Archive for Cancer

Why haven’t we cured cancer yet? (Revisited): Personalized medicine versus evolution

About a year ago, I addressed what might seem to the average reader to be a very simple question: Why haven’t we cured cancer yet? As I pointed out at the time, it’s a question that I sometimes even ask myself, particularly given that cancer has touched my life. Three years ago, my mother-in-law died of a particularly nasty form of breast cancer. Even though I am a breast cancer surgeon, I still wonder why there was nothing that could save her (and there still is nothing that could have saved her, if it existed then) from a decline over several months followed by an unpleasant death. Yet, as a cancer researcher, I do understand somewhat. A couple of years ago, I wrote in depth about the complexity of cancer from a science-based viewpoint, as compared, of course, to the incredibly simplistic view that many purveyors of alternative medicine quackery promote as being The One True Cause of Cancer. As I put it at the time, shamelessly stealing from Douglas Adams: Cancer is complicated. You just won’t believe how vastly, hugely, mind-bogglingly complicated it is. I mean, you may think algebra is complicated, but that’s just peanuts to cancer.

I saw more evidence of that at the American Association for Cancer Research meeting last week. In fact, if there’s anything I’ve learned, it’s that developing personalized therapy for cancer is going to be a hell of a lot more difficult than we had ever suspected. Actually, it wasn’t just the AACR meeting that taught me this, but it’s as good a pretext as any to discuss some cool new science. I only wish it was science that pointed an obvious path forward to the development of personalized therapy. On the other hand, if it were easy then anyone could do the “personalized therapy for dummies” approach that, for example, Stanislaw Burzynski takes. Then there’s the even more ridiculously simplistic approach that certain practitioners of “complementary and alternative medicine” (CAM) take.

So why haven’t we cured cancer yet? Again? One reason that I discussed last time I covered this topic concerns a study that used the latest next generation sequencing (NGS) techniques to sequence seven aggressive and advanced prostate cancers. I described the results as these genomes looking like someone threw a miniature grenade into the nucleus of a prostate epithelial cell. In other words, these are some really messed up genomes. (I wanted to use another word to describe it, but this is a family blog—sort of, anyway.) I used this example to explain once again that cancer is not a single disease. It’s hundreds of diseases. Although there are common themes in how cells become cancerous, such as loss of responsiveness to growth signals with a resultant ability to grow unchecked, evasion of programmed cell death (apoptosis), inducing the surrounding tissue to provide a blood supply (angiogenesis), evading the immune system, and invading the blood or lymphatic systems to travel elsewhere in the body and take up shop in other organs, such as liver, lung, or bone, individual cancers acquire these necessary (to the cancer) abilities through many different mechanisms. For this reason, it’s completely ridiculous to speak of a “cure for cancer.”

It’s also the reason I expressed skepticism when Steve Novella discussed a potential universal anti-cancer drug. Ditto when the press breathlessly reports studies suggesting a “universal cancer vaccine.” While these sorts of research findings are promising, they need to be put into perspective. We’ve seen their like many times before, and various cancers are still deadly diseases. In fact, my career intersected with this sort of hype back in the 1990s, when I studied combining angiogenesis inhibitors with radiation therapy in experimental models of cancer in mice. For a period of time in the late 1990s, I lived the hype. Then reality, as it always does, brought us all down to earth. Now, 15 years later, we know that angiogenesis inhibitors, although useful, are not any sort of “magic bullet” cure for all solid tumors. Like many advances before, they have now taken their place in the armamentarium of anticancer drugs, more important than some but not as important as others.

It’s even more complicated than that.


Posted in: Basic Science, Cancer, Evolution

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Are Cell Phones a Possible Carcinogen? An Update on the IARC Report

EDITOR’S NOTE: Because I am at the annual meeting of the American Association for Cancer Research in Chicago, between the meetings, working on a policy statement, working on a manuscript, and various other miscellaneous tasks, I alas was unable to produce a post worthy of the quality normally expected by SBM readers. Fortunately, Lorne Trottier, who’s done a great job for us twice before, was able to step in again with this great post about “safe” cell phone cases. Speaking of the manufactroversy over whether cell phone radiation causes brain cancer, there’s a session at the AACR that I’ll have to try to attend entitled Do Cell Phones Cause Brain Cancer? Who knows? It might be blogging material. I also might post something later that those of you who know of my not-so-super-secret other blog might have seen before. However, I often find it useful to see how a different audience reacts. Now, take it away, Lorne…

In May of last year, the International Agency for Research on Cancer (IARC) issued a press release (1) in which it classified cell phones as Category 2B, which is “possibly carcinogenic to humans“. This ruling generated headlines world wide. Alarmist groups seized on it and now regularly cite this report to justify their concerns for everything ranging from cell phones to WiFi and smart meters.

