Articles

Human subjects protections and research ethics: Where the rubber hits the road for science-based medicine

Arguably the most difficult aspect of science-based medicine is where the rubber hits the road, so to speak. That’s where scientists and physicians take the results of preclinical studies performed in vitro in biochemical assays and cell culture models and in vivo in animal models to humans. There are numerous reasons for this, not the least of which that preclinical models, contrary to what animal rights activists would like you to believe, do not predict human responses to new therapeutic agents as much as we would like. However, the single biggest reason that we cannot answer questions in human studies as easily as we can in cell culture and animal studies is ethics. Of course, answering questions using cell culture and animal studies is not “easy,” either, but performing studies using human beings as subjects is an order of magnitude (at least) more difficult because the potential to cause harm exists, and if harm is caused by the experimental treatment under study, that harm will be done to human beings, rather than cells in a dish or mice bred for research.

The “gold standard” type of study that we do to test the efficacy of a new drug is known as the randomized, placebo-controlled, double-blinded study, often abbreviated RCT. Indeed, this remains the gold standard and is accorded the highest level of “power” in the framework of evidence-based medicine. Of course, as we have argued time and time again, using the RCT to test therapies that are incredibly implausible on a strictly scientific basis (homeopathy or reiki, for instance) inevitably leads to numerous “false positives” in which the therapy appears to produce results statistically significantly better than the control. John Ioannidis has done numerous clever analyses that demonstrate how easily clinical research is led astray if it is not grounded in scientific plausibility. Indeed, the probability of false positive studies increases, the more improbable the modality. It is for these very reasons that we have proposed the concept of science-based medicine, which takes into account estimates of prior probability based on preclinical studies and basic scientific principles, rather than evidence-based medicine, which does not. Indeed, Wally Sampson has even proposed a “plausibility scale” for rating RCTs, and Steve Novella has pointed out how difficult it can be to interpret the medical literature.
(more…)

Posted in: Clinical Trials, Medical Ethics, Politics and Regulation, Surgical Procedures, Vaccines

Leave a Comment (19) →

14 Studies Later*

First off, I have deliberately not read the entries on Fourteen Studies by fellow bloggers on SBM. I wanted to go through the information on the site myself. So if some of the information is repetitive, sorry.

Second, in the interest of openness and transparency, I will state my conflicts of interest up front: none. I have not talked to a drug rep in at least 20 years. Outside of a trip to San Francisco as a fellow, paid for by the company who was funding a drug study my boss was participating in, I have accepted no gifts or money of any kind from big (or little) pharma since I was a medical student. Nothing. I don’t even eat the pizza at conferences (1).

Third, I am a hospital based adult Infectious Disease doctor. I make zero money from vaccines. In fact, I only make money if people get sick with infections. For my bottom line, giving vaccines to prevent disease is counter productive to my bottom line.

Why 14 studies?
(more…)

Posted in: Public Health, Science and the Media, Vaccines

Leave a Comment (37) →

J.B. Handley, Generation Rescue, and attacks on critics

I am writing this because a colleague of mine has been attacked, specifically, our fearless leader Steve Novella. J.B. Handley, Founder of “Jenny McCarthy and Jim Carrey’s Autism Organization – Generation Rescue” (whose usurpation by Jenny and Jim was apparently done in an opportunistic fashion but has had a consequence that must be galling to J.B., namely that some interviewers apparently think that Jenny McCarthy and Jim Carrey, not J.B. and his wife, are the true founders of Generation Rescue), did not like something that Steve wrote and in his characteristic fashion, has responded with a vicious ad hominem attack. Normally I wouldn’t feel obligated to put my two cents in, as Steve is more than capable of taking care of himself in a scientific argument and quite able to refute anything J.B. can throw at him. Moreover, whenever J.B. Handley attacks someone in a fashion this nasty, it is an excellent indication that the person he is attacking has scored some serious points against him. Indeed, I have twice been on the receiving end of J.B.’s tirades on the Generation Propaganda blog Age of Autism. On one occasion, he referred to me as the “worldwide wanker of woo,” and on another occasion seemed to think that I criticized Generation Rescue so harshly because I “don’t like full page ads,” rather than because I hate pseudoscience and anti-vaccine nonsense. When criticism really hits a nerve with J.B. Handley, he lashes out in a characteristic fashion. Clearly Steve’s reasoned, level-headed criticism of the latest Generation Rescue anti-vaccine propaganda initiative did just that.

