Clinical trials

Why haven't we cured cancer yet? If we can put a man on the moon, why can't we cure cancer? If we can harness the atom, why can't we cure cancer? How many times have you heard these questions, or variants thereof? How many times have you asked this question yourself? Sometimes, I even ask this question myself. Saturday was the two year anniversary of the death of my mother-in-law from a particularly nasty form of breast cancer, and, even though I am a breast cancer surgeon, I still wonder why there was nothing in the armamentarium of science-based medicine that could save her from a several…
As most of you know, most of the basic and translational biomedical research in the U.S. is funded by the National Institutes of Health (NIH). Unfortunately, the NIH budget has been stagnant for the last five or six years. That's been bad enough, leading to a decline in funding success rates for applicants for research grants to a low level that we haven't seen in nearly 20 years. Worse, even though FY2011 started October 1, the federal government still doesn't have a real budget. It's operating on a continuing resolution. While this plays havoc with all government agencies, it's particularly…
I've made no secret about the fact that I am not a fan of the National Center for Complementary and Alternative Medicine (NCCAM). I consider it a useless, redundant center within the National Institutes of Health because it does nothing that could't be done as well or better in the institutes and centers of the NIH that existed before woo-friendly Senator Tom Harkin (D-IA) created NCCAM's precursor and then saw to it that it grew to a full center, with a budget in the $125 million a year range. Personally, if something has to be cut fromt the government in this time of fiscal austerity, I…
Back in December, I took issue with a highly irritating article by someone who normally should know better, Jonah Lehrer, entitled The Truth Wears Off: Is There Something Wrong With the Scientific Method?, so much so that I wrote one of my typical long-winded deconstructions of the article. One thing that irritated me was contained in the very title itself, namely the insinuation that the "decline effect," which is the tendency of effects observed in early scientific experiments demonstrating a phenomenon to "decline" or become less robust as more and more experiments are performed, is…
In discussing "alternative" medicine it's impossible not to discuss, at least briefly, placebo effects. Indeed, one of the most common complaints I (and others) voice about clinical trials of alternative medicine is lack of adequate placebo controls. Just type "acupuncture" in the search box in the upper left hand corner of the blog, and you'll pull up a number of discussions of acupuncture clinical trials that I've done over the years. If you check some of these posts, you'll find that in nearly every case I discuss whether the placebo or sham control is adequate, noting that, the better the…
During the six years of its existence, one frequent complaint I've had on this blog, it's been about how the press covers various health issues. In particular, it's depressing to see how often dubious and even outright false health claims, such as the claim that vaccines cause autism, that cell phones or powerlines cause cancer, or that various questionable or even quack remedies work for various diseases are reported credulously. Often this takes the form of a journalistic convention that is more appropriate for politics and other issues but not so appropriate for scientific and medical…
NOTE: Orac was actually out rather late last night. It turns out that the more administrative responsibility he somehow seems to find the more he has to go out to dinner as a part of various cancer center-related functions. As a result, he is recycling a bit of recent material from elsewhere that he in his extreme arrogance considers just too good not to post up on this blog too. In any case, it's always interesting to see how a different audience reacts to his stuff, and he did make some alterations to this post. 'Tis the season, it would seem, for questioning science. Not that there's…
It's times like these that I'm glad I'm a clinician-scientist: Or maybe not. The reason is that the same conversation in a clinician-scientist's review would be asking why he's only produced X number of RVUs last year and suggesting pointedly that he needs to double his RVU output. Oh, and, by the way, he needs to get grants, publish clinical trials, and teach residents and medical students, too, all while taking more call. And don't forget that it's the very rare clinician-scientist who can bring in more money to a department in indirect costs from federal grants than he or she could bring…
Given that I've dedicated my life to treating cancer and researching the biology of cancer, the ultimate goal being to use that knowledge of cancer biology to develop ever more effective treatments directed at the specific molecular derangements that lead to cancer, it's not surprising that I'm very much anti-tobacco. After all, arguably there is no known behavior that causes more cancer-related deaths than smoking tobacco. It's not just lung cancer, either. Smoking causes a wide variety of cancers, chronic obstructive pulmonary disease (COPD), and cardiovascular disease, all of which result…
I advocate science-based medicine (SBM) on this blog. However, from time to time, consider it necessary to point out that SBM is not the same thing as turning medicine into a science. Rather, I argue that what we do as clinicians should be based in science. Contrary to what some might claim, this is not a distinction without a difference. If we were practicing pure science, we would theoretically be able to create algorithms and flowcharts telling us how to care for patients with any given condition, and we would never deviate from them. It is true that we do have algorithms and flowcharts…
