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 5^th, 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!

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

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

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.

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 →

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:

• Announcing the Science-Based Medicine Blog
• Yes, Jacqueline: EBM ought to be Synonymous with SBM
• Answering a criticism of science-based medicine
• Placebo effects without deception? Well, not exactly.

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:

• Dr. Oz Embraces Joseph Mercola
• For shame, Dr. Oz, for promoting Joseph Mercola on your show!
• Dr. Mehmet Oz completes his journey to the Dark Side
• Dr. Oz, you’re not helping diabetics
• Dr. Oz and John Edward: Just when I thought Dr. Oz couldn’t go any lower, he proves me wrong
• Dr. Oz promotes homeopathy

From other sources:

• Dr. Oz: America’s doctor and the abdication of professional responsibility (apparently flashed on the screen at the beginning of Dr. Oz’s segment).
• Dr. Oz and John Edwards = Bad Medicine
• Dr. Oz asks who can we trust when it comes to Genetically Engineered Crops?
• Dr. Oz – so corrupted by fame he even sells himself out
• Emmys, don’t be led down Dr. Oz’s yellow brick road: Oprah’s favorite doctor promotes quackery
• The 5 Worst Promoters of Nonsense
• The Irresponsible Dr. Oz, Softening The Public Up for Charlatans
• Just in time for April Fools’ Day…Dr. Oz and the Pigasus Awards! (in which Dr. Oz also promotes homeopathy)
• More health tips from Dr. Oz
• Oz: The great and gullible
• Questioning Dr. Oz

If there’s one thing about the anti-vaccine movement, it’s all about the ad hominem attack. Failing to win on science, clinical trials, epidemiology, and other objective evidence, with few exceptions, anti-vaccine propagandists fall back on attacking the person instead of the evidence. For example, as I’ve noted numerous times, Paul Offit has been the subject of unrelenting attacks from Generation Rescue and other anti-vaccine groups, having been dubbed “Dr. Proffit” and accused of being so in the pocket of big pharma that he’ll do and say anything for it. I personally have been accused by Jake Crosby of a conflict of interest that isn’t, based on conspiracy mongering and an utterly brain dead argument (which is much like every other argument Jake likes to make on this issue). Steve Novella, Paul Offit, Amy Wallace, Trine Tsouderos, and others were portrayed as cannibals sitting down to a Thanksgiving feast of baby. Meanwhile, anti-vaccine luminaries invoke the pharma shill gambit with abandon and try their best to smear journalists who write about how anti-vaccine views are endangering herd immunity, journalists such as Trine Tsouderos, Amy Wallace, Chris Mooney, and Seth Mnookin, to name a few.

Sometimes, however, for whatever reason karma, fate, God, or whatever you want to call it smiles on anti-vaccine activists, dropping a story into their laps that allow them to indulge the worst of their tendencies towards ad hominem attacks and seem superficially credible. So it was about a year ago when an financial fraud investigation was being undertaken in the case of Poul Thorsen, a Danish investigator who had contributed to two large Danish studies, one of which failed to find an association between the MMR and autism in the immediate wake of Andrew Wakefield’s falsified data suggesting such an assocation and one of which failed to find an association between mercury in the thimerosal preservative in vaccines and an increased incidence of autism. At the time longstanding anti-vaccine propagandist Robert F. Kennedy, Jr. tore into Thorsen with abandon before he was even indicted or charged (he was only under investigation at the time) as though, even if he actually did commit fraud, such fraud invalidated the two large studies regarding MMR and autism and thimerosal and autism with which he had been involved. Did it?

To find out, let’s hop into our SBM TARDIS and go back in time about a year, in order to see the genesis of this manufactorversy that AoA is currently flogging. Let’s look at the case of Danish investigator Poul Thorsen as it developed.

