Articles

Archive for Clinical Trials

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 Grants.gov 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.
(more…)

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

Leave a Comment (22) →

Anesthesia-Assisted Rapid Opioid Detox

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor's Office of Drug Control Policy.

Legitimately prescribed drugs can be stolen from a medicine cabinet a few at a time, usually without notice. From the Iowa Governor’s Office of Drug Control Policy.

Opioids are widely available as prescription drugs for pain: hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), and codeine. Heroin, which has no medically approved use, is also an opioid. Unfortunately, opioids are also widely abused.

How enticing it is to imagine a magic bullet for opioid drug addiction. Addiction causes huge social problems. Yet it is hard to treat and suffers from a stigma that does not attach to other chronic diseases, like diabetes. Drugs like naltrexone, methadone and buprenorphine, as well as behavioral therapies, are common opioid addiction treatments, although the relapse rate for addiction treatment is high.

One of the barriers to treatment is the addict’s fear of the side effects of withdrawal, which can be extremely uncomfortable, including nausea, cramping and vomiting. It is no wonder, then, that the opioid addict and his family would be drawn to a detoxification procedure advertised as both rapid, to speed up the initiation of relapse-prevention therapy, and relatively painless: anesthesia-assisted rapid opioid detox (AAROD), sometimes called ultra-rapid detox, or even just plain rapid detox, although the latter also refers to detox under lighter sedation.

(more…)

Posted in: Clinical Trials, Legal, Pharmaceuticals, Politics and Regulation

Leave a Comment (82) →

Integrative medicine, naturopathy, and David Katz’s “more fluid concept of evidence”

The Integrative Medicine Wheel

The Integrative Medicine Wheel

Dr. David Katz is undoubtedly a heavy hitter in the brave new world of “integrative medicine,” a specialty that seeks to “integrate” pseudoscience with science, nonsense, with sense, and quackery with real medicine. In fairness, that’s not the way physicians like Dr. Katz see it. Rather, they see it as “integrating” the “best of both worlds” to the benefit of patients. However, as we’ve documented extensively here, on our personal blogs, and even in the biomedical literature (plug, plug), what “integrative” medicine means in practice is indeed what I characterized, the infiltration of woo into medicine. This infiltration seems to have started mainly in academia—hence the term “quackademic medicine” and “quackademia”—with the steady infiltration of nonsense into medical schools and academic medical centers, but has since metastasized to the world of community hospitals. This “integration” (or, as I like to refer to it, “infiltration”) has become so pronounced that a few years ago The Atlantic published an article entitled “The Triumph of New Age Medicine“, and just last December the Journal of the National Cancer Institute (JNCI) published a monograph full of articles touting “integrative oncology,” including guidelines recommended by the Society of Integrative Oncology (SIO) for the “integrative” treatment of breast cancer symptoms.

I mention Dr. Katz for two reasons. First, he’s taken another broadside at us at Science-Based Medicine in blog entry at The Huffington Postwhere else?—entitled “Holism, Holes and Poles” that I’ve been meaning to address for a while. But before I address Dr. Katz’s most recent complaint against science-based medicine (SBM), it’s necessary to step back and look at some history.
(more…)

Posted in: Clinical Trials, Homeopathy, Medical Academia, Naturopathy

Leave a Comment (170) →

How should the FDA regulate homeopathic remedies?

Hyland's "4 Kids Complete Allergy" homeopathic preparation (not for use with food allergies)

Hyland’s “4 Kids Complete Allergy” homeopathic preparation (not for use with food allergies), one of many unregulated, unproven over-the-counter preparations sold in the United States

The FDA announced recently that it is holding a public hearing on April 21 and 22,

to obtain information and comments from stakeholders about the current use of human drug and biological products labeled as homeopathic, as well as the Agency’s regulatory framework for such products. These products include prescription drugs and biological products labeled as homeopathic and over-the-counter (OTC) drugs labeled as homeopathic. FDA is seeking participants for the public hearing and written comments from all interested parties, including, but not limited to, consumers, patients, caregivers, health care professionals, patient groups, and industry.

It’s about time. We know that homeopathic remedies are not, and cannot be, effective. I will not plough that ground again here. Unfortunately, the FDA does not have any authority to bar these fraudulent products from sale altogether. Only Congress can do that.

