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Archive for July, 2011

Spin City: Using placebos to evaluate objective and subjective responses in asthma

As I type this, I’m on an airplane flying home from The Amazing Meeting 9 in Las Vegas. Sadly, I couldn’t stay for Sunday; my day job calls as I’ll be hosting a visiting professor. However, I can say—and with considerable justification, I believe—that out little portion of TAM mirrored the bigger picture in that it was a big success. Attendance at both our workshop on Thursday and our panel discussion on placebos on Saturday was fantastic, beyond our most optimistic expectations. There was also a bit of truly amazing serendipity that helped make our panel discussion on placebo medicine an even bigger success.

If there’s one thing about going away to a meeting, be it TAM or a professional meeting, it’s that it suddenly becomes very difficult for me to keep track of all the medical and blog stuff that I normally keep track of and nearly impossible to keep up with the medical literature. This is the likely explanation for why I had been unaware of a study published in the New England Journal of Medicine (NEJM) on Thursday that was so relevant to our discussion and illustrated out points so perfectly that it was hard to believe that some divine force didn’t give it to us in order to make our panel a total success.

Just kidding. It was TAM, after all. It was, however, embarrassing that I didn’t see the study until the morning of our panel, when Kimball Atwood showed it to me.

Before I get to the meat of this study and why it fit into our nefarious plans for world domination, (or at least the domination of medicine by science-based treatments), a brief recap of the panel discussion would seem to be in order. First, for the most part, we all more or less agreed that the term “placebo effect” is a misnomer and somewhat deceptive because it implies that there is a true physiologic effect caused by an inert intervention. “Placebo response” or “placebo responses” seemed to us a better term because what we are observing with a placebo is in reality a patient’s subjective response to thinking that he is having something active done having something done. In general, we do not see placebo responses resulting improvement in objective outcomes; i.e., prolonged survival in cancer. The relative contributions of components of this response, be they expectancy effects (if you expect to feel better you likely will feel better), conditioning, or one that is frequently dismissed or downplayed, namely artifacts of the design of randomized clinical trials and even subtle (or even not-so-subtle) biases in trial design. This issue of placebo responses being observed only in subjective patient-reported clinical outcomes (pain, anxiety, and the like) and not in objectively measured outcomes is an important one, and it is one that goes to the heart of the NEJM study that so serendipitously manifested itself to us. As Mark Crislip so humorously pointed out, the placebo response is the beer goggles of medicine (this is not a spoiler or stealing Mark’s line; several TAM attendees have already tweeted Mark’s line), and much of what is being observed are changes in the patient’s perception of his symptoms rather than true changes in the underlying pathophysiology. This study drove the point home better than we could.

Another point discussed by the panel is also quite relevant. As more and more studies demonstrate very convincingly that “complementary and alternative medicine” (CAM) or “integrative medicine” (IM) therapies do not produce improvements in symptoms greater than placebo. Moreover, multiple studies, including a famous NEJM meta-analysis and a recently updated Cochrane review, demonstrate, placebo responses probably do not constitute meaningful responses. In light of these findings, CAM apologists, driven by ideology rather than science and masters of spin, have begun to admit grudgingly that, yes, in essence their treatments are elaborate placebos. Not to be deterred, instead of simply concluding that their CAM interventions do not work, they’ve moved the goal posts and started to try to argue that it doesn’t matter that CAM effects are placebo effects because placebos are “powerful” and good and—oh, yes, by the way—there are a lot of treatments in science-based medicine that do little better than placebos. In other words, CAM advocates elevate the subjective above the objective and sell the subjective, and that’s exactly what they are doing with this study.
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Posted in: Acupuncture, Clinical Trials, Medical Ethics

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Honey

I cram for TAM, and, combined with other commitments, not the least of which is that it is finally sunny and warm in Portland, after a year that has resembled All the Summer in a Day,  which leads to a relatively short post.  There are just so many hours in a day and if possible those days need to be spent in the sun.

In my first year in practice I was sitting on a nursing station writing a note when a patient started howling in pain.  Further investigation revealed that the patient had a chronic, open surgical wound and the (old) surgeon had ordered sugar poured into the wound as part of wound care.  The cafeteria mistakenly sent up salt, and a metaphor became reality.  It did pique my interest in both sugar and honey for wound care,  an area where you have to be careful not to fall prey to all the errors in CAM thinking: a reliance on anecdotes, using suboptimal studies as evidence, mistaking a gobbet of basic science as a meaningful clinical application, and not realizing the warping effect of confirmation bias.

