Articles

Archive for Clinical Trials

NCCAM on “integrative medicine”: What’s in a word?

I don’t know how I’ve missed this, given that it’s been in existence now for a month and a half, but I have. Regular readers (and even fairly recent readers, given that I write about this topic relatively frequently) know that I’m not a big fan of the National Center for Complementary and Alternative Medicine (NCCAM). (Come to think of it, neither is anyone else writing for this blog.) Just search this blog for “NCCAM” if you don’t believe me. I’ve explained the reasons many times, but the CliffsNotes version is that NCCAM is an enormous waste of taxpayer money, dedicated as it is to the study of modalities that are at best highly implausible and at worst break well-established laws of physics (i.e., “energy healing”). I do concede that, since the latest NCCAM director (Dr. Josephine Briggs) took over, there has been a noticeable attempt to bring more scientific rigor to NCCAM, and to some extent Dr. Briggs has succeeded. At the very least she is a legitimate scientist with an impressive pre-NCCAM track record, and I do fear who will succeed her when she moves on or retires given that there is enormous pressure from the CAM community to appoint one of their own as director.

Unfortunately, as rigorous a scientist as Dr. Briggs was in her former life, since coming to NCCAM she has gradually been assimilated into the culture of the place. Indeed, although it is good that NCCAM has backed away from studying woo like homeopathy and distance healing, the co-optation of science-based modalities such as exercise, diet, and natural products pharmacology has continued apace. Worse, the recently released five year strategic plan for NCCAM admitted that the science funded by NCCAM in the past was crap and, in essence, promised to do some real science for a change. That’s why on occasion I’ve jokingly said that we should take off and nuke NCCAM from orbit. It’s the only way to be sure. On the other hand, no doubt someone would think I seriously mean that we should nuke NCCAM. Of course, I’d never advocate that! NCCAM is located right smack dab in the middle of the NIH campus. The collateral damage would be unacceptable.

I keed. I keed. I’m not kidding, though, when I echo the questioning of why NCCAM still exists.
(more…)

Posted in: Clinical Trials, Medical Academia, Politics and Regulation

Leave a Comment (23) →

POM: Not So Wonderful

“POM Wonderful” is a brand of pomegranate juice. It is manufactured by a company owned by Linda and Stewart Resnick, California billionaires who pretty much single-handedly created a multi-million dollar market for pomegranate juice where none existed before. Or, as LA Times columnist Michael Hilzik wrote,

It has long been clear that the most wonderful thing about Pom Wonderful pomegranate juice is the spectacular marketing skill that persuades consumers to fork over their hard-earned cash for a liquid that sells for five to six times the price of, oh, cranberry juice.

He’s right about the expense: a daily 8 oz. dose of POM Wonderful juice costs about $780 annually according to a recent Federal Trade Commission case, which we’ll get to soon.

The Resnicks parlayed their success selling pomegranate juice into two additional products, both dietary supplements, in the form of POMx pills and POMx liquid. The Resnicks and their companies have shelled out $35 million in sponsored research to determine what health benefits might arise from ingesting pomegranate juice or its components, research they have not been shy about using in touting their products. The couple apparently has a flair for taking the mundane and making it appear, well, wonderful to the consumer – they also own Fiji Water and the Franklin Mint, among other business interests.

In 2010, the Federal Trade Commission (FTC) filed a complaint against Resnicks, one of their business partners, and two of their companies (which I’ll refer to collectively as “POM”), alleging unfair and deceptive trade practices. POM, according to the FTC complaint, made false and misleading claims that its POM products treat, prevent, and reduce the risk of heart disease, prostate cancer and erectile dysfunction.

An Administrative Law Judge (ALJ) agreed with the FTC and on May 17, 2012, issued a 335-page decision and cease and desist order, ruling POM lacked competent and reliable scientific evidence that drinking 8 ounces of POM Wonderful Juice daily, or taking one POMx pill, or one teaspoon of POMx liquid, treats, prevents or reduces the risk of heart disease, prostate cancer, or erectile dysfunction. In the Matter of POM Wonderful, LLC, et al., F.T.C. No. 9344 (May 17, 2012).

