Posts Tagged clinical research

Acupuncture/TCPM Crapfest

Acupuncture needling

Look Ma! No gloves!

As I get older I get more grumpy. Issues that at one time I was rather sanguine about, now irritate the hell out of me. It is not like it was when I started practice. Information was hard to come by. Going through the Index Medicus, with the world’s tiniest font, wandering the stacks looking for papers, sending off for reprints, getting a precious Xerox (or even a mimeograph) of a classic paper from an attending.

You understood the value of eminence-based medicine, as it took a career to acquire and master the literature. You relied on the wisdom of old geezers like me who had decades of experience and reading.

That was then. Now? The world’s information is available almost instantaneously. You may not be able to master a new topic spending a day on Google and Pubmed, but you can acquire a reasonable understanding, especially of you have some background.

Because of Google and Pubmed, the only reasons for ignorance of your area of expertise in medicine are time, laziness, or stupidity. As a specialist, only time is an excuse. It is my job to keep up with infectious diseases, although with over 10,000 articles a year in ID, it is impossible to read everything. But if I have a question concerning patient care, I need to look it up. I have another blog whose raison d’être is looking up answers to the daily questions that arise in practice.

On the characteristics of a useful clinical trial

So the characteristics of a useful clinical trial are not hard to determine: Randomized, double blind, placebo controlled, adequately powered. Because you want to avoid spending time and money on a study only to end up with no useful conclusions. This is especially important with acupuncture where it not does matter what kind of acupuncture is used, if needles are used, where the needles are placed or even if you mime acupuncture or perform acupuncture on a rubber hand. The key features for success in acupuncture are belief that the patient is receiving acupuncture and that the patient believes the acupuncture will be effective. And the stronger the belief, the better the subjective response. (more…)

Posted in: Acupuncture, Clinical Trials, Traditional Chinese Medicine

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Stem cell clinics and unapproved, for-profit human experimentation

Editor’s note: I met Dr. Paul Knoepfler online in the wake of my two posts on Gordie Howe and his stem cell treatment for stroke. I was impressed by his posts on the topic and what I saw at his own blog. Given that he’s a stem cell researcher, I wanted him to write a post on stem cell clinics like the one that treated Gordie Howe, and, I’m happy to say, he accepted my invitation and agreed to write this post. I hope to persuade him to write more for us in the future, even though he has his own blog.

When I started blogging in 2010 the stem cell arena was a very different place.

Back then the hot topic was the battle over the legality of federal funding of embryonic stem cell research. That battle is over, or at least in hibernation, with a 2013 federal court ruling allowing such funding to continue. The stem cell debate of today, which in its own way is just as fierce as the old one, is focused on how best to regulate the clinical translation and commercialization of innovative stem cell technologies.

The stakes in this new stem cell battle on the regulatory front are very high both for the stem cell field and for patients. Too little regulation could lead to harm to patients and damage to the stem cell field at a crucial juncture in its history, while too much regulation could stifle stem cell and regenerative medicine innovations.

Stem cell clinics should be better-regulated than a Starbucks

Stem cell clinics should be better-regulated than a Starbucks

The goal of stem cell advocates, including myself, is to find a regulatory sweet spot where science-based, innovative stem cell medicine can advance expeditiously. On the other side we have largely physicians and lawyers along with some patients arguing for drastically-reduced regulation and acceleration of for-profit stem cell interventions to patients, even without concrete data supporting safety or efficacy.

The latter group is a key part of a rapidly-proliferating stem cell clinic industry in the US. It consists of for-profit stem cell clinics that collectively have already conducted stem cell transplants on potentially thousands of patients without federal regulatory approval. These clinics have in effect thrown down the gauntlet to the US Food and Drug Administration (FDA) with their use of non-FDA approved stem cell products on patients. (more…)

Posted in: Legal, Medical Ethics, Politics and Regulation, Science and the Media

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The problem with preclinical research? Or: A former pharma exec discovers the nature of science

If there’s one thing about quacks, it’s that they are profoundly hostile to science. Actually, they have a seriously mixed up view of science in that they hate it because it doesn’t support what they believe. Yet at the same time they very much crave the imprimatur that science provides. When science tells them they are wrong, they therefore often try to attack the scientific method itself or claim that they are the true scientists. We see this behavior not just in quackery but any time scientific findings collide with entrenched belief systems, for example, medicine, evolution, anthropogenic global warming, and many others. So it was not surprising that a rant I saw a few weeks ago by a well-known supporter of pseudoscience who blogs under the pseudonym of Vox Day caught my interest. Basically, he saw a news report about an article in Nature condemning the quality of current preclinical research. From it, he draws exactly the wrong conclusions about what this article means for medical science:

Fascinating. That’s an 88.6 percent unreliability rate for landmark, gold-standard science. Imagine how bad it is in the stuff that is only peer-reviewed and isn’t even theoretically replicable, like evolutionary biology. Keep that figure in mind the next time some secularist is claiming that we should structure society around scientific technocracy; they are arguing for the foundation of society upon something that has a reliability rate of 11 percent.

Now, I’ve noted previously that atheists often attempt to compare ideal science with real theology and noted that in a fair comparison, ideal theology trumps ideal science. But as we gather more evidence about the true reliability of science, it is becoming increasingly obvious that real theology also trumps real science. The selling point of science is supposed to be its replicability… so what is the value of science that cannot be repeated?

