Posts Tagged clinical trial

The Worst Homeopathy Study. Ever

A rare double-face palm, so you can't see the tears

A rare double-face palm, so you can’t see the tears

I run across a lot of information in my feeds that I need to save for further evaluation. The study “Does additional antimicrobial treatment have a better effect on URTI cough resolution than homeopathic symptomatic therapy alone? A real-life preliminary observational study in a pediatric population“, I saved with the file name, ‘jaw droppingly stupid’.

The worst homeopathy clinical trial ever doesn’t spring full formed like Athena from the head of Zeus. No. The worst homeopathy clinical trial ever started with a seed. The seed is “Homeopathic medicine for acute cough in upper respiratory tract infections and acute bronchitis: A randomized, double-blind, placebo-controlled trial, which is a standard lousy homeopathic study. (more…)

Posted in: Clinical Trials, Ethics, Homeopathy

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Stem cells versus Gordie Howe’s stroke, part 3

Gordie Howe in his Red Wings days.

Gordie Howe in his Red Wings days.

Here I am in Philadelphia attending the 2015 American Association for Cancer Research (AACR) meeting to imbibe the latest basic and translational science about oncology. So what am I doing in my non-conference time? I’m holed up in my hotel room near Rittenhouse Square writing a DoD Grant and this post. Fortunately, I am nearly done with the grant, with nothing I can do until I receive one last letter of support from a person who, as much as he’s my bud, is incredibly annoying and always makes me sit on pins and needles waiting for his letter of support. (Those of you who’ve applied for a lot of grants know what I mean.) Then tomorrow I will have to assemble the PDF package to get to my grants office two days before the deadline, which is pushing it to make sure they get it uploaded to in time. Fun times.

With the Stanley Cup playoffs just getting underway (complete with the ugly faux “Stanley Cup” made out of garbage cans our next door neighbor’s son puts on his lawn every year, bathed in red light for the Red Wings), it’s also the perfect time to revisit a story I’ve written about a couple of times before right here on this very blog. I’m referring (this time) to the story of hockey legend Gordie Howe and news stories of his “miraculous” recovery from a serious stroke suffered back in October due to treatment at a stem cell clinic in Tijuana back in December. Of course, when I looked into it, there were a lot of holes in the story and clearly a lot of hype on the part of several parties: Howe’s son Murray Howe, whose love for his father apparently blinded him to some rather obvious issues with the care that his father was receiving and whether it was responsible for his recovery; Stemedica, the American stem cell company based in San Diego that sells its stem cells to a dubious Mexican stem cell company, Novastem, for use outside its U.S. clinical trials; and, of course, the credulous sports media, led by that most credulous of the credulous (with respect to Gordie Howe), Keith Olbermann, who was none too pleased with a certain not-so-pseudonymous “friend” of SBM and completely embarrassed himself in the process of attacking anyone who questioned whether stem cells caused Howe’s recovery. The whole story did have one salutary effect, though. It introduced me to a real stem cell scientist, Paul Knoepfler, who did a guest post for us.

It’s been a couple of months since I last paid attention to what was going on with Gordie Howe’s recovery. Fortunately, our very own Scott Gavura tweaked me by sending me a story by Avis Favaro and Elizabeth St. Philip that appeared over the weekend in the Toronto Star, entitled “A closer look at the startling recovery of Gordie Howe.” Accompanying the story is a broadcast on CTV’s W5 entitled “Gordie’s Comeback”. (See part 1, part 2, part 3.) Also accompanying all of this is a press release discussing how a Canadian stem cell researcher visited Novastem and left unimpressed.