In this case, however, I feel some explanation is in order because I feel a bit responsible for having brought J.B.’s wrath down upon Steve. First, a little history (albeit recent history) is in order. As I described in detail last week and the week before, Generation Rescue, with Jenny McCarthy and Jim Carrey at the fore, sometimes with J.B. himself, has mounted an impressive anti-vaccine propaganda effort. It started with a media tour promoting her most recent paean to anti-vaccine pseudoscience and autism quackery written with “co-author” Dr. Jerry Kartzinel. The book is entitled Healing and Preventing Autism: A Complete Guide, and three weeks ago Jenny McCarthy and her boyfriend Jim Carrey showed up on Larry King Live to tout a truly incompetent and intellectually dishonest “study” that purported to find that U.S. children are the “most highly vaccinated children in the world” and that that’s correlated with our higher autism rates. I would have none of it. Next, Generation Rescue introduced its equally intellectually dishonest “Fourteen Studies” website, which launched dubious attacks from pseudoexperts on fourteen of the major studies that failed to find a correlation between vaccines and autism or thimerosal-containing vaccines and autism. I wrote a lengthy post for SBM describing the utter intellectual and scientific bankruptcy of the entire enterprise.
(more…)

Posted in: Public Health, Science and the Media, Vaccines

Leave a Comment (36) →

Double-Talk And Paternalism

One of the more frustrating things about practitioners who promote unsafe and scientifically discredited medical practices is their tendency to change their message for different audiences. One day they’ll tell you that they espouse only evidence-based practices and the next they’ll be promoting snake oil. This double talk is hard to combat, since to disprove them one would essentially have to provide a video of their contradictory remarks.

One day I participated in a series of business meetings with a CAM practitioner in attendance (he was an MD who graduated from UCSF). During one meeting he boldly proclaimed his support of scientifically rigorous research, and praised the Cochrane Collaborative’s efforts to provide systematic reviews of the evidence (or lack thereof) for various practices.

Several hours later we were sitting together in another meeting in which I objected to the publication of a consumer article that would assist parents of children with autism in finding a DAN! practitioner who could provide chelation therapy to their children. I explained that there was no evidence for the efficacy of such treatments, and plenty of evidence for their harm (including the death of at least one child that I’d read about in the news). I suggested that an article describing these dangers might be in order, but that an article encouraging chelation use for autism was simply unethical and I would not allow it to be published.

Instead of agreeing with me, the CAM MD suggested that I was being “narrow” and that I should allow consumers to “explore all their options.” I was stunned. This was the same person who had just said that he fully supported scientific inquiry. So I asked him how he could say that he supported evidence-based medicine, and then turn around and ignore evidence at will – even at the peril of human life.

His response dumbfounded me:

“I am just as comfortable practicing within an evidence-based framework as I am outside it.”
(more…)

Posted in: Public Health, Science and Medicine

Leave a Comment (19) →

Pseudoscience In Medical News at the Huffington Post

As many have pointed out, we are in the midst of a transformation in the way news is created, distributed, and monetized – all brought on by the internet. Access to information has dramatically increased, while the traditional news outlets are fading away. The new internet-based outlets that are cropping up are often hybrids that do not fit into any existing definition. Science-based medicine itself is such an outlet – it’s primarily a group professional blog, but we have editors and take submissions. We also plan to expand the type of resources available on SBM. We’re experimenting.

Others, like Plos ONE, are experimenting with open-access peer-reviewed journals. And there are online newspapers that are part blog, part news feed, part something else.

While we are in this phase of experimentation it is important to monitor quality control, as the old institutions lose their grip on the flow of information. Health information in particular, now the most common type of information on the internet, suffers from poor quality control, leading the average consumer with too much information of too low quality.

(more…)

Posted in: Science and the Media

Leave a Comment (55) →

Is IV Sedation Over-Used?