IARC maintains a list of 269 substances in the 2B category, most of which are chemical compounds. A number of familiar items are also included in this list: coffee, pickled vegetables, carbon black (carbon paper), gasoline exhaust, talcum powder, and nickel (coins). The IARC provides the following definition of the 2B category (2  P 23): “This category is used for agents for which there is limited evidence of carcinogenicity in humans and less than sufficient evidence of carcinogenicity in experimental animals. It may also be used when there is inadequate evidence of carcinogenicity in humans but there is sufficient evidence of carcinogenicity in experimental animals“.

The Category 2B “possible carcinogen” classification does not mean that an agent is carcinogenic. As Ken Foster of the University of Pennsylvania pointed out to me. “Their conclusion is easy to misinterpret.” “Saying that something is a “possible carcinogen” is a bit like saying that someone is a “possible shoplifter” because he was in the store when the watch was stolen. The real question is what is the evidence that cell phones actually cause cancer, and the answer is — none that would persuade a health agency.”

None the less this ruling was highly controversial. Expert groups of most of the world’s major public health organizations have taken the same position as the European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) which had stated that (3  P 8): “It is concluded from three independent lines of evidence (epidemiological, animal and in vitro studies) that exposure to RF fields is unlikely to lead to an increase in cancer in humans“. The representative of the US National Cancer Institute walked out of the IARC meeting before the voting. The NCI issued a statement (4) quoting other studies stating that: “overall, cell phone users have no increased risk of the most common forms of brain tumors — glioma and meningioma“.

Immediately following the IARC decision the WHO issued a reassuring new Fact Sheet (5) on mobile phones and public health: “A large number of studies have been performed over the last two decades to assess whether mobile phones pose a potential health risk. To date, no adverse health effects have been established as being caused by mobile phone use”. Since this controversial IARC classification, several new papers have been published that substantially undermine the weak evidence on which the IARC based its assessment.

The evidence that IARC cited to support its assessment was poor to begin with. Their initial press release (1) was followed by a more complete report that was published in the July 1, 2011 issue of the Lancet Oncology as well as online (6). In this article, I will review the evidence cited by IARC in support of its conclusion. I will also review updates from new papers published over the past year that cast further doubt on IARC’s conclusion.

Posted in: Cancer, Public Health, Science and Medicine

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A Universal Anti-Cancer Drug?

We frequently deal with fraud and quackery on this blog, because part of our mission is to inform the public about such things, and also they are great examples for explaining the difference between legitimate and dubious medical claims. It is always our goal not just to give a pronouncement about this or that therapy, but to work through the logic and evidence so that or readers will learn how to analyze claims for themselves, or at least know when to be skeptical.

One skepticism-inducing red flag is any treatment that claims to treat a wide range of ailments, especially if those ailments are known to have difference causes and pathophysiologies. Even claiming that one treatment might be effective against all cancer is dubious, because cancer is not one disease, but a category of disease. We are fond of pointing out that there are many types and stages of cancer, and each one requires individualized treatments. As an aside, it is ironic that CAM proponents often simultaneously tout how individualized their treatment approach is, but then claim that one product or treatment can cure all cancer. Meanwhile they criticize the alleged cookie-cutter approach of mainstream medicine, which is actually producing a more and more individualized (and evidence-based) approach to such things as cancer.

In any case – my immediate response to any article or website claiming to treat most or all cancer is to be highly skeptical, but I reserve final judgment until after I read through the details. What kinds of evidence are being presented to support the claims, and what are the alleged mechanisms of action? Are those making the claims being cautious like a scientist should, or are they being promotional like a used-car salesman?

