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Bogus Diagnostic Tests

A few years ago a friend asked me to comment on advice given to her adult daughter by a psychiatrist whom she’d consulted for depression. The psychiatrist had recommended testing samples of saliva and urine for hormone and neurotransmitter levels, the results of which would likely indicate a need for supplements to correct deficiencies or imbalances. According to the psychiatrist, who had an academic appointment at a medical school in New York City, “I have been using these supplements with a great deal of success.” My friend is not medically or scientifically sophisticated, but this made her a little uncomfortable. In that, she was entirely justified.

During our recent panel discussion at the NECSS, a member of the audience identified himself as a clinical pathologist at a major medical center, and wondered what he might do to become involved in the good fight against encroaching pseudoscience in medical schools. Clinical pathology is the medical specialty that concerns itself, in summary, with laboratory tests—their development, their validity, their interpretation, their usefulness and, by implication, their misuse. A topic that we haven’t much featured on SBM (we touched upon it here, here and here, and probably elsewhere) is that of bogus laboratory or other diagnostic tests.

Early in my own education in modern quackery, I found it particularly distasteful not merely that quacks misuse laboratory tests, but that several commercial laboratories market misleading tests. To the untrained eye these laboratories appear to be legitimate, even to the point of their being approved by apparently legitimate certifying bodies. We’ll discuss that below, but first let’s look more closely at the psychiatrist’s recommendations to my friend’s daughter and at other examples of bogus tests.

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Posted in: Diagnostic tests & procedures, Health Fraud, Medical Ethics, Politics and Regulation

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Social Factors in Autism Diagnosis

There is no question that the incidence and prevalence of autism are on the rise. Starting in the early 1990s and continuing to today, there has been a steady rise in the number of children diagnosed with autism. Prior to 1990 the estimates of autism prevalence were about 3 per 10,000. The most recent estimates from the CDC and elsewhere now have the number at about 100 per 10,000, or 1%.

The burning question is – why are the rates increasing steadily? There are those, particularly in the anti-vaccine community, who conclude that the increase in prevalence is a real biological effect – an epidemic – and is evidence for an environmental cause (which they believe is vaccines, even though the scientific evidence does not support this position). However, the evidence strongly suggests that the rising prevalence of autism is largely an artifact of broadening the diagnosis and increased surveillance.

It should be noted that the data cannot rule out a small true increase in autism prevalence. Some hypothesize that increasing maternal and paternal age are contributing to the incidence of autism, but I will leave that question for another post.

A new study now adds significant support to the surveillance hypothesis – Ka‐Yuet Liu, Marissa King, and Peter S. Bearman from Columbia University, publishing in the American Journal of Sociology, report that the risk of being diagnosed with an autism spectrum disorder (ASD) correlates with social proximity to another family with a child with an ASD diagnosis. For those interested in this topic, the full paper is worth a read. While it gets technical at times, the authors do an excellent job of reviewing this topic in detail.

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Posted in: Neuroscience/Mental Health, Vaccines

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Steven Higgs: Another antivaccine reporter like Dan Olmsted in the making?

April is National Autism Awareness Month, and as of today April is nearly half over. Do you notice anything different compared to the last couple of years? I do. Can you guess what it is?

The anti-vaccine movement’s usual suspects haven’t been all over the mainstream media, as they usually are this time every year, often as early as April 1 or even March 31. In fact, over the last couple of years I had come to dread April 1, not because it’s April Fools’ Day (although the things that made me dread that particular day were often indistinguishable from an April Fools’ Day prank, so full of idiocy were they), but rather the expected carpet bombing of the media by the likes of Jenny McCarthy, J. B. Handley, and their ilk, some or all of whom would show up on various talk shows to spread their propaganda that vaccines cause autism. For instance, last year Jenny McCarthy and her former boyfriend Jim Carrey showed up on Larry King Live! with Dr. Jerry Kartzinel (her co-author on her latest book of autism quackery) and J. B. Handley, the last of whom even contributed a guest post on Larry King’s blog, in which he touted an incredibly bad, pseudoscientific “study” commissioned by Generation Rescue. The “study” (and calling it a “study” is way too generous) was no more than cherry-picked random bits of data twisted together into a pretzel of nonsense, as I described. Around the same time, Jenny McCarthy was interviewed by TIME Magazine, an interview in which she uttered these infamous words:

I do believe sadly it’s going to take some diseases coming back to realize that we need to change and develop vaccines that are safe. If the vaccine companies are not listening to us, it’s their fucking fault that the diseases are coming back. They’re making a product that’s shit. If you give us a safe vaccine, we’ll use it. It shouldn’t be polio versus autism.