Thorsen in 2010: Robert F. Kennedy, Jr. parties like it’s 2005

It was back in March 2010. Andrew Wakefield had just had his 1998 Lancet paper retracted by the editors in the wake of his having lost his medical license in the U.K. as a result of his research misconduct. Just when times seemed darkest for those who promote the scientifically discredited notion that vaccines cause autism, a miracle occurred! So great was the miracle that it enticed Robert F. Kennedy, Jr., who for quite some time before had actually been pretty quiet about vaccine/autism issues, to let himself be pulled out of storage, dusted off, and sent once again to tilt at mercury windmills. Not unsurprisingly, he reappeared on that bastion of anti-vaccine pseudoscience, The Huffington Post, and the title of his post was Central Figure in CDC Vaccine Cover-Up Absconds With $2M. In what appeared to be a coordinated attack, the anti-vaccine group Generation Rescue‘s blog Age of Autism was promoting RFK, Jr.’s article and adding a few of its own with titles such as Poul Thorsen’s Mutating Resume by the not-so-dynamic duo of Mark Blaxill and Dan Olmsted and NBC 11 Atlanta Reports: Vaccine Researcher Flees with $2M, featuring this news report:

These were among the earliest reports about Poul Thorsen. So what was going on? Let’s look at RFK’s article and how he started it:

A central figure behind the Center for Disease Control’s (CDC) claims disputing the link between vaccines and autism and other neurological disorders has disappeared after officials discovered massive fraud involving the theft of millions in taxpayer dollars. Danish police are investigating Dr. Poul Thorsen, who has vanished along with almost $2 million that he had supposedly spent on research.

Thorsen was a leading member of a Danish research group that wrote several key studies supporting CDC’s claims that the MMR vaccine and mercury-laden vaccines were safe for children. Thorsen’s 2003 Danish study reported a 20-fold increase in autism in Denmark after that country banned mercury based preservatives in its vaccines. His study concluded that mercury could therefore not be the culprit behind the autism epidemic.

But was Thorsen really the driving force behind the Danish vaccine-autism studies that the anti-vaccine movement hates so much? I had been paying close attention to the vaccine-mercury-autism manufactroversy for nearly five years then, and I had never heard of him, although I had heard of one of his coauthors. If Thorsen was so important to the pro-vaccine movement, you wouldn’t have known it from the two studies that the mercury militia was hoping to discredit by turning up its propaganda machine to 11 about Thorsen’s possible criminal behavior. Those papers were:

• Madsen KM, Hviid A, Vestergaard M, Schendel D, Wohlfahrt J, Thorsen P, Olsen J, Melbye M. A population-based study of measles, mumps, and rubella vaccination and autism. N Engl J Med. 2002 Nov 7;347(19):1477-82.
• Madsen KM, Lauritsen MB, Pedersen CB, Thorsen P, Plesner AM, Andersen PH, Mortensen PB. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. 2003 Sep;112(3 Pt 1):604-6.

It is the Pediatrics paper that the mercury militia appeared to be concentrating mostly on because it directly deals with thimerosal in vaccines. But look at the citations above for both papers anyway. Do you notice something? Look where Thorsen’s name is in the list of authors in both studies. Notice that it is not first, nor is it last. This is important because author order matters in scientific and medical studies. In straight science studies, the two most important authors are usually the first author and the last author. The last author is usually the senior author in whose laboratory the work was done, while the first author is the person whose project the work represents and who was the primary author of the manuscript. In medical papers, as in Pediatrics or NEJM, the author list usually signifies the relative contribution of each author to the article, the first being the most important and the last being the least important. In both types of articles, there is always designated one author who is the corresponding author. In scientific papers, the corresponding author is almost always the last author; in medical papers it is usually the first author. The corresponding author is responsible for answering inquiries about the study and, way back in the age before PDF files, used to be the author to contact to request reprints. Not only that, the corresponding author is generally considered to be the primary author for the paper.

Notice something else?

That’s right. Poul Thorsen was not the first author for either of these studies. He was not the last author, either. He was not the corresponding author; that would be Kreesten M. Madsen, MD, who was corresponding author on both the NEJM and Pediatrics papers. As it turns out, Thorsen was safely ensconced in the middle of the pack of co-authors. That’s why, when RFK, Jr. referred to the Pediatrics study as “Thorsen’s study,” he had to be either grossly ignorant or intentionally misleading (Take your pick.) Anyone who knows anything about how the scientific literature works would be able to spot that immediately just by looking at the abstracts of these articles. Trust me, if studies this large really were Thorsen’s babies his name would not have been relegated to fourth or sixth on the list of authors. Basically, Thorsen’s position in the author lists of these two papers indicated that, whatever leadership position he may have held at Aarhus University and in its vaccine studies group, he clearly was not the primary contributor for these studies.

