Clinical trials

About a week ago, my good bud Steve Novella noted a tasty bit of silly pseudoscience finding its way around the usual places, such as Facebook, Twitter, and the like. It was one of those times where I smacked myself on the forehead (metaphorically speaking, of course) and asked, “How on earth did I miss this bit of pseudoscience?” It is, after all, more than Your Friday Dose of Woo-worthy, even though I haven’t done a YFDoW segment for over a year. (Remember, I found that my creation had become too constraining; so I retired it. I might bring it back someday, but today is not the day,…
"Team aerobic" by Berner Kantonalturnfest 2010 (Utzenstorf, Bätterkinden, Kirchberg, Koppigen). Original uploader was Equilibrium suisse at de.wikipedia - Transferred from de.wikipedia; transferred to Commons by User:Boteas using CommonsHelper. (Original text: http://www.ktf2010.ch). Licensed under CC-BY-SA-3.0-de via Wikimedia Commons. Few people know better than I that times are tough in the world of biomedical research. It’s been eight or nine years since the “hard landing” that occurred after the near doubling of the NIH budget that occurred between FY1998 and FY2003, a crash that was…
There’s a point I feel that I have have to make briefly as I begin this post. Basically, this might look familiar, but given that I was at TAM Wednesday through Sunday, I didn’t have time to produce two separate posts, and this is important enough to be distributed as widely as possible. In any event, as I started writing this, I was on a miserably crowded, hot, stinky flight winging my way home from TAM (nothing like being stuck in coach on the tarmac in the middle of the desert before taking off—the sweat never quite goes away even after the plane cools down). This puts me in the perfect…
Three months ago, I wrote about how the Cleveland Clinic had recently opened a clinic that dispensed herbal medicine according to traditional Chinese medicine (TCM) practice. As regular readers might expect, I was not particularly impressed or approving of this particular bit of infiltration of quackademic medicine into a major, generally well-respected academic medical center, particularly given some of the amazingly pseudoscientific treatments espoused by the naturopath who was running the clinic. I also pointed out that, although herbalism is the most plausible (or perhaps I should say the…
Our regularly scheduled post will go live later this morning. In the meantime, this is a public service announcement...with GUITAR! (Oh, wait.) As you recall, last week, the FDA inexplicably decided to lift the partial clinical hold on Stanislaw Burzynski's bogus clinical trials of antineoplastons, which he's used since the 1990s as a pretext to charge huge sums of money for "case management fees" to patients for a treatment whose efficacy he has never demonstrated. Yesterday, the Center for Inquiry laid in, and has sent a letter to legislators: “We are frankly stunned to hear that the…
Can we just say that vaccines are safe, already? Can we just say that, of all the medical interventions ever conceived by the minds of humans, vaccines have almost certainly saved more lives and prevented more illness? Can we finally say that vaccines do not cause autism? Of course not, unfortunately. I ask the same question about whether we can finally say that the earth isn’t 6,000 years old, but rather billions of years old, and there are still people out there who believe that evolution is a sham and the earth really is only 6,000 years old. Truly, the irrationality of humans is without…
It's hard for me to believe that it's been almost three years since I first started taking an interest in the Houston cancer doctor and Polish expat Stanislaw Burzynski. Three long years, but that's less than one-twelfth the time that Burzynski has been actually been administering an unproven cancer treatment known as antineoplastons (ANPs), a drug that has not been FDA-approved, to patients, which he began doing in 1977. Yes, back when Burzynski got started administering ANPs to patients, I was just entering high school, the Internet as we know it did not exist yet, just a much smaller…
If this looks a bit familiar to some of you, let's just say that it's grant crunch time again. This should be over after today. I hope. In the meantime, one of the difficult things about science-based medicine is determining what is and isn't quackery. While it is quite obvious that modalities such as homeopathy, acupuncture, reflexology, craniosacral therapy, Hulda Clark's "zapper," the Gerson therapy and Gonzalez protocol for cancer, and reiki (not to mention every other "energy healing" therapy) are the rankest quackery, there are lots of treatments that are harder to classify. Much of the…
As if yesterday's post weren't depressing enough, last weekend I attended the annual meeting of the American Society of Clinical Oncology (ASCO) meeting in Chicago, which is part of the reason I didn't produce much in the way of posts about a week ago. Last Sunday, while aimlessly wandering from session to session and checking Twitter and e-mail between sessions, I noticed that a lot of people, including the official ASCO Twitter feed @ASCO, were Tweeting and re-Tweeting a link to this official story from ASCO, "Integrative Oncology Can Add Benefit to Traditional Cancer Treatments." It was…
Here we go again. Two months ago, I noted that Dr. Stanislaw Burzynski, the Polish expatriate physician who started out as a legitimate medical researcher and then in the late 1970s took a turn away from science-based medicine and towards being a "brave maverick doctor" through his discovery in blood and urine of substances he called antineoplastons with—or so Burzynski claims—major anticancer activity, had finally published the results of one of his clinical trials. Actually, he published the results of 42.5% of one of his clinical trials, given that he had, without adequate explanation,…
