world! Check it out:

Alternative medicine, I think, is at the grassroots level, and because of that nobody owns it. Now, that stated, I think we got our homework to do. But I think alternative medicine empowers us, and that’s the big message–but only if you know more about it. And if it does work for you, trust me, do not let anybody take it away from you.

In other words, you brave maverick Dr. Oz viewers, don’t worry your little heads about science. Don’t listen to those buzz killer skeptics who just don’t like alternative medicine and Dr. Oz. They’re so much less interesting than cupping, acupuncture, homeopathy, reiki, and various other forms of mystical, magical woo. They’re paternalistic, too! (Never mind Dr. Oz oozes paternalism.) Be “empowered” by listening to whatever message that the latest seller of snake oil is promoting to you. “Learn” more about alternative medicine from Dr. Oz; don’t worry if the information is science-based. Be good Dr. Oz fans. Above all, take your “empowerment” to buy what Dr. Oz says you should buy (and, as the segment right after Steve’s segment takes great pains to point out to Dr. Oz fans, even to the point of bragging about the number of “cease and desist letters” Dr. Oz’s lawyers have sent to supplement hawkers claiming an endorsement, don’t buy goods not endorsed by Dr. Oz on his show–they sully and dilute the Dr. Oz brand, after all).

And, of course, keep watching his show.

Additional commentary:

  1. Alternative Medicine: The Magic of Oz
  2. Dear Dr. Oz: I Just Think it’s Very Dismissive of You to Reject Reality
  3. The Dr. Oz Show: The Price is Right of Medical Woo
  4. Steve Novella goes to Oz
  5. Steve Novella on Dr. Oz
  6. Steven Novella on Dr. Oz
  7. Dr. Steven Novella vs. Dr. Oz

Facebook Google Buzz Digg LinkedIn StumbleUpon LiveJournal Share

Conflicts of Interest

Posted on by

When an article is published in a medical journal, the authors must disclose any conflicts of interest. This is important, because even if they think owning stock in the drug company won’t influence their scientific judgment, we know that subtle biases can creep in to somehow affect the findings of studies. It has been shown that studies funded by drug companies are more likely to get positive results for their drug than studies funded by independent sources. Andrew Wakefield, author of the infamous retracted Lancet study suggesting a relationship between MMR vaccine and autism, was severely chastised for not disclosing that he received money from autism litigators and expected to earn a fortune from his own patented products if the MMR vaccine could be discredited.

I was recently contacted by an acupuncturist who plans to critique an article I wrote. It was a commentary in the journal Pain that accompanied a systematic review of systematic reviews of acupuncture by Ernst et al. For details of Ernst’s and my articles, see my previous post. He challenged my statement that I had no conflicts of interest to report. He apparently thinks I should have said I have a conflict of interest in that I am anti-CAM and anti-acupuncture. When he writes about my article, he plans to attack me for not declaring this alleged conflict of interest and he plans to set a good example with a conflict of interest statement of his own, divulging that he makes his living practicing acupuncture, has financial investments in it and many personal relationships, that his self-identity and prestige are dependent on his belief in acupuncture’s efficacy, and that he is biased towards constructivism and away from positivism. (I think this is a fancy way of saying he favors experience over the scientific method.) I agree that he has conflicts of interest, but was I wrong to say I had no conflicts of interest? I don’t think so.

He cited the International Committee of Medical Journal Editors (ICMJE) criteria on conflict of interest:

Public trust in the peer-review process and the credibility of published articles depends in part on how well conflict of interest is handled during writing, peer review, and editorial decision making….Conflict of interest exists when an author … has financial or personal relationships that inappropriately influence (bias) his or her actions… Financial relationships (such as employment, consultancies, stock ownership, honoraria, and paid expert testimony) are the most easily identifiable conflicts of interest and the most likely to undermine the credibility of the journal, the authors, and of science itself. However, conflicts can occur for other reasons, such as personal relationships, academic competition, and intellectual passion.

Financial relationships? Something that would make it financially advantageous for me to disparage acupuncture? Employment, consultancies, stock ownership, honoraria, paid expert testimony? Nope, nope, nope, nope, and nope. None of these apply to me. I’m retired, so I can’t even be accused of competing for patients with acupuncturists. I would have nothing to gain financially if acupuncture vanished from the earth overnight.