Posted in: Clinical Trials, Neuroscience/Mental Health, Science and the Media

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Stem cells versus Gordie Howe’s stroke, part 2


Another Christmas has come and gone, surprisingly fast, as always. I had thought that it might make a good “last of 2014″ post—well, last of 2014 for me, anyway; Harriet and Steve, at least, will be posting before 2014 ends—to do an end of year list of the best and worst of the year. Unfortunately, there remains a pressing issue that doesn’t permit that, some unfinished business, if you will. I’m referring to a story I commented on last week, specifically the credulously-reported story of how 86-year-old hockey legend Gordie Howe is doing a lot better after having undergone an experimental stem cell therapy for his recent stroke. As you might recall at the time, I saw a lot of holes in the story. It turns out that over the last week there have been developments that allow me to fill in some of those holes. Unfortunately, other holes still remain.

First, a brief recap is in order (You can click here for a more detailed timeline). Gordie Howe suffered a massive stroke on October 26, leaving him hemiplegic and with serious speech impairment. Since then, judging from various media reports, he has been slowly improving, although not without significant setbacks. We also know that Howe suffers from significant dementia. Out of the blue, a press release issued on December 19 by the Howe family announced that on December 8 and 9, Gordie Howe “underwent a two-day, non-surgical treatment at Novastem’s medical facility. The treatment included neural stem cells injected into the spinal canal on Day 1 and mesenchymal stem cells by intravenous infusion on Day 2.” His response was described as “truly miraculous,” although, as I pointed out in my post, it’s not clear exactly what “miraculous” meant, given conflicting contemporaneous news accounts before the Howe family press release, particularly his hospitalization from December 1 to 3 for a suspected stroke that turned out to be dehydration.

I noted a number of problems with the story, the first of which is that Howe was clearly not eligible for the clinical trial offered by Stemedica, a company in San Diego that manufactured the stem cells used. Another glaring issue was my inability to locate any description of an actual clinical trial for stroke offered by Novastem. I could find no such trial listed in, and you, our intrepid readers, searched the registry maintained by the Mexican Federal Commission for the Protection Against Sanitary Risk (COFEPRIS) and were not able to find any registered clinical trials for stroke being carried out by Clínica Santa Clarita, the clinic Novastem operates. What you, our intrepid readers, did find were trials of stem cells for:

I did the search again over the weekend, and there were no further trials that I could find.

Posted in: Clinical Trials, Medical Ethics, Science and the Media

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Stem cells versus Gordie Howe’s stroke


Note: There is now a major update to this story published here, which explains a lot of the questions remaining in this blog post.

Seven years ago I returned to Michigan, where I was born and spent the first quarter century of my life, after an absence of more than 20 years. In the interim, I had done my surgical residency and earned my PhD in Cleveland, a surgical oncology fellowship in Chicago, and worked in New Jersey at my first academic job for eight and a half years. Then I was lured back with a job in Detroit. One of the odd things about this return after such a long absence was the culture shock, how much I had forgotten about the Detroit area. One of those things that I had forgotten is just how crazy about hockey Michigan, in particular Detroit (meaning the Detroit metropolitan area), is. Detroiters love their Red Wings—love them. Hockey is ingrained in the suburban culture from a very young age, so much so that many Canadians would feel right at home here. Memories of trying and failing to be halfway decent at street hockey and of not being anywhere good enough a skater even to try real hockey as a teen came flooding back to me. (It didn’t help that back then I was approaching six feet tall and weighed only 135 lbs.; “beanpole” didn’t even begin to describe me back then.) In fact, the “cultural center” of the town where I live consists of—I kid you not—a hockey rink and some classrooms that are used for various community functions. No, really, it’s named the city’s Cultural Center.

So it should be no surprise, given how much Detroiters love hockey in general and their Red Wings in particular that it was big news here in late October when Red Wing legend Gordie Howe at age 86 suffered a debilitating stroke that paralyzed the right side of his body, a condition known as hemiplegia. Understandably, there was an outpouring of good wishes for recovery, coupled with retrospectives of Howe’s stellar hockey career. Indeed, I remember that Howe’s condition sounded bad enough from the tenor of the news reports at the time that it seemed likely that he would not survive. But survive he did, and is apparently recovering slowly, with occasional setbacks, such as a recent hospitalization in early December for a suspected “mini-stroke” that turned out to be dehydration and several much smaller strokes before that. The most recent press report I saw before the announcements I’m going to discuss described Howe as on the upswing again.

