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Reporting Preliminary Findings

While scanning through recent science press releases I came across an interesting study looking at the use of a pharmaceutical grade antioxidant, N-Acetylcysteine (NAC), in the treatment of certain symptoms of autism. This is a small pilot study, but it did have a double-blind placebo controlled design. The press release reports:

During the 12-week trial, NAC treatment decreased irritability scores from 13.1 to 7.2 on the Aberrant Behavior Checklist, a widely used clinical scale for assessing irritability. The change is not as large as that seen in children taking antipsychotics. “But this is still a potentially valuable tool to have before jumping on these big guns,” Hardan said.

But concluded:

“This was a pilot study,” Hardan said. “Final conclusions cannot be made before we do a larger trial.”

I also noticed that two of the authors list significant conflicts of interest – patents on the use of NAC, and one has equity in the company that makes it.  It occurred to me that a larger question than the efficacy of NAC for these autism symptoms is this – if this is a pilot study only and we should not base any firm conclusions on the results, then why the press release?

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Posted in: Herbs & Supplements, Science and the Media

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More “bait and switch” acupuncture studies

Acupuncture has been a frequent topic on this blog because, of all the “complementary and alternative medicine” (CAM) modalities out there, it’s arguably the one that most people accept as potentially having some validity. The rationale behind acupuncture is, as we have explained many times before, little different than the rationale behind any “energy healing” method (like reiki, for example) in that it claims to redirect the flow of “life energy” (the ever-invoked qi). The only difference is that acupuncturists claim to bring this therapeutic qi rearrangement about by sticking thin needles into the pathways in the body through which this qi is fantasized to flow. These pathways, called meridians, are just as much a fantasy as qi itself or the “universal source” that reiki masters claim to be able to channel through themselves and into believers. Contributing to the popularity of acupuncture is its mythology as having been routinely practiced for over two thousand years, a myth that was the creation of Chairman Mao, who elevated what was a marginal practice at the time to a modality that the state supported and promoted (1,2,3,4).

In addition, because acupuncture involves sticking actual metal objects into the skin rather than simply laying on hands or making magical gestures over the patient, it retains some credibility, even among doctors. It doesn’t matter that, reviewing the totality of the research, one finds that it doesn’t matter where you stick the needles or even if you stick the needles in the skin. The results are the same and indistinguishable from placebo. The inescapable conclusion is that acupuncture is placebo medicine with needles. Personally, I’d prefer my placebo medicine without needles, but that’s just me.

Yet, the studies keep rolling in, trying desperately to demonstrate that acupuncture works or assuming that acupuncture works . Two more popped up within the last couple of weeks, and one of them, if you read the press releases, sounds really convincing. As is frequently the case, for this latter study, there is less to it than meets the eye. I’ll start, however, with a study that is a followup to a study I blogged about a couple of years ago that I characterized as another overhyped acupuncture study misinterpreted. This one, thankfully, is not nearly as hyped as the study from two years ago—or as the second study I will discussed, but it is very instructive how the original misinterpreted story is leading to a classic CAM “bait and switch” applied to acupuncture.
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Posted in: Acupuncture, Basic Science, Energy Medicine, Science and the Media

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Dental X-rays and Brain Tumors — Oh My!

Fear sells, and the media loves it. If it’s scary, no matter how tenuous the link or inconclusive the study, you are going to see it on the news. How many times over the years have you heard that your cell phone might give you brain cancer, even though it never turns out to be true? Once such a claim is made, however, it becomes lodged into the public’s psyche and is accepted as true, even after refutations and retractions are published (see Wakefield, Andrew).