Personal relationships? Should Dr. Oz should divulge that his wife is a Reiki master before he pontificates about the wonders of Reiki on national television? I think he should; if it hasn’t influenced his views, I can’t imagine what his marriage is like.  Do I need to state that I associate in cyberspace with other science-based writers who have questioned the evidence for acupuncture? Do I need to say that I have 3 friends who accept acupuncture and 6 who reject it? I don’t think so.  Does a scientist doing a drug study need to divulge that his cousin or his next-door neighbor or one of his Facebook friends works for the drug company? I don’t think so.

Academic competition? I am not and have never been an academic. I’m a retired family physician with no ties to any academic institution.

Intellectual passion? My passion is for science and reason, not for or against acupuncture or any other particular treatment. I have no brief against acupuncture. I have had no personal experiences, good or bad, that would tend to prejudice me for or against it. My initial opinion of acupuncture was favorable. When I was in med school, the head of anesthesia, Dr. John Bonica, was enthusiastic about acupuncture and was actively investigating it as a possibly worthwhile addition to his field. He thought it worked by the gate control theory of pain. (As he studied it, his initial enthusiasm soon waned.)  I believed the first reports I heard about its effectiveness for surgical anesthesia and pain relief. Through the years, I read the reports that came out in the medical literature and I perceived that the weight of evidence was gradually turning against it. I also learned about the psychology of how patients and doctors can come to believe that a treatment works when it really doesn’t, and I learned some of the things that can go wrong in research to produce results that are not valid. Eventually I came to the provisional conclusion that acupuncture probably has no specific effects but is very good at eliciting non-specific effects of treatment. I don’t say that acupuncture doesn’t work: I only say that the entire body of published evidence is compatible with the hypothesis that it doesn’t work better than placebo.

I have never seen a conflict of interest statement that mentioned the authors’ worldview. No prayer study lists “I believe in God” as a conflict of interest. No scientist is expected to state “I believe the scientific method is the best way to evaluate claims.”

If conflicts of interest make an article less credible, should we also be required to disclose factors that would tend to make it more credible?  When Ernst writes an article critical of homeopathy, should he divulge that he was trained as a homeopath and used to work in a homeopathic hospital? Should we be more disposed to believe his criticisms of homeopathy because he is a “convert”? No, the content of the article can be judged on its own merits. Only significant conflicts of interest need be reported. We can keep them in the back of our mind to moderate our confidence in the study’s findings but we can never assume they mean the study is not credible.

I have no particular attachment to my provisional conclusion about acupuncture. It really makes no difference to me personally whether it works or not. Really. I would welcome proof that acupuncture works, as it would give me another option for treating any pains of my own. I am always ready to change my mind and have done so innumerable times in my career in response to better evidence. As Emerson said, “A foolish consistency is the hobgoblin of little minds.” It can’t hurt my pride to change my mind as long as I change it in response to evidence and reason; I am proud when I have learned that I was wrong about something and was able to correct my error.

If new evidence convinced me that acupuncture worked, I would write about it and explain the evidence and my reasoning. This wouldn’t hurt my reputation. If anything, it would enhance my prestige in the skeptical community. It would demonstrate that I didn’t have an ax to grind, that I was willing to follow the evidence wherever it led.

The acupuncturist’s arguments for more complete disclosure remind me of a “complete” informed consent for surgery that was written as a joke. It advised patients of everything that could possibly happen, including an earthquake during surgery and the chance that the surgeon could die suddenly of a heart attack and fall on top of the patient. Informed consent and disclosing conflicts of interest are both important, but it’s possible to get too carried away.

In summary, the acupuncturist would have a great deal to lose if he rejected acupuncture, while I would have nothing to lose if I accepted it. He has a conflict of interest. I don’t.

Facebook Google Buzz Digg LinkedIn StumbleUpon LiveJournal Share

The trouble with Dr. Oz

Posted on by

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

  1. Controversial Medicine: Alternative Health, Part 1
  2. Controversial Medicine: Alternative Health, Part 2
  3. Controversial Medicine: Alternative Health, Part 3

Welcome, Dr. Oz viewers!

As managing editor of the Science-Based Medicine (SBM) blog, I am writing this post because our founder and exective editor Dr. Steven Novella was invited to be on The Doctor Oz Show. Later today, the episode in which he will appear will air in most of your local markets, and we wanted to make sure that any Dr. Oz viewer who sees the segment and as a result is intrigued (or angered) enough to wonder what it is that we are all about will have a convenient “primer,” so to speak, on the problem with Dr. Oz from a science-based perspective. In other words, who are these obnoxious upstart bloggers who are so critical of Dr. Oz are and, far more importantly, exactly why are we so critical? What is science-based medicine, anyway?

