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The Great and Powerful Oz versus science and research ethics

That Dr. Mehmet Oz uses his show to promote quackery of the vilest sort is no longer in any doubt. I was reminded yet again of this last week when I caught a rerun of one of his shows from earlier this season, when he gazed in wonder at the tired old cold reading schtick used by all “psychic mediums” from time immemorial, long before the current crop of celebrity psychic mediums, such as John Edward, Sylvia Browne, and the “Long Island Medium” Theresa Caputo, discovered how much fame and fortune they could accrue by scamming the current generation of the credulous. Speaking of Theresa Caputo, that’s exactly who was on The Dr. Oz Show last week (in reruns), and, instead of being presented as the scammer that she is, never was heard even a hint of a skeptical word from our erstwhile “America’s doctor,” who cheerily suggested that seeing a psychic medium scammer is a perfectly fine way to treat crippling anxiety because, well, Caputo claims that it is. Even worse, apparently it wasn’t even the first time that Dr. Oz had Caputo on his show, and Caputo wasn’t even the first psychic whose schtick he represented as somehow being a useful therapeutic modality for various psychological issues. “Crossing Over” psychic John Edward was there first in a segment Oz entitled Are Psychics the New Therapists? I could have saved him the embarrassment and simply told him no, but apparently Oz is too easily impressed. As I said before, if he’s impressed by clumsy cold readers like Browne, Caputo, and Edward, it doesn’t take much to impress him. Also, apparently his producers aren’t above editing science-based voices beyond recognition to support their quackery.

I was further reminded how Dr. Oz promotes quackery by an article in Slate yesterday entitled Dr. Oz’s Miraculous Medical Advice: Pay no attention to that man behind the curtain. I suppose it would be mildly hypocritical of me to snark at the rather obvious “Wizard of Oz” jokes aimed at Dr. Oz. After all, I’ve used the same joke myself at one time or another and, in light of the Slate.com article, couldn’t resist using it in the title of my post. However, I wasn’t about to let that distract me from the article itself, which is very good. The reason is that there are two aspects to Dr. Oz’s offenses against medical science. There is the pure quackery that he features and promotes, such as psychic scammers like John Edward and Theresa Caputo, faith healing scammers like Dr. Issam Nemeh, and “alternative health” scammers like reiki masters, practitioners of ayruveda, Dr. Joe Mercola, who was promoted as a “pioneer” that your doctor doesn’t want you to know about. Never was it mentioned that there are very good reasons why a competent science-based physician would prefer that his patients have nothing to do with Dr. Mercola, who runs what is arguably the most popular and lucrative alternative medicine website currently in existence and manages to present himself as reasonable simply because he is not as utterly loony as his main competition, Mike Adams if NaturalNews.com (who has of late let his New World Order, anti-government, “Obama’s coming to take away your guns” conspiracy theory freak flag fly) and Gary Null.

The second aspect is that Dr. Oz also does give some sensible medical advice. The problem, as I’ve pointed out before, is that he “integrates” all manner of quackery into his science-based advice. Now, that pure nonsense is being “integrated”is pretty obvious when we’re talking about faith healing and psychic mediums, but Dr. Oz’s “integration” is actually seamless in that he integrates all manner of dubious and scientifically questionable claims with the more standard, stodgy, boring science-based advice (e.g., lose weight, exercise more, eat more vegetables and less red meat, treat your high blood pressure, and the like). For example, it is not surprising that Oz features a lot of dubious diet supplements on his show, given that losing weight is one of the single most important health issues many people face and the fact that effective weight loss strategies are rarely easy. They involve diet and exercise, neither of which is fun or easy for many people. So what we hear from Oz are stories like this:

As people were getting ready for the holiday season and its accompanying waist expansion late last year, Dr. Mehmet Oz let viewers of his TV show in on a timely little secret. “Everybody wants to know what’s the newest, fastest fat buster,” said the board-certified cardiothoracic surgeon and one of People magazine’s sexiest men alive. “How can I burn fat without spending every waking moment exercising and dieting?”