Not that that stopped the mercury militia from going out of its way to paint him as such, referring to him as a “central figure.” At the time, I had to tip my hat to RFK, Jr. his language throughout his article is truly Orwellian, a propaganda masterpiece of prestidigitation of language and innuendo. Here are just a few examples of perfectly loaded phrases sprinkled throughout the article, all designed to suggest concealment and conspiracy:

• …”built a research empire…”
• “…failed to disclose…”
• “…has disappeared…”
• “…damning e-mails surfaced…”
• “…culprit behind…”
• “…leading independent scientists have accused CDC of concealing the clear link between the dramatic increases in mercury-laced child vaccinations.”
• “…safe to inject young children with mercury…”
• “…CDC officials intent on fraudulently cherry picking…”

RFK, Jr. also parroted anti-vaccine talking points about the study that were hoary back when David Kirby first published the mercury militia Bible, Evidence of Harm, talking points like:

His study has long been criticized as fraudulent since it failed to disclose that the increase was an artifact of new mandates requiring, for the first time, that autism cases be reported on the national registry. This new law and the opening of a clinic dedicated to autism treatment in Copenhagen accounted for the sudden rise in reported cases rather than, as Thorsen seemed to suggest, the removal of mercury from vaccines. Despite this obvious chicanery, CDC has long touted the study as the principal proof that mercury-laced vaccines are safe for infants and young children. Mainstream media, particularly the New York Times, has relied on this study as the basis for its public assurances that it is safe to inject young children with mercury — a potent neurotoxin — at concentrations hundreds of times over the U.S. safety limits.

Notice how RFK Jr. really, really wanted you to believe that the Danish studies are the primary foundation upon which the science exonerating MMR and thimerosal-containing vaccines as a cause of autism rests, the be-all and end-all of the epidemiology studying thimerosal-containing vaccines, when in fact there are multiple studies and lines of evidence, of which the Danish studies are but a part. Also notice how he conflated a study’s being weak with its being fraudulent. The two are entirely different concepts, and it is entirely possible for a study to be poorly designed and executed without even a whiff of fraud. Be that as it may, the Danish studies, although they have weaknesses inherent in a retrospective design, are actually pretty darned good studies. As I said before, RFK’s whine in the passage above is the parroting of a hoary criticism of the Danish studies cribbed straight from anti-vaccine sites. The criticism goes like this. Anti-vaccine propagandists argue that because, beginning in 1994, outpatient records were used in addition to inpatient records for case ascertainment in Denmark for purposes of these studies, the whole set of studies must be crap. As Steve Novella pointed out, this change was not chicanery, and in fact Madsen et al tried to test whether the change in case reporting by doing this was significant. Here is a quote from Madsen et al:

In additional analyses we examined data using inpatients only. This was done to elucidate the contribution of the outpatient registration to the change in incidence. The same trend with an increase in the incidence rates from 1990 until the end of the study period was seen.

In other words, Madsen et al considered the possibility that adding outpatient records to inpatient records beginning in 1994 might change the results. They tested for that possibility and determined that the addition of outpatient cases did not change the trend of increasing autism diagnoses. Again, RFK, Jr. was either grossly ignorant of the facts or consciously distorting. (Take your pick–again.) The same was true of J.B. Handley when he repeated the same misinformation, and and of Ginger Taylor when she also repeated the same fallacious argument.

Here’s what was going on. In the wake of debacle the implosion of Andrew Wakefield represented, the anti-vaccine movement needed a distraction—badly—and they needed it fast. It would have been even better if the distraction were one that they could spin to make it look as though there were some dark corruption at the heart of the vaccine science. Like manna from heaven, about a year ago Dr. Thorsen’s case dropped seemingly from the sky. Never mind that it makes absolutely no difference to the science exonerating vaccines or thimerosal in vaccines as a cause of autism whether Thorsen is a criminal and thief or not. It was convenient propaganda, even though there is abundant evidence that Thorsen was not a major player in the Pediatrics and NEJM publications reporting the Danish studies.

Fast forward to 2011: The indictment of Poul Thorsen for fraud

As we have seen, in the wake of the commencement of an investigation of Poul Thorsen for fraud and embezzlement of CDC grant money, it was not surprising that the anti-vaccine movement struggled mightily to elevate him to being the prime mover and shaker of the Danish studies. The reason was obvious: They wanted to discredit “inconvenient” studies that did not support their belief that mercury in vaccines causes autism. It was an ad hominem attack, plain and simple, because the primary argument was not against the data or the studies, but against the man. It’s a form of poisoning the well or guilt by association. It’s the same thing as if I were to point to physicians who have defrauded Medicare or insurance companies and argue that all science-based medicine is thus somehow suspect. Unfortunately, this sort of tactic frequently works–which is why propagandists without moral qualms about smearing their opponents frequently use it.