In this post, I review the current regulatory framework for homeopathic products. I then explore the possibilities, given the opportunities for regulatory change presented by the FDA at this time. In doing so, I answer some of the questions posed by the FDA in its formal notice of the hearing, printed in the Federal Register.

I argue that the FDA has no statutory authority for the manner in which it currently regulates (or, actually, doesn’t regulate) homeopathic drugs. I further argue this system, largely controlled by the homeopathic industry, must be abandoned, and that there is no reason why homeopathic drugs should not be regulated just like any other OTC or prescription drug.

(Note to those wanting to submit written comments or attend the hearing: there are deadlines and other requirements for participation. You can read those in the Federal Register.)
(more…)

Posted in: Clinical Trials, Homeopathy, Legal, Politics and Regulation

Leave a Comment (123) →

Clinical trials of homeopathy versus “respect for science”

Trojan Rabbit

A few months ago, Steve Novella and I published an article in Trends in Molecular Medicine entitled “Clinical trials of integrative medicine: testing whether magic works?” It was our first foray together into publishing commentary about science-based medicine versus evidence-based medicine, using a topic that we’ve both written extensively about over the years on this blog and our respective personal blogs. Specifically, we discussed whether it is worthwhile to do randomized clinical trials (RCTs) testing highly improbable treatments, such as reiki and homeopathy, both of which have no physical basis to believe that they do anything whatsoever. As I’ve said many times before, reiki is simply faith healing in which Eastern mysticism is substituted for Christian beliefs, and homeopathy, as we’ve discussed many times here on SBM, is vitalistic sympathetic magic with no evidence to support its two laws.

To our surprise, that article generated a fair amount of press (for example this), with accounts of it showing up in the media in various places and Steven and I being asked to do a fair number of interviews. Part of the reason, I suspect, is that the editor made the article available for free for a month after its initial publication. (Unfortunately it’s back behind the pay wall again.) Part of the reason is that, intuitively, it makes sense to people not to waste money testing what is, at its core, magic. When I followed up that publication with an article criticizing “integrative oncology” in Nature Reviews Cancer entitled “Integrative oncology: Really the best of both worlds?“, the target was well and truly on my back. Indeed, let’s just say that the Society for Integrative Oncology and the Consortium of Academic Health Centers for Integrative Medicine (CAHCIM) are quite unhappy with me. When both their letters to the editor are published (right now, only one is), I might even blog about them.

In the meantime, I want to deal with criticism published in an unexpected place, albeit not by unexpected critics. The reason is that this criticism relies on a common straw man caricature of what we are saying when we advocate science-based medicine (SBM) that considers prior plausibility in determining what modalities to test in clinical trials and understands Bayesian thinking in which prior plausibility affects posterior plausibility that a “significant” result is not a false positive in contrast to the current evidence-based medicine (EBM) paradigm, which relegates basic science knowledge, even well-established principles of science that show that something like, say, homeopathy or reiki is impossible under the current understanding of physics, chemistry and biology, to the lowest rung on the EBM pyramid. It’s also a criticism that comes up frequently enough that, even though it’s been addressed before in various ways by various SBM bloggers, it’s worth revisiting from time to time. In this case, that’s particularly so because one of the two critics taking Steve and me to task is currently embroiled in a controversy about testing homeopathy for attention deficit hyperactivity disorder (ADHD) at the University of Toronto (more details on that later). Let’s just say, the criticism of Steve and me gives me an “in” to address a story that I thought had passed me by, and I intend to take it.
(more…)

Posted in: Clinical Trials, Energy Medicine, Homeopathy

Leave a Comment (339) →

Psychology Journal Bans Significance Testing

p-valuesThis is perhaps the first real crack in the wall for the almost-universal use of the null hypothesis significance testing procedure (NHSTP). The journal, Basic and Applied Social Psychology (BASP), has banned the use of NHSTP and related statistical procedures from their journal. They previously had stated that use of these statistical methods was no longer required but can be optional included. Now they have proceeded to a full ban.

The type of analysis being banned is often called a frequentist analysis, and we have been highly critical in the pages of SBM of overreliance on such methods. This is the iconic p-value where <0.05 is generally considered to be statistically significant.