He then told his audience about a “breakthrough,” “magic,” “holy grail,” even “revolutionary” new fat buster. “I want you to write it down,” America’s doctor urged his audience with a serious and trustworthy stare. After carefully wrapping his lips around the exotic words “Garcinia cambogia,” he added, sternly: “It may be the simple solution you’ve been looking for to bust your body fat for good.”

In Dr. Oz’s New York City studio, garcinia extract—or hydroxycitric acid found in fruits like purple mangosteen—sounded fantastic, a promising new tool for the battle against flab. Outside the Oprah-ordained doctor’s sensational world of amazing new diets, there’s no real debate about whether garcinia works: The best evidence is unequivocally against it.

As Julia Belluz and Steven J. Hoffman, the authors of the article, point out, garcinia extract has been tested, and in a randomized trial in 1998 it was no better than placebo for weight loss. A more recent systematic review of the literature concluded that the evidence was at best equivocal and that the effects, even if real, were so small as make it unlikely they were clinically relevant. Belluz and Hoffman also point out that Dr. Oz takes full advantage of the scientific respectability that his current position affords him:

Oz may be the most credentialed of celebrity health promoters. He’s a professor and vice-chair of surgery at Columbia University College of Physicians and Surgeons. He earned his degrees at Ivy League universities, namely Harvard and the University of Pennsylvania. He’s won a slew of medical awards (in addition to his Emmys) and co-authored hundreds of academic articles. He’s clearly a smart guy with qualifications, status, and experience. It’s reasonable to assume he is well-versed in the scientific method and the principles of evidence-based medicine. “Because he’s a physician, that lends a certain authority and credibility to his opinions,” said Steven Novella, a clinical neurologist and assistant professor at Yale University School of Medicine who has taken Oz to task for his science. “But it lends credibility to anything he says.”

Indeed it does. I often wonder about this. First of all, I wonder how Dr. Oz can manage to do a daily hour-long talk show and still see patients and hold all the academic positions that he holds. I realize that it’s Oz’s producers and writers who do most of the grunt work for his show, but it’s still hard to believe that during the nine months or so a year when his show is in production Oz doesn’t spend at least 20 hours a week working on it. Just the taping of five episodes a week alone must surely, when added up, take up at least a full (and long) day, given all the filing of audiences in and out, changes in the set, and the like. Then there’s oversight, consultations with the producers and writers, story approval, not to mention travel and promotion. It’s a huge time commitment. Or, if it’s not a huge time commitment and Oz really doesn’t do that much, then we’d have to conclude that Dr. Oz is nothing more than a figurehead, a Ted Baxter– or Ron Burgundy-like character, who comes in one day a week, reads his cue cards, and has little or nothing to do with the creative process behind the show. Somehow, given how driven he’s always been, I think Oz has more involvement in putting his show together than that. Sheer ego alone, at the very minimum, makes me think that, too, as I doubt Oz would want his brand and message to be completely controlled by others. Assuming he does have significant involvement in putting his show together, it’s hard to figure out how from September to June Dr. Oz has enough time to take care of patients, handle his administrative duties, and do anything resembling academic work. Besides the difficulty of maintaining one’s technical operative skills and knowledge base in a surgical specialty as complex as cardiac surgery, Dr. Oz must have the most understanding surgical partners in the world, given how often and for how long they must have to cover his patients, and he must have the most understanding department chair in the world given how little time he probably has left after his show to do any real administrative work. (Remember, he’s not just the vice chair of the department of surgery; he’s also the director of the Cardiovascular Institue and the Complementary Medicine Program at New York Presbyterian Hospital.) On the other hand, no doubt Columbia derives considerable rewards from Dr. Oz in terms of publicity for its medical school, programs, and hospitals, not to mention probably a not insignificant amount of cold, hard cash. So it’s probably not that surprising that Oz’s administration and partners put up with him and bend over backwards to enable him.

