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Archive for Clinical Trials

Study of “Acupressure” for Constipation

constipationA recent study in the Journal of General Internal Medicine evaluated a treatment for constipation. It tested whether training patients to massage the perineum (the area between the vagina or scrotum and the anus) would improve their reported bowel function and quality of life at 4 weeks after training. They found that it did. It’s a simple, innocuous treatment that may be worth trying, but why, oh why, did they have to call it “acupressure”? That irritated me. Should it have? Why should it matter? Isn’t a rose by any other name still a rose? Is this a meaningless semantic quibble and hypersensitivity on my part, or am I right to see it as yet another example of quackademia’s attempts to infiltrate science-based medicine? I’ll explain my thinking and let you decide for yourself. (more…)

Posted in: Acupuncture, Clinical Trials, Traditional Chinese Medicine

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Selling “integrative oncology” as a monograph in JNCI

pancreatic-cancer-diagnostics-l

Sometimes, it’s hard not to get the feeling that my fellow bloggers at Science-Based Medicine and I are trying to hold back the tide in terms the infiltration of pseudoscience and quackery into conventional medicine, a term I like to refer to as quackademic medicine. In most cases, this infiltration occurs under the rubric of “complementary and alternative medicine” (CAM), which these days is increasingly referred to as “integrative medicine,” the better to banish any impression of inferior status implied by the name “CAM” and replace it with the implication of a happy, harmonious “integration” of the “best of both worlds.” (As I like to point out, analogies to another “best of both worlds” are hard to resist.) Of course, as my good buddy Mark Crislip has put it, the passionate protestations of CAM advocates otherwise notwithstanding, integrating cow pie with apple pie doesn’t make the cow pie better. Rather, it makes the apple pie worse.

In any case, over the last three months, Steve Novella and I published a solid commentary in Trends in Molecular Medicine decrying the testing in randomized clinical trials of, in essence, magic, while I managed to score a commentary in Nature Reviews Cancer criticizing “integrative oncology.” Pretty good, right? What do I see this month in the Journal of the National Cancer Institute (or JNCI, as we like to call it)? An entire monograph devoted to a the topic, “The Role of Integrative Oncology for Cancer Survivorship”, touting integrative oncology, of course. And where did I find out about this monograph? I found out about it from Josephine Briggs, the director of the National Center for Complementary and Alternative Medicine (NCCAM) herself, on the NCCAM blog in a post entitled “The Evidence Base for Integrative Approaches to Cancer Care“, in which she touts her perspective piece in the JNCI issue entitled “Building the Evidence Base for Integrative Approaches to Care of Cancer Survivors.” In an introductory article, Jun J. Mao and Lorenzo Cohen of the Department of Family Medicine and Community Health, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania and the University of Texas M.D. Anderson Cancer Center, respectively, line up this monograph thusly:
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Posted in: Cancer, Clinical Trials, Medical Academia

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Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Eminent Harvard psychologist, mother of positive psychology, New Age quack?

Be less curious about people and more curious about ideas.
– Marie Curie’s advice to journalists

langer cbs this

Harvard psychologist Ellen Langer was on CBS This Morning News explaining plans for a psychosocial intervention study with women with Stage IV metastatic breast cancer. The project would attempt to shrink women’s tumors by shifting their mental perspective back to before they were diagnosed.
Seeing her on TV unsettled me because I had just supplied a journalist with quotes for his article in the New York Times about Langer. I hadn’t been following her recently. Instead I focused on her now-famous study from the 70s. Langer had claimed that giving nursing home residents a plant for which they were responsible cut their mortality by half (the nursing home residents, not the plant), compared to residents whose plants were attended by staff. The paper continues to get uncritical coverage in the media and in introductory psychology texts.

I looked up the Timesarticle after seeing CBS This Morning News, and it accurately quoted me:
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Posted in: Cancer, Clinical Trials, Medical Ethics

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Retconning the story of traditional Chinese medicine

Retcon

Retcon (shortened form of RETroactive CONtinuity; first made popular in the comic book world):

  1. (original meaning) Adding information to the back story of a fictional character or world, without invalidating that which had gone before.
  2. (more common usage) Adding or altering information regarding the back story of a fictional character or world, regardless of whether the change contradicts what was said before.

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Posted in: Clinical Trials, History, Medical Academia, Traditional Chinese Medicine

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Conspiracy theories and Ebola virus transmission

Yesterday, I spiffed up a post that some of you might have seen, describing how a particular medical conspiracy theory has dire consequences in terms of promoting non-science-based medical policy. Specifically, I referred to how the myth that there are all sorts of “cures” for deadly and even terminal diseases that are being kept from you by an overweening fascistic FDA’s insistence on its approval process is an important driving force behind ill-advised “right to try” legislation that’s passed in four states and likely to pass in Arizona by referendum tomorrow. I’m not exaggerating, either. If you have the stomach to delve into the deeper, darker recesses of alternative medicine and conspiracy theory websites, you’ll find words far worse than that used to describe the FDA, such as this little gem from everyone’s favorite über-quack Mike Adams basically portraying the FDA as Adolf Hitler. Even more “mainstream” advocates, such as Reason.com’s Ronald Bailey and Nick Gillespie, are not above using a version of this myth stripped of the worst of its conspiracy mongering for public consumption, claiming that the FDA is killing you.

