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Archive for 2012

NIH Director Francis Collins doesn’t understand the problem with CAM

As the sole cancer surgeon among our stable of Science-Based Medicine (SBM) bloggers, I’m probably the most irritated at the infiltration of pseudoscience into academia (or, as we sometimes like to call it, quackademic medicine) in the realm of cancer. Part of the reason, of course, is that cancer is so common and that the consequences of adding pseudoscience to cancer therapy are among the most devastating. Witness, for instance, the use of Gonzalez therapy to treat pancreatic cancer, a form of quackery that harms patients and resulted in incredibly unethical and disastrous clinical trial of Gonzalez quackery versus chemotherapy whose results were entirely predictable, given the lack of prior plausibility of the treatment: Gonzalez protocol patients did worse, with no evidence that the therapy impacted the natural history of the disease and the Gonzalez patients scoring lower on quality of life measures. Or look at what happens when patients with breast cancer choose quackery over science-based therapy.

I realize that “complementary and alternative medicine” (CAM) or, what quackademics like to call it now, “integrative medicine” (IM) is meant to refer to “integrating” alternative therapies into SBM or “complementing” SBM with a touch of the ol’ woo, but I could never manage to understand how “integrating” quackery with SBM would do anything but weaken the scientific foundation of medicine. Moreover, weakening those foundations would have more consequences than just “humanizing” medicine; weaker scientific standards would allow not just ancient quackery like traditional Chinese medicine (TCM) into academia, but it would also provide an opening for drug and device companies to promote their wares under less rigorous requirements for evidence. There’s also perhaps a touch of personal embarrassment involved. After all, oncology and cancer surgery tend to be specialties that are the most steeped in science. If I had to rank specialties for how science-based they are, I’d certainly put oncology near the top, which is why I tend to come down so hard on “integrative oncology” and, even worse, “naturopathic oncology.”

Consequently, I was doubly disturbed several months ago when I learned that the director of the National Institutes of Health, Francis Collins, had agreed to be the keynote speaker at the Eight International Society for Integrative Oncology Conference in Cleveland, OH. I say “doubly” disturbed because it disturbed me that Francis Collins would agree to speak at such a function and, perhaps even more, because the host institution was Case Western Reserve University, the institution where I both completed my surgery residency and my PhD in Physiology and Biophysics. Sadly, it now appears that my old stomping grounds at University Hospitals has been thoroughly infiltrated with quackademic medicine, as evidenced by this clinical trial of reiki for psoriasis that’s making the rounds of news services and the offering of acupuncture, reiki, and even reflexology at various UH facilities through the University Hospitals Connor Integrative Medicine Network. Let me tell you, there was none of this pseudoscience going on when I finished my residency there in 1996. Seeing it there now provokes a reaction in me not unlike Sylvester Junior’s reaction when his father Sylvester embarrasses him, particularly when I noted that the director of the CWRU Comprehensive Cancer Center, Dr. Stanton L. Gerson, was to give one of the keynote talks, entitled, “The Future of Integrative Oncology.” (Hint for those of you not familiar with classic Looney Tunes cartoons: A paper bag is involved.) I guess that by expressing my extreme disappointment and embarrassment that the institution where I learned to become a surgeon has during the last 15 years gone woo, I’ve probably just killed any opportunity I might have to work at the Case Comprehensive Cancer Center ever again. Oh, well, add it to the list, along with Beth Israel and my alma mater the University of Michigan.)

Back when I first learned about it, I thought about blogging the meeting, but without much concrete to go on, given the copious other SBM-related topics to blog about, all I could do was to write a critical open letter to Dr. Collins about his decision to accept the offer to be the keynote speaker at the Society for Integrative Oncology (SIO). Then yesterday I saw popping up in my e-mail a notice from the American Society of Clinical Oncology (ASCO), along with a link to a story in its publication The ASCO Post entitled NIH Director Calls for Rigorous Evaluation of Integrative Medicine to Provide Evidence of Efficacy.

