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Conflicts of Interest

When an article is published in a medical journal, the authors must disclose any conflicts of interest. This is important, because even if they think owning stock in the drug company won’t influence their scientific judgment, we know that subtle biases can creep in to somehow affect the findings of studies. It has been shown that studies funded by drug companies are more likely to get positive results for their drug than studies funded by independent sources. Andrew Wakefield, author of the infamous retracted Lancet study suggesting a relationship between MMR vaccine and autism, was severely chastised for not disclosing that he received money from autism litigators and expected to earn a fortune from his own patented products if the MMR vaccine could be discredited.

I was recently contacted by an acupuncturist who plans to critique an article I wrote. It was a commentary in the journal Pain that accompanied a systematic review of systematic reviews of acupuncture by Ernst et al. For details of Ernst’s and my articles, see my previous post. He challenged my statement that I had no conflicts of interest to report. He apparently thinks I should have said I have a conflict of interest in that I am anti-CAM and anti-acupuncture. When he writes about my article, he plans to attack me for not declaring this alleged conflict of interest and he plans to set a good example with a conflict of interest statement of his own, divulging that he makes his living practicing acupuncture, has financial investments in it and many personal relationships, that his self-identity and prestige are dependent on his belief in acupuncture’s efficacy, and that he is biased towards constructivism and away from positivism. (I think this is a fancy way of saying he favors experience over the scientific method.) I agree that he has conflicts of interest, but was I wrong to say I had no conflicts of interest? I don’t think so. (more…)

Posted in: Science and Medicine

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GSK Tells BC and Goody’s to Take a Powder

After spending the first 21 years of life in New Jersey and Philadelphia, I ventured to the University of Florida for graduate school. For those who don’t know, UF is in the north-central Florida city of Gainesville – culturally much more like idyllic south Georgia than flashy south Florida.

It was in Gainesville – “Hogtown” to some – that I first encountered the analgesic powder. I believe it was BC Powder, first manufactured just over 100 years ago within a stone’s throw of the Durham, NC, baseball park made famous by the movie, Bull Durham. I remember sitting with my grad school buddy from Kansas City watching this TV commercial with hardy men possessing strong Southern accents enthusiastically espousing the benefits of BC. I looked at Roger – a registered pharmacist – and asked, “what in the hell is an analgesic powder?”

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Posted in: Humor, Pharmaceuticals, Science and Medicine

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What does a new drug cost?

Despite the variety of health systems across hundreds of different countries, one feature is near-universal: We all depend on private industry to commercialize and market drug products. And because drugs are such an integral part of our health care system, that industry is generally heavily regulated. Yet despite this regulation, little is publicly known about drug development costs. But aggregate research and development (R&D) data are available, and the pharmaceutical industry spends billions per year.

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Posted in: Clinical Trials, Pharmaceuticals, Science and Medicine

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The Role of Experience in Science-Based Medicine

Before we had EBM (evidence-based medicine) we had another kind of EBM: experience-based medicine. Mark Crislip has said that the three most dangerous words in medicine are “In my experience.” I agree wholeheartedly. On the other hand, it would be a mistake to discount experience entirely. Dynamite is dangerous too, but when handled with proper safety precautions it can be very useful in mining, road-building, and other endeavors.

When I was in med school, the professor would say “In my experience, drug A works better than drug B.” and we would take careful notes, follow his lead, and prescribe drug A unquestioningly. That is no longer acceptable. Today we ask for controlled studies that objectively compare drug A to drug B. That doesn’t mean the professor’s observations were entirely useless: experience, like anecdotes, can draw attention to things that are worth evaluating with the scientific method.

We don’t always have the pertinent scientific studies needed to make a clinical decision. When there is no hard evidence, a clinician’s experience may be all we have to go on. Knowing that a patient with disease X got better following treatment Y is a step above having no knowledge at all about X or Y. A small step, but arguably better than no step at all. (more…)

Posted in: Science and Medicine

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Can Vitamin C Induce Abortion?

Editors Note: This is a guest contribution from two medical students, one from Chicago and one from Queensland. If you like their work, we’ll consider having them write more for us.

Authors:

Andrey Pavlov Jr.
UQ-Ochsner
University of Queensland School of Medicine

Igor Irvin Bussel
Chicago Medical School
Rosalind Franklin University of Medicine and Science

In hopes of joining the SBM movement as medical students, we wanted to take aim at a topic that has yet been finely dissected a la Novella or logorrheicly dismembered a la Gorski. Having realized that a fellow medical student, Tim Kreider, is already addressing integrative medicine on campus, we decided that we would attempt to find a controversial topic that has yet to be addressed on SBM. A serendipitous question from a friend sent us on a mission to explore the pseudo-scientific underbelly of the web and science-based rationale of the claim that vitamin C can induce abortion.

