Clinical trials

Over the last two Mondays, I've been writing about an unproven cancer therapy that I hadn't really heard much about before. The cancer treatment is called Rigvir; it is manufactured in Latvia and marketed primarily through a Latvian entity called the International Virotherapy Center (IVC). To recap, Rigvir is an unmodified Echovirus, specifically ECHO-7, that, according to the IVC, seeks out cancer cells, replicates in them, and thus lyses the cancer cells (causes their membranes to break, spilling out the cancer cells contents, thus killing the cell), hence the term "oncolytic virus."…
It's October again, which is Breast Cancer Awareness Month. As someone who takes care of breast cancer patients, I have a love-hate relationship with October. On the good side, I like seeing positive messages about what's going on in breast cancer research, advocacy, and clinical treatment. On the other hand, the quacks come out. I also see a lot of bad breast cancer studies. You might think that I'd like that too because it provides blog fodder. I could actually do without that, but in this case I happened to come across a "study" that illustrates why I detest how those promoting unproven…
This blog is based in the United States, and I'm an American. Unfortunately, this produces a difficult-to-avoid baked-in bias towards medicine as it is practiced in the US and, to a lesser extent, as it is practiced in the English-speaking world, because English is my language and I can read accounts coming out of English-speaking countries. The same bias exists with respect to pseudo-medicine, with our concentration having been primarily on either quackery that is practiced in the US, UK, Canada, or Australia (and sometimes New Zealand). It's not because I'm not interested in medicine and…
The reason there wasn't a post yesterday is simple. The night before, I was feeling a bit under the weather. As a result, I went to bed early, neglecting my blogly responsibilities. As I result, I missed the release of a whopper of a study that normally would have been all over like...well...choose your metaphor. On the other hand, the one day delay isn't necessarily all bad because it lets me see the reaction of cranks to this study, the better to apply some not-so-Respectful Insolence to it. The crankiest of these cranks, of course, is Mike Adams, a grifter deep in the thrall of any form of…
Regular readers know that, as a cancer surgeon, I become particularly worked up about stories of naturopaths taking care of cancer patients, which all too often end in disaster for the patient. I've lost count of how many naturopaths I've seen, either on their websites, in talks, or in published literature, claiming that they can cure cancer "naturally," using any of a number of unproven methods, an example being the Gerson protocol, a form of quackery involving 13 larges glasses of raw vegetable and fruit juice, around 150 supplements, and five coffee enemas a day, each and every day. Others…
Yesterday I discussed a highly unethical clinical trial of a new herpes vaccine, based on what appears to be questionable science but backed by über-Libertarian Peter Thiel. The reason the trial is so unethical is because Rational Vaccines, the company that developed the herpes vaccine and is conducting the clinical trial, not only arranged to carry it out offshore but, unlike all American companies carrying out clinical trials offshore for purposes of gathering data to support an application for FDA approval, Rational Vaccines apparently carried the trial out without any oversight by an…
I've caught a fair amount of flak over my opposition to so-called "right-to-try" laws. Right-to-try laws have proliferated throughout the US like so much kudzu over the last three and a half years, to the point where 37 states now have some version of these profoundly anti-patient laws on the books. At the federal level, three weeks ago the Senate passed a federal version of right-to-try, with the House scheduled to take up the bill when Congress returns from recess next week. Granted, it's watered down and therefore less horrible than the original version, which Senator Ron Johnson (R-WI_…
Acupuncture is nothing more than a theatrical placebo. I wish I could take credit for the term "theatrical placebo" to describe acupuncture, just as I wish I could take credit for coining the term "quackademic medicine" to describe the unfortunately increasing infiltration of quackery into academic medical centers and medical schools and as I wish I could take credit for the term "Tooth Fairy science" to describe doing scientific studies on a phenomenon that has not been proven to exist, but alas I cannot. I can, however, use the terms as I see fit, even if it might annoy some believers in…
Alternative medicine, by definition, consists of medicine that either has not been shown to work or has been shown not to work. To paraphrase an old adage yet again, medicine that has been shown to work with an acceptable risk-benefit ceases to be "alternative" and becomes simply "medicine." Unlike the case for many conditions commonly treated with alternative medicine, whether or not a treatment works against cancer is determined by its impact on the hardest of "hard" endpoints: Survival. A patient either survives his cancer or he does not. Even the "softer" endpoints used to assess the…
Here we go again. Antivaxers don't like vaccines. This, we know. They blame them for everything from autism to autoimmune diseases to diabetes to sudden infant death syndrome. They even sometimes claim that shaken baby syndrome is a "misdiagnosis" for vaccine injury. However, there are two vaccines that stand out above all as the objects of antivaccine scorn. the first, of course, is the MMR vaccine. That's on Andrew Wakefield., of course, who almost singlehandedly popularized the fear that the MMR vaccine causes autism. The second most hated vaccine (by antivaxers) is Gardasil or Cervarix,…