On to some of the answers!

Who is Steve Novella?

First of all, who is Dr. Steven P. Novella, the man who had the chutzpah to go into the proverbial lions’ den of Oz? An Assistant Professor of Neurology at the Yale School of Medicine and founder and president of the New England Skeptical Society, in his spare time Dr. Novella is also the host of the popular science and skepticism podcast, The Skeptics’ Guide to the Universe, as well as a blogger at his own personal blog, NeuroLogica Blog, and other related blogs, including The Rogues’ Gallery and SkepticBlog. A fellow of the Committee for Skeptical Inquiry and Chairman of the Board for the Institute for Science in Medicine, Steve was most recently named a Senior Fellow of the James Randi Educational Foundation (JREF) and director of its new Science-Based Medicine Project. As a result of this most recent appointment, SBM will be collaborating more closely with the JREF on projects related to science in medicine. As you can see, Dr. Novella’s activism on behalf of skepticism and SBM is extensive and varied. That’s why we can think of no better person to have appeared with Dr. Oz to try to explain what it is we at SBM find objectionable about how he covers many medical topics on his show.

What is science-based medicine?

Many readers have likely heard the term “evidence-based medicine” (EBM). It’s a (relatively) new buzzword designed ostensibly to describe medicine that is based on solid evidence, in contrast to much medicine practiced in the past that may or may not have been based on solid evidence. Indeed, I sometimes jokingly refer to some forms of medicine, particularly from more than a few decades ago, as “dogma-based” medicine or “tradition-based” medicine. We at SBM, however, have noted a problem with EBM. Specifically, EBM elevates clinical trial data to the highest level of its “hierarchy of evidence,” in particular, randomized, double blind clinical trial data. Under normal circumstances, where new treatments are developed “organically” from basic science and clinical observations, through preclinical experimentation (biochemistry, in vitro work, cell culture, and animal models), all the way to clinical trials, it is correct to rank randomized clinical trials as the “gold standard” of scientific evidence for or against a particular therapy. After all, many are the therapies and drugs that look promising in preclinical investigations, only to fail when tested in humans, many more than the therapies and drugs that succeed and prove their worth. Here’s the problem with EBM. While EBM works well for science-based medical interventions, it has a distressing tendency to break down when applied to medical interventions that are, from a basic scientific standpoint, highly improbable. And I’m not just talking mildly improbable, either, but interventions that are incredibly improbable.

To try to explain, my favorite example of this phenomenon is homeopathy. Homeopathy, you see, is improbable. Really improbable. You just won’t believe how hugely, mindbogglingly improbable it is. (Apologies to Douglas Adams.) Basically, homeopathy postulates two “laws,” the law of similars and the law of infinitesimals. The law of similars states that “like cures like”; for example, something that causes itching (poison ivy, for instance) can be used to cure itching. The law of infinitesimals then states that the more you dilute a remedy, the stronger it gets. It also postulates that the remedy is “potentized” by vigorous shaking between each dilution. A typical homeopathic remedy is diluted 30C, each “C” being a 100-fold dilution, which makes 30C a mixture that’s been diluted 100-fold thirty times. This results in a 1060-fold dilution, a one with sixty zeroes after it (by comparison, a trillion is represented by a one with twelve zeroes after it). To understand the significance of this, you need to know that a unit that chemists use to measure quantities of chemicals is the mole. One mole is roughly 6 x 1023 molecules. (One mole of table sugar, sucrose, for instance, weighs approximately 342 grams, which is less than 14 oz.) What this means is that typical homeopathic remedies are diluted way, way, way beyond the point where not a single molecule of original remedy remains. Indeed, some homeopathic remedies go up to 200C, which is a 10400-fold dilution. By comparison, the number of molecules in the known universe is estimated to be between 1078 and 1082. Clearly, for homeopathy to work, huge swaths of what we know about chemistry, physics, and biology would have to be not just wrong, but spectacularly wrong. It’s about as close to being impossible as can be imagined in modern science. Yet Dr. Oz promoted homeopathy on his show not long ago, and millions still swear by it.

Why?