The World Wide Web is a stranger place than we can ever imagine. Most users are aware that they can’t believe everything they read on the Internet, yet they often feel like Sherlock Holmes when they find an esoteric and isolated clue to their own unique health puzzle. Recently, we were asked if there was a connection between vitamin C, menstruation and abortion. We were caught off guard by the question, finding it such a strange connection to make. The story, it seems, is that our friend had come down with a cold and taken mega doses of vitamin C to stave it off (another false belief, but not the subject here). A couple of days later her menses began and she was surprised since it was 4 days earlier than normal. She of course turned to Dr. Google and was quickly provided with numerous sources indicating that indeed, vitamin C would induce the start of a menstrual cycle and can even act as a “natural” abortefacient and a substitute for the ‘morning after’ pill. Being a bit more keen than your average Dr. Google user, she was surprised and continued searching, trying to find evidence to contradict these claims. Alas, she found nothingexcept more sites parroting and corroborating the claim. Then she realized she knew a couple of medical students and asked us what we thought. Our literature review turned up a slew of websites using the standard repertoire of trite pseudo-scientific tactics. Any attempt to find a credible source, validated claim, or independent consensus proved futile.
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Posted in: Clinical Trials, Science and Medicine

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The Hazards of “CAM”-Pandering

Steven Salzberg, a friend of this blog and Director of the Center for Bioinformatics and Computational Biology at the University of Maryland, is on the editorial boards of three of the many journals published by BioMed Central (BMC), an important source of open-access, peer-reviewed biomedical reports. He is disturbed by the presence of two other journals under the BMC umbrella: Chinese Medicine and BMC Complementary and Alternative Medicine. A couple of days ago, on his Forbes science blog, Dr. Salzberg explained why. Here are some excerpts:

The Chinese Medicine journal promotes, according to its own mission statement, studies of “acupuncture, Tui-na, Qi-qong, Tai Chi Quan, energy research,” and other nonsense. Tui na, for example, supposedly “affects the flow of energy by holding and pressing the body at acupressure points.”

Right. What is this doing in a scientific journal?… I support BMC…But their corporate leaders seem to care more about expanding their stable than about maintaining the integrity of science. Chinese Medicine simply does not belong in the company of respectable scientific journals.

Forming a scientific journal whose goal is to validate antiquated, unproven superstitions is simply not science, whatever the editors of Chinese Medicine claim.

BMC should be embarrassed to be publishing journals that promote anti-scientific theories and otherwise muddy the literature. By supporting these journals, they undermine the credibility of many excellent BMC journals. They should cut these journals loose.

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Posted in: Acupuncture, Clinical Trials, Energy Medicine, Herbs & Supplements, History, Homeopathy, Medical Academia, Pharmaceuticals, Science and Medicine, Science and the Media

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Asian Bear Bile Remedies: Traditional Medicine or Barbarism?

Imagine living 20 years spending 24 hours a day in a cage that tightly fits your body, not giving you room to stand up, stretch out, turn around, or move at all.

Imagine that twice a day during these years you would have a metal catheter inserted into a hole which has been cut into your abdomen, allowing the catheter to easily puncture your gall bladder, or maybe a long syringe inserted into your gall bladder, piercing through your skin again and again, by people who are not doctors.

Imagine becoming infected and cancerous because of this twice-daily physical invasion, and becoming neurotic due to your claustrophobic imprisonment.

Imagine having one or both of your hands cut off so someone can sell them for a lot of money.

Imagine you begin to chew at your hands, if you are lucky enough to have one or both left, due to your developing neuroticism, and to distract yourself from the pain you experience twice a day, every day, for your entire life.

This is reality for an estimated minimum of 12,000 bears across Asia.

– Sara Pegarella, JD

Currently, animal activists across China are up in arms because Gui Zhen Tang Pharmaceutical Corporation, a Fujian-based company that sells bear bile for use in Traditional Chinese Medicine (TCM), has tried to increase production through an initial public offering (IPO). The company is being accused of cruelty towards animals in the process of extracting their bile at an industrial scale. Bear bile, or Xiong Dan (熊胆), is an important ingredient in TCM.

