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WHO Statement on Reporting Clinical Trials

Flag of the World Health Organization (WHO)

Flag of the World Health Organization (WHO)

The World Health Organization (WHO) has recently released a new position statement on mandatory reporting of all interventional clinical trials. This is a positive step in the trend towards higher quality and greater transparency in clinical trials.

The underlying ethical concept here is that the public has a right to data that results from experimentation on humans. The researchers do not ethically own that data. They have been granted the privilege of performing research on humans as part of a social contract that includes the timely public reporting of the data.

The WHO statement calls for all registered clinical trial results to be made public in an open-access public forum in a searchable format within 12 months, and publication in the peer-reviewed literature within 24 months. They urge more rapid dissemination, but state that the 12/24 month time frame is the upper limit of when results should be reported.

The WHO statement is part of a larger trend toward greater transparency but also quality in scientific research. It is part of a recognition that we cannot understand how to best practice medicine and allocate resources based upon individual studies. We need to look at the entire scientific literature as a whole. Even when individual studies may be of high quality, there are many potential factors that can distort the scientific literature and therefore misinform doctors, scientists, and regulatory agencies. (more…)

Posted in: Science and Medicine

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The Wild West: Tales of a Naturopathic Ethical Review Board

Two recent SBM posts have used the “Wild West” metaphor for poor health care regulation. Arizona may be the wildest: a worst-case scenario of a state licensing pseudoscience as medicine, under the cover of so-called naturopathy “research.” (Photo courtesy of the Orange County Archives, some rights reserved).

Right before I left the naturopathic profession, an Arizona naturopath told me that “all NDs are doing something borderline illegal.” Alarmed, I began looking around me.

Arizona naturopathic cancer clinics promote illegal substances, advertise results that are too good to be true, and use compounds that have yet to be proven effective in humans. Many clinics focus on intravenous therapies using ozone, hydrogen peroxide, sodium bicarbonate, vitamin C, and blood UV irradiation; some drugs and herbal preparations for injection are claimed to be imported from Europe.

In Arizona, current regulation enables naturopaths to craft hollow research projects under the cover of a private naturopathic institutional review board (an IRB, also often called an ethical review board). This allows them to legitimize experimentation on patients in private clinics and expand the naturopathic scope of practice in the name of so-called research. The IRB appears to influence the state’s naturopathic board, which seems reluctant to do its job properly.

Naturopathic regulation in Arizona may be the worst-case scenario of any state licensing pseudoscience as medicine. The ramifications are grave. Patients, especially those with cancer or other serious conditions, are easily duped and can be severely harmed by medical practitioners who seem kind, charismatic, and confident, but are actually inept and experimenting without the oversight of an ethical review board.

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Posted in: Health Fraud, Legal, Medical Ethics, Naturopathy, Science and Medicine

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March Madness: Basketball, Brackets and Psi! Oh my!

complicatedgraph

A complicated graph, shown here mere moments before proving the existence of precognition

In 2011, psychologist Daryl Bem published a highly controversial series of nine experiments designed to tease out the potential existence of precognition, the ability to experience future events. In order to isolate the potential influence of future events on the present, Bem’s experimental design reversed the standard order of psychological investigations. In one experiment, for example, subjects were allowed to practice with random words after having already taken a memory test comprised of some of them.

Bem’s results were controversial for many reasons, mostly because they were positive. But the question of whether or not they should have even been published in the first place, regardless of the results, was raised by many in the scientific and skeptical community. As history has shown us repeatedly, the risk of falsely legitimizing nonsense by publishing positive but typically poorly-designed studies is very real. And negative studies tend to be ignored by believers and policy makers.

Bem’s experimental design was made available from the beginning of his research in 2002, and he encouraged others to perform their own studies. Unfortunately for Bem, attempts at replicating his findings were largely reported, if not always published, as negative. Apparently this was not enough to discourage the intrepid believer. In fact, he currently has a meta-analysis of 90 experiments using the same protocols as his original research under editorial review.

The conclusions of his new analysis [PDF] are, not surprisingly, supportive of the existence of precognition, and in his manuscript he attempts to address all of the skepticism regarding his findings. He even quotes Feynman and implies that physicists are taking the possibility of quantum-based explanations of psi seriously. It’s an interesting read to say the least.

What does NCAA basketball have to do with the topic of psi research?