A recent study claiming a potential treatment for many types of cancer has been making the rounds. The title of the article being circulated is, One Drug to Shrink All Tumors. What made me take immediate interest in this article was that it was not on a dubious website, sensational tabloid, or even mainstream news outlet, but on the news section of the American Academy for the Advancement of Science (AAAS) website. This is a report of serious medical research. The title, I suspect, is perhaps a bit more sensational than it otherwise would have been because of a geeky nod to the “one ring to bind them all” Lord of the Rings quote. Regardless of the source and the headline – what is the science here?


Posted in: Cancer

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A surprising article about “integrative” medicine in The New England Journal of Medicine vs. “patient-centered” care

The New England Journal of Medicine (NEJM) is published on Thursdays. I mention this because this is one of the rare times where my owning Mondays on this blog tends to be a rather large advantage. Fridays are rotated between two or three different bloggers, and, as awesome as they are as writers, bloggers, and friends, they don’t possess the rabbit-like speed (and attention span) that I do that would allow me to see an article published in the NEJM on Thursday and get a post written about it by early Friday morning. This is, of course, a skill I have honed in my not-so-super-secret other blogging identity; so if I owned the Friday slot I could pull it off. However, the Monday slot is good enough because I’ll almost always have first crack at juicy studies and articles published in the NEJM before my fellow SBM partners in crime, unless Steve Novella managed to crank something out for his own personal blog on Friday, curse him.

My desire to be the firstest with the mostest when it comes to blogging about new articles notwithstanding, as I perused the table of contents of the NEJM this week, I was shocked to see an article that made me wonder whether the editors at NEJM might just be starting to “get it”—just a little bit—regarding “integrative” medicine. As our very own Mark Crislip put it a little more than a week ago:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

Lately, though, I’ve been more fond of a version that doesn’t use fancy words like “instantiate”:

If you integrate fantasy with reality, you don’t make the fantasy more real. You temporarily make your reality seem more fantasy-based, but reality always wins out in the end.

The part about the cow pie needs no change, although I think ice cream works a bit better than apple pie. Your mileage may vary. Feel free to make up your own metaphor inspired by Mark’s.

In any case, in the Perspective section, I saw three articles about “patient-centered” care:

Posted in: Cancer, Medical Academia, Medical Ethics

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Dr. Oz revisited

We here at SBM have been very critical of Dr. Mehmet Oz, who through his relentless self-promotion (and with more than a little help from his patron Oprah Winfrey) has somehow become known as “America’s doctor.” Back in the early days, when he was the regular medical expert on The Oprah Winfrey Show, Dr. Oz was at least tolerable. Much of what he discussed was reasonably science-based and even sensible, mainly advice to eat better and get more exercise, which is what most primary care doctors tell their patients every day. True, he did “integrate” some non-evidence-based therapies in with the evidence-based therapies, which was not good given how a typical viewer wouldn’t be able to tell where the science-based advice ended and the magical thinking began, but for the most part, even on Oprah’s show, he kept his woo somewhat in check. At least, there were boundaries beyond which he wouldn’t pass, even though Dr. Oz’s wife is a reiki master and he has been a fan of reiki (gaining fame for inviting reiki masters into his operating room during cardiac surgery) since at least the 1990s. More recently, Dr. Oz has testified in front of NCCAM patron Senator Tom Harkin’s committee to promote “complementary and alternative medicine” (CAM) or, as its advocates like to call it now, “integrative medicine.” He’s also been the Medical Director for the Integrative Medicine Program at New York-Presbyterian Hospital/Columbia University Medical Center since 2001. (How he does his TV show, holds a job as a professor of surgery at Columbia University, and holds positions as Clinical Trials of New Surgical Technology, Attending Surgeon, and Director, Clinical Perfusion Services at the same hospital, I’ll never know. He must have the most understanding partners ever.)