Then, on Friday, I saw headlines all over the place that were basically similar to this Detroit Free Press headline, “Gordie Howe underwent stem cell clinical trial in Mexico.” The story consisted largely of a press release from Howe’s family that read:

Posted in: Clinical Trials, Medical Ethics, Pharmaceuticals, Science and the Media

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The deceptive rebranding of aspects of science-based medicine as “alternative” by naturopaths continues apace

That naturopathy is a veritable cornucopia of quackery mixed with the odd sensible, science-based suggestion here and there is not in doubt, at least not to supporters of science-based medicine (SBM). However, what naturopaths are very good at doing is representing their pseudoscience as somehow being scientific and thus on par with conventional SBM. So how do they accomplish this? Certainly, it’s not through the validation of any of the cornucopia of pseudoscience and quackery that naturopaths apply to their patients as though picking “one from column A and one from column B” from a proverbial Chinese menu of woo. Naturopaths’ favored modalities include homeopathy (which remains to this day an integral part of naturopathy that all naturopaths are taught), acupuncture and traditional Chinese medicine (TCM), “detoxification” practices (a key precept of a lot of naturopathy) such as juicing, enemas, and chelation therapy, and the various other quack modalities that make up the practice of naturopathy. Treatments like these (especially homeopathy, whose precepts would require a massive rewriting of the laws of physics and chemistry for it to work) have not been and almost certainly cannot ever be scientifically validated with an evidence base of the quality and quantity supporting SBM.

So, instead naturopaths play a very clever game. In all fairness, naturopaths are not the only practitioners of so-called “complementary and alternative medicine” (CAM) or “integrative medicine” who play this game, but from my observations they appear to be the most talented at it. Their skill at obfuscating the line between SBM and naturopathy is evidenced by the success they have had in state legislatures in expanding their scope of practice, most recently in Colorado, where, if there is not a groundswell of support urging the Governor to veto SB-215 (or, as Jann Bellamy aptly called it, the quack full employment act), consumer protections against quackery in Colorado will be laid waste. At the same time, there is a naturopath licensing act (HB-1111) sitting on the Governor’s desk as well that would license naturopaths and give them the path to mandatory reimbursement from insurance companies. Instructions to write to the Governor opposing both bills can be found here and here; they would be disastrous for efforts to keep full vaccination in Colorado. A direct link to write the Governor can be found here.

Posted in: Clinical Trials, Homeopathy, Naturopathy, Nutrition, Science and the Media

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The Great and Powerful Oz versus science and research ethics

That Dr. Mehmet Oz uses his show to promote quackery of the vilest sort is no longer in any doubt. I was reminded yet again of this last week when I caught a rerun of one of his shows from earlier this season, when he gazed in wonder at the tired old cold reading schtick used by all “psychic mediums” from time immemorial, long before the current crop of celebrity psychic mediums, such as John Edward, Sylvia Browne, and the “Long Island Medium” Theresa Caputo, discovered how much fame and fortune they could accrue by scamming the current generation of the credulous. Speaking of Theresa Caputo, that’s exactly who was on The Dr. Oz Show last week (in reruns), and, instead of being presented as the scammer that she is, never was heard even a hint of a skeptical word from our erstwhile “America’s doctor,” who cheerily suggested that seeing a psychic medium scammer is a perfectly fine way to treat crippling anxiety because, well, Caputo claims that it is. Even worse, apparently it wasn’t even the first time that Dr. Oz had Caputo on his show, and Caputo wasn’t even the first psychic whose schtick he represented as somehow being a useful therapeutic modality for various psychological issues. “Crossing Over” psychic John Edward was there first in a segment Oz entitled Are Psychics the New Therapists? I could have saved him the embarrassment and simply told him no, but apparently Oz is too easily impressed. As I said before, if he’s impressed by clumsy cold readers like Browne, Caputo, and Edward, it doesn’t take much to impress him. Also, apparently his producers aren’t above editing science-based voices beyond recognition to support their quackery.