A new name in the field of parapsychology research has been making headlines since going public with his efforts on the 1st of the month, and not surprisingly the media coverage is increasing now that his findings have been announced. Dr. Mort Fishman, a psychologist and paranormal researcher out of Tuono di Legno University in Florence, has ingeniously incorporated one of the world’s most popular sporting events, the NCAA Men’s Basketball Tournament, into a study of precognitive abilities. The results, if they are to be believed, may change the minds of even the hardiest psi skeptics.

In anticipation of March Madness each year, millions of basketball fans around the world fill out tournament brackets in an attempt to correctly predict which teams will win, and ultimately who will emerge victorious from the championship game. Many make a contest out of it, with office pools now a nearly ubiquitous aspect of life this time of year. ESPN even holds a Tournament Challenge, the winner of which is given a chance for $20,000 and a trip to Hawaii. It might even be Mitt Romney this year, leading some to regret their vote in the 2012 Presidential election.

The reasons people give for their choices are myriad, ranging from a thorough evaluation of the various teams’ stats to something as primitive and powerful as a gut feeling or how cute the mascot is. Fishman, an avid basketball fan who played three seasons for the European Basketball Federation’s Florence Nightingales, set out at the beginning of the NCAA college basketball season to determine if there might be a precognitive component to these choices. Inspired by Bem’s study designs, he also incorporated a reversal of standard protocols into his research.

The typical approach to filling out a bracket is to do so before the first game of the tournament. In fact, most official contests require it in order to avoid any unfair advantage. Fishman, who had a league record foul-to-rebound ratio of 2.5 during his stint on the Nightingales, instead asked study participants to fill out their bracket after the completion of the championship game, which was won by beloved perennial tournament underdogs, the Duke Blue Devils. According to Fishman, the most challenging aspect of the study was preventing participants from being exposed to any potential contamination with information about the teams during the season.

We went to great expense to protect subjects from potential bias or even outright cheating by basing their bracket picks on outside information. They were sequestered in a reasonably priced hotel, without access to the internet, television, or radio from November 1st of last year through Monday night. They were not allowed to speak to anyone outside of each other and us. No family. No friends. I think there were a few old Reader’s Digests and maybe a Redbook in the room. Progress requires sacrifice.

Once the brackets were completed and turned over to the research team, the real science began. Each subject entered a sensory deprivation tank and was randomly exposed to the results of 25 of the tournament’s 67 total games. The brackets were analyzed using math to see if subject picks were retroactively impacted by knowing the result of games after the fact. Choosing to courageously forego the stifling process of peer review, Fishman announced the positive findings at a press conference held in the parking lot of a Buffalo Wild Wings eight minutes from Lucas Oil Stadium on East Washington Street in Indianapolis.

Conclusion

As believers in Science-Based Medicine, we must have open minds when it comes to fringe or even highly implausible claims because you never know when seemingly-incontrovertible assumptions about the natural world will be proven wrong. Science is imperfect and historically has been very wrong on many occasions. Experts used to believe that the Earth was flat and we still don’t know how Tylenol even works.

Intellectual humility is a key component of scientific skepticism. Sometimes ideas which were ridiculed turn out to be true. Having a closed mind might help prevent any untrue new idea from being accepted, but some of them are pretty interesting and already very popular with the public. Who are we to judge truth from fiction?

Though the existence of psi has now been proven by the Fishman study, it doesn’t mean that more studies aren’t needed. In fact, the hard part lies ahead. We need to figure out how best to harness its potential in order to improve patient outcomes, and only science can lead the way in that regard. But we must not be afraid of the unknown or of different approaches to discovery. As Endocrinologist Dr. Deepak Chopra said, “All great changes are preceded by chaos.”

 

 

Posted in: Humor, Science and Medicine

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Wikipedia vs Quackery – Standards vs Chaos

Wikipediasmall

Wikipedia’s front page

Wikipedia, an online open-source encyclopedia, can boast 470 million visitors each month, making it one of the most popular websites on the internet. It is an incredibly useful resource – I think it’s fair to say it is the online reference of record. For that reason people care how topics important to them are represented in Wikipedia.

