Clinical trials

What the hell is going on with The New York Times' health reporting? I've had my share of disagreements with the way that the NYT has covered various health issues over the years that I've been blogging, but I don't recall ever having seen it embrace pseudoscience. I can recall being a bit miffed at some of the articles that the NYT has published about biomedical research and its various perceived failings. On the other hand, I've also praised the NYT reporting on various issues, such as medical radiation and the risks it can pose. But lately, it seems, the NYT has gone into the crapper with…
Geron press release: "We are pleased with the FDA's decision to allow our planned clinical trial of GRNOPC1 in spinal cord injury to proceed," said Thomas B. Okarma, Ph.D., M.D., Geron's president and CEO. "Our goals for the application of GRNOPC1 in subacute spinal cord injury are unchanged - to achieve restoration of spinal cord function by the injection of hESC-derived oligodendrocyte progenitor cells directly into the lesion site of the patient's injured spinal cord. Additionally, we are now formally exploring the utility of GRNOPC1 in other degenerative CNS disorders including Alzheimer'…
Remember Dr. David Katz? Fellow skeptic and supporter of science-based medicine Dr. Steve Novella is unfortunate to be saddle with Dr. Katz on the same faculty as him at Yale. He achieved some notoriety a couple of years ago when at a Yale conference on complementary and alternative medicine (CAM), he laid down this gem: I think we have to look beyond the results of RCTs in order to address patient needs today, and to do that I've arrived at the concept of a more fluid form of evidence than many of us have imbibed from our medical educations. In one fell swoop, Dr. Katz rallied supporters of…
June is almost over. If you work in an academic medical center, as I do, that can mean only one thing. The new interns are coming, and existing residents will soon be advancing to the next level. The joy! The excitement! The trepidation! And it's not all just the senior residents and the faculty feeling these emotions. It's the patients too. At least, it's the patients feeling the trepidation. The reason is the longstanding belief in academic medical centers, a belief that has diffused out of them and into "common wisdom," that you really, really don't want to get sick in July. But is there…
I've had the immense good fortune to have trained and ultimately become a physician-scientist during a time when the pace of discovery and the paradigm changes in science have occurred just over the course of my career in medicine and science has been staggering. microRNA, the shift from single gene studies to genomics, the development of targeted therapies, the completion of the Human Genome Project, these are but a few examples. Of course, arguably the Human Genome Project is the granddaddy of all of the huge changes and paradigm shifts that has occurred to revolutionize biomedical research…
Here we go again. I've written a few times before about the controversy over whether cell phones (a.k.a. mobile phones in most of the rest of the world) cause brain cancer, concluding on more than one occasion that the evidence does not support a link. For example, there has not been a large increase in brain cancer or other cancers claimed to be due to cell phone radiation in the 15 to 20 years since the use of cell phones took off back in the 1990s, nor has any study shown a convincing correlation between cell phone use and brain cancer. Of course, one would not expect a priori, based on…
As a followup to my rather "epic post" on dichloroacetate, I thought I'd just post a brief follow up. A reader sent me this video of Evangelos Michelakis, the investigator who has been testing DCA in the clinic and who did the study testing DCA against gliblastoma, describing his results: It's always interesting to hear research results "straigh from the horse's mouth, so to speak."