I was further reminded how Dr. Oz promotes quackery by an article in Slate yesterday entitled Dr. Oz’s Miraculous Medical Advice: Pay no attention to that man behind the curtain. I suppose it would be mildly hypocritical of me to snark at the rather obvious “Wizard of Oz” jokes aimed at Dr. Oz. After all, I’ve used the same joke myself at one time or another and, in light of the article, couldn’t resist using it in the title of my post. However, I wasn’t about to let that distract me from the article itself, which is very good. The reason is that there are two aspects to Dr. Oz’s offenses against medical science. There is the pure quackery that he features and promotes, such as psychic scammers like John Edward and Theresa Caputo, faith healing scammers like Dr. Issam Nemeh, and “alternative health” scammers like reiki masters, practitioners of ayruveda, Dr. Joe Mercola, who was promoted as a “pioneer” that your doctor doesn’t want you to know about. Never was it mentioned that there are very good reasons why a competent science-based physician would prefer that his patients have nothing to do with Dr. Mercola, who runs what is arguably the most popular and lucrative alternative medicine website currently in existence and manages to present himself as reasonable simply because he is not as utterly loony as his main competition, Mike Adams if (who has of late let his New World Order, anti-government, “Obama’s coming to take away your guns” conspiracy theory freak flag fly) and Gary Null.

Posted in: Clinical Trials, Science and the Media

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The result of the Trial to Assess Chelation Therapy (TACT): As underwhelming as expected

Chelation therapy.

It’s one of the most common quackeries out there, used by a wide variety of practitioners for a wide variety of ailments blamed on “heavy metal toxicity.” Chelation therapy, which involves using chemicals that can bind to the metal ions and allow them to be excreted by the kidneys, is actually standard therapy for certain types of acute heavy metal poisoning, such as iron overload due to transfusion, aluminum overload due to hemodialysis, copper toxicity due to Wilson’s disease, acute heavy metal toxicity, and a handful of other indications.

My personal interest in chelation therapy developed out of its use by unscrupulous practitioners who blamed autism on the mercury-containing thimerosal preservative that used to be in many childhood vaccines until 2001 but has since all but disappeared from such vaccines except for one vaccine (the flu vaccine, for which a thimerosal-free alternative is available) and in trace amounts in some other vaccines. Mercury became a convenient bogeyman to add to the list of “toxins” antivaccinationists hype in vaccines. In fact, my very first post after I introduced myself on this very blog discussed the idea that mercury in vaccines was a significant cause of autism and autism spectrum disorders, and I’ve periodically written about such things ever since, in particular the bad science of Mark and David Geier, whose idea that chemical castration of children with Lupron “works” against “mercury-induced” autism is based on a chemically ridiculous idea that somehow testosterone binds mercury and makes it harder to chelate. Unfortunately, this particular autism quackery has real consequences and has been responsible for the death of a child.

Chelation isn’t just for autism, however. Despite many practitioners advertising it for autism, cancer (often with dubious studies that I might have to take a look at), Alzheimer’s disease (which Hugh Fudenberg has blamed on the flu vaccine, a claim parroted by Bill Maher, of course!), and just about every ailment under the sun, it’s easy to forget that the original use for chelation therapy promoted by “alternative medicine” practitioners was for cardiovascular disease. When it is used for coronary artery disease or autism, on a strictly stoichiometric and pharmacological basis, it is extremely implausible. Moreover, it is not without potential complications, including renal damage and cardiac arrhythmias due to sudden drops in calcium levels. Such arrhythmias can and have led to death in children, and in adults complications such as renal failure and death.

Posted in: Clinical Trials

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