Wikipedia, in fact, has become no less than a battleground over certain controversial topics. In essence people generally want Wikipedia to reflect their opinions on controversial topics, and if it doesn’t then there must be something wrong with Wikipedia (rather than there being something wrong with their opinions). I don’t mean to imply that Wikipedia always gets it right – it is a crowdsourced reference and the content is only as good as the editors. But at least they make honest efforts to be neutral and to have standards.

Those standards are the real conflict here, and it is part of a broader conflict over standards. In medicine there is a standard of care, which in turn is based on an underlying system of professional and scientific standards. Medical education is standardized, students have to pass standardized exams, post-graduate clinical training is standardized, there are standardized exams for specialty certification, there are ethical standards enforced by institutions, hospitals, professional organizations, and the state boards of health, and peer-reviewed journals have standards.

This is all meant to ensure that individual patients receive the highest quality of care.

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Posted in: Politics and Regulation, Science and Medicine

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Psychology and Psychotherapy: How Much Is Evidence-Based?

psychology gone wrong
Despite all those Polish jokes, Poland has its share of good scientists and critical thinkers. A superb new book illustrates that fact in spades:

Psychology Gone Wrong: The Dark Side of Science and Therapy, by Tomasz Witkowski and Maciej Zatonski, Witkowski is a psychologist, science writer, and founder of the Polish Skeptics Club; Zatonski is a surgeon and researcher known for debunking unscientific therapies and claims in clinical medicine. Together, they turn a spotlight on research and treatment in the field of psychology. They uncover distressing flaws, show that many commonly accepted psychological principles are based on myths, argue that psychotherapy is a business and a kind of prostitution rather than an effective evidence-based medical treatment, and question whether psychotherapy should even exist, since in most cases it offers no advantage over talking to a friend about one’s problems, and in some cases can cause harm. (more…)

Posted in: Book & movie reviews, Neuroscience/Mental Health, Science and Medicine

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Separating Fact from Fiction in the Not-So-Normal Newborn Nursery: Chiropractic and Craniosynostosis

cranialsutures

Pediatricians, particularly those who spend a significant amount of time caring for newborns, see a lot of babies with unusually-shaped heads. Although to be fair, the fact that the overwhelming majority of vaginally-delivered babies, and quite a few born via Caesarean section, will have a transient and abnormal shape to their heads makes it, well, not unusual. In fact, I rarely make it out of the room without some discussion and reassurance regarding the lumps and bumps of a new arrival’s head.

The potentially lumpy and misshapen head of the newborn occurs for a variety of reasons, some common and some extremely rare. It often is related to the development of the bones of the skull but can also involve the surrounding tissues of the scalp. A vaginal delivery, and some difficult Caesarean births, subject a baby’s head to a lot of pressure. This pressure frequently results in swelling of the scalp that can be quite impressive, but tends to resolve in a day or two.

This same pressure can also cause bleeding, perhaps because of an insufficient amount of vitamin K available to optimally activate clotting, that collects under the top layer of one or more of the bones of the skull. These cephalohematomas can also be impressive and may take weeks to completely resolve. Rarely the trapped blood becomes calcified and requires surgical correction to remove the otherwise-permanent lump and restore a normal contour to the head.

Newborns very frequently have a molded skull. Depending on the timing and severity of the pressure experienced during delivery, the shape and size of the uterus and positioning of the baby in the womb, the newborn can emerge with a variety of head shapes. The most common one that I see is a cone. If you’re thinking of a classic Saturday Night Live sketch right now, you’ve got the correct mental image.

Babies who are breech also have a distinct pattern of molding which involves a flattened and elongated top of the head because of pressure against the uterine wall. Abnormal positioning in the womb can also result in asymmetric molding of the head and facial structures like the jaw, nose and ear. Fortunately these pressure-induced and positional deformities usually resolve without intervention, often within a few days, but some are serious enough to require intervention and even surgical correction.

Why are the cranial bones of newborns so easily molded by the pressure of birth? This is a question I answer frequently for new parents and inexperienced medical students. The answer will segue us into the primary topic of this post, but before I discuss craniosynostosis, and the sadly unsurprising claims of some in the chiropractic community, a review of normal cranial anatomy is in order. (more…)

Posted in: Science and Medicine

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Lyme: Two Worlds Compared and Contrasted

The Lyme tick

The western black-legged tick, carrier of the Borrelia burgdorferi bacteria which causes Lyme disease.

The practice of infectious disease (ID) is both easy and difficult. If you read my ID blog on Medscape you are aware of my trials and tribulations in diagnosing and treating infections.