Soon after, Generation Rescue created a website called Fourteen Studies, which they promoted hither, thither, and yon. The idea of the website was to attack the main studies that failed to find a link between vaccines and autism and to promote the pseudoscientific studies that anti-vaccinationists like. In 2008, it was pretty much the same — well, worse, even. When she appeared on Larry King Live! with our old “friend,” anti-vaccine pediatrician to the stars, Dr. Jay Gordon, McCarthy shouted down real experts by yelling, “Bullshit!” (behavior trumpeted by Rachel Sklar of the Huffington Post).

This year? Oddly enough (and to me unexpectedly), there’s been almost nothing. J.B. Handley seems to be the man who wasn’t there. Well, not quite. It turns out that J. B. Handley has managed to get a little bit of fawning media attention, but just a little bit, in the form of an interview in The Bloomington Alternative entitled J. B. Handley: It’s unequivocal; vaccines hurt some kids. Apparently Mr. Handley has come down quite a bit in the world. Where’s his appearance with Jenny on Larry King Live! this year? Maybe it’s coming in the second half of the month. Or maybe the mainstream media, in the wake of the fall of Andrew Wakefield, have finally figured out how disreputable Generation Rescue is when it comes to vaccines. In the meantime Steven Higgs will have to do as a new mouthpiece for the anti-vaccine movement.

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Posted in: Neuroscience/Mental Health, Science and the Media, Vaccines

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Autism Onset and the Vaccine Schedule – Revisited

This week on Science-Based Medicine I wrote an article about a new study looking at the onset of autism symptoms, showing that most children who will later be diagnosed with autism will show clear signs of autism at 12 months of age, but not 6 months. This is an interesting study that sheds light on the natural course of autism. I also discussed the implications of this study for the claim that autism is caused by vaccines.

Unfortunately, I made a statement that is simply wrong. I wrote:

Many children are diagnosed between the age of 2 and 3, during the height of the childhood vaccine schedule.

First, this was a vague statement – not quantitative, and was sloppily written, giving a different impression from the one I intended. I make these kinds of errors from time to time – that is one of the perils of daily blogging about technical topics, and posting blogs without editorial or peer-review. Most blog readers understand this, and typically I will simply clarify my prose or correct mistakes when they are pointed out.

However, since I often write about topics that interest dedicated ideologues who seek to sow anti-science and confusion, sometimes these errors open the door for the flame warriors. That is what happened in this case.

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Posted in: Science and Medicine, Vaccines

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Yet another nail in the coffin of the myth that the MMR vaccine causes autism

Arguably, the genesis of the most recent iteration of the anti-vaccine movement dates back to 1998, when a remarkably incompetent researcher named Andrew Wakefield published a trial lawyer-funded “study” in the Lancet that purported to find a link between “autistic enterocolitis” and measles vaccination with the measles-mumps-rubella (MMR) trivalent vaccine. In the wake of that publication was born a scare over the MMR that persists to this day, 11 years later. Although peer reviewers forced the actual contents of the paper to be more circumspect, in the press Wakefield promoted the idea that the MMR vaccine either predisposes, causes, or triggers autistic regressions. Even though over the next several years, investigations by investigative journalist Brian Deer revealed that not only was Wakefield’s research funded by trial lawyers looking to sue vaccine manufacturers for “vaccine injury” when he did his research (for which he is now being charged by the U.K.’s General Medical Council with scientific misconduct), but during the Autism Omnibus trial testimony by a world-renowed expert in PCR technology showed that he was incompetent. Even worse for Wakefield, in February 2009 Brian Deer published a news expose based on strong evidence that Wakefield may very well have falsified data for his Lancet paper.