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Posted in: Medical Ethics, Politics and Regulation, Science and Medicine

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CAM and Evidenced-Based Medicine

Mark Tonelli, MD has problems with evidence-based medicine (EBM). He has published a few articles detailing his issues, and he makes some legitimate points. We at science-based medicine (SBM) have a few issues with the execution of EBM as well, so I am sympathetic to constructive criticism.

In an article titled: Integrating evidence into clinical practice: an alternative to evidence-based approaches. The abstract states:

Evidence-based medicine (EBM) has thus far failed to adequately account for the appropriate incorporation of other potential warrants for medical decision making into clinical practice. In particular, EBM has struggled with the value and integration of other kinds of medical knowledge, such as those derived from clinical experience or based on pathophysiologic rationale. The general priority given to empirical evidence derived from clinical research in all EBM approaches is not epistemically tenable. A casuistic alternative to EBM approaches recognizes that five distinct topics, 1) empirical evidence, 2) experiential evidence, 3) pathophysiologic rationale, 4) patient goals and values, and 5) system features are potentially relevant to any clinical decision. No single topic has a general priority over any other and the relative importance of a topic will depend upon the circumstances of the particular case. The skilled clinician must weigh these potentially conflicting evidentiary and non-evidentiary warrants for action, employing both practical and theoretical reasoning, in order to arrive at the best choice for an individual patient.

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Posted in: Science and Medicine

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Help – My Doctor is a Crank!

I often receive e-mail from SBM readers (or SGU listeners) who have had the experience of their doctor, nurse, dentist, physical therapist, or other health care provider recommending to them a treatment option that seems dubious, if not outright pseudoscientific. They want advice on what to do.  There are common themes to the e-mails – the writer often feels very uncomfortable in the situation. They do not feel comfortable confronting their provider directly, yet they do not want to acquiesce to the advice either. They are also often asking my opinion about the advice – is it really as wacky as it seems. This uncertainty saps them of their resolve, leaving them feeling a bit helpless.

Here is one such e-mail:

Ten days ago, my wife and I welcomed our first child into the world. She was born a couple weeks early, which left her mouth a bit too small and week to breastfeed effectively. To prevent her from losing too much weight, we were referred to a lactation consultant (who works out of the pediatrics department at the hospital where our daughter was born). This consultant (who is also an RN) suggested a regimen of supplementing nursing with pumped breast milk.

This was working great until my wife’s milk production dropped the day before our follow-up appointment. When we asked what to do about this, the nurse recommended that my wife take fenugreek, an herbal supplement. I was a bit skeptical of this advice, so I asked what it was about fenugreek that helped with milk production. The lactation nurse’s answer was vague — she said things like, Herbs can be helpful for lots of health issues, and, a lot of women I see seem to think it helps (oh, the logical fallacies). When we pushed her on this a little more, she handed us a flyer, printed by the hospital about fenugreek. The flyer seemed to support the use of the supplement, but mentioned that there was no scientific research demonstrating that fenugreek increases milk supply. When we asked why it hadn’t been researched, the nurse responded that there wasn’t a lot of money in lactation and that scientists generally aren’t interested in the kind of things she does (basically, that she was doing the good work that cold-hearted scientists refused to do).

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Posted in: Science and Medicine

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Triskaidekaphobia times two.

There is germaphobia, the fear of germs. Or Germans.  One of the two. Oddly, I do not fear most germs, despite my daily reminders as to how destructive these wee beasties can be.   I recognize their limits and my immunologic strengths and know I have more to fear from cars or unsaturated fats than E. coli or influenza.

There is also a fear of vaccines, the too many too soon that is said to be at the heart, or maybe the left atrial appendage, of one of the imaginary problems with vaccines.  There are, by my counting, 5 live attenuated viruses and 21 different antigens in the vaccine schedule by age 6, for a total of 26 or twice thirteen.  Some fear those antigens and viruses, making it a  triskaidekaphobia times two (1).

From my perspective the paltry quantity of antigens children receive with the vaccine schedule are, when compared to the enormity of antigens in the environment, a rounding error.  We are awash in bacteria, fungi, viruses and an enormous number of environmental organisms.  I think of each of us like Pig-Pen, but instead of dirt, we are in a cloud of micro-organisms.

Our immune systems, contrary to the opinions of the unimaginative who direct scorn and derision at Dr. Offit, can cope.  As discussed, we have a ability to stave off the phenomenal number of organisms that would just as soon use us as the ultimate supersized meal.  Of course, it is not all the immune system that keeps the wee beasties away.  Being warmer than ambient temperature helps.  Understanding disease epidemiology, hygiene and the prn malum q 24 h also keeps the doctor away. (more…)

Posted in: Science and Medicine, Vaccines

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