It’s also why, when I saw this article a couple of weeks ago, I knew that it wouldn’t be long before Age of Autism and other anti-vaccine minions would be swarming. After all, in January the BMJ had published the rest of Brian Deer’s expose of Andrew Wakefield’s research fraud, showing his actions to be even worse than we had suspected. The anti-vaccine movement needed another distraction, and the indictment of Poul Thorsen was a convenient one, which is why it wasn’t long before the anti-vaccine blog Age of Autism was on the case after Thorsen had been indicted. Since then, Thorsen has been a regular feature on AoA (up to and including today’s post) and other anti-vaccine blogs and websites. You’ll see why from this news report:

A Danish man was indicted Wednesday on charges of wire fraud and money laundering for allegedly concocting a scheme to steal more than $1 million in autism research money from the Atlanta-based Centers for Disease Control and Prevention.

The indictment charges Poul Thorsen, 49, with 13 counts of wire fraud and nine counts of money laundering. The wire fraud counts each carry a maximum of 20 years in prison and the money laundering counts each carry a maximum of 10 years in prison, with a fine of up to $250,000 for each count.

The federal government also seeks forfeiture of all property derived from the alleged offenses, including an Atlanta residence, two cars and a Harley-Davidson motorcycle.

This is how Thorsen is now accused of having done it:

Once in Denmark, THORSEN allegedly began stealing the grant money by submitting fraudulent documents to have expenses supposedly related to the Danish studies be paid with the grant money. He provided the documents to the Danish government, and to Aarhus University and Odense University Hospital, where scientists performed research under the grant. From February 2004 through June 2008, THORSEN allegedly submitted over a dozen fraudulent invoices, purportedly signed by a laboratory section chief at the CDC, for reimbursement of expenses that THORSEN claimed were incurred in connection with the CDC grant. The invoices falsely claimed that a CDC laboratory had performed work and was owed grant money. Based on these invoices, Aarhus University, where THORSEN also held a faculty position, transferred hundreds of thousands of dollars to bank accounts held at the CDC Federal Credit Union in Atlanta, accounts which Aarhus University believed belonged to the CDC. In truth, the CDC Federal Credit Union accounts were personal accounts held by THORSEN. After the money was transferred, THORSEN allegedly withdrew it for his own personal use, buying a home in Atlanta, a Harley Davidson motorcycle, and Audi and Honda vehicles, and obtaining numerous cashier’s checks, from the fraud proceeds. THORSEN allegedly absconded with over $1 million from the scheme.

If Thorsen is convicted, I have no problem saying unequivocally that he should go to prison for a long time. As was pointed out in this Reuters story about the indictment, research dollars are a precious commodity. In fact, with the recent budget battles and cuts in Washington, government research grants haven’t been this hard to come by for 20 years, and there’s no sign of improvement in the situation in sight; it will likely be several years before things get better, if they ever get better at all. So, I’m as angry as anyone to see a researcher abuse research funds by, if the indictment is correct, buying a home and a Harley-Davidson motorcycle. Of course, having had to deal with the bureaucracy at my university and cancer institute that oversees my grants, I really don’t understand how it is even possible to buy a house and a Harley using grant funds. Every major expenditure (for me, at least) is closely tracked and matched to the approved budget. I can’t even envision how, even if I wanted to try to misuse large sums of my grant funds, I could even find a way to do it. I really can’t. To me, if Thorsen really did abuse his research funds this way, it points to a serious accounting and oversight problem in his university that allowed such chicanery to occur.

Be that as it may, reading between the lines I do find one bit of information that might explain some things about the Danish studies. Madsen was the first and corresponding author, but it’s pointed out that Thorsen became principal investigator of the CDC grant in 2002. That doesn’t help AoA at all, though. I went and looked up the two articles again and noticed something interesting that I hadn’t really paid attention to before.

The NEJM article lists its funding sources as:

Supported by grants from the Danish National Research Foundation; the National Vaccine Program Office and National Immunization Program, Centers for Disease Control and Prevention; and the National Alliance for Autism Research.