That being said, I have suggested honey and sugar for years for patients, and many patients with prior refractory wounds had healing.  And what are the three most dangerous words in medicine?  In my experience.  I have recommended honey less in the era of the wound vac, but there are not an insignificant number of people with insufficient financial resources who cannot afford even simple wound care supplies. Many  of the ointments, creams and special bandages for wound care costs too much.  Patients also like honey as it is natural (people do love to fall for the naturalistic fallacy) and inexpensive, and I always tell patients that the data is iffy, but not stupid. (more…)

Posted in: Herbs & Supplements, Science and Medicine, Surgical Procedures

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SBM at TAM9

Many of the SBM blogger are at The Amazing Meeting 9 this week – or TAM9 From Outer Space, as it is whimsically called. The JREF, who sponsors TAM, is a big supporter of our efforts at SBM and, in fact, as of this year co-sponsors this blog along with the New England Skeptical Society (both non-profits).

This year, as with the last two TAMs, there will be a workshop on SBM. The topic is, “Oh no, not again! – Recurring themes in medical mythology.” David Gorski, Kimball Atwood, Harriet Hall, Mark Crislip and I decided to discuss the most common recurrent themes in unscientific or philosophy-based medicine (which is much of what passes for CAM). The core idea of the workshop is that the same basic themes keep cropping up again and again in CAM modalities. They may contain slight variations on the basic theme, but mostly are just the same thing with a different superficial window dressing.

So, for example, many systems are based upon the common theme of “energy medicine” – the notion that there is a life force or life energy that is responsible for health, and blockages in the flow or power of this energy cause “unwellness.” Modalities as apparently distinct as straight chiropractic, acupuncture, and Reiki are all based on this pre-scientific idea.

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Posted in: Announcements

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Electrodermal Testing Part II: Legal and Regulatory Aspects

Last week I described electrodermal testing. I’m sure many readers thought, “There oughta be a law against that.” Well, there are laws. Unfortunately, having laws and enforcing them are two different things.

Some of these devices are not approved at all. Most have received 501(k) approval from the FDA as biofeedback devices so similar to previous devices that they do not require new approval — for biofeedback. It is illegal to use the devices for anything other than biofeedback. The FDA has prohibited their sale or importation for unapproved purposes like electrodermal testing; it has sent warnings to companies, raided clinics, and confiscated machines. States have prosecuted users for practicing medicine without a license. Medical boards have chastised licensed providers. The Quackwatch website lists these regulatory actions but points out that there has been no systematic effort to drive these devices from the marketplace.

Excuses, Excuses

One electrodermal testing website admits that what it is doing is illegal and tries to fight back with this specious disclaimer:

It is important to understand that the laws in the USA forbid me from being able to treat, diagnose, cure or prevent disease. The AMA has a patent on those words and only a licensed medical doctor can do that.  And although it is legal for a licensed medical doctor to violate the Hippocratic oath and prescribe toxic drugs that cause harm and sometimes even kill patients, it is illegal for me to claim you can be cured using natural, nontoxic remedies, even though thousands of people can testify how they have been healed using natural remedies.

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Posted in: Energy Medicine, Legal

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Anti-vaccine propaganda in The Baltimore Sun

The hypothesis that vaccines cause autism has been about as thoroughly falsified through research as any health hypothesis can be. Even if, by bending over backward into a back-breaking contortionist pose to be “open-minded”, some people will concede that there’s still a bit of room for reasonable doubt about whether there is no link between vaccines and autism in “susceptible” populations, there is no room for reasonable doubt left over whether vaccines caused the so-called “autism-epidemic” of the last two decades. They did not. Similarly, the mercury-containing preservative thimerosal, which used to be in several childhood vaccines until the end of 2001, when thimerosal was removed from all but some flu vaccines, has been about as cleared of being a cause of autism as it is possible for a substance to be. Basically, if thimerosal-containing vaccines were a cause of autism, we would have expected to see a decrease in autism prevalence beginning three to five years after the removal of thimerosal. Epidemiological studies have failed to find such a decline and have also failed to find evidence of correlation. I realize that anti-vaccine activists argue that there are still trace amounts of thimerosal in some vaccines, but, even so, thimerosal exposure in children fell almost overnight to levels lower than the 1980s, which was before the beginning of the “autism epidemic.” At the very least, one would expect autism rates to fall back to 1980s levels if thimerosal in vaccines were a driving force behind this “epidemic.” They haven’t. Quite the contrary, they’ve continued to climb.