(more…)

Posted in: Clinical Trials, Herbs & Supplements, Legal, Nutrition, Politics and Regulation

Leave a Comment (13) →

Plausibility bias? You say that as though that were a bad thing!

On Friday, you might have noticed that Mark Crislip hinted at a foreshadowing of a blog post to come. This is that blog post. He knew it was coming because when I saw the article that inspired it, I sent an e-mail to my fellow bloggers marking out my territory like a dog peeing on every tree or protecting my newfound topic like a mother bear protecting her cubs. In other words, I was telling them all to back off. This article is mine.

Mine! Mine! Mine! I tell you!

My extreme territorial tendencies (even towards my friends and colleagues) notwithstanding on this issue aside, if you read Mark’s post (and if you didn’t go back and read it now—seriously, go now), you might also remember that he was discussing a “reality bias” in science-based medicine (SBM), a bias that we like to call prior plausibility. In brief, positive randomized clinical trials (RCTs) testing highly implausible treatments are far more likely to be false positives than RCTs testing more plausible treatments. That is the lesson that John Ioannidis has taught us and that I’ve written about multiple times before, as have other SBM bloggers, most prominently Kimball Atwood, although nearly all of us have chimed in at one time or another about this issue.

Apparently a homeopath disagrees and expressed his disagreement in an article published last week online in Medicine, Health Care, and Philosophy entitled Plausibility and evidence: the case of homeopathy. You’ll get an idea of what it is that affected us at SBM like the proverbial matador waving his cape in front of a bull by reading this brief passage from the abstract:

Prior disbelief in homeopathy is rooted in the perceived implausibility of any conceivable mechanism of action. Using the ‘crossword analogy’, we demonstrate that plausibility bias impedes assessment of the clinical evidence. Sweeping statements about the scientific impossibility of homeopathy are themselves unscientific: scientific statements must be precise and testable.

Scientific. You keep using that word. I do not think it means what you think it means. Of course, his being a homeopath is about as close to a guarantee as I can think of that a person doesn’t have the first clue what is and is not scientific. If he did, he wouldn’t be a homeopath. Still, this particular line of attack is often effective, whether yielded by a homeopath or other CAM apologist. After all, why not test these therapies in human beings and see if they work? What’s wrong with that? Isn’t it “close-minded” to claim that scientific considerations of prior plausibility consign homeopathy to the eternal dustbin of pseudoscience?

Not at all. There’s a difference between being open-minded and being so “open-minded” that your brains threaten to fall out. Guess which category homeopaths like Rutten fall into. But to hear them tell it, homeopathy is rejected because because we scientists have a “negative plausibility bias” towards it. At least, that’s what Rutten and some other homeopaths have been trying to convince us. This article seems to be an attempt to put some meat on the bones of their initial trial balloon of this argument published last summer, which Steve Novella duly deconstructed.

Before I dig in, however, I think it’s necessary for me to “confess” my bias and why I think it should be your bias too.
(more…)

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

Leave a Comment (30) →

Funding CAM Research

Paul Offit has published a thoughtful essay in the most recent Journal of the American Medical Association (JAMA) in which he argues against funding research into complementary and alternative therapies (CAM). Offit is a leading critic of the anti-vaccine movement and has written popular books discrediting many of their claims, such as disproved claim for a connection between some vaccines or ingredients and risk of developing autism. In his article he mirrors points we have made here at SBM many times in the past.

Offit makes several salient points – the first being that the track record of research into CAM, mostly funded by the NCCAM, is pretty dismal.

“NCCAM officials have spent $375,000 to find that inhaling lemon and lavender scents does not promote wound healing; $750,000 to find that prayer does not cure AIDS or hasten recovery from breast-reconstruction surgery; $390,000 to find that ancient Indian remedies do not control type 2 diabetes; $700,000 to find that magnets do not treat arthritis, carpal tunnel syndrome, or migraine headaches; and $406,000 to find that coffee enemas do not cure pancreatic cancer.”