The sad thing is that Dr. Oz, for all his fascination with reiki even as far back in the 1990s, used to be a halfway decent surgical scientist. The vast majority of his publications from that period are pretty mainstream and unremarkable. They were competently done, although I didn’t find any major breakthroughs or any new really interesting findings, admittedly Oz did produce a lot of publications.

Of course, all of this makes it even sadder to see what Dr. Oz has become. He’s already proven that he knows how to do decent science; the evidence is in dozens of publications from years past. Yet when he’s on TV all of that flies out the window, and Oz apparently either forgets (or rejects) everything his pre-Oprah scientific career. For example:

Take a breaking-news segment about green coffee-bean supplements that “can burn fat fast for anyone who wants to lose weight.” Oz cited a new study that showed people lost 17 pounds in 22 weeks by doing absolutely nothing but taking this “miracle pill.”

A closer look at the coffee-bean research revealed that it was a tiny trial of only 16 people, with overwhelming methodological limitations. It was supported by the Texas-based company Applied Food Sciences Inc., a manufacturer of green coffee-bean products. Oz didn’t mention the potential conflict of interest, but he did say he was skeptical. To ease his mind, he conducted his own experiment: It involved giving the pills to two audience members for five days and seeing what would happen. Unsurprisingly, both women reported being less hungry, more energetic, and losing two and six pounds, respectively.

Dr. Oz knows as well as any regular reader of this blog who has imbibed of its content and message how worthy of ridicule such a TV “study” of two is: no blinding, no control group, far too short a time period of observation, and a number so small as to be meaningless; yet somehow Dr. Oz thinks that something like this “eases his skepticism” about the tiny study (which only had either four or six subjects in each experimental group). Particularly informative is Figure 2 of the study, in which all three groups basically decreased their BMI at the same rate in the initial period regardless of whether they were in the group to receive placebo, low dose, or high dose green coffee bean supplement. One also notes that there were no error bars on any of the graphs to provide an idea of the scatter in the data. All in all, it’s a pretty worthless and unconvincing study, not even taking into account the conflict of interest. Come to think of it, one wonders whether Dr. Oz (or any promoter of alternative therapies and supplements) would accept a study like this from a pharmaceutical company as convincing evidence that the company’s product worked. Somehow I doubt it.

Oz then went beyond this, as Scott Gavura described yesterday, setting up what he called the Green Coffee Bean Project. Scott quite accurately described it as a “made for TV clinical trial,” and that’s exactly what it was: a randomized clinical trial set up for Dr. Oz’s television show. True, it was a shoddily designed and useless clinical trial, but it was clearly a clinical trial nonetheless. Unfortunately, there was no statistical analysis and no approval by an institutional review board (IRB), even though this was clearly human subjects research. Quite frankly, doing a research project like this involving human subjects is profoundly unethical without IRB approval. In fact, arguably, Dr. Oz was in direct violation of Columbia University’s Human Research Protection Program, which states:

The IRB has the responsibility to oversee the conduct of research that it approves. Consistent with this responsibility, the IRB may audit research studies conducted at Columbia University or Columbia University Medical Center as well as research in which faculty and/or staff of Columbia University are engaged outside the institution. The Compliance Oversight Manager is responsible conducting audits at both campuses and reports to the Executive Director of the IRB.

If that’s not clear enough, the executive summary states:

The Columbia HRPP covers all entities, offices, and individuals engaged in and/or responsible for the review and conduct of human research at Columbia and New York Presbyterian Hospital (NYPH). CU has two Federalwide Assurances (FWAs): one for Columbia University Medical Center (CUMC) and one for the main campus at Morningside Heights (CU-MS). NYPH has its own FWA and is a separate legal entity from CU. Although there are three FWAs, the Columbia HRPP is responsible for all human research conducted at CUMC, CU-MS, and NYPH, or by any affiliated faculty, employees, or staff of CU and NYPH regardless of location.