So why does the manufactroversy that vaccines cause autism persist? There is no longer a scientific controversy; by and large, the question has been asked and answered. Vaccines do not cause autism, as far as we can detect. True, it’s impossible to completely prove a negative hypothesis, but if there is any way that vaccines do cause autism, it’s at a level below the ability of large epidemiological studies with tens or even hundreds of thousands of children to detect. Yet the fear persists.

One reason is that it’s very hard to eradicate a false belief, once entrenched. I’ve discussed many times how difficult it is to change people’s minds, as motivated reasoning leads them to seek confirming evidence and discount all else. Disconfirming evidence can even lead people to harden their beliefs even more. In particular, the hardcore anti-vaccine activists who persist in spreading the vaccine-autism myth have an interest and motivation in this mythology at least as potent as the interest pharmaceutical companies have in defending vaccines—more so, arguably, given the emotional attachment people have for their children. After all, all pharmaceutical companies are interested in, according to this mythology, is profit. If a parent, correctly or incorrectly, somehow comes to believe that something or someone has hurt his or her child, it is among the most potent motivations known to do something about it.

Another reason is that the concept has become entrenched in our culture—or at least parts of our culture—to the point where it appears regularly in the media, thus reinforcing the idea among those who don’t pay attention to the issue or those who do but haven’t decided if they believe that vaccines cause autism that maybe there is something to fear. Maybe there is still a controversy. A perfect example appeared in The Baltimore Sun over the weekend entitled We don’t know enough about childhood vaccines and subtitled Researcher asks: Are 36 doses of vaccine by age 2 too much, too little, or just right? I contend that the editors of The Baltimore Sun, by publishing this anti-vaccine propaganda, which would have been at home on the websites of the anti-vaccine blog Age of Autism or on the website of anti-vaccine groups SafeMinds, Generation Rescue, the International Medical Council on Vaccination or the National Vaccine Information Center (NVIC). Examining this article, written by Margaret Dunkle, described as a “senior research scientist at the Department of Health Policy at George Washington University and director of the Early Identification and Intervention Collaborative for Los Angeles County” and as having “a family member who is vaccine-injured,” is what I would consider a “teachable moment” in analyzing the tactics of the anti-vaccine movement.
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Posted in: Public Health, Science and the Media, Vaccines

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Scientific evidence for synergy in a botanical product

So, you’re curious about herbal medicine. Is there any truth to this stuff?

Uncle Howie tells you that he read in the National Enquirer about an herb that has better antibacterial effects on cuts and scrapes than Neosporin ointment — never mind that Neosporin is composed of three different antibiotics that come originally from bacteria themselves.

So you set out on a quest to purchase some of this herb, known colloquially as goldenseal. When you go to your local Whole Hippie Dump-a-Load-of-Cash Emporium you find goldenseal alright, in about twenty different forms. On one side of the aisle are containers with loose, crushed up leaves and roots that look like medical marijuana. On a shelf, you find see-through capsules that seem to contain a powdered version of the herb. Down the aisle a bit you find boxes of blister-packs containing a proprietary extract of free-range goldenseal from the Appalachians harvested under moonlight by bare-breasted virgins. The same company also makes an ointment, allegedly procured the same way.

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Posted in: Basic Science, Herbs & Supplements

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Vaccine Confidence: Attitudes and Actions

Few groups are more hazardous to public health than the anti-vaccine movement — because there’s a body count affiliated with their actions. When vaccination rates drop, communicable diseases re-emerge, and people suffer. While anti-vaccine sentiment will probably persist as long as vaccines are around, we’re fortunate that vaccination rates, on balance, remain very high. In 2009, U.S. vaccination rates for most childhood vaccines were over 90%. And less than 1% are completely unvaccinated. But do high vaccination rates mean that parents have confidence in the safety and effectiveness of vaccines? Most states and provinces maintain public health regulation that require documentation of vaccination status for school or day care admission. So vaccines may be seen as a requirement or obligation which may override lingering concerns. Do concerns remain? That’s what a recent survey undertook to explore. (more…)

Posted in: Vaccines

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The Neurontin Seeding Trial

Any institution that is based upon science is also dependent upon the integrity of the scientific process, and must guard that integrity jealously. That is certainly one of the missions of Science-Based Medicine. A particular challenge is that medicine is a massively expensive enterprise, and growing in both absolute and relative terms. This means that there is a great deal of money at stake (to be potentially earned and spent) and this fact constantly threatens to distort the process of science that is supposed to underlie medicine.