And so it is with x-rays. The latest scare du jour, a recent study out of Yale that claims to show a correlation between dental x-rays and intracranial meningioma — the most common brain tumor and usually benign — has been enjoying widespread attention in newspapers and on the evening news. We don’t know if it will be on Dr. Oz, because we can’t bring ourselves to watch that show, but we feel the chances are good. Other alt-medders will no doubt have collective woogasms over the story and will further incite fear and mistrust into the doctor-patient relationship. In fact, the Mercola website wasted no time in weighing in:

While this study does not necessarily establish causation between dental X-rays and tumors, previous research has also implicated dental X-rays in the development of thyroid cancer, and research clearly shows this type of radiation is not harmless…

Typical alarmist fear-mongering. When has any health care professional claimed that radiation is harmless? This is not cutting edge research; Wilhelm Röntgen, the discoverer of x-rays in 1895 and winner of the Nobel Prize in 1901 for his research in the field, advocated the use of lead aprons for protection from the ionizing radiation way back when. Further, trying to lump one study linking dental x-rays to meningioma to another study linking them to thyroid cancer is taking quite the kitchen sink approach. But if there are multiple alleged possible potential theoretical adverse effects from our dental death rays, it must be true, right?

Well, not so fast. We’re dentists, and unlike many knee-jerkers, we’ve actually read the study and would like to offer a little bit of insight into this before everyone panics. In fact, with respect to Letterman, we’d like to offer our Top Three Reasons Not To Panic:
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Posted in: Cancer, Dentistry, Epidemiology, Medical Academia, Science and the Media

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Consumer Reports and Alternative Therapies

Consumer Reports (CR) and its Health Newsletter provide sound advice about nutrition and medicine, with one exception: their recommendations concerning alternative therapies, especially dietary supplements. With regard to dietary supplements, part of the problem is the failure of CR to make a distinction between authentic dietary supplements, such as multivitamins and minerals, and non-vitamin, non-mineral medicinal products. For example, the September 2010 issue of CR contains a table listing “Eleven supplements to consider”. The list includes calcium and vitamin D supplements, and St. John’s wort and Pygeum herbals.

The nomenclatural confusion was created by the Dietary Supplement Health and Education Act of 1994 (DSHEA), which was termed “The Snake Oil Protection Act” by the New York Times. DSHEA, which was passed after a massive lobbying campaign by industry, arbitrarily designated herbals and other traditional medicinal products as dietary supplements. Herbals are used worldwide as medicines and in Europe some are available by prescription only.

The purpose of the Act was to prevent the Food and Drug Administration (FDA) from effectively regulating those products, and it succeeded brilliantly. Sales of dietary supplements rose from $4 billion annually in 1994 to $28 billion in 2007, and reports of severe adverse events caused by those products rose in parallel (1). Another consequence of DSHEA is that designating herbals as dietary supplements misleads consumers about their medicinal nature and conceals their potential for causing severe adverse effects.

The selling points for herbals are that as “natural” products they are safer and gentler than the powerful “foreign” chemicals in purified medications, and they possess unique qualities not found in conventional medications. Dr. Varro Tyler, an expert in the medicinal use of plants, termed those unfounded claims “paraherbalism”, and described herbals as “crude drugs of vegetable origin” (2). In reality, the active ingredients of plants are chemicals that are similar or identical to conventional medications, and many of the latter were first identified in plant extracts. It is no more “natural” to swallow dozens of chemicals in a plant extract than to ingest a single purified chemical – a drug is a drug. Before discussing CR’s advice about supplements, it is necessary to consider briefly basic differences between herbals and conventional medications.

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Posted in: Herbs & Supplements, Legal, Science and the Media

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Cancer care in the U.S. versus Europe: Is more necessarily better?

The U.S. is widely known to have the highest health care expenditures per capita in the world, and not just by a little, but by a lot. I’m not going to go into the reasons for this so much, other than to point out that how to rein in these costs has long been a flashpoint for debate. Indeed, most of the resistance to the Patient Protection and Affordable Care Act (PPACA), otherwise known in popular parlance as “Obamacare,” has been fueled by two things: (1) resistance to the mandate that everyone has to buy health insurance, and (2) the parts of the law designed to control the rise in health care costs. This later aspect of the PPACA has inspired cries of “Rationing!” and “Death panels!” Whenever science-based recommendations are made that suggest ways to decrease costs by reevaluating screening tests or decreasing various tests and interventions in situations where their use is not supported by scientific and clinical evidence, whether by the government or professional societies, you can count on it not being long before these cries go up, often from doctors themselves.