None of this mattered. Andrew Wakefield still enjoys a cult of personality among the anti-vaccine crowd that no revelation seems able to dislodge, even the revelation that at the time he was both in the pay of trial lawyers and working on his study, Andrew Wakefield was also applying for a patent for a rival measles vaccine. Indeed, the anti-vaccine propaganda blog Age of Autism bestowed upon him last year its “Galileo Award” as the “persecuted” scientist supposedly fighting for truth, justice, and anti-vaccinationism against the pharma-funded or brainwashed minions of the “Church of the Immaculate Vaccination.” In the meantime, MMR uptake rates in the U.K. have plummeted over the last decade, far below the level needed for herd immunity, to the point where, last year the Health Protection Agency declared measles to be once again endemic in the U.K., 14 years after the local transmission of measles had been halted.

Since Wakefield’s study was released, a number of studies have shown that there is no epidemiologically detectable link between vaccination with MMR and autism, including one by a researcher who once appeared to be a believer in the idea that vaccines are somehow linked with autism, Mady Hornig. Hornig actually tried very hard to replicate Wakefield’s 1998 Lancet study, only this time with more children, and she found no link between MMR and autism using methodology similar to Wakefield’s. None of these studies has had any effect on the anti-vaccine movement, except to motivate them to circle the wagons even more, as J.B. Handley of Generation Rescue did when he launched a website called Fourteen Studies, whose purposes are to launch fallacious and pseudoscientific attacks on studies failing to find a link between vaccines and autism (often involving accusations of being a “pharma shill”), to promote the lousy science that gives the appearance of supporting the hypothesis that there is a link between the MMR vaccine and autism, and then slime anyone who points out how deceptive their attacks were.

Now, yet another study has been released studying whether there is a link between MMR vaccination and autism. Yet another study has failed to find a link between MMR vaccination and autism. Yet another study is all set to be attacked by Generation Rescue and the anti-vaccine movement. The sad and sordid history of reactions of the anti-vaccine movement to studies that do not support its belief in the unsinkable rubber duck of a myth that vaccines cause autism. This study was published online in The Pediatric Infectious Disease Journal by a group from Department of Epidemiology and Preventive Medicine, Jagiellonian University, Collegium Medicum, Krakow, Poland (a Polish group, my people!) and entitled Lack of Association Between Measles-Mumps-Rubella Vaccination and Autism in Children: A Case-Control Study. It’s yet another nail in the coffin of the myth that the MMR causes or contributes to autism. Indeed, this study not only shows that MMR vaccination is not associated with autism but that it may even be protective against autism. True, for reasons I will discuss shortly, I doubt that that latter interpretation is true, but there’s no doubt that this study is powerful evidence against the view that there is an association between MMR and autism. Unfortunately, I fear that all the nails in my local Home Depot would not be enough to keep the zombie of this pseudoscience from rising from its grave yet again.
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Posted in: Clinical Trials, Vaccines

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Early Intervention for Autism

Many parents of children with autism have expressed to me their dismay that the anti-vaccine lobby is sucking all the oxygen out of the room for autism awareness. They feel that just being a parent of a child with autism makes others assume that they are anti-vaccine. They also worry that resources and attention are being diverted from promising legitimate research because of all the attention being paid to the failed vaccine hypothesis.

So it is good to occasionally focus on mainstream autism research to show that progress is being made, despite the unfortunate anti-vaccine sideshow.

A recent study published in the latest issue of Pediatrics shows that early intervention in toddlers with autism can have significant benefits. The study is a randomized controlled trial of  the Early Start Denver Model compared to conventional treatment in 18-30 month old children with a diagnosis of autism spectrum disorder (ASD). The study is a reasonable size for this kind of intervention – 48 children were randomized – and this is sufficiently powered to get statistical significance. But it should be noted this is still a smallish study and replication to confirm the results is welcome.

Another potential weakness is that the control group was “referral to community providers for intervention commonly available in the community.” Therefore the control group was not standardized and it’s possible this group was sub-optimally treated. Further, while the groups were randomized they were not blinded.