Given that homeopathy is nothing more than water, one reason is nonspecific placebo effects. Combine placebo effects with the fact that, by design based on the way we calculate whether the results of a clinical trial are statistically “significant,” at least 5% of clinical trial results will be false positives; i.e., give a “positive” result when the treatment really doesn’t work. This is true for drugs as well as implausible remedies like homeopathy. In fact, it’s considerably higher than a 5% chance of a false positive, because the 5% number is more theoretical than anything else. It applies only when a clinical trial is perfectly designed and perfectly carried out, and there’s no such thing as a perfect clinical trial. Unfortunately, EBM does not take into account the extreme implausibility of a treatment like, for example, homeopathy, reiki, therapeutic touch, or many other “energy healing” methods. Clinical trials are all that matter, and the flaws in clinical trials can lead to the appearance that such remedies have an effect. SBM, in marked contrast, is evidence-based medicine that takes scientific plausibility into account. Because all the ins and outs of SBM could take up a book, we’ve written up a primer describing the concept of SBM, along with a bunch of links for those interested in learning more about it. Personally, I suggest starting with four posts:

The bottom line is that we at SBM reject the whole concept of “alternative health” in the title of Dr. Oz’s segment featuring Steve Novella. “Alternative medicine” represents a false dichotomy. Indeed, I frequently repeat an old joke that asks: What do you call alternative medicine that has been scientifically proven to work?

The answer: Medicine.

That’s because alternative medicine by definition is medicine that either hasn’t been scientifically proven to work or has been scientifically proven not to work, while “integrative medicine” is nothing more than “integrating” unproven “alternative” medicine with medicine scientifically proven to work.

Which finally brings us back to Dr. Oz.

The trouble with Dr. Oz

I can’t speak for the rest of the bloggers here at SBM, but up until about a year ago, I really didn’t have that much of a problem with Dr. Oz. I really didn’t. Admittedly, he did annoy me a bit with his tendency towards credulity towards certain forms of dubious medicine, such as reiki (which, when you come right down to it, is faith healing based on Eastern mysticism rather than Christianity). Also admittedly, I found Dr. Oz’s on-air persona to be a bit on the cheesy side. However, for the most part, before he got his own show and even early on after he got his own show, most of Dr. Oz’s health advice was at least semi-reasonable, much of it even science-based. As time went on, however, we did notice that, more and more, Dr. Oz seemed to want to “go with the flow” and “give the people what they want.” Why? we wondered. Dr. Val Jones, formerly a regular blogger for SBM, thought she knew the answer:

I told him [a business colleague] that I was contributing to a blog called Science-Based Medicine in an effort to combat some of the medical quackery that is being promoted online. He looked at me and said I’d never be a success with that message. He said that people like Oprah and Mehmet Oz were successful because they “went with the flow” and gave people what they wanted.

“Most people don’t want to think critically about things – they want to hear about miracle cures, self-help, and vitamins. They already have the media they ‘deserve.’ You’ll never appeal to a mass audience with your skeptical message.”

Even if that’s true, we view it as our mission to try to change that and encourage as many people as we can reach to learn to think critically about medicine.

So why would Steve agree to be on Dr. Oz’s show? It was a difficult decision, actually. Even in our wildest dreams we had no idea that our criticisms were even being noticed by Dr. Oz or his producers, much less having any effect. So, on the one hand, we were grateful to Dr. Oz’s producers for inviting our representative on the show. On the other hand there was very little time for Steve to make a decision, much less prepare, and, given Dr. Oz’s history, Steve and the rest of us were all—understandably, I believe—wary about how he might end up being portrayed. In the end, given that the mission of this blog is to promote science in medicine and medicine based on good science, we agreed that this invitation was an opportunity that we had to seize, even knowing the risk that Steve might be portrayed unfavorably. Even though, as I write this, I haven’t seen the episode yet, I have seen the preview. What I see is that my fears weren’t unfounded. The very title (“Controversial medicine: Why your doctor is afraid of alternative health”) is clearly slanted against the SBM point of view. Worse, even in just the brief promo clip presented, Dr. Oz:

  • Challenges Steve by asking, “Why do you not want me to talk about these therapies on the show?” This is a distortion of our position. Nothing could be further from the truth to claim that we don’t want Dr. Oz to talk about these therapies. What we don’t wnat him to do is to promote them as efficacious when they are not. What we want is a skeptical, science-based assessment of them. Despite the claim by Dr. Oz and his producers that we are “afraid” of alternative health, in actuality we crave an open dialogue based on science, both preclinical and clinical trials, not marketing hype, pseudoscientific claims, and testimonials.
  • Says it’s “very dismissive” of Steve to challenge these therapies as not working. This is the infamous “don’t be close-minded” gambit. Of course, the problem with being too open-minded is that your brains might fall out.

No wonder our readers are pessimistic at how Steve will be portrayed in the episode, and no wonder I took umbrage at being called “afraid” of alternative medicine.