Et tu, Dr. Collins?
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Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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The New England Journal of Medicine Sinks a Bit Lower

I suppose it was bound to happen, but it still rankles. Here is the back cover of last week’s issue of the decreasingly prestigious New England Journal of Medicine:

 


Here’s the front cover:

It’s the 200th Anniversary issue, no less. Some might protest that ‘probiotics’—live bacteria of ‘good’ varieties, as far as the gut is concerned—aren’t all that implausible, and that there is some trial evidence that they help for some conditions. That’s true, but as is typically the case even for the somewhat plausible end of the “CAM” spectrum, the hype greatly surpasses the evidence. The abstract of the most recent systematic review that I could find for probiotic treatment of irritable bowel syndrome (IBS: symptoms and signs that best match the claims in the advertisement above) concluded:

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Posted in: Clinical Trials, Herbs & Supplements, History, Legal, Medical Ethics, Pharmaceuticals, Politics and Regulation, Science and Medicine, Science and the Media

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Legislative Alchemy: The New Year

A new year brings new opportunities for practicing the magic of legislative alchemy, the process by which state legislatures transform implausible and unproven diagnostic methods and treatments into perfectly legal health care practices, such as naturopathy, chiropractic and acupuncture. Different states have different legislative calendars, but many begin a new session soon after the first of the year. This gives “complementary and alternative medicine” providers a fresh opportunity to increase their scope of practice, insurance coverage and influence.

The state house doors have barely opened but CAM-friendly bills are already being docketed and sent on to health care and other committees for analysis. Unfortunately, legislators seem less than adept at critical thinking when it comes to perusing CAM legislation. To this point, I’ll start with an example from 2011: “Vertebral Subluxation Awareness Month” in Pennsylvania.

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Posted in: Chiropractic, Legal, Naturopathy, Politics and Regulation

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Tonsillectomy Indications and Complications

Tonsillectomy remains a common surgical procedure with over half a million cases in the US per year, the most common surgical procedure in children. The indications and effects of tonsillectomy remain a matter of research and debate, as is appropriate. It is also a subject of popular misinformation and alarmism.

A recent article by Seth Roberts raises many of the issues with tonsillectomy, but also reveals the pitfalls of non-experts trying to understand the clinical literature and the effects of bias on evaluating a complex medical question. Throughout the article Roberts displays a persistent bias toward downplaying the benefits and exaggerating the risks of tonsillectomy, while accusing the medical establishment of doing the exact opposite.  The purpose of this post is not to defend the practice of tonsillectomy but to review some of the relevant issues and explore how bias can affect an assessment of the evidence.

Indications for Tonsillectomy

Roberts tells the story of Rachael who was offered tonsillectomy for her son and so did some research on her own. She looked on Pubmed (a good place to start) and found a Cochrane review from 2009.

The Cochrane Review that Rachael found (“Tonsillectomy or adeno-tonsillectomy versus non-surgical treatment for chronic/recurrent acute tonsillitis”) was published in 2009. It describes four experiments that compared tonsillectomy to the care a sick child would otherwise receive. All four involved children like Rachael’s son, and all four had similar results: Tonsillectomies had only a small benefit. (Contrary to what Rachael was told.) During the year after random assignment to treatment — the point at which some children had their tonsils removed, other children did not — children whose tonsils were removed had one less sore throat than children who were not operated on (two instead of three for children like Rachael’s son).

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Posted in: Clinical Trials, Surgical Procedures

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Acupuncture, the Navy, and Faulty Thinking

A Navy neurologist, Capt. Elwood Hopkins, has posted a 3-part article on  “The Power of Acupuncture” on Navy Medicine Live, the official blog of Navy and Marine Corps Health Care. It can serve as a useful lesson in how not to think about medicine. It is a prime example of how an intelligent, educated doctor can be fooled and can fool himself into thinking that a placebo is an effective treatment.

To set the scene: acupuncture has been increasingly accepted in military circles. The Air Force is teaching its doctors “battlefield acupuncture” based on the faulty evidence of one Air Force doctor, Richard Niemtzow.  The Army is using it to treat PTSDThe Navy offers it too.

Hopkins says that after 40 years of practicing neurology, “It was only natural to begin thinking about something else.” (Why? Boredom? And why pick acupuncture?) When he got an e-mail from his Specialty Leader announcing the opportunity for Navy doctors to learn how to do acupuncture, he submitted his application that same day. He was undoubtedly impressed that this training was being offered by the Navy, lending it the imprimatur of authority. His prior impression of acupuncture was that it was a “mysterious tool” that seemed to work; and instead of asking critical questions, he says he was looking for “a fundamental scientific understanding of acupuncture” and asking to see the supporting research and data.  (more…)

Posted in: Acupuncture

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The rebranding of CAM as “harnessing the power of placebo”

If there’s one thing I’ve learned over the past seven years or so that I’ve been blogging, first at my other “super secret” (or, more accurately, super “not-so-secret”) blogging location, and then the four years I’ve been blogging here at Science-Based Medicine (SBM), it’s that the vast majority of “alternative medicine,” “complementary and alternative medicine” (CAM), and “integrative medicine” (IM) treatments (or whatever you want to call them) are nothing more than placebo medicine. True, there are exceptions, such as herbal treatments, mainly because they can contain chemicals in them that are active drugs, but any critical look at things like homeopathy (which is water), reiki (which is faith healing substituting Eastern mystical beliefs for Christianity), acupuncture (whose effects, when tested rigorously, are found to be nonspecific), or “energy healing” must conclude that any effects these modalities have are placebo effects or responses. Given writings on this topic by Steve Novella, Mark Crislip, Harriet Hall, Peter Lipson, myself, and others, this should be abundantly clear to readers of this blog, but, even so, it bears repeating. In fact, it probably can’t be repeated enough.