We criticize alternative medicine for not being evidence-based, and they criticize conventional medicine in turn, saying that much of what conventional medicine does is not based on evidence either. Sometimes that criticism is justified. I have run across a conventional practice that I suspect began because it sounded like a good idea, but that never was adequately tested and is not carefully thought out for individual patients.

I recently had a bone marrow aspiration. The written instructions said not to eat or drink for 6 hours before the procedure, to bring someone to drive me home, and to expect an IV. I suspected from these instructions that they were planning to use IV sedation, and I was right.

I questioned the need for sedation. I am prejudiced about bone marrow aspirations. I observed several and did one myself during my internship. When I had finished, the patient asked me when I was going to start. We did the procedure at the patient’s bedside in a multi-bed ward with no sedation, only local anesthesia. So my prejudice was that the procedure was no big deal and was not terribly painful.

I can imagine that some patients may be terrified by the idea of a needle going into their bone and may want to be sedated and not remember the experience. But I was not anxious about it, and I saw no need for the fentanyl and Versed they wanted to give me. I figured it would only prolong my time in the hospital, produce amnesia, expose me to a small risk of adverse effects, and leave me groggy; so I asked to opt out. They readily agreed – although they did keep asking me if I was really sure I didn’t want it. They would not have offered the option of no sedation if I had not known to ask. (more…)

Posted in: Pharmaceuticals, Surgical Procedures

Leave a Comment (46) →

Mathematically modeling why quackery persists

ResearchBlogging.orgIt’s often puzzled me (and, I daresay, many other skeptics and boosters of science- and evidence-based medicine) why various forms of quackery and woo that have either about as close to zero prior probability as you can get and/or have failed to show evidence greater than placebo in clinical trials manage to retain so much traction among the public. Think homeopathy. Think reiki. The former is nothing more than sympathetic magic prettied up with science-y sounding terms, while the latter is nothing more than faith healing given a slant based on Eastern mysticism and religion instead of Christianity. Indeed, reiki was even inspired by stories of Jesus’ healing powers, complete with a trip into the wilderness for fasting and prayer, resulting in revelation. Or consider acupuncture, a modality that is seemingly more popular than ever, even invading the very sanctum sanctorum of the ivory towers of academic medicine, yet every study of which that is done under rigorous conditions with proper placebo controls shows it to be no more efficacious than a placebo. It’s easy enough to shake one’s head and chalk it up to irrationality, ignorance of science, or even religious faith, but I’ve always been dissatisfied with such glib explanations, even though admittedly I have myself used them on occasion.

That’s why a study released last week in PLoS One by Mark M. Tanaka, Jeremy R. Kendal, Kevin N. Laland out of the Evolution & Ecology Research Centre, School of Biotechnology & Biomolecular Sciences, University of New South Wales, the Department of Anthropology, University of Durham, and the School of Biology, University of St Andrews, Fife, respectively, entitled From Traditional Medicine to Witchcraft: Why Medical Treatments Are Not Always Efficacious. Besides loving the title, I also like the methodology, which in essence adapts the tools of modeling evolution and the spread of traits throughout a population and asks the question: Why do ineffective or even harmful (or, as the authors characterize them, “maladaptive”) treatments for various illnesses persist in populations? The results are surprising and counterintuitive, yet ring true. In essence, the authors conclude that the most efficacious self-treatments are not always the ones that spread and that even harmful treatments can spread. Both of these observations are entirely plausible based on the prevalence of usage of common woo and quackery, and what the authors have done, in essence, is to model mathematically why quackery persists.

Indeed, the authors set the stage:
(more…)

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

Leave a Comment (30) →

Harvard Medical School: Veritas for Sale (Part V)

September 26, 2002

Kimball Atwood, M.D.
xxxxxxxxxxxxxxx
xxxxxxxxxxxxxxxxx

Dear Kim,

I have now had time to look into the allegations in your letter of June 14th which, incidentally, I shared with Dr. David Eisenberg and he with several others. I have sought consultation about our exchanges and the gist of my response follows.

Some of your concerns and allegations are very helpful and constructive. Perceptions are particularly important in controversial fields where there is limited objective proof. Your cautions and interpretations in this area have been very useful to us.