The process of hypothesis testing and rigorous statistical methods for doing so were worked out in the 1920s. Ronald Fisher developed the statistical methods, while Jerzy Neyman and Egon Pearson developed the process of hypothesis testing. They certainly deserve a great deal of credit for their role in crafting modern scientific procedures and making them far more quantitative and rigorous.

However, the p-value was never meant to be the sole measure of whether or not a particular hypothesis is true. Rather it was meant only as a measure of whether or not the data should be taken seriously. Further, the p-value is widely misunderstood. The precise definition is:

The p value is the probability to obtain an effect equal to or more extreme than the one observed presuming the null hypothesis of no effect is true.

(more…)

Posted in: Basic Science, Clinical Trials, Science and Medicine

Leave a Comment (117) →

Placebo, Are You There?

By Jean Brissonnet, translation by Harriet Hall

Note: This was originally published as “Placebo, es-tu là?” in Science et pseudo-sciences 294, p. 38-48. January 2011. It came to my attention in the course of an e-mail correspondence with the editors of that magazine, where one of my own articles was published in French translation in January 2015. I thought this was the best explanation of placebo that I had ever read. It covers the same points my colleagues and I have addressed and more. It describes the pertinent research and uses particularly effective graphs to illustrate the principles (a picture is worth a thousand words). The author, Jean Brissonnet, kindly gave his permission for me to translate it and share it with our readers.


In fact, you don’t need to give a placebo to get a placebo effect and therefore we can now think about how we can maximize the placebo component of routine care.

~ Damien Finniss, 2010

The scene takes place in a surgical suite where they are preparing to do a cataract operation. The patient is lying on the operating table. A few minutes earlier the anesthetic gel was applied to the cornea to permit an operation under simple local anesthesia. The surgeon arrives in the company of the anesthetist. They are engaged in a spirited discussion and don’t seem to be agreeing.

“It has been proven,” says the surgeon, “that 30% of the action of a medical treatment is due to the placebo effect.”

“I doubt that,” retorts his interlocutor, “I think that placebo story is one of those medical myths on a par with the idea that we only use 10% of our brain, that nails and hair grow after death, or that cellphones create interference in hospitals.”[1]

“No,” insists the surgeon with a superior tone, “the fact is established and has been proven by numerous studies.”

The anesthetist shakes his head with a slight smile, but he doesn’t reply. As for the patient, who might have much to say on the subject, he keeps quiet, because it would not be prudent to argue with someone who is about to suck the lens out of your eye.

This true anecdote would not be of interest if it didn’t concern two members of the medical profession. Why such uncertainty? Why such lack of knowledge about such a fundamental subject? This faith in an all-powerful, magical, and mysterious placebo is common among the general public and it serves as justification for resorting to unconventional medicines that have never been able to show solid proof of efficacy; but we see that it still persists among the medical profession.

To know whether the placebo effect is real or should be relegated to the same category as poltergeists, it will help to go back in history.

cartoon

(more…)

Posted in: Clinical Trials, Science and Medicine

Leave a Comment (79) →

2015 NHIS Report on Complementary Health Approaches (whatever that means)

Formerly known as "relaxing," now known as a "complementary health approach." Gustav Courbet, "Young ladies on the banks of the Seine," 1857.

Formerly known as “relaxing,” now known as a “complementary health approach.” Gustav Courbet, “Young ladies on the banks of the Seine,” 1857. Public domain, via Wikimedia Commons.

Back in 2004, data from the 2002 National Health Interview Survey (NHIS) appeared in a report titled “Complementary and Alternative Medicine Use Among Adults: United States, 2002.” It showed a whopping 62% of adults had used CAM in the past 12 months, but only if prayer for health reasons was included. With prayer excluded, the percentage was substantially lower, at 35%.

“CAM” was defined as:

a group of diverse medical and health care systems, therapies, and products that are not presently considered to be part of conventional medicine.

The authors noted that, in earlier surveys of CAM use, “CAM has been operationally defined in a variety of ways” and the lists of CAM interventions/therapies included “varied considerably among the surveys.”