ID is easy since, at least in theory, diseases have patterns and an infecting organism has a predictable epidemiology and life cycle. So if you can recognize the pattern and relate it to the life cycle and exposure history, you can often make a diagnosis before the cultures come back.

My favorite story is the time I was asked to see a young girl with endocarditis. The history was she had a week of fevers, headache and myalgia that went away for five days, returned for a week, went away for five days and returned yet again.

So I asked her “How was your vacation at Black Butte?”

The look of astonishment on her face as she asked how I knew she had been to Black Butte was so satisfying. (more…)

Posted in: Legal, Naturopathy, Politics and Regulation, Public Health, Science and Medicine

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Making One’s Own Reality – Food Babe Edition

Vani Hari, aka the "Food Babe".

Vani Hari, the “Food Babe”.

The default mode of human activity is to construct our own internal model of reality based upon our desires, biases, flawed perceptions, memories, and reasoning, and received narratives from the culture in which we live. That model of reality is then reinforced by confirmation bias and jealously defended.

But we also have the capacity to transcend this pathway of least resistance. Philosophy is the discipline of thinking carefully and systematically about ideas to see if they at least are internally consistent. Science is the discipline of systematically and carefully comparing our internal models of reality against objective reality, and then changing those models to suit the evidence.

Everyone engages in a combination of bias, superstition, logic, and evidence-based reason to varying degrees – the question is, to what degree? The goal of science-based medicine is to increase the proportion of science and reason in the mix with respect to the practice of medicine and public health.

There are many forces at work in society, however, that explicitly oppose the role of science because, in my opinion, they find it inconvenient to their internal model of reality or whatever narrative they are selling.

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Posted in: Science and Medicine

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Bias and Spin

We all construct our narrative based on our biases and spin the facts so that the narrative confirms our biases. Among other characteristics, what separates an SBM provider from a SCAM provider is realizing that biases are always active and apply to me as well as everyone else.

My biases are simple: I am skeptical that humans can reliably understand reality without assistance and the best source of assistance is science.

I have a job where the expectation is that I will change practice as information changes. How I practiced medicine 30 years ago is very different from how I practice it today. Still, I note it is harder and harder to change my approaches as I get older. I get more set in my ways and it takes more effort to change as new studies are published. Sometimes it seems almost physically difficult.

Again, it is expected that not only will I change my mind over time, as the sole ID doctor at my hospitals, I will be the one to lead the change. Imagine how much harder it would be to change your mind if you were committed to a universal truth such as those that are alleged to underlie reiki or chiropractic. Years committed to a pseudo-medicine probably renders changing one’s mind virtually impossible. (more…)

Posted in: Chiropractic, Science and Medicine

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Personal Belief Exemptions for Vaccines

vaccinationRates

Click to enlarge

Positive change not only requires a valid argument, it requires political will. My colleagues and I have been pointing out for years that vaccines are safe and effective, and the anti-vaccine movement, which is built largely on misinformation, threatens the public health by eroding herd immunity. These arguments are no more valid today than they were five or ten years ago (except that new scientific evidence continues to support our conclusion).

We also predicted that it will likely take the significant return of vaccine-preventable diseases to muster the political will to effectively push back against the anti-vaccine movement. Parents need to be more afraid of infectious disease than the false fearmongering surrounding vaccines. We, of course, did not want this to happen, we just thought this was a likely scenario.

I did not think, however, that it would be so sudden and dramatic. The Disneyland measles outbreak created an undeniable media and popular backlash against the anti-vaccine movement. Recent evidence for this is the Jimmy Kimmel segment in which he blasted anti-vaxxers and showed a fake PSA in which real doctors express their frustration over vaccine refusers. Anti-vaxxers replied with their usual shrill nonsense, comparing Kimmel’s statements to hate speech and falsely accusing him of attacking autistic children. Kimmel responded with still more ridicule, making a mockery of anti-vaxxer tweets attacking him. Being the butt of late night comedian jokes is a reasonable sign of popular backlash.

Popular opinion, which is turning against vaccine refusers for threatening the public health, translates into political will. In the case of vaccines there is a specific focus for this political will – state laws allowing exemptions from the requirement for children to be up to date on their vaccines in order to attend public school.

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Posted in: Science and Medicine, Vaccines

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