The reason for the poor track record is fairly simple to identify – by definition CAM includes treatments that are scientifically implausible, which means there is a low prior probability that they will work. If the treatments were scientifically plausible then they wouldn’t be alternative.

(more…)

Posted in: Clinical Trials, Herbs & Supplements, Medical Ethics, Politics and Regulation, Science and Medicine

Leave a Comment (64) →

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, NaturalNews.com, 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…
(more…)

Posted in: Basic Science, Cancer, Clinical Trials

Leave a Comment (16) →

Keeping the customer satisfied

One thing about blogging once a week or so compared to my other blogging gig, which is usually close to every day, occasionally more often, is that I really can’t cover everything I want to cover for this blog. Even more so than at my not-so-super-secret other blogging gig, I have to pass on topics that could be fodder for what could be excellent to even awesome posts—or, self-congratulating hyperbole aside, at least reasonably interesting to the readers of this blog. When that happens, I can only hope that one of my co-bloggers picks up on it and gives the subject matter the treatment it cries out for. Or, sometimes, such subject matter just has to be dealth with elsewhere by me—or not at all. Even a hypercaffeinated blogger like myself has limits.

Sometimes, however, I actually get a second chance. In other words, I get a chance to revisit a topic that I passed by. Usually, this happens when something new happens that gives me an excuse to revisit the topic. So it was last of week, when I was perusing the New York Times by an oncology nurse named Theresa Brown. Her article was titled, appropriately enough, Hospitals Aren’t Hotels. It will become very apparent very quickly why in a moment. But first, let’s sample Brown’s article a bit, because it brings up an issue that is very pertinent to science-based medicine:
(more…)

Posted in: Clinical Trials, Epidemiology, Science and Medicine

Leave a Comment (25) →

The Application of Science

It all seemed so easy

In 2010 an article was published in the New England Journal of Medicine, Preventing Surgical-Site Infections in Nasal Carriers of Staphylococcus aureus .  Patients were screened for Staphylcoccus aureus ( including MRSA, methicillin resistant Staphylococcus aureus) and those that were positive underwent a 5 day perioperative decontamination procedure with chlorhexidine baths and an antibiotic, mupirocin, in the nose.  The results were impressive.  Before the intervention the infection rates were 7.7 % and after the intervention it was 3.4 %.  That is an impressive drop in surgical infections.

One of the orthopedic groups approached us (us being the hospital administration, pharmacy, nursing  and infection control, of which I am Chair) to implement the protocol in their patients, citing a similar study on an orthopedic population.  Great.  It should be an easy enough intervention.  I should have known better, of course, long experience has continually demonstrated that what appears to be simple never is.

First was the question as to whether the study was applicable to our patients.  Resources were going to be devoted to an intervention, so going forward we had to demonstrate that the bang would be worth the buck.  These are financially lean times, with cutbacks and declining reimbursement, so every expenditure of time and money needs to be justified.  In the bizarro accounting of health care, not every hospital administration will include money saved in the evaluation of interventions, only the money spent.   I work in a hospital system with a remarkably strong commitment to patient safety and quality, so there was little  worry on that point. (more…)

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

Leave a Comment (19) →

Does massage therapy decrease inflammation and stimulate mitochondrial growth? An intriguing study oversold

If there’s one form of so-called “complementary and alternative medicine” (CAM) that I find more tolerable than most, it’s massage therapy. The reason, of course, is that, whatever else anyone claims about massage, there’s no doubt that it feels good. Indeed, I’ve sort of come around to Kimball Atwood’s way of thinking. Back when he and I were on a panel together at TAM9, Kimball said something somewhat surprising, namely that he’s not sure we even need to test massage in randomized clinical trials because we all know that it feels good and if it feels good it can certainly be helpful at the very least to improve patients’ quality of life. Unfortunately, there’s a lot of woo in massage these days, and massage therapists who buy into the woo aren’t satisfied with simply using the rationale that massage feels good to recommend it to patients. They just can’t resist going beyond that to infuse massage therapy with every bit as much woo as any chiropractor or acupuncturist infuses into his respective specialty. For instance, some of the claims for massage include:

  • Decreases muscle pain & tension.
  • Rejuvenates the body and mind and lifts the spirit.
  • Relieves anxiety, stress and tension.
  • Relaxes muscles.
  • Alleviates headaches.
  • Hastens healing.
  • Increases ranges of motion.
  • Facilitates removal of waste and inflammation by-products.
  • Stimulates the immune system.
  • Eases symptoms related to fibromyalgia.
  • Promotes relaxation and comfort.
  • Reduces nausea in pregnant women.
  • Accelerates weight gain in premature infants.
  • Helps premature infants become more active and aware.
  • Increases energy and alertness.
  • Enhances morale and attitude.

Of course, there’s little doubt that a good massage probably can relax muscles, promote relaxation and comfort (which seems like the same thing to me), and enhance morale and attitude. I’d even be willing to concede that massage, properly administered, can probably also alleviate headaches (tension headaches, anyway) and increase range of motion in joints. But facilitate the removal of waste and inflammation byproducts? Stimulate the immune system (the all-purpose meaningless claim)? Hasten healing? Not so much.

All too often massage therapists ruin a perfectly good massage by imposing pseudoscientific and quack claims on it, such as claims that they are stimulating acupressure points or their adoption of the language of “energy healing.” So it was with a bit of trepidation (but also more than a bit of interest) that I took a look at some links that readers sent me about a week ago (too late, alas, for me to write about this last Monday). These links were to news stories with titles like Scientists Uncover Why Massage Heals Sore Muscles and Massage Reduces Inflammation And Promotes Growth Of New Mitochondria Following Strenuous Exercise, Study Finds. My first impression, actually, was that this was somewhat counterintuitive in that one might predict that deep kneading of muscles might actually cause a bit of inflammation and that it’s the counterirritation effect that leads to the perceived reduction in the amount of pain. Yet, according to the press release issued by McMasters University, whose contents were mirrored in many news stories, a study claiming state-of-the-art methods is concluding that massage is reducing inflammation:
(more…)

Posted in: Basic Science, Clinical Trials, Science and the Media

Leave a Comment (23) →

Does thinking make it so? CAM placebo fantasy versus scientific reality

Last week, I discussed a rather execrable study. Actually, the study itself wasn’t so execrable, at least not in its design, which was a fairly straightforward three-arm randomized clinical trial. Rather it was the interpretation of the study’s results that was execrable. In brief, the authors tested an “energy healing” modality known as “energy chelation” versus a placebo (sham “energy chelation”) and found, as is so often the case in studies of “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) that both modalities did better than no treatment on the primary outcomes but that the “real” treatment (if one can call energy chelation “real treatment”) produced outcomes that were statistically indistinguishable from the “sham” treatment. Not surprisingly, the next move on the part of the researchers was to do a bunch of comparisons, and, as is so often the case (particularly when one fails to correct statistically for multiple comparisons), they found a couple of secondary endpoints with barely statistically significant differences and trumpeted them as meaning that their “energy chelation therapy” has “significant promise for reducing fatigue.” They then argued that the study was also ” designed to examine nonspecific and placebo elements that may drive responses.”

Which brings us to the “power” of placebo.

As I was contemplating what I wanted to discuss this week, I thought about the study that Drs. Coyne, Johansen, and I objected to, but then I also thought about Dr. Crislip’s post last week and post I did about a month ago in which I noticed how lately CAM apologists seem to be—shall we say?—retooling their message in the wake of negative trial after negative trial of their implausible treatments. Gone (mostly) are claims of powerful specific effects and efficacy from treatments such as various “energy healing” modalities, acupuncture, homeopathy, and the like themselves, to be replaced by claims that physicians should embrace CAM because it’s “harnessing the power of placebo” to produce “powerful mind-body healing.” It’s a powerful message that has sucked in people who normally would be considered skeptics, such as Michael Specter, who, as I described, apparently bought into the message sufficiently that when Ted Kaptchuk was making the media round right before the holidays he happily published a fairly credulous interview with him entitled, The Power of Nothing: Could Studying the Placebo Effect Change the Way We Think About Medicine? (My answer: Very likely no.) Even Ira Flatow of Science Friday fell hard for Kaptchuk’s message, declaring at the beginning of the interview that Kaptchuk’s irritable bowel syndrome study is evidence that “placebos work even when patients are in on the secret.” (It’s not.)