No, a problem with science as it is carried out by scientists in the real world doesn’t mean that religion is true or that a crank like Vox is somehow the “real” intellectual defender of science. Later, Vox doubles down on his misunderstanding by trying to argue that the problem in this article means that science is not, in fact, “self-correcting.” This is, of course, nonsense in that the very article Vox is touting is an example of science trying to correct itself. Be that at it may, none of this is surprising, given that Vox has demonstrated considerable crank magnetism, being antivaccine, anti-evolution, an anthropogenic global warming denialist, and just in general anti-science, but he’s not alone. Quackery supporters of all stripes are jumping on the bandwagon to imply that this study somehow “proves” that the scientific basis of medicine is invalid. A writer at Mike Adams’ wretched hive of scum and quackery,, crows:

Begley says he cannot publish the names of the studies whose findings are false. But since it is now apparent that the vast majority of them are invalid, it only follows that the vast majority of modern approaches to cancer treatment are also invalid.

But does this study show this? I must admit that it was a topic of conversation at the recent AACR meeting, given that the article was published shortly before the meeting. It’s also been a topic of e-mail conversations and debates at my very own institution. But do the findings reported in this article mean that the scientific basis of cancer treatment is so off-base that quackery of the sort championed by Mike Adams is a viable alternative or that science-based medicine is irrevocably broken?

Not so fast there, pardner…

Posted in: Basic Science, Cancer, Clinical Trials

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The final nail in the mercury-autism hypothesis?


Two and a half years ago, very early in the history of this blog, I wrote one of my usual logorrheic (although I prefer the word “comprehensive”) posts entitled Mercury in vaccines as a cause of autism and autism spectrum disorders (ASDs): A failed hypothesis. In that post, I characterized the scientifically discredited notion that the mercury in the thimerosal preservative that used to be in several childhood vaccines was the cause of the “autism epidemic” as “one of the most pernicious medical myths of recent years.” And so it is. I like to characterize the notion that thimerosal-containing vaccines (TCVs) cause autism as the American version of the British myth, popularized by Andrew Wakefield and a sensationalistic British press, that the measles-mumps-rubella (MMR) vaccine causes autism and “autistic enterocolitis.”

Both notions were based on confusing correlation with causation, aided and abetted by some truly bad science, and both notions have been painfully difficult to dislodge. Indeed, in the case of Wakefield, only now that Wakefield was stripped of his license to practice in the U.K. by its General Medical Council, leading to The Lancet finally doing what it should have done six years ago and retracting Wakefield’s 1998 study that sparked the MMR frenzy in the U.K. and arguably kickstarted the modern anti-vaccine movement, do I sense that journalists are finally “getting” that science does not support the idea that the MMR vaccine causes autism. Andrew Wakefield may be trying to fight back with his book Callous Disregard after his disgrace was complete, basking in the glow of admiration of die-hard anti-vaccine groups, but, for now, at least, Wakefield and his MMR fear mongering are yesterday’s news, and that’s a very good thing indeed–at least for as long as it lasts.

Perhaps it is the fall of Andy Wakefield that has led to an apparent resurgence of the concept that mercury in TCVs somehow causes autism, after having faded into the background after the CDC and AAP recommended that thimerosal be removed from all childhood vaccines in 1999 and the last TCV having expired towards the end of 2001. After all, if the hypothesis that TCVs cause autism had been correct, we should have expected to see a marked decrease in the incidence of autism and autism spectrum disorders (ASDs) within about 5 years of 2002, given that the vast majority of cases of ASDs are diagnosed between the ages of 2 and 5. We have not, and, even though its adherents have kept moving the goalposts back regarding the date that we should start to see a leveling off and drop in the incidence of ASDs, starting with 2005, then 2007, and now, apparently, 2011 (which is only less than four months away, by the way), even Jenny McCarthy’s anti-vaccine organization originally founded by J.B. Handley and his wife, namely Generation Rescue, began demphasizing mercury in 2007, after having stated flatly on its website that autism is a “misdiagnosis for mercury poisoning” for so long. Since then, “too many, too soon” has been the favored propaganda talking point.

Of course, not every crank is ready to abandon the myth that TCVs cause autism. Indeed, tomorrow two mercury militia “heavy hitters” and bloggers for the anti-vaccine propaganda blog Age of Autism, Mark Blaxill and Dan Olmsted, will be releasing a book entitled Age of Autism: Mercury, Medicine, and a Manmade Epidemic. In anticipation, four weeks ago I actually e-mailed the publicist to send me a review copy of Age of Autism. I have yet to receive the book. I wonder why. Be that as it may, it amuses me that the official release of the release of the not-so-dynamic duo of the mercury militia’s book actually will one day after a study that is arguably the last nail in the coffin of the very dead hypothesis that TCVs cause autism was released. Either the great pharma conspiracy is far more conniving and effective than even J.B. Handley thinks, or Blaxill and Olmsted’s luck is just that bad. As I anticipate the conspiracy mongering posts about this bad timing aside, let’s just take a look at this last coffin nail, which is a study by Price et al that was released today in the journal Pediatrics entitled Prenatal and Infant Exposure to Thimerosal From Vaccines and Immunoglobulins and Risk of Autism.

Posted in: Neuroscience/Mental Health, Vaccines

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