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Posted in: Neuroscience/Mental Health

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The autism “biomed” movement: Uncontrolled and unethical experimentation on autistic children

Ever since I first discovered the anti-vaccine movement, first on Usenet, specifically on a Usenet newsgroup devoted to discussing alternative medicine (misc.health.alternative, or m.h.a. for short) and then later on web and on blogs, there have been two things that have horrified me. First, there are the claims that children suffer all sorts of harm from vaccines, be it being made autistic (with the attendant “autism epidemic” caused by vaccines), suffering neurological damage, immune system damage, and all manner of other adverse consequences. There is no good evidence for these claims (although, as has been documented right here on this very blog time and time again, anti-vaccine activists will trot out all manner of awful studies to support their contentions), but that doesn’t keep useful celebrity idiots like Jenny McCarthy, Jim Carrey, Don Imus, or Bill Maher from repeating the same myths over and over again. Worse, the permeation of society with these myths about vaccines has led to declining vaccination rates and the resurgence of potentially deadly vaccine-preventable diseases. It began first in the U.K. in the wake of Andrew Wakefield’s trial lawyer-funded, incompetent, and possibly fraudulent “research,” and has spread to the U.S., thanks to Jenny McCarthy and her ilk, who won’t take responsibility for their words and actions.

Even worse, the myth that vaccines cause autism has led to ideas. Dangerous ideas, and not because they “challenge” medical orthodoxy. These ideas are dangerous because they have direct consequences for children with autism. These consequences take the form of subjecting children to unscientific treatments that are ineffective at best and harmful at worst, sometimes even life-threatening. Indeed, I have written about case histories in which children were subjected to injections of “stem cells” into their cerebrospinal fluid by lumbar puncture and various other “treatments,” as well as chemical castration in combination with chelation therapy. That latter bit of quackery is something I wrote about years ago, but that the mainstream press only just noticed earlier this year. Better late than never, I guess. Even better than that, though, the same reporting team at the Chicago Tribune that reported on Mark and David Geier’s advocacy of Lupron to treat autistic children back in May. Sadly, the result of that story does not appear to have been actions by the State of Maryland to take away Dr. Mark Geier’s medical license or to go after his son David for practicing without a license. Neither does it appear to have resulted in insurance companies going after them for prescribing an expensive drug for an indication for which it is not appropriate. What it does appear to have done, however, is to inspire the same journalist, Trine Tsouderos, along with another journalist from the Chicago Tribune, Patricia Callahan, to pursue an even bigger target that Mark and David Geier, namely the entire “autism biomed movement,” which is for the most part rank quackery, in the following articles:

This is another rare case of excellent reporting on this issue, and I hope that this report (another installment of which was published early this morning after I had written this post) will grab the attention of more reporters and news outlets, leading to shining a light on the dark underbelly of the autism biomed movement.
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Posted in: Health Fraud, Herbs & Supplements, Public Health, Vaccines

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A Not-So-Split Decision

For those who battle tirelessly against the never ending onslaught of anti-vaccine propaganda, misinformation, and fear, there was great news the other day from Merck. The pharmaceutical company, and maker of the MMR vaccine against measles, mumps, and rubella, has decided not to resume production of the individual, or “split”, components of the vaccine. A Merck representative made the announcement during a meeting of the CDC Advisory Committee on Immunization Practices (ACIP) on Tuesday. During previous ACIP meetings, science experts on that committee presented compelling arguments against  continued, large scale production of the monovalent components of the MMR vaccine, which were echoed by scientists in Merck’s vaccine division. In a moment, I’ll discuss the arguments against the split vaccine, and why this is so important a decision. First, some background on the issue of splitting the MMR.
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Posted in: Science and Medicine, Vaccines

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David & Goliath: A Dramatic Role Reversal Spurred On By The Media

The Internet is teeming with false health claims and a long line of celebrities willing to throw their media weight behind every new flavor of snake oil. The irony is that alternative medicine proponents see themselves as a persecuted minority – the victims of some nebulous health industry conspiracy. But in reality, they have ingratiated themselves with the media to such an extent that they may in fact have the upper hand.

Pseudoscience has become Goliath, and physicians have never faced a more pernicious foe. With patients’ lives hanging in the balance, some of us are waging the war for hearts and minds with gumption, zeal, and a little help from a brave minority of media who have finally woken up and realized that alternative medicine is not as soft and cuddly as they once thought.