That skeptics and scientists find the idea that the mind has the power to heal the body, often referred to as “self-healing” or “mind-body healing,” so seductive should probably not be surprising. After all, who wouldn’t want to be able to cure themselves simply by willing it to be so? It’s a concept that, like so many concepts in CAM, goes far back into ancient times and stretches forward to today in ideas like The Secret, which goes quite a bit beyond the whole idea of “mind-body healing” or healing yourself because you wish it to be so, and declares that you can have virtually anything you want simply by thinking the right thoughts. In fact, to me it appears that the “powerful placebo” is being drafted in the service of supporting what are, at their core, mystical beliefs far more than science. I’d like to elaborate on that idea a bit more than I did last time I discussed this isssue, where I concluded by writing:

In the end, all too much of the rebranding of CAM as placebo and the selling of placebos as some sort of powerful “mind-body healing” strikes me as being much like The Secret, in which wishing makes it so.

Let’s take a look at just how far this goes.
(more…)

Posted in: Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Religion

Leave a Comment (23) →

What is Science?

Consider these statements:

…there is an evidence base for biofield therapies. (citing the Cochrane Review of Touch Therapies)

The larger issue is what constitutes “pseudoscience” and what information is worthy of dissemination to the public. Should the data from our well conducted, rigorous, randomized controlled trial [of 'biofield healing'] be dismissed because the mechanisms are unknown or because some scientists do not believe in the specific therapy?…Premature rejection of findings from rigorous randomized controlled trials are as big a threat to science as the continuation of falsehoods based on belief. Thus, as clinicians and scientists, our highest duty to patients should be to investigate promising solutions with high benefit/risk ratios, not to act as gatekeepers of information based on personal opinion.

–Jain et al, quoted here

Touch therapies may have a modest effect in pain relief. More studies on HT and Reiki in relieving pain are needed. More studies including children are also required to evaluate the effect of touch on children.

Touch Therapies are so-called as it is believed that the practitioners have touched the clients’ energy field.

It is believed this effect occurs by exerting energy to restore, energize, and balance the energy field disturbances using hands-on or hands-off techniques (Eden 1993). The underlying concept is that sickness and disease arise from imbalances in the vital energy field. However, the existence of the energy field of the human body has not been proven scientifically and thus the effect of such therapies, which are believed to exert an effect on one’s energy field, is controversial and lies in doubt.

—Cochrane Review of Touch Therapies, quoted here

 …

Science is advanced by an open mind that seeks knowledge, while acknowledging its current limits. Science does not make assertions about what cannot be true, simply because evidence that it is true has not yet been generated. Science does not mistake absence of evidence for evidence of absence. Science itself is fluid.

—David Katz

When people became interested in alternative medicines, they asked me to help out at Harvard Medical School. I realized that in order to survive there, one had to become a scientist. So I became a scientist.

—Ted Kaptchuk, quoted here.

 …It seems that the decision concerning acceptance of evidence (either in medicine or religion) ultimately reflects the beliefs of the person that exist before all arguments and observation.

 —Ted Kaptchuk, quoted here.

Together they betray a misunderstanding of science that is common not only to “CAM” apologists, but to many academic medical researchers. Let me explain. (more…)

Posted in: Basic Science, Book & movie reviews, Clinical Trials, Energy Medicine, Faith Healing & Spirituality, Homeopathy, Medical Academia, Science and Medicine

Leave a Comment (37) →
Page 12 of 31 «...1011121314...»