Be that as it may, even after Dr. Oz landed The Doctor Oz Show, for the first half of his first season he kept it fairly straight and science-based. However, two years ago the mask began to slip when Dr. Oz first aired a credulous feature about reiki under the title Dr. Oz’s Ultimate Alternative Medicine Secrets. Not long after that, Dr. Oz featured a man who is in my opinion arguably the foremost promoter of quackery on the Internet, Dr. Joe Mercola, along with the master of quantum quackery, Dr. Deepak Chopra. It was at that point that one could rightly say that Dr. Oz had “crossed the Woobicon.” Since then, it’s been one thing after another, beginning in earnest about a year ago. For instance, in January 2011, Dr. Oz featured Dr. Mercola again in a completely credulous portrait that painted him a “brave maverick doctor,” only without a hint of irony. A couple of weeks later, he featured a yogi who advocated “detoxing” and a faith healer from my old stomping grounds in Cleveland. Then, just when I thought Oz couldn’t go any lower, he featured psychic scammer John Edward.

Finally, back in April 2011, Dr. Oz’s producers apparently figured out that there was a problem with Dr. Oz’s image, except that they saw it as an opportunity to gin up a little controversy on the show. They invited our very own Dr. Steve Novella on the show as the “skeptic” who criticizes Dr. Oz. I very much admire Steve for going into the lion’s den, where, he knew in advance, he would be the underdog and the audience would be against him. Steve acquitted himself well, and after his appearance, I have to admit, I pretty much stopped paying attention to Dr. Oz for several months. He basically faded into the background of quackery, a prominent voice “integrating” quackery with medicine, pseudoscience with science, in the apparent belief that mixing fantasy with reality somehow improves medicine. Personally, I prefer Mark Crislip’s take and will steal his statement about “integrative medicine”:

If you integrate fantasy with reality, you do not instantiate reality. If you mix cow pie with apple pie, it does not make the cow pie taste better; it makes the apple pie worse.

I just learned last week that Dr. Oz, while trying to make the cow pie taste better, is only continuing to succeed in making the apple pie taste worse. Witness an episode from last week featuring a long segment entitled Dr. Mercola’s Most Radical Alternative Cures, or, as the banner on the segment calls it, “Radical Cures Your Doctor Thinks Are Crazy.” Not surprisingly, Dr. Mercola has been bragging about his fourth appearance on Dr. Oz’s show yet again. (Video: Part 1 and Part 2).

Posted in: Cancer, Energy Medicine, Science and the Media

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SANE Vax adopts Dr. Hanan Polansky’s “microcompetition” as its own. Hilarity ensues.

One of the hallmarks of science as it has been practiced for the last century or so is that scientists share their discoveries in the peer-reviewed literature, where their fellow scientists can evaluate them, decide if they’re interesting, and then replicate them, usually as a prelude to building upon them. While the system of publication and peer review in science is anything but perfect (and, indeed, we have discussed many of its shortcomings right here on this very blog), I tend to like to view it in much the same way Winston Churchill characterized democracy:

Many forms of Government have been tried and will be tried in this world of sin and woe. No one pretends that democracy is perfect or all-wise. Indeed, it has been said that democracy is the worst form of government except all those other forms that have been tried from time to time.

I would rephrase this as:

Many forms of evaluating science have been tried and will be tried in this world of sin and woe. No one pretends that peer review is perfect or all-wise. Indeed, it has been said (by me) that peer review is the worst form of evaluating science except all those other forms that have been tried from time to time.

As mainstream medicine has become more scientific over the last century in the wake of the Flexner Report, physicians and medical researchers have similarly come to view publication in the peer-reviewed literature to be a very important component of communicating and evaluating medical discoveries. It’s not as though this is even a particularly high bar to pass, either. After all, many are the absolutely execrable papers that I (and my partners in crime here at SBM) have discussed over the last four years, nearly all of which were in peer-reviewed journals, some very prestigious. After all, if papers on “energy chelation” can find their way into decent journals and the likes of Mark and David Geier can publish in the peer-reviewed literature, while someone like Christopher Shaw can get cringe-worthy confusions of correlation with causation published, I don’t take seriously the whines of cranks who claim that they can’t publish in the peer-reviewed literature for one reason or another.

That’s why I view being published in the peer-reviewed literature as a minimum, but by no means sufficient, requirement good science. It’s also why, whenever I see a new claim, my first reaction is to see if (1) the person making the claim has published on it and (2) there are publications in the peer reviewed literature that support the claim. The first criterion helps me judge whether the person is a serious scientist; the second, whether there is any plausibility to his ideas. Sure, it’s not a foolproof scheme, but it is helpful.