There was a time not so long ago when proponents of unscientific medicine tried very, very hard to argue that their nostrums have real effects on symptoms and disease above and beyond placebo effects. They would usually base such arguments on small, less rigorously designed clinical trials, mainly because, if there’s another thing I knew before from my medical education but that has been particularly reinforced in me since I started blogging, it’s that small clinical trials are very prone to false positives. Often they’d come up with some handwaving physiological or biological explanation, which, in the case of something like homeopathy, often violated the laws of chemistry and physics. Be that as it may, the larger and more rigorously designed the clinical trial, the less apparent effects become until, in the case of CAM therapies that do nothing (like homeopathy), they collapse into no effect detectable above that of placebo. Even so, there are often enough apparently “positive” clinical trials of water (homeopathy) that homeopaths can still cling to them as evidence that homeopathy works. Personally, I think that Kimball Atwood put it better when he cited a homeopath who said bluntly, “Either homeopathy works, or clinical trials don’t!” and concluded that, for highly implausible treatments like homeopathy, clinical trials as currently constituted under the paradigm of evidence-based, as opposed to science-based, medicine don’t work very well. Indeed, contrasting SBM with EBM has been a major theme of this blog over the last four years. In any case, for a long time, CAM enthusiasts argued that CAM really, really works, that it does better than placebo, just like real medicine.

Over the last few years, however, some CAM practitioners and quackademics have started to recognize that, no, when tested in rigorous clinical trials their nostrums really don’t have any detectable effects above and beyond that of placebo. A real scientist, when faced with such resoundingly negative results, would abandon such therapies as, by definition, a placebo therapy is a therapy that doesn’t do anything for the disease or condition being treated. CAM “scientists,” on the other hand, do not abandon therapies that have been demonstrated not to work. Instead, some of them have found a way to keep using such therapies. The way they justify that is to argue that placebo medicine is not just useful medicine but “powerful” medicine. Indeed, an article by Henry K. Beecher from 1955 referred to the “powerful placebo.” This construct allows them then to “rebrand” CAM unashamedly as “harnessing the power of placebo” as a way of defending its usefulness and relevance. In doing so, they like to ascribe magical powers to placebos, implying that placebos can do more than just decrease the perception of pain or other subjective symptoms but in fact can lead to objective improvements in a whole host of diseases and conditions. Some even go so far as to claim that there can be placebo effects without deception, citing a paper in which the investigators — you guessed it! — used deception to convince their patients that their placebos would relieve their symptoms. Increasingly, placebos are invoked as a means of “harnessing the power of the mind” over the body in order to relieve symptoms and cure disease in what at times seems like a magical mystery tour of the brain.

Part of what allows CAM practitioners to get away with this is that placebo effects are poorly understood even by most physicians and, not surprisingly, even more poorly understood by the public. Moreover, we all like to think that we have more control than we do over our bodies and, in particular, illnesses and symptoms, which is why the selling of placebo effects as a means of harnessing some innate hidden power we have to control our own bodies through the power of mind is so attractive to so many, including some scientists and physicians. Exhibit A is Ted Kaptchuk, the researcher from Harvard University responsible for spinning an interesting study of placebo effects in asthma into the invocation of the power of placebo. Kimball Atwood has written extensively about Kaptchuk recently, revealing his rather dubious background and arguments. More recently, however, Kaptchuk seems to be everywhere, appearing in articles and interviews, promoting just the argument I’m talking about, that CAM is a way of harnessing placebo effects, so much so that I felt it was time to take a look at this argument.

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Posted in: Basic Science, Clinical Trials, Medical Ethics, Science and Medicine

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Why Do We Really Need Clinical Trials?