This article was, however, published in November 2002. Given that it takes months, sometimes even a year or more, for a manuscript to go from submission to publication, this work had almost certainly been completed and was in the publication pipeline before Thorsen took over as principal investigator of the CDC grant. The Pediatrics paper, which was published after Thorsen went back to Denmark, lists its funding thusly:

The activities of the Danish Epidemiology Science Centre and the National Centre for Register-Based Research are funded by a grant from the Danish National Research Foundation. This study was supported by the Stanley Medical Research Institute. No funding sources were involved in the study design.

That’s right. The Pediatrics thimerosal study was not even funded by the CDC! Even if it were, given that large epidemiological studies take years to carry out, it probably was in the last leg of its analysis when Thorsen showed up anyway. Even worse for the “guilt by association” crowd, all of the fraudulent charges to the grant are alleged to have occurred between 2004 and 2008, as described above–well after the Danish studies were published.

Of course, none of this stops AoA from opining:

We have written several articles about Dr. Poul Thorsen (4th from the left in the back row with his CDC colleagues), whose research known as “The Danish Study” is quoted extensively to “debunk” the autism vaccine connection. The mainstream media was silent when he disappeared. Here are some of the posts we’ve run on the topic along with today’s article in the Atlanta Bizjournals below. Will they give Thorsen “the Wakefield treatment” now, or have they been given their marching orders to look the other way?

Of course, not noted by the author is that Thorsen has already been treated far more harshly than Wakefield ever was! He’s been indicted on criminal charges; all that happened to Wakefield is that he was struck off the register of licensed UK physicians, and then only after a ridiculously long (two and a half year) hearing by the British General Medical Council. He just had a couple of his papers retracted, the most prominent of which being the Lancet paper from 1998 for which strong evidence was found that he had falsified data. In the meantime, he had moved to Texas to make big bucks applying his woo to autistic children, at least until the scandal led even his friends kick him out of the practice. Thorsen faces decades in prison if convicted of these crimes. My guess right now is that Thorsen is praying for “the Wakefield treatment.” It was so much less harsh than what he faces if he is convicted of defrauding the federal government. My other guess is that Thorsen would gladly take the “Wakefield treatment” over the possibility of 20+ years in a federal prison.

Not long after AoA, the anti-vaccine group Autism Action Network (formerly known as A-CHAMP) also piled on. If you read this “action alert,” you’ll notice the clever linking of Thorsen’s indictment for defrauding the federal government of research funds with baseless criticism of the two main Danish studies that provide strong epidemiological evidence that failed to find a link between the MMR vaccine and autism or thimerosal in vaccines and autism. It doesn’t matter that Thorsen’s alleged fraud didn’t even occur until at least a year after the publication of the thimerosal study.

Then, of course, the anti-vaccine group Safeminds had to weigh in with its own press release. Sallie Bernard, unfazed by reality and science, stares bravely into the abyss that was once what little credibility she has, and insists that “many biological studies support a link between mercury and autism, but these Danish studies have been used to suppress further research into thimerosal. With clear evidence of Dr. Thorsen’s lack of ethics, it is imperative to reopen this investigation.” And there you have it, the clearest and most honest statement of the intent of the anti-vaccine movement. In essence, all they want is any excuse they can find to try to demand “more studies,” even as the hypothesis that vaccines cause autism continues to pine for the fjords. Like Polly, however, it is still an ex-hypothesis, while, like Frankenstein, Bernard thinks she can infuse life into the dead. (I do so love to mix metaphors when it suits my purpose.) However, instead of using electricity from lightening Bernard uses nonsense like this:

In addition, internal emails obtained via FOIA document discussion between the Danish researchers and Thornsen which acknowledge that the studies did not include the latest data from 2001 where the incidence and prevalence of autism was declining which would be supportive of a vaccine connection. The emails also include requests from Thornsen to CDC asking that the agency write letters to the journal Pediatrics encouraging them to publish the research after it had been rejected by other journals. A top CDC official complied with the request sending a letter to the editor of the journal supporting the publication of the study which they called a “strong piece of evidence that thimerosal is not linked to autism”.