I only wish antivaccinationists would do the same. That they don’t explains why they seem to be embracing someone named Dr. Hanan Polansky.

Posted in: Basic Science, Cancer, Vaccines

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Adventures in defending science-based medicine in cancer journals: Energy chelation

My co-bloggers and I have spent considerable time and effort over the last four years writing posts for this blog (and I for my not-so-super-secret other blog) bemoaning the infiltration of quackademic medicine into what once were bastions of evidence- and science-based medicine. We’ve discussed at considerable length reasons for why this steady infiltration of pseudoscience into medical academia has been occurring. Among other potential explanations, these reasons range from the ascendence of postmodernism in areas where it really doesn’t belong; to a change in our medical culture to a more “consumer”-oriented, “keep the customer satisfied”-sort of model in which patients are often referred to as “clients” or “customers”; to the corrosive influences of moneyed groups (such as the Bravewell Collaborative) and government agencies (such as the National Center for Complementary and Alternative medicine, a.k.a. NCCAM); to the equally corrosive influences of powerful woo-friendly legislators who use their position and influence to create such agencies (such as Senator Tom Harkin and Representative Dan Burton) and otherwise champion “complementary and alternative medicine” (CAM) and “integrative medicine” because they are true believers in quackery; to cynical legislators, like Senator Orrin Hatch, who champions such government programs supporting pseudoscience because he represents a state that is home to the largest concentration of supplement manufacturers in the United States and is consequently a master at bringing any initiative to regulate the supplement industry more tightly to a screeching halt.

As a result of our efforts and the need for a counterweight to the quackery that has infiltrated so much of academia, SBM has become fairly prominent in the medical blogosphere. Our traffic is good, and we have a number of “thought leaders” who regularly read what we write. We’ve even caught the attention of Dr. Josephine Briggs, director of NCCAM, and our founder Steve Novella was even invited to appear on The Dr. Oz Show for “balance.” All of this is something that we are justly proud of. On the other hand, I can’t help but keep things in perspective. While our traffic as a blog is quite respectable and we have become prominent in the skeptical and medical blogosphere and even, to some extent, in academia—we’re particularly gratified at the number of medical students who are regular readers—compared to the forces arrayed against SBM in academia and the media, we have to face facts: We are truly a tiny voice in the wilderness. For instance, we average around 9,000 to 16,000 visits a day. Compare that traffic to the many millions who used to watch Oprah Winfrey and still watch her protégé Dr. Oz or to health media and product empires of people like Andrew Weil and Deepak Chopra, and you get the idea.

All of this is why I started looking for opportunities to respond more directly to incursions of pseudoscience into medical academia. Occasional SBM contributor Peter Lipson provided me with just such an opportunity last summer when he sent me a link to a brain-meltingly bad study about the use of CAM in cancer that shows just how bad a study can be and still be published in what I used to consider a reasonably good cancer journal. I say “used to consider,” because the fact that this journal accepted a study this ludicrous indicates to me that its peer review is so broken that I now wonder about what else I’ve read in that journal that I should now discount as being too unreliable to take seriously. Maybe everything. I don’t know. What I do know is that seldom have I seen such a bad study in such a good cancer journal. Studies like the one about Tai Chi in fibromyalgia or placebo acupuncture applied to asthma don’t even come close.

Soon after this study appeared online ahead of print, James Coyne contacted me and asked me if I wanted to be co-author on a letter to the editor of the journal. Honored by Dr. Coyne’s request, I immediately said yes (of course), and together with Dr. Christoffer Johansen at the Survivorship Unit of the Danish Cancer Society, we submitted our letter to the editor. To my surprise, given the utter failure of past efforts to publish letters to the editor about studies of this sort, our letter was accepted for publication. Last week, the study in question saw print, and our letter was published online ahead of print, along with the response of the authors. All are instructive and, to me, show just what we are up against in trying to prevent pseudoscience from creeping into academia.