If there's one thing that confounds advocates of so-called "complementary and alternative medicine" (CAM), it's the placebo effect. That's because, whenever most such remedies are studied using rigorous clinical trial design using properly constituted placebo controls, they almost always end up showing effects no greater than placebo effects. That's the main reason why they frequently suggest that, you know, all those rigorous, carefully constructed randomized placebo-controlled clinical trials aren't really the best way to investigate their woo after all. To them, it's much better to do "…
Last week blew by me in a blur. Because I was in full grant writing frenzy to get an R01 in the can by Friday, pretty much anything that wasn't totally urgent got shoved aside, at least after Wednesday. Of course, it was last Wednesday that yet another mammography study was being touted as a "landmark" study. I had just enough time to look it over briefly and decide that I really should blog about it, particularly given that it came hot on the heels of a Norwegian study less than a week before that found the benefits of mammography to be less than previously believed and even more…
One of the favorite fallacious arguments favored by pseudoscientists and denialists of science is the ever infamous "science was wrong before" gambit, wherein it is argued that, because science is not perfect or because scientists are not perfect, then science is not to be trusted. We've seen it many times before. Indeed, we saw it just yesterday, when promoters of quackery and anti-vaccine cranks leapt all over the revelation that American scientists had intentionally infected Guatemalan prisoners with syphilis without their consent as part of an experiment in the 1940s. They didn't attack…
If there's one thing that burns me about so-called "complementary and alternative medicine" (CAM) clinical trials, it's how unethical many of them are. This is particularly true for trials that test modalities that, on the basic science grounds alone, can be dismissed as so highly implausible and with such a low prior probability of success that it is unethical to subject patients to risk with close to zero potential for benefit. Perhaps the most egregious example of such a clinical trial is the Gonzalez protocol in pancreatic cancer, a cornucopia of woo and quackery including up to 150…
Unfortunately, it's grant application crunch time again over the weekend. That means something's got to give, and what happened to be the thing to give was this blog. Fortunately, all is not lost, as a "good friend" of mine has commented on a recent New England Journal of Medicine study from Thursday about mammography. It may not be as "insolent" as the commentary that Orac lays down, but it's pretty darned good. I'm fully expecting that the "alternative" medicine crowd will soon jump all over this study as "proof" that mammography is useless. It's nothing of the sort, and, more importantly,…
A critical aspect of both evidence-based medicine (EBM) and science-based medicine (SBM) is the randomized clinical trial. Ideally, particularly for conditions with a large subjective component in symptomatology, the trial should be randomized, double-blind, and placebo-controlled. As Kimball Atwood pointed out just last week (me too), in EBM, scientific prior probability tends to be discounted while in SBM it is not, particularly for therapies that are wildly improbable strictly on the basis of basic science, but for both the randomized clinical trial remains, in essence, where the "rubber…
I hate to do this to Bora again. I really do. I'm also getting tired of blogging all these crappy acupuncture studies. I really am. However, sometimes a skeptic's gotta do what a skeptic's gotta do, and this is one of those times. As you may recall, a mere week ago I was disturbed to have discovered the publication of a truly horrifically bad acupuncture study in PLoS ONE. It had all the hallmarks of quackademic medicine: an implausible hypothesis, trying to correlate mystical concepts of meridians and qi to anatomy and failing miserably, and dubious statistical modeling. That PLoS ONE…
Here and elsewhere in the blogosphere, over the last several years, what started out as a more general interest in skepticism and science with a natural focus on medicine and a side interest in combatting Holocaust denial became more focused on promoting science-based medicine. As the saying goes, "Science, it works, bitches," and I make no apologies for promoting science-based medicine as the best medicine and applying skepticism and science to claims of purveyors of unscientific so-called "alternative" medicine advocates and anti-vaccine loons. However, I am not blind to the shortcomings of…
One of the most frustrating aspects of taking care of cancer patients is that in general, with a handful of specific exceptions, we do not have good curative therapies for patients with stage IV cancer, particularly solid tumors. Consequently, we are forced to view patients with stage IV cancer as "incurable" because, the vast majority of the time, they are incurable. Over the years, we have thrown everything but the kitchen sink at patients with stage IV disease, largely with dissapointing results. That's not to say that the few specific exceptions to which I alluded are not a reason for…
Nearly a month ago, I expressed my dismay and displeasure at the infiltration fo quackademic medicine into what is arguably the premier medical journal in the world, The New England Journal of Medicine (NEJM) in the form of a highly credulous review on the use of acupuncture for low back pain that brought eternal shame on the hallowed pages of a once-great journal. As Mark Crislip put it, trust, once damaged or lost, is very hard to restore, and I definitely lost a lot of trust for the NEJM compared to what I had for it a month ago. Since then, I've been keeping my eyes out for other examples…