The moment I have feared ever since Republicans took control of all three branches of Congress last fall has come one step closer to reality. Actually, it's merely one of many. occurrences that I have feared, given that Donald Trump has been our President for over six months. Although you won't find much in the news about it, yesterday the Senate easily passed a federal version of so-called "right-to-try." Senator Ron Johnson, who threatened to hold up Senate business unless a right-to-try rider was approved for the bill funding the FDA for the next seven years, was ecstatic: I’m proud the…
I've written quite a few times about stem cell quackery. Although I had taken an interest in dubious stem cell treatments before, because I live in the Detroit area, the stories from a couple of years ago about hockey great Gordie Howe's stem cell treatment for his stroke, how it was credulously reported in the media, and how expressing the slightest degree of skepticism about "miracle cure" testimonials like Howe's is not appreciated by the media or patient families because it's interpreted incorrectly as attacking the patient or the family. Basically, people want to believe and don't like…
One of the most persistent narratives latched on to by advocates of "integrative medicine" is that the "mind" can somehow "heal" the body. Sometimes, the claim is that such interventions work through "powerful placebo" effects. Sometimes it involves the abuse of emerging science, such overblown claims about what can be accomplished through epigenetic modifications of DNA and gene expression. While my wife and I were away on vacation last month, there was another example of this claim popping up in the media under headlines like these: Mindfulness and meditation dampen down inflammation genes…
In pseudomedicine, fake diseases predominate. Basically, fake diseases are diseases that do not exist in conventional medicine as diagnostic entities because there does not exist sufficient sufficient evidence to support them as one or there exists compelling evidence that they are not. Naturopaths, for instance, like to diagnose people with "adrenal fatigue," which is one of the prototypical "fake diseases." Basically, it involves a constellation of vague symptoms that may include a combination of several of the following: fatigue, inability to handle stress, cravings for salty foods,…
If there's one form of quackery that is among the most "respected," it has to be acupuncture. I've often speculated about why this might be, and the best that I can come up with is that doctors are a bit more open to acupuncture because it involves sticking actual needles into the body. It's very easy to ignore the mystical, vitalistic BS about "redirecting the flow of qi" because doctors can easily handwave and postulate other, more scientific-sounding explanations, such as that it releases endorphins or adenosine. If that doesn't work, then acupuncturists add electricity and thereby rebrand…
Surprisingly, I made it through an entire three day weekend without posting anything to the blog. Believe it or not, this is a good thing. It means that I actually worked on my grant that's due at the end of the week. Still, a blogger's gotta blog; so I can't just shut down until the end of the week. So, hwere we go. I've long lamented the creeping infiltration of quackery into medical academia in which modalities once considered quackery, such as acupuncture, reiki, naturopathy, homeopathy, and various other dubious treatments, have found their way into what should be bastions of science-…
When I first started to take an interest in medical marijuana, I was struck by how much it reminded me of herbalism. Although herbalism is scientifically the most plausible of modalities commonly associated with "complementary and alternative medicine" (CAM), the use of herbal medicines still involve a number of problems, the biggest of which is what I like to call either the delivery problem or the bioavailability problem. In brief, herbs, when they work, are adulterated drugs. The active ingredient is often a relatively small, embedded in thousands of other constituents that make up herbs,…
As much as I like to deconstruct pseudoscientific claims, particularly about health, medicine, and health care, Sometimes it gets a bit draining. There's just so much pseudoscience, so much credulity, so much sheer idiocy out there that trying to refute them and encourage a more skeptical mindset often feels like pissing into the ocean, for all the effect it has. In the age of fake news and Donald Trump, it even feels as though we're going backward—and not slowly, either. That's why I felt it was time for a bit of a break, a bit more optimism than I've been able to muster before. So it was a…
It looks as though the check has finally cleared. You might be wondering what I'm referring to. A little more than a week ago, I took note of how a truly awful survey masquerading as a "study" had risen from the dead once again as two publications in a notorious bottom-feeding predatory "open access" journal after having been retracted after publication in a somewhat less notorious but similarly bottom-feeding predatory "open access" journal. Whether or not these studies were actually retracted the second time around is somewhat unclear. What is known is that they were on the Open Access Text…
Of all the modalities of alternative medicine currently in use, arguably acupuncture is the one that has achieved the most mainstream acceptance in medicine. I've often asked why it has become so common in academic medical centers and elsewhere, despite the evidence being overwhelmingly in favor of the conclusion that it is nothing more than a theatrical placebo. It doesn't matter that acupuncture is part of a prescientific system of medicine now known as traditional Chinese medicine (TCM), whose concepts are rooted in vitalism. It doesn't matter that what has passed for acupuncture since the…