Let me emphasize: This policy applies to research carried out by all Columbia and NYP-affiliated faculty regardless of the location where the research is done. Quack researchers like Mark and David Geier seem to be able to manage to skirt these laws because they aren’t faculty at an institution that receives federal funding and because they fly under the radar. In contrast, Dr. Oz is Columbia faculty. Even though he conducted human subjects research outside of Columbia university and clearly his research is not federally funded, it’s hard not to wonder whether he violated Columbia’s HRPP policy. Federal law is very clear on this. Institutions receiving federal funding must abide by the Common Rule, which states that all human subjects research that’s federally funded carried out at such institutions or by the faculty of such institutions must be overseen by a duly constituted IRB. All such institutions that I’ve ever worked at or had dealings with also agree to apply the Common Rule to all human subjects research conducted at their facilities and/or by their faculty, regardless of whether the research is federally funded or not. Also, it doesn’t matter if the research in question is being carried out at a location outside of the university. If the Office for Human Research Protections ever had a mind to investigate and concluded that Oz did perform human subjects research without proper oversight by Columbia’s IRB, Columbia University could potentially be in for a world of hurt, up to and including the possibility of having its federal research funding withheld. At the very least, a federal investigation would be very intrusive and painful, even if it ultimately exonerated Oz and Columbia. At the very least we have to wonder whether Oz violated Columbia policy on human research subjects protection, which is why the university should investigate, in my opinion. It likely won’t, however. This is the Great and Powerful Oz, and the university gets too many rewards in terms of publicity and probably cash.

I can speculate endlessly why Dr. Oz has devolved from a respected cardiothoracic surgeon and surgical investigator into, let’s face it, a huckster selling whatever he thinks his audience will buy. Well, that’s not exactly true. As Dr. Oz so often and so piously reminds us, he doesn’t make any money from endorsements, and he claims to aggressively go after companies that falsely advertise his endorsement to sell products. The product that Dr. Oz is selling to America is, above all else, Dr. Oz. There’s also the relentless pressure to come up with material to fill five hour-long episodes a week for nine months a year. TV is a bottomless sink for material, and it demands material that will attract, engage, and, above all, entertain its audience. Telling people to lose weight and exercise isn’t that entertaining or interesting. Telling people there are supplements that will let you lose weight without dieting or exercise is. Strategies to deal with anxiety based on research are difficult to present in an entertaining fashion. Presenting psychics like John Edward or Theresa Caputo as being therapeutic is easy and potentially entertaining even to skeptics, and it can be done with Dr. Oz’s “aw, shucks” disclaimer that fools no one in which he opines over and over again that “science doesn’t know everything” and that “medicine can’t explain everything.” So, as Dara O’Briain puts it, Oz fills in the blanks with whatever fairy story appeals to him—or, more accurately, appeals to his audience.

As 2013 begins, I’ve been thinking a lot. We skeptics and supporters of science-based medicine are massively outgunned, and Dr. Oz is simply the most telling example of this. Quacks have Dr. Oz to sell their products. We have a loosely-knit, unorganized bunch of bloggers trying to refute the torrents of nonsense that promoters of quackery like Dr. Oz spew forth, and a few academics like Dr. Edzard Ernst trying to counter the flood of quackademic medicine filling academic journals. Dr. Oz has an audience of millions every day. Bloggers like Steve Novella, Steve Salzberg, and I have an audience of a few thousand each every day, and our audiences have considerable overlap. Moreover, even in the skeptic movement itself, countering quackery and medical pseudoscience is all too often the neglected stepchild that gets far less time, attention, and love than creationism, Bigfoot, the paranormal, and religion. Even within the skeptical movement itself, I’ve personally all too often seen a shocking level of tolerance or even acceptance of antivaccine views and alternative medicine.

That’s why one of my aims this year is to come up with ideas about how we can work to change this, because this matters, or should matter, to everyone. All of us will get sick at some point in our lives. Many of us will become seriously ill at some point in our lives, and all of us have known or will know someone who becomes seriously ill. All of us will require medical care, and many of us require chronic treatment for some condition or other. Blogging is important. Exposing quackery and medical pseudoscience is important. However, it isn’t enough.

Posted in: Clinical Trials, Science and the Media

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