The most commonly used CAM therapies (excluding prayer) were non-vitamin, non-mineral natural products (18.9%), deep breathing exercises (11.6%), chiropractic care (7.5%), yoga (5.1%), massage (5.0%) and diet-based therapies (3.5%). CAM was most often used to treat back pain or problems, head or chest colds, neck pain or problems, joint pain or stiffness, and anxiety or depression. Most CAM use was self-prescribed. Rebranding things like exercise (yoga) as “CAM” was in the mix from the get-go.

(more…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Energy Medicine, Herbs & Supplements, Homeopathy, Naturopathy, Traditional Chinese Medicine

Leave a Comment (45) →

Glucosamine Update

 Stick-and-ball model of the glucosamine molecule (from the Wikimedia Commons, image by Benjah-bmm27)

Stick-and-ball model of the glucosamine molecule (from the Wikimedia Commons, image by Benjah-bmm27)

Osteoarthritis, the “wear-and-tear” type of arthritis, affects a great many of us as we grow older. Knee pain is a common symptom. The diet supplements glucosamine and chondroitin have been proposed as a more “natural” treatment than pharmaceuticals, and they are components of a number of proprietary “joint health” formulations like Osteo Bi-Flex. The GAIT study (Glucosamine/Chondroitin Arthritis Intervention Trial), compared glucosamine, chondroitin, a combination of the two, and a pharmaceutical (celecoxib) to a placebo in patients with knee pain from osteoarthritis. The only one that worked better than placebo was celecoxib. I wrote about the GAIT trial in 2008. The study was reported in the media as both negative and positive. The positive reports emphasized the subgroup analysis: in one of ten subgroups, patients with moderate to severe pain, the combination of glucosamine and chondroitin outperformed placebo. But in the subgroup of patients with mild to moderate pain, it did not. The authors themselves commented that their study was not powered to draw any conclusions from subgroups and that further studies would be required. (The “power” of a study is a measure of its ability to show an association or relationship between two variables if such a relationship exists.) Now a further study with sufficient power claims to have confirmed the subgroup findings. This may encourage some people to try glucosamine/chondroitin, but I remain skeptical.

(more…)

Posted in: Clinical Trials, Herbs & Supplements

Leave a Comment (160) →

A Scientist in Wonderland

Edzard Ernst is one of those rare people who dare to question their own beliefs, look at the evidence without bias, and change their minds. He went from practicing alternative medicine to questioning it, to researching it, to becoming its most prolific critic. I have long admired his work, and I finally met him in person when we were invited to speak at the same conferences. He shattered my stereotype of the stern, formal, self-important German “Herr Professor Doktor.” He was affable, unassuming, and funny; he was even a jazz musician. I wished I knew more about his history, and my wishes have been granted in the form of his new autobiographical book, A Scientist in Wonderland: A Memoir of Searching for Truth and Finding Trouble.

This is a well-written, entertaining book that anyone would enjoy reading and that advocates of alternative medicine should read: they might learn a thing or two about science, critical thinking, honesty, and the importance of truth.

This is a well-written, entertaining book that anyone would enjoy reading and that advocates of alternative medicine should read: they might learn a thing or two about science, critical thinking, honesty, and the importance of truth.

Edzard Ernst, the early years

Dr. Ernst was born in post-war Germany; his family had suffered greatly during the war and his uncle had been a general in the Waffen SS. He felt slightly ashamed to be German, and as a result he researched and wrote about Nazi health beliefs and medical atrocities so the history of their misdeeds would not be forgotten.

His father was a doctor, his mother an enthusiastic devotee of alternative medicine who subjected him to homeopathy, ice cold baths, and barefoot walks at dawn through wet grass. Early in life, Ernst began to manifest a tendency towards doubt and irreverence, along with an irrepressible sense of curiosity.

Music was his first love. He earned good money when he and his friends spent their summer vacation busking on the beach at St. Tropez, and he had been seriously considering a musical career until his mother persuaded him to study medicine. He earned an MD in Germany, in an environment where alternative medicine was unquestioningly integrated with mainstream medicine. He received hands-on training in acupuncture, autogenic training, herbalism, homeopathy, cupping, massage therapy, spinal manipulation, even leeches. His first job was in a homeopathic hospital where a colleague chose remedies by dowsing with a pendulum. (more…)

Posted in: Book & movie reviews, Clinical Trials, Critical Thinking

Leave a Comment (48) →
Page 1 of 34 12345...»