Unfortunately, this sort of medical conspiracy theory is very common. Like all conspiracy theories, medical conspiracy theories tend to involve “someone” hiding something from the public. I like to refer to this as the fallacy of “secret knowledge.” That “someone” hiding the “secret knowledge” is usually the government, big pharma, or other ill-defined nefarious forces. The “secret knowledge” being hidden comes invariably in one of two flavors. Either “they” are hiding cures for all sorts of diseases that conventional medicine can’t cure, or “they” are hiding evidence of harm due to something in medicine. Although examples of the former are common, such as the “hidden cure for cancer,” it is examples of the latter that seem to be even more common, in particular the myth that vaccines cause autism and all sorts of diseases and conditions, that genetically modified organisms (GMOs) are dangerous, or that radiation from cell phones causes cancer. In these latter examples, invariably the motivation is either financial (big pharma profits), ideological (control, although descriptions of how hiding this knowledge results in control are often sketchy at best), or even some seriously out there claims, such as the sometimes invoked story about how mass vaccination programs are about “population control” or even “depopulation.” Either way, “The Truth” needs to be hidden from the population, lest they panic and revolt.
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Posted in: Basic Science, Clinical Trials, Public Health

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Using the fear of Ebola to promote the placebo legislation that is “right to try”

rick-snyder

Perhaps the most pervasive medical conspiracy theory of all involves stories that there exist out there all sorts of fantastic cures for cancer and other deadly diseases but you can’t have them because (1) “they” don’t want you to know about them (as I like to call it, the Kevin Trudeau approach) and/or (2) the evil jackbooted thugs of the FDA are so close-minded and blinded by science that they crush any attempt to market such drugs and, under the most charitable assessment under this myth, dramatically slow down the approval of such cures. The first version usually involves “natural” cures or various other alternative medicine cures that are being “suppressed” by the FDA, FTC, state medical boards, and various other entities, usually at the behest of their pharma overlords. The second version is less extreme but no less fantasy-based. It tends to be tightly associated with libertarian and small government fantasists and a loose movement in medicine with similar beliefs known as the “health freedom” movement, whose members posit that, if only the heavy hand of government were removed and the jack-booted thugs of the FDA reined in, free market innovation would flourish, and the cures so long suppressed by an overweening and oppressive regulatory apparatus would burst the floodgates and these cures, long held back by the dam of the FDA, would flow to the people. (Funny how it didn’t work out that way before the Pure Food and Drug Act of 1906.) Of course, I can’t help but note that in general, in this latter idea, these fantastical benefits seem to be reserved only for those who have the cash, because, well, the free market fixes everything. At least, that seems to be the belief system at the heart of many of these conspiracy theories.

The idea that the FDA is keeping cures from desperate terminally ill people, either intentionally or unintentionally, through its insistence on a rigorous, science-based approval process in which drugs are taken through preclinical work, phase 1, phase 2, and phase 3 testing before approval is one of the major driving beliefs commonly used to justify so-called “right-to-try” laws. These bills have been infiltrating state houses like so much kudzu, and the Ebola outbreak has only added fuel to the fire based on the accelerated use of ZMapp, a humanized monoclonal antibody against the Ebola virus, in some patients even though it hadn’t been tested in humans yet (more on that later). Already four of these laws have been passed (in Colorado, Missouri, Louisiana, and now Michigan) with a referendum in Arizona almost certain to pass next week to bring the total to five states with such laws. Basically, these laws, as I’ve described, claim to allow access to experimental drugs to terminally ill patients with a couple of major conditions: First, that the drug has passed phase I clinical trials and second that the patient has exhausted all approved therapies. As I’ve explained before more than once, first when the law hit the news big time in Arizona and then when a right-to-try bill was introduced into the legislature here in Michigan, they do nothing of the sort and are being promoted based on a huge amount of misinformation detailed in the links earlier. First, having passed phase 1 does not mean a drug is safe, but right-to-try advocates, particularly the main group spearheading these laws, the Goldwater Institute, make that claim incessantly. Second, they vastly overstate the likelihood that a given experimental drug will help a given patient. The list goes on.
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Posted in: Cancer, Clinical Trials, Pharmaceuticals, Politics and Regulation

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Lessons from the dubious rise and inevitable fall of green coffee beans