My perspective on this issue is that we already “ration” care. It’s just that government-controlled single payer plans and hybrid private-public universal health care plans use different criteria to ration care than our current system does. In the case of government-run health care systems, what will and will not be reimbursed is generally chosen based on evidence, politics, and cost, while in a system like the U.S. system what will and will not be reimbursed tends to be decided by insurance companies based on evidence leavened heavily with business considerations that involve appealing to the largest number of employers (who, let’s face it, are the primary customers of health insurance companies, not individuals insured by their health insurance plans). So what the debate is really about is, when boiled down to its essence, how to ration care and by how much, not whether care will be rationed. Ideally, how funding allocations are decided would be based on the best scientific evidence in a transparent fashion.

The study I’m about to discuss is anything but the best scientific evidence.
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Posted in: Cancer, Politics and Regulation, Science and the Media

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Update: Homeopathy in Brazilian Scientific American

Last week I wrote about a regrettable piece on homeopathy that was published in Scientific American Brasil.  There have been gratifying developments. Within hours, the editor in chief of Scientific American, Mariette DiChristina, appeared in the Comments. She said that Scientific American does not condone the pseudoscience of homeopathy, that the piece clearly should not have been published, that it would never have been published if Scientific American had been consulted beforehand, and that she had complained to the responsible parties. I was very grateful for her response to my article, for her intervention, and for her willingness to speak out in support of good science.

An Apology

Lo and behold, two days later Ms. DiChristina reported that the editor of Scientific American Brasil had written a letter of apology and had published it on the website. Here is a full translation:

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Posted in: Homeopathy, Science and the Media

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Scientific American Declares Homeopathy Indispensable to Planet and Human Health

I recently received an e-mail from one of SBM’s readers in Brazil, Felipe Nogueira Barbara de Oliveira, a PhD candidate in Medical Science who holds an MS in Computer Science and is who is trying to promote critical thinking and scientific medicine in his country. He sent me a jpeg copy of a short piece that was published (in Portuguese) in the April, 2012 issue of Scientific American Brasil. He was appalled that this appeared under the aegis of Scientific American, and so was I.  He provided the translation which follows.

Warning: this is painful.

The Questioned Effectiveness of Homeopathy

Application of this technique in agriculture shows recuperation of plants and environment.

Homeopathy is known as an alternative treatment for human beings, but few people know about its utilization on animals, plants, soils, and water. This technique is the target of critiques regarding results and efficacy.  One of them is about the “placebo effect” of its remedies, which do not contain any trace of the raw material used in its preparation. To answer this criticism, a clarification is necessary: homeopathy is not related to chemistry, but to quantum physics, because it works with energy, not with chemical compounds that can be qualified and quantified. (more…)

Posted in: Homeopathy, Science and the Media

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Autism prevalence: Now estimated to be one in 88, and the antivaccine movement goes wild

Editor’s Note: Some of you might have seen this before, but it’s an important (and timely) enough topic that I figure it’s worth exposing to a different audience. It’s been updated and edited to style for SBM. Enjoy.

If there’s one thing that I’ve learned that I can always—and I do mean always—rely on from the antivaccine movement, it’s that its members will always be all over any new study regarding vaccines and/or autism in an effort to preemptively put their pseudoscientific spin on the results. It’s much the same way that they frequently storm into discussion threads after stories and posts about vaccines and autism like the proverbial flying monkeys, dropping their antivaccine poo hither and yon all over science-based discussions.