Posted in: Cancer, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Medical Academia

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Reassessing whether low energy electromagnetic fields can have clinically relevant biological effects

It is with some trepidation that I write this, given that I realize this post might lead to charges that I’ve allowed myself to become so open-minded that my brains fell out, but I think the issues raised by what I’m about to discuss will make our readers think a bit—and perhaps spark some conversation. Because I’m in a bit of a contrarian mood, I’ll take that risk, although it’s possible I might end up with the proverbial egg on my face. As our regular readers know, the issue of the health effects of radiation from mobile phones has been a frequent topic of this blog. The reasons are obvious because fear mongering claims not based in science are frequently made in the lay press and in books (for example, Disconnect by Devra Davis) and, unfortunately, also by some physicians and scientists. Moreover, like homeopathy, the issue demands a discussion of prior probability and plausibility based on basic science alone, but the issues are a bit less clear-cut. Whereas the tenets of homeopathy clearly violate multiple laws of physics and chemistry, it is possible, albeit very unlikely, that radio waves might produce significant biological changes.

There’s also sometimes a maddening dogmatism on the part of some physicists that it’s “impossible” that long term exposure to radio waves could possibly cause cancer because such electromagnetic waves do not have anywhere near enough energy to cause ionization and thereby break chemical bonds. While it is certainly true that such radio waves can’t break chemical bonds and the likelihood that the radio waves from cell phones can cause cancer appears very low based solely on physics considerations, all too often the arguments made based on physics considerations alone use a simplistic understanding of cancer and carcinogenesis as their basis. It’s not for nothing that I have referred to such arguments as being based on a high school or freshman level of understanding about cancer—or just an outmoded understanding that prevailed a decade or two ago but today no longer does. Bernard Leikind, for instance, argued and famed skeptic Michael Shermer accepted that, because the radio waves used in cellular communications are too low energy to break chemical bonds and do not produce significant heating compared to other sources, “cell phones cannot damage living tissue or cause cancer.” Note the implicit assumption: That it is somehow necessary to “damage” living tissue in order to cause cancer. That’s an assumption that is arguably quite simplistic and ignores knowledge we’ve gained about epigenetics and how potential metabolic influences might cause cancer. Cancer is associated with characteristic cellular metabolic abnormalities, and determining which is responsible for the formation of cancer, metabolic abnormalities or gene mutations, has become a “chicken or the egg”-type of question.

I do not in any way believe that cell phone radiation actually is a cause of cancer because, unlike the case in homeopathy, where multiple well-established laws of physics would have to be overturned for homeopathy to work, I find the argument that a causation is “utterly impossible” far less persuasive than some physicists do when it comes to cell phone radiation and cancer. Even dismissing the “impossibility” argument, however, clearly such a link is at the very least incredibly implausible on physics considerations alone, as I have pointed out time and time again. Add to that the nearly completely negative epidemiological data in which only one group of researchers has been able to produce apparently “positive” studies, and my personal conclusion is that we probably already have enough data to reject a connection between radio waves and cancer and don’t need any more new large epidemiological studies; following up long term results on the ones already under way should be sufficient. That is not the same thing as arguing that radio waves have no significant biological effect, which is what, in essence, the argument from physics is based on. In fact, the inspiration for the rest of this post came from a meeting I had last week with a scientist and that scientist’s talk for our cancer center’s weekly Grand Rounds. What I learned did not demonstrate that cell phones cause cancer or even that they might cause cancer. Not even this scientist claimed his results were consistent with cell phone radiation causing cancer; in fact, he quite clearly stated they were not. However, what I learned from him cast some doubt (to me, at least) on the assumption that radio waves cannot have profound biological effects. In fact, ironically enough, this scientist is proposing the use of amplitude-modulated (AM) radio waves to treat cancer. I’m not yet convinced by any stretch of the imagination that this researcher is on to something, but his findings made me think about the perils and pitfalls of declaring something “impossible” solely on basic science considerations, because he has some very intriguing results that I can’t find a compelling reason to dismiss.

And, at least as of now, there’s no known physical mechanism that can explain his findings. Leaving aside the possibility of fraud or some sort of systematic bias that is not apparent in the methods sections of the papers I’m about to summarize, either he’s found something new and potentially promising, or he’s somehow very, very wrong.

Posted in: Basic Science, Cancer, Clinical Trials

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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?

Posted in: Basic Science, Cancer, Clinical Trials, Politics and Regulation

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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.


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

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