In particular, wherever there are millions or billions of dollars to be made, the motivation to find clever and subtle ways to distort the scientific process is huge. We find such behavior among any industry that has a medical product or service to sell. A recent example of this behavior was recently published in the Archives of Internal Medicine – Study of Neurontin: Titrate to Effect, Profile of Safety (STEPS) Trial.

Krumholz et al. reviewed the documents resulting from Harden Manufacturing vs Pfizer and Franklin vs Warner-Lambert and concluded:

The STEPS trial was a seeding trial, used to promote gabapentin and increase prescribing among investigators, and marketing was extensively involved in its planning and implementation.

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Posted in: Pharmaceuticals

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Electrodermal Testing Part I: Fooling Patients with a Computerized Magic Eight Ball

Remember the Magic Eight Ball toy? You could ask it a question and shake it and a random answer would float up into a window: yes, no, maybe, definitely, etc. There is even a website where you can ask an Eight Ball questions online.

I have been meaning to write about bogus electrodiagnostic machines for a long time. These devices supposedly diagnose diseases and/or energy imbalances, indicate which remedies will correct the problem(s), and sometimes even treat the imbalances by transmitting a balancing frequency to the patient. I knew they were bogus, but I had never really realized the full extent of the deception until I viewed a set of training videos recently sent to me by a correspondent. I had never realized how similar electrodermal testing was to the Magic Eight Ball. I was further amazed at how they managed to combine every kind of alternative medicine into one incoherent package and to bamboozle patients with an appalling display of pseudoscientific babble.

This will be a two-part series. In the first, I will describe what the machines and their operators do. In the second (next week), I will address the legal and regulatory issues.

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Posted in: Acupuncture, Energy Medicine, Homeopathy

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An open letter to NIH Director Francis Collins regarding his appearance at the Society for Integrative Oncology

Note from the editor: Since today is a holiday in the U.S., I had planned on taking the day off. Then I saw the subject of today’s post and had to respond. Also, please remember that, as always, the usual disclaimers apply. This letter represents my opinion, and my opinion alone. It does not represent the view or opinion of my university or cancer center—or anyone else, for that matter, other than me.

Francis S. Collins, MD, PhD
Director, National Institutes of Health

Dear Dr. Collins:

I am normally not one for writing open letters, but in this case I feel compelled to make an exception. This letter will have little or nothing to do with what seems to be the usual criticism leveled against you, namely your intense religious faith and claims. Personally, as a physician and scientist I don’t much care about what religion you follow and, unlike some writers such as Sam Harris, most definitely do not consider your strong Christian faith a disqualification for holding the position that you now hold. All I care about in an NIH director is how well he or she shepherds the scientific mission of the NIH and runs the organization. As a past (and hopefully future) NIH grantee, I want the NIH to fund and support only the most rigorous science and to be a well-run organization. Thus far in your tenure, I haven’t seen any anything major to worry about on that score.

Recently, however, I was very disappointed to discover that you will be the keynote speaker at the 8th International Conference of the Society of Integrative Oncology (SIO) in November. I hope that, when you agreed to accept this speaking engagement, you didn’t know just what it is that what you were accepting or what the Society for Integrative Oncology is, other than a professional society that was interested in hearing your views on faith and spirituality in cancer. In brief, it is our position that “integrative oncology” is a discipline that, at its core, is dedicated to “integrating” pseudoscience with science. No doubt you will think I am exaggerating, but I am not, as I hope to demonstrate. Worse, by agreeing to speak to the SIO, you will be providing it with the imprimatur of your position as NIH director. The NIH, as you know, is the most respected biomedical research institution in the U.S., if not the world, and that respect rubs off wherever you speak.
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Posted in: Faith Healing & Spirituality, Politics and Regulation, Science and the Media

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