Green-Coffee-Bean-BOGUS

News this week that a randomized controlled trial of green coffee bean (GCB) has been officially retracted from the medical literature signals what is hopefully the end to one of the most questionable diet products to appear on the market in years. Plucked from obscurity and then subjected to bogus research, it’s now clear that the only people that actually benefited from GCB were those that profited from its sale. GCB had some powerful boosters, too. Once it became one of Dr. Oz’s “miracle” weight loss cures, sales exploded following two hype-filled episodes. Oz even did a made-for TV clinical trial with GCB, ignoring the requirements for researchers to obtain ethical approvals before conducting human subject research. Oz’s promotion of GCB was so breathless and detached from the actual evidence that his actions were subsequently eviscerated by Senator Clair McCaskill during televised hearings on weight loss scams. It’s a long, sordid, ugly and yet entirely predictable story. (more…)

Posted in: Clinical Trials, Health Fraud, Herbs & Supplements, Science and the Media

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Do doctors pay attention to negative randomized clinical trials?

vertebroplasty

We at the Science-Based Medicine blog believe that all medicine, regardless of where it comes from, should be held to a single science-based standard with regards to efficacy, effectiveness, and safety. We tend to focus primarily on “complementary and alternative medicine” (CAM), now more commonly known as “integrative medicine,” because (1) we believe it to be undermining the scientific basis of medicine and allowing outright quackery (or, as I like to refer to it, quackademic medicine) to infiltrate medical academia, which is fast becoming medical quackademia and (2) because when it comes to the other threats to the scientific basis of medicine as it is practiced today, such as pharma influence and various medical dogmatism, there are a whole host of active critics better equipped and more energetic than we are who can do the job (usually) better. That is why, whenever I hear advocates of CAM/”integrative medicine” attack us for not spending enough time on various corruptions of clinical trial processes or the perfidy of big pharma, I tend to gently tell them in my characteristically diplomatic manner that that’s what I like to call the “Why don’t you blog about what I think is important and interesting instead of what you think is important and interesting?” criticism, then I refer them to our posts on John Ioannidis, overdiagnosis and overtreatment, the shortcomings of mammography, or any number of other posts we at SBM have done through the years pointing out where current medical practice falls short. Indeed, it never fails to amuse me to point out how angry an eminent radiologist became at me for my posts criticizing him for his misleading attacks on certain studies that question the value of screening mammography.

In particular, though, I like to point out a post I did on vertebroplasty as a treatment for vertebral compression fractures (VCFs) due to osteoporosis. Basically, I discussed then recent evidence showing how vertebroplasty for such fractures is, basically, placebo medicine, no better than acupuncture. Indeed, I likened the state of evidence regarding vertebroplasty to that of acupuncture, in which small, pilot studies appear to be positive, but then the follow-up rigorous randomized clinical trials fail to find a benefit greater than that of placebo. It turns out that a rather telling study regarding vertebroplasty was published earlier this year that I somehow missed that addresses a problem we have in “conventional” medicine.
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Posted in: Clinical Trials, Medical devices

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That’s so Chiropractic

Alien autopsy (Wikimedia Commons), by Flickr user Jim Trottier

Alien autopsy (Wikimedia Commons), by Flickr user Jim Trottier

Old bad studies: Fantastical autopsy results

I found the following quote at “Chiropractic care can treat more than just bad backs” (FYI. Chiropractic can’t):

Luse references a study published in The Medical Times authored by Dr. Henry Windsor [sic], M.D. that showcases the correlation of spinal health to overall wellness. Windsor dissected 75 human cadavers to investigate their causes of death. The study showed that 138 of the 139 diseases of the internal organs that were present were in connection to the misalignments of the vertebrae.

But I was intrigued. So I went to the video tape. Well, the PDF.

It is an interesting read by a physician who was looking for an association between curvature of the spine and visceral pathology.

He had 50 corpses, age unknown, that he dissected, looked at the spine for curvature and then looked for pathology in organs in the same distribution of sympathetic nervous system as the level of the spine curvature.
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Posted in: Chiropractic, Clinical Trials, Energy Medicine, Science and Medicine

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Tens of millions for CAM research — and it’s all on your dime

George-Washington-dollar-bill-480x384

The Federal Funding Accountability and Transparency Act (FFATA) was signed on September 26, 2006. The intent is to empower every American with the ability to hold the government accountable for each spending decision. The end result is to reduce wasteful spending in the government. The FFATA legislation requires information on federal awards (federal financial assistance and expenditures) be made available to the public via a single, searchable website, which is www.USASpending.gov.

And what subject is more deserving of being held accountable by the American people than complementary/alternative/integrative medicine? After all, in what other area of government spending does scientific implausibility – indeed, even scientific impossibility – offer no impediment to spending millions of taxpayer dollars in research funds? We’ve complained about the NCCAM’s wasteful spending on pseudomedicine here on SBM several times: here, here, here and here, among others. As you shall see, the problem doesn’t stop at that particular $2.5 billion. (more…)

Posted in: Acupuncture, Chiropractic, Clinical Trials, Energy Medicine, Homeopathy, Medical Academia, Naturopathy, Politics and Regulation

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