The latter accusation above is just plain silly, as this link shows. Basically, it’s a letter of support from the CDC for the Danish thimerosal article, and there’s nothing there in any way incriminating. I do find it odd, however, that clearly the second page of the letter is missing, which makes me wonder why that is. The e-mails already say who signed the letter. As for the e-mails about the data from 2001, it’s impossible to tell exactly what the correspondents are saying. There are only two brief e-mails, and much text is redacted with black marker, that consist of an exchange between Marlene Lauritsen, who’s second author on the paper, and Kreesten Madsen, the first author. It’s cryptically mentioned that the incidence and prevalence are “still decreasing in 2001,” but the sentence immediately following it is redacted. Most of Madsen’s reply to this e-mail is also redacted.

In other words, the e-mails tell us little or nothing. More importantly, as Sullivan has shown by listing the studies rejecting the vaccine-autism hypothesis on which Thorsen is a co-author, you could eliminate every study with which Thorsen was associated, and the literature refuting the hypothesis is only reduced slightly.

Finally, of all the reactions to the study, there is one that made me laugh out loud when I read it. I’m talking about Katie Wright:

Who would make serious health care decisions based upon the work of a thief and a fraud.

Come on CDC, you cannot be serious.

Given that Wright and the many AoA followers have routinely made health care decisions based upon the work of Andrew Wakefield, who, while not a thief, was clearly a scientific fraud, I posit that Wright owes me a new irony meter. She blew mine up again–melted that sucker into a pool of gurgling plastic, rubber, and copper wire so that it’s now sputtering pathetically on my desk. Yet Wright and her fellow travelers defend Wakefield to the death metaphorically speaking, with J.B. Handley, for example, even going so far in this weekend’s New York Times Magazine as to liken him to “Nelson Mandela and Jesus Christ rolled up into one” and Michelle Guppy, coordinator of the Houston Autism Disability Network, darkly threatening a reporter, “Be nice to him [Wakefield], or we will hurt you.”

Double standard? You be the judge.

Conclusion

To a certain extent, I understand the assertion of “once a cheat, always a cheat.” I understand that the lead author (Madsen) and Thorsen’s other co-investigators might now want to check over Thorsen’s contribution to the two papers (as relatively small as it appears to be compared to the other authors), even for the paper whose work was not funded by the CDC at all and therefore has zero financial dependency on the CDC. That’s normal caution. However, normal caution is most definitely not what these attacks by Safeminds and AoA are about. They’re about the denialist technique of spreading FUD (fear, uncertainty, and doubt) about vaccines. Let’s just put it this way. Let’s say the anti-vaccine movement’s wet dream about Thorsen came true and it was somehow discovered that his science was also falsified and that, further, his fraud was enough to call the conclusions of every study for which Thorsen was a co-author in doubt. Even in that highly unlikely scenario, in which both studies were somehow completely discredited as a result of Thorsen’s financial chicanery with grant funds, it would not be nearly enough for scientists to call into question the scientific consensus that neither the MMR nor thimerosal are associated with an increased risk for autism. The reason is that there’s so much other evidence that is consistent with the Danish studies and similarly shows that neither the MMR nor thimerosal in vaccines is associated with autism.

What AoA, Safeminds, and other denialists refuse to understand is that science is rarely, if ever, a matter of a scientific consensus being based on one study, two studies, or a handful of studies. A scientific consensus is based on examining all the evidence from all relevant studies, deciding which studies are most methodologically powerful, and then synthesizing it all into a conclusion. Contrast this to how the anti-vaccine movement treats its “brave maverick doctors” like Andrew Wakefield, Mark Geier, Rashid Buttar, et al, and the difference between real science and anti-vaccine pseudoscience couldn’t be clearer.

ADDENDUM: I can’t resist pointing you to a hilariously misguided attack against me that proves once again that, for the anti-vaccine activists, it’s all about the ad hominem. Clifford Miller, a.k.a. ChildHealthSafety, was apparently unhappy that in the comments of Seth Mnookin’s post complaining about J.B. Handley’s attacking him solely based on his having once been a heroin addict, an addiction that Seth managed to beat, I dared to criticize J.B. for an ad hominem attack. In response, Miller fired off a counterattack. Not only was he unhappy about a post of mine that was over a year old, but he regurgitated Jake Crosby’s fallacious pharma shill gambit that used against me last summer.

Thank you, Mr. Miller, for a hearty chuckle and for, in your utterly irony challenged manner, proving my point about the anti-vaccine movement and ad hominem attacks better than I ever could.