Take for example those who wrongly believe that vaccines cause autism. Many of them subject their children to unproven and harmful therapies, diets, and regimens – some of which are tantamount to child abuse. Consider the cases described most recently by David Gorski here. One child underwent repeated IV chelation therapy for years followed by the invasive injection of “stem cells” into her cerebrospinal fluid. (more…)

Posted in: Science and the Media

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Monkey business in autism research, part II

Over the last couple of months, I’ve noticed something about the anti-vaccine movement. Specifically, I’ve noticed that the mavens of pseudoscience that make up the movement seem to have turned their sights with a vengeance on the Hepatitis B vaccine. The reason for this new tactic, I believe, is fairly obvious. The fact that the Hep B vaccine is administered shortly after birth seems somehow to enrage the anti-vaccine movement more than just about any other vaccine. Moreover, given that, aside from maternal-child transmission when the mother is infected, hepatitis B is usually only contracted through either bloodborne contact (the sharing of needles, the administration of contaminated blood) or sexual activity, it’s very easy for anti-vaccinationists to make a superficially plausible-sounding argument that it’s not a necessary vaccine, even though there are reasonable rationales for giving it to infants. The image of sticking a needle into a newborn infant trumps that, though, at least for the anti-vaccine movement. Another possibility, suggested by Steve Novella just yesterday, is that, with the collapse under a overwhelmingly huge pile of evidence of the idea that the mercury-containing preservative thimerosal that used to be used in childhood vaccines until 2001, caused an “epidemic” of autism and the failure of the “too many too soon” slogan to convince anyone who is not already an anti-vaccinationist, the movement needed a new bogeyman to blame for autism. The hepatitis B vaccine, which was added to the pediatric vaccination schedule in the 1990s, around the right time to confuse correlation with causation when it comes to the increase in autism diagnoses (just like thimerosal) was a perfect next target, given that it’s administered shortly after birth.

Indeed, just the other day, the anti-vaccine crank groups the National Vaccine Information Center (NVIC), Talk About Curing Autism (TACA), and the anti-vaccine crank blog Age of Autism posted a call for the elimination of hepatitis B vaccination for newborns:

Washington, DC – National Vaccine Information Center and Talk About Curing Autism are calling on President Obama to order the immediate suspension of the Centers for Disease Control and Prevention recommendation of the birth dose of the Hepatitis B vaccine after two recent studies linking the Hepatitis B vaccine to functional brain damage in U.S. male newborns and infant primates.  In a related development today, the United States Department of Health and Human Services, including the Health Resources and Services Administration and Centers for Disease Control and Prevention,  announced that 1 in every 91 children are now diagnosed with an autism spectrum disorder as reported in the November 2009 issue of Pediatrics. Previous data released by the CDC indicated a prevalence of 1 in every 150 children affected by the disorder.

Note how AoA not-so-subtly interposed the latest information about autism prevalence with its call to eliminate the birth dose of the hepatitis B vaccine. Very clever. By doing so, it linked the two in readers’ minds, as if one had something to do with the other. There’s no good scientific evidence that the hepatitis B vaccine has anything to do with the “autism epidemic.” Meanwhile, David Kirby is up to his usual nonsense, and the resident anti-vaccine propagandist at CBS News, Sharyl Attkisson, who has been known to feed Age of Autism information on at least one occasion in the past, served up this credulous, noncritical interview with Andrew Wakefield:

The quantity of misinformation in that single six minute video is far beyond the scope of this article. Were I to start dissecting it, I would not have time to do what the purpose of this article was intended to do: To deal with the study Wakefield is hawking. That’s why I leave the dissection of this pièce de résistance of disingenuousness and misinformation as an exercise for SBM readers–after reading the rest of this post, of course. Trust me, it will help you.

At the heart of this latest propaganda onslaught by the anti-vaccine movement are two studies, one a restrospective study in humans and the other a study in monkeys, both of which the anti-vaccine movement is promoting as slam dunk evidence that the hepatitis B vaccine is causing all sorts of horrific problems. Taking both of them on in one post is too much, even for my logorrheic tendencies. So I’ll deal first with Wakefield’s monkey study and then, either later this week or sometime next week, hopefully discuss the human study.
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Posted in: Public Health, Science and Medicine, Science and the Media, Vaccines

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