In any case, antivaxers are also known for not respecting embargoes. They infiltrate their way into mailing lists for journalists in which newsworthy new studies are released to the press before they actually see print and then flood their propaganda websites with their spin on the studies, either attacking the ones they don’t like or trying to imprint their interpretation on ones on which they can, all before the skeptical blogosophere—or even the mainstream press—has a chance to report. So it was late last week, when vaccine-autism cranks jumped the embargo on a CDC study that announced new autism prevalence numbers. This is nothing new; it’s the antivaccine movement’s modus operandi, which makes me wonder why the various journals don’t shut off the flow. The study, of course, was announced in press conferences and a number of news stories. No doubt by now many of you have seen them. The stories I’ve seen thus far have focused on the key finding of the CDC study, which is that the prevalence of autism in the U.S. has risen to approximately 1 in 88, a finding reported in the CDC’s Morbidity and Mortality Weekly Report.

This is how the CDC came up with the new prevalence:
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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California Bill AB 2109: The Antivaccine Movement Attacks School Vaccine Mandates Again

Of all the preventative treatments ever developed through science- and evidence-based medicine, vaccines have arguably saved more lives, prevented more illness and disability, and in general alleviated more suffering than any single class of treatments or preventative measures throughout history. Given the obvious and incredible success of vaccines at decreasing the incidence of infectious diseases that used to ravage populations, it seems incredible that there would be such a thing as an antivaccine movement, but there is. Indeed, when I first encountered antivaccine zealots on the Usenet newsgroup misc.health.alternative about ten or twelve years ago, as a physician I really had a hard time wrapping my head around the fact that such people existed. No doubt the same is true of many physicians, who take the scientific evidence for the safety and efficacy for vaccines for granted. However, I am a cancer surgeon, and I do not treat children; so until I discovered antivaccine rhetoric on the Internet I was blissfully ignorant that such views even existed. Other health care professionals knew better. Pediatricians, nurses, and any health care professionals who deal with children and the issue of vaccinations know better, because they face antivaccine views on a daily basis. It is because of the incredible importance of vaccination and the danger to public health the antivaccine movement represents that we at Science-Based Medicine write so frequently about vaccines and the antiscientific, pseudoscientific, and misinformation-packed fear mongering about vaccines that is so prevalent today.

The success of vaccination campaigns has recently been endangered by a number of factors, in particular the antivaccine movement. Because of various groups opposed to vaccination, either for philosophical reasons or because they incorrectly believe that vaccines cause autism, neurodevelopmental disorders, sudden infant death syndrome, and autoimmune diseases, among others, one of the most potent tools for encouraging high rates of vaccine uptake, school vaccine mandates, have come under attack. Alternatively, increasing numbers of parents have taken advantage of religious or philosophical exemptions in order to avoid the requirement to have their children vaccinated prior to entry to school. As a result, of late some states with lax vaccination requirements have begun to try to tighten up requirement for non-medical vaccine exemptions. The arguments used by the antivaccine movement against such legislation are highly revealing about their mindset, in particular their attitude towards issues of informed consent, which I will discuss a bit. But first, here’s a little background.
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Posted in: Politics and Regulation, Public Health, Science and the Media, Vaccines

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An antivaccine tale of two legal actions

I don’t know what it is about the beginning of a year. I don’t know if it’s confirmation bias or real, but it sure seems that something big happens early every year in the antivaccine world. Consider. As I pointed out back in February 2009, in rapid succession Brian Deer reported that Andrew Wakefield had not only had undisclosed conflicts of interest regarding the research that he did for his now infamous 1998 Lancet paper but that he had falsified data. Then, a couple of weeks later the Special Masters weighed in, rejecting the claims of autism causation by vaccines made in three test cases about as resoundingly as is imaginable. Then, in February 2010, in rapid succession Andrew Wakefield, the hero of the antivaccine movement, was struck off the British medical register, saw his 1998 Lancet paper retracted by the editors, and was unceremoniously booted from his medical directorship of Thoughtful House, the autism quack clinic he helped to found after he fled the U.K. for the more friendly confines of Texas. Soon after that, the Special Masters weighed in again, rejecting the claims of autism causation by vaccines in the remaining test cases. Then, in January 2011, Brian Deer struck again, publishing more damaging revelations about Wakefield, referring to his work as Piltdown medicine in the British journal BMJ.

This year, things were different.
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Posted in: Politics and Regulation, Science and the Media, Vaccines

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