Late last week, a crank I hadn't heard from in a while showed up in my comments. I'm referring to DaveScot, who normally was known for promoting anti-evolution rhetoric in the service of the pseudoscience known as "intelligent design" creationism. This is what he said: Hi Orac, terrasig suggested you do a followup article on dichloroacetate (DCA) given the paper just published on the phase 1 trial in Edmonton. Three years have passed and countless cancer patients were denied this drug. Now at the end of its first phase one trial we know exactly what we did from the reports of people self-…
The following is a rather curious promotional video that was shown at the plenary sessions of the AACR 2010 meeting. I first saw it yesterday, and thought my readers might be interested in it while I'm winding my way home: It's basically a compendium of various facts about cancer and cancer research with a rather obnoxious techno soundtrack to make it "hip" in the way that middle-aged white guys think is "hip." (Believe it or not, the AACR actually played this loud enough to feel the bass.) Annoying music aside, though, the graphics in the video compellingly boil down a large amount of…
Eat your fruits and vegetables. Hasn't that been a constant refrain over the years from public health authorities? Certainly, I have. The benefits of eating fruits and vegetables have been widely touted, and seemingly with good reason. A diet high in fruits and vegetables, it is said, reduces the risk of cardiovascular disease and cancer. In the case of the latter, it as claimed that potential decreases in the risks of some cancers could be as high as 50% a day. As a result, the National Cancer Institute developed the 5-A-Day program, whose goal was to increase people's consumption of fruits…
One advantage of blogging is that I can sometimes tap into the knowledge of my readers to help me out. Some of you may recall a little something I created a couple of years ago known as the Academic Woo Aggregator. Basically, it was a list of medical schools and academic medical centers in the U.S. and Canada with departments or divisions of "integrative medicine" that promote what has been termed "quackademic medicine." Unfortunately, I've been very remiss in updating it. The last update was in May 2008. I think it's long past due for an update. I haven't decided whether I will post such an…
Just a quick post on an article that caught my eye: Jazz Pharmaceuticals of Palo Alto, CA, has announced that the US FDA has accepted their new drug application (NDA) filing for JZP-6, or sodium oxybate, for the treatment of pain and fatigue associated with fibromyalgia. The NDA was based on positive outcomes of two, Phase III clinical trials - those randomized, placebo-controlled double-blind trials that serve as the gold standard for drug efficacy. The company expects an approval decision from FDA by October 2010. Jazz has already garnered approval for sodium oxybate under the brand name…
I'd like to start this post by thanking a commenter named Paul Grenville. He provided me with this blogging material and, indeed, may have supplied me with material for two blog posts. He did it by showing up in an old post about a homoepath named Jeremy Sherr, who has been bringing woo to the natives, so to speak, by treating HIV/AIDS patients in Africa with homeopathy. Sherr, as you may recall, Sherr had announced his plans to do "clinical trials" using homeopathy for HIV/AIDS and even bragged about treating Tanzanians with quackery. He then tried--shall we say?--to revise history by making…
While the coffee wasn't quite ready this morning, I ventured to the Wall Street Journal health page at the Wall Street Journal, one of my frequent first-reads. I was immediately intrigued by a short article from the excellent Jennifer Corbett Dooren about Roche-Genentech gaining US FDA approval for a new rheumatoid arthritis drug, Actemra. Actemra (tocilizumab) is a monoclonal antibody that works via a novel mechanism of blocking the receptor for interleukin-6, a pro-inflammatory molecule called a cytokine. What is most important is that Actemra appears to work in patients who have not been…
NOTE: Orac is on semi-vacation this week, trying very hard to recharge his Tarial cells. Actually, although he is at home, he is spending much of his time in his Sanctum Sanctorum (i.e., his home office) working on an R01 for the February submission cycle. Given that the week between Christmas and New Years Day tends to be pretty boring, both from a blogging and blog traffic standpoint, he's scaling back the new, original stuff and mixing in some "best of" reruns, as well as some more recent stuff that appeared in a different form elsewhere, modified a bit to be more appropriate to this blog…
Ha! So true, although in academia we aren't so much concerned with getting products into consumers' hands; so the exact times may be different: Via xkcd, of course!
A while back I wrote about really rethinking how we screen for breast cancer using mammography. Basically, the USPSTF, an independent panel of physicians and health experts that makes nonbinding recommendations for the government on various health issues, reevaluated the evidence for routine screening mammography and concluded that for women at normal risk for breast cancer, mammography before age 50 should not be recommended routinely and should be ordered on an individualized basis, and that routine formalized breast self-examination (BSE) should also not be routinely recommended. In…
I'm beginning to understand why evolutionary biologists are so sensitive about how creationists abuse and twist any research that they think can be used to cast doubt upon evolution. Whenever there is research that changes the way we look at evolution or suggest aspects of it that we didn't appreciate before, where scientists get excited because they see an opportunity for better understanding of evolution, creationists see a chance to use it to launch specious and fallacious attacks against evolution. Sadly, there is no shortage of creationists willing to make fools of themselves to try to…
As I discussed in detail when I analyzed them, the new USPSTF recommendations for screening mammography for breast cancer have sparked a debate that has degenerated from a scientific and public policy debate into pure emotional rhetoric. When last I visited this topic, yesterday, I had intended it to be my last post for a while, perhaps ever. However, the amount of idiocy that I was dealing with became so overwhelming and the post grew to even huger than Orac-ian proportions. So I decided to split the post into two parts, because the particular argument I'm about to discuss deserves its very…
"Early detection saves lives." Remember how I started a post a year and a half ago saying just this? I did it because that is the default assumption and has been so for quite a while. It's an eminently reasonable-sounding concept that just makes sense. As I pointed out a year and a half ago, though, the question of the benefits of the early detection of cancer is more complicated than you think. Indeed, I've written several posts since then on the topic of mammography and breast cancer, the most recent of which I posted just last week. As studies have been released and my thinking on…