Still, that Dr. Oz apparently was sufficiently stung by our criticisms over the last several months that he felt the need to have Dr. Novella on his show tells me that there may well be more hope than is readily obvious. My optimism aside, though, it’s impossible for us to deny that at huge part of the reason that Dr. Oz’s show is so successful is, no doubt, because he does “go with the flow,” serving up for the most part lightweight, fluffy, uplifting entertainment which sometimes contains good medical information. In this, he clearly learned at the feet of the Master, his mentor and the person who got him started as a media doctor, Oprah Winfrey, who has come under considerable criticism herself for promoting pseudoscience and New Age mystical beliefs. He’s also apparently learned at the feet of Oprah how to gin up a controversy, as his promo for Steve’s appearance shows.

Most disturbingly, though, of late Dr. Oz has been also promoting pseudoscience and what can only be described, in my opinion, as quackery. The snake oil that Dr. Oz has promoted over the last several months includes Dr. Joe Mercola, one of the biggest promoters of “alternative” health, whom Dr. Oz first had on his show about a year ago and then defiantly defended in a return appearance in early 2011. Then, in a rapid one-two punch, Dr. Oz had an ayurvedic yogi named Cameron Alborzian, who promoted highly dubious medicine, including “tongue diagnosis,” to be followed a few days later by something I would never, even in my most cynical assessment of Dr. Oz, expected, namely the appearance of faith healer Issam Nemeh on his show. Worse, Dr. Oz showed zero signs of skepticism. Unfortunately, Dr. Oz wasn’t done. In rapid succession next Dr. Oz endorsed a diet that he once eschewed as quackery and then, to top it all off, invited psychic John Edward onto his show, asking Is talking to the dead a new kind of therapy? This latter episode so shocked me that I basically said, “Stick a fork in him, Dr. Oz is done when it comes to SBM.”

Dr. Oz’s descent was complete, and that is now the trouble with Dr. Oz and much of the reason why in 2011 the James Randi Educational Foundation awarded him the The Media Pigasus Award for the second year in a row. I fear he very well may three-peat in 2012. The only thing that might save him is listening to his critics, but I fear that is unlikely. We’ll see.

Further reading about Dr. Oz

I hope you, our regular readers, will comment on Dr. Novella’s appearance, both here and in Dr. Novella’s post about his experience, the latter of which will be posted this evening after he gets a chance to see how the segment turned out after editing. I also invite Dr. Oz viewers to join in. Just register a user name and password here. In the meantime, here is a collection of critical posts and articles about Dr. Oz. Also, don’t forget to dive into the discussion forums at Dr. Oz’s website after the episode with Steve airs in your area.

From Science-Based Medicine:

From other sources:

Facebook Google Buzz Digg LinkedIn StumbleUpon LiveJournal Share

A Skeptic In Oz

Posted on by

UPDATE 4/27/2011: Here’s the online video of Dr. Novella’s appearance on The Dr. Oz Show:

  1. Controversial Medicine: Alternative Health, Part 1
  2. Controversial Medicine: Alternative Health, Part 2
  3. Controversial Medicine: Alternative Health, Part 3

I must say I was a bit shocked two weeks ago when I was contacted by a producer for The Dr. Oz Show inviting me on to discuss alternative medicine. We have been quite critical of Dr. Mehmet Oz over his promotion of dubious medical treatments and practitioners, and I wondered if they were aware of the extent of our criticism (they were, it turns out).

Despite the many cautions I received from friends and colleagues (along with support as well) – I am always willing to engage those with whom I disagree. I knew it was a risk going into a forum completely controlled by someone who does not appear to look kindly upon my point of view, but a risk worth taking. I could only hope I was given the opportunity to make my case (and that it would survive the editing process).

The Process

Of course, everyone was extremely friendly throughout the entire process, including Dr. Oz himself (of that I never had any doubt). The taping itself went reasonably well. I was given what seemed a good opportunity to make my points. However, Dr. Oz did reserve for himself the privilege of getting in the last word—including a rather long finale, to which I had no opportunity to respond. Fine—it’s his show, and I knew what I was getting into. It would have been classy for him to give an adversarial guest the last word, or at least an opportunity to respond, but I can’t say I expected it.

In the end I decided that I had survived the taping of the show and did fairly well. After watching the final version that aired I feel that the editing was fair. They allowed me to make my major points, and did not change anything significant about the discussion. Again, the real problem was that Dr. Oz controlled the framing of the discussion and made many fallacious points at the end that I was given no opportunity to respond to.
Continue reading →