Some of what you said is just plain wrong. This includes the allegation the Harvard has “a stake” in the area and therefore would not look into your allegations objectively. Relatedly, Dr. Howard Koh has written us a construction of the events in the Massachusetts Special Commission that is strikingly different from yours. And Dr. Anthony Komoroff has pointed out that many of your comments about the InteliHealth treatment of CAM are now grossly out of date as the material inherited from another provider has been reviewed by HMS faculty and modified. [Indeed, you have referred in other correspondence to modifications you have noticed.] Dr. Komaroff also commented on the misleading way your citation the treatment of homeopathy was disconnected from the rest of the paragraph.

Some of what you said is a matter of taste or interpretation, where even well intentioned people may disagree. In this particular area I have weighed your arguments carefully and, in places, learned from them.

But I think the biggest difference may be in a misperception about what our purposes are. The Council of Academic Deans of Harvard Medical School approved beginning a Division of Research and Education in Complementary and Alternative Therapies with exactly the focus described. Our goal is to do peer-reviewed basic and clinical research on the claimed, but unproven, efficacies of complementary and alternative approaches to therapeutics. The recent scientific sessions and requests for proposal held by the Division are clear testament to this intent. In addition, in common with the Association of American Medical Colleges and most of the allopathic schools of medicine, we intend to teach our students something about CAM and in particular how to assess its claims rigorously. We do not, repeat NOT, have any intention of making our students CAM practitioners. They have enough to do learning what we have always focused on.

Sincerely,

Daniel D. Federman, M.D.

cc: David M. Eisenberg, M.D.

………………………….

(more…)

Posted in: Health Fraud, Medical Academia, Medical Ethics, Science and Medicine, Science and the Media

Leave a Comment (23) →

Homeocracy

Recent comments on homeopathy again resulted in references to the 1994 Pediatrics paper by Jacobs et al on use of homeopathic remedies for childhood diarrhrea.  The authors of that paper concluded from their blinded study that homeopathic remedies, tailored to the individual infants and children, were effective in reducing the number of diarrhea stools and thus in shortening the illness.  The paper has been widely referenced and reported to have proved  homeopathy efficacy, and the critiques have been argued by homeopaths as irrelevant, as has been done by Mr. Ullman.

In this short series I want to recount my experience with the report, its predecessor, and its two major sequellae, as well as its effect on systematic reviews of homeopathy.  I will begin with a description of the first two studies, concentrating on their methods. Then I will discuss the results of the 1994 Pediatrics report and the authors’ interpretation of the results. Then (I hope last) I will discuss the third paper which the authors claimed supported findings of the first two and the meta-analysis which combined data from all three. If you are imagining why this  series interests me, and imagining the worst, you are probably right. The sequence will  help to reveal how some of the information in “holistic” and “alternative” systems become published, and despite critiques and disproofs through a sort of systematic deconstructions, still develop wheels of their own and enter the fund of general knowledge seemingly forever. Or, at least for several decades, until a social belief switch is finally turned off.
(more…)

Posted in: Basic Science, Clinical Trials, Homeopathy

Leave a Comment (25) →

Differences Of Opinion

After my fairly recent awakening from shruggieness  (i.e. a condition in which one is largely unaware of or uninterested in CAM) I decided to discuss my concerns about pseudoscience with my friends. One particular friend is a nationally recognized physician who believes in the importance of accurate health information and the promotion of science. However, he sees no urgent need to warn people against snake oil, and so long as it’s correctly labeled he doesn’t seem to mind it co-existing with scientific alternatives.

My friend and I had dinner a few weeks ago, and our conversation was both animated and disappointing. I somehow felt inadequate in conveying my objections (both ethical and scientific) to the promotion of pseudoscience. My best explanations were met with cheerful rebuttals, and while not intellectually convincing to me, those retorts satisfied my friend just fine. I guess the bottom line was that he was more interested in maintaining his position than reconsidering it… and so it left me feeling rather frustrated and a little sad.
(more…)

Posted in: Science and Medicine

Leave a Comment (42) →
Page 171 of 213 «...140150160169170171172173...»