A point I make over and over again when talking about new or alternative therapies that are not supported by good clinical trial evidence is that lower-level evidence, such as theoretical justifications, anecdotes, and pre-clinical research like in vitro studies and animal model testing, can only be suggestive, never reliable proof of safety or efficacy. It is necessary to begin evaluating a new therapy that does not yet have clinical evidence to support it by showing a plausible theory for why it might work and then moving on to demonstrate that it actually could work through pre-clinical research, which includes biochemistry, cell culture, and animal models. These sorts of supporting preclinical evidence are what we refer to when we refer to the “prior plausibility” of a clinical study. But this kind of evidence alone is not sufficient to support using the therapy in real patients except under experimental conditions, or when the urgency to intervene is great enough to balance the significant uncertainty about the effects of the intervention.

In support of this conclusion, we can consider the inherent unreliability of individual human judgments and all the many ways in which inadequately controlled research can mislead us. And we can reflect on how promising results in early trials often melt away when better, larger, more rigorous studies are done that better control for bias (the so-called Decline Effect). And it is not at all difficult to compile a large list of examples of the harm inadequately studied medical interventions can cause.

But what I’d like to do here is focus on a particularly good specific example of why thorough clinical trial evaluation of promising ideas is not just a nice extra to confirm what we already believe is true, it is the only way to genuinely know whether our treatments to more good than harm.

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Posted in: Cancer, Clinical Trials, Herbs & Supplements, Science and Medicine

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Generic Drugs: Are they Equivalent?

With healthcare costs continuing to rise, generic drugs are looking more attractive than ever. The prospect of getting the same drug at a lower cost is tempting to anyone with a large drug bill — patient or insurer alike. The savings are massive: Lipitor lost patent protection last month — it was a $10 billion drug, and the generic versions are priced at a fraction of the original cost. In 2012, Plavix and Seroquel, two other blockbusters, will lose patent protection too — that’s another $10 billion in drug costs that will shrink. This “patent cliff” will shrivel about $255 billion in worldwide patented drug sales over the next five years. If you’re taking a prescription drug and not already on a generic, you probably will be soon. And depending on where you live, you may be automatically switched to a generic version of your prescription drug as soon as it’s available.

Pharmacists are responsible for most of the switches from brand to generic drugs. In Ontario, where I work, regulations specify which drugs and brands may be automatically substituted — that is, without patient or prescriber consent.  This doesn’t mean a  lack of transparency, however, so I spend a lot of time speaking with patients about generic drugs. Misconceptions are common, ranging from manufacturing standards (“they’re weaker!”) to efficacy (“the drugs don’t work!”). I’ve seen a number of questions and comments about generic drugs in the comments section here at SBM as well. So today’s post is an overview of the science of evaluating generic drugs. Specifically, I want to review the concept of bioequivalence, the confirmation of which assures us of the interchangeability of different drugs — that is, one can be substituted for another. (more…)

Posted in: Basic Science, Pharmaceuticals

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The Cancer Cure Anecdote

Dr. Ian Gawler, a veterinarian, suffered from osteogenic sarcoma (a form of bone cancer) of the right leg when he was 24 in 1975. Treatment of the cancer required amputation of the right leg. After completing treatment he was found to have lumps in his groin. His oncologist at the time was confident this was local spread from the original cancer, which is highly aggressive. Gawler later developed lung and other lesions as well, and was given 6 months to live due to his metastatic disease.

Gawler decided to embark on an alternative treatment regimen, involving coffee enemas, a vegetarian diet, and meditation. Eventually he was completely cured of his terminal metastatic cancer. He has since become Australia’s most famous cancer survivor, promoting his alternative approach to cancer treatment, has published five books, and now runs the Gawler Foundation.

At least, that is the story he believes. There is one major problem with this medical tale, however – while the original cancer was confirmed by biopsy, the subsequent lesions were not. His oncologist at the time, Dr. John Doyle, assumed the new lesions were metastatic disease and never performed a biopsy. It was highly probable – the timing and the location of the new lumps following a highly aggressive cancer. But even a diagnosis that is 95% likely will be wrong in 1 patient out of 20 – which means a working physician will have patients with the 5% diagnosis about once a week. The standard of practice today would be to do a biopsy to get tissue confirmation of the diagnosis, and rule out the less likely alternatives.

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Posted in: Cancer

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Reducing the Risk of Adverse Drug Events

Critics of mainstream medicine often point to the dangers of drugs. I previously wrote about “Death by Medicine,” where I explained the fallacy of fixating on harmful effects of drugs without putting them into perspective with all the good drugs do. Yes, patients have died from severe allergic reactions to penicillin, but penicillin has also saved countless lives.

A recent article in The New England Journal of Medicine looks at emergency hospitalizations for adverse drug events in elderly Americans. It confirms that adverse reactions are a serious problem, but some of its findings are surprising.
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Posted in: Pharmaceuticals

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