I happen to be out of town right now, attending the annual meeting of the American Society of Clinical Oncology in Chicago. It's been a more—shall we say?—eventful trip than anticipated, which is why at my not-so-super-secret other blog we have a guest post today and here I will (probably) be shorter than usual. I'm not really going to say much about what I mean by "more eventful than usual," because it's more personal than anything else. Suffice to say that it kept me from delivering the usual logorrhea. Well, the unexpected event plus spending the day visiting my sister and my nephews, one…
Being a cancer surgeon, I realize that my tendency is to view my blogging material through the prism of cancer, particularly breast cancer, my specialty. it's easy to forget that there are diseases every bit as horrible, some arguably even more so than the worst cancer. When I think of such diseases, it's not surprising that amyotropic lateral sclerosis (ALS), commonly known as Lou Gehrig's disease after its most famous victim. It's a progressive degenerative neurologic disease that affects the motor neurons, resulting in progressive muscle weakness throughout the body. Eventually, victims…
Although I'm a translational researcher, I'm also a surgeon. That was my first and primary training and only later did I decide to get my PhD during my residency, when the opportunity to do so with a decent stipend presented itself. From my perspective, clinical research in surgery is difficult, arguably more difficult than it is for other medical modalities, at least in some ways. For instance, in surgery, it usually very difficult to do a double-blind placebo-controlled trial. For one thing, doing "sham" surgery on patients in the placebo arm is ethically dicey, and it's very hard to…
Pretty much everyone who's gotten through junior high recognizes the line from the William Shakespeare play Romeo and Juliet, when Juliet says, "What's in a name? that which we call a rose by any other name would smell as sweet. So Romeo would, were he not Romeo call'd, retain that dear perfection which he owes without that title." It's a succinct contemplation of how much a name means, which, according to Juliet, isn't that much. She (and Shakespeare) were right then, and the same thing is still true. In particular, it's true when referring to things perhaps less appealing than young love…
Well, it snuck up on me again, the way it has a tendency to do every year. Maybe it's because Memorial Day is so early this year. Maybe it's because there's just so much work to do this week given the multiple grant deadlines. Whatever the case, it just dawned on my last night that today is the first day of the yearly autism quackfest known as AutismOne (AO), which is being held at the Intercontinental O'Hare Hotel near Chicago. Of course, things are different this year. Given the schism between team Crosby and pretty much everyone else in the antivaccine movement, it's unclear what the deal…
I hadn't really planned on writing again about everyone's favorite conspiracy theorist and promoter of quackery, Mike Adams, at least not so soon after the last time I did it, which was only last week after Adams appeared on Dr. Oz's daytime television show to push his "laboratory." Adams, as you might recall, goes by the Internet moniker the "Health Ranger" (which would really more appropriately be "Health Danger") and is the man responsible for one of the quackiest sites on the Internet, NaturalNews.com, a repository for nearly every form of medical pseudoscience known to humans, mixed in…
Over the years, the criticism of "evidence-based medicine" (EBM) that I have repeated here and that I and others have repeated at my not-so-super-secret other blog is that its levels of evidence relegate basic science considerations to the lowest level evidence and elevate randomized clinical trial evidence to the highest rung, in essence fetishizing it above all, a form of thinking that I like to call methodolatry. Now, when EBM works correctly, this is not an entirely unreasonable way to look at things. After all, we just want to know what works in patients. Basically, when EBM is working…
I was torn about what to blog about today. There were lots of things floating around that caught my eye and appear worthy of of a little taste of Insolence, either Respectful or not-so-Respectful, so much so that I couldn't decide. None of them really stuck out. Then I saw this news story pop up in my Google Alerts, Houston-area doctor grateful for time spent with Pope John Paul II: My first thought was that Stanislaw Burzynski must have one hell of a publicist. Either that, or he has a good buddy at KHOU in Houston. My second thought was of a bill that was recently introduced into the…
I don't recall if I've ever mentioned my connection with the Cleveland Clinic Foundation (CCF). I probably have, but just don't remember it. Longtime readers might recall that I did my general surgery training at Case Western Reserve University at University Hospitals of Cleveland. Indeed, I did my PhD there as well in the Department of Physiology and Biophysics. Up the road less than a mile from UH is the Cleveland Clinic. As it turns out, during my stint in Physiology and Biophysics at CWRU, I happened to do a research rotation in a lab at the CCF, which lasted a few months. OK, so it's not…
Damn it. After hearing the horrible news that Laura Hymas had died on the same day that I found out that the pro-quackery "health freedom" Alliance for Natural Health (ANH) was supporting a federal "right to try" bill, I thought it would just be a one-off post about Burzynski, his allies, and the human toll exacted by his cancer quackery. No such luck. The reason is that yesterday morning I awoke to e-mails and Tweets from multiple colleagues and bloggers making me aware of an article published in a journal that (once again) I had never heard of, Child’s Nervous System. The article is by—…