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Why the latest Geier & Geier paper is not evidence that mercury in vaccines causes autism

Several people have been sending me either links to this paper or even the paper itself:

Young HA, Geier DA, Geier MR. (2008). Thimerosal exposure in infants and neurodevelopmental disorders: An assessment of computerized medical records in the Vaccine Safety Datalink. J Neurol Sci. 2008 May 14 [Epub ahead of print]. (Full text here.)

A few have asked me whether I was planning on deconstructing this study, given that antivaccinationists have apparently been promoting it as “evidence” that it really, truly, and honestly was the mercury in vaccines after all that caused autism. In actuality, I really didn’t feel the need to bother to do a full deconstruction because a new blogger called EpiWonk did a three part take-down that eviscerated this latest bit of “science” from Geier père et fils so thoroughly and with a much greater knowledge of epidemiology than I could ever muster, that I saw no need. Add to that a four-part takedown on the Pathophilia blog, and there was really no need for me to write a detailed deconstruction of my own. Unfortunately, since this study appears to be rearing its ugly head again and again in the blogosphere, I think it’s worth directing you to these discussions. I had been meaning to to this anyway, but had gotten side-tracked by numerous other topics. To make up for my lapse, here we go:

  1. New Study on Thimerosal and Neurodevelopmental Disorders: I. Scientific Fraud or Just Playing with Data?
  2. New Study on Thimerosal and Neurodevelopmental Disorders: II. What Happened to Control for Confounding?
  3. New Study on Thimerosal and Neurodevelopmental Disorders: III. Group-Level Units of Analysis and the Ecological Fallacy

Meanwhile, the Pathophilia blog also has a multi-part deconstruction of the latest Geier study from a different viewpoint:

  1. IRB Approval of Geier Autism Study: Yes or No?
  2. I’ve Been Sucked Into the Thimerosal-Autism-Geier Vortex
  3. Young-Geier Autism Study: What the—? (Part 1)
  4. Young-Geier Autism Study: What the—? (Part 2)
  5. Young-Geier Autism Study: What the—? (Part 3)
  6. Young-Geier Autism Study: What the—? (Part 4)

Ow! That’s gonna leave a mark!
Enjoy! And the next time an antivaccinationist points to this particular study, send ‘em over to see EpiWonk and Pathophilia.

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

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The media versus the frontiers of medicine and surgery

A couple of months ago, one of my esteemed co-bloggers, Wally Sampson, wrote an excellent article about borderlines in research in conventional medicine. Such borderlines are particularly common in my area of expertise (cancer, which is also Dr. Sampson’s area of expertise) because there are so many cancers for which we do not as yet have reliably curative therapies. Patients faced with unresectable pancreatic cancer (as, for example, Patrick Swayze and the President of the American Medical Association have been diagnosed with) or metastatic solid cancers against which medicine generally has mostly palliative treatments, it is very tempting to take a “what have we got to lose?” attitude and pursue increasingly aggressive therapies that may actually shorten what little life a patient has left, all too often making that little bit of life more miserable than it had to be. As Dr. Sampson described in great detail, this sort of push to the borderlines and beyond led to the widespread acceptance during the 1990s of bone marrow transplantation as a treatment for advanced or inflammatory breast cancer based on uncontrolled studies that suggested a benefit. Later studies demonstrated no survival benefit (and possibly even a detriment), and that, or so it would seem, was that.

Except it wasn’t. Indeed, the other point that Dr. Sampson made was how the press covers these sorts of issues. He discussed a story that appeared in the San Francisco Chronicle about a young woman with advanced breast cancer who underwent stem cell transplantation for stage IV breast cancer at M.D. Anderson Cancer Center and was embroiled in a fight with Kaiser Permanente, her insurer, which refused to cover the treatment because it was deemed experimental and was at the time covering the cost of radiation therapy but refusing to cover the costs of extra followup scans required by the M.D. Anderson protocol. The article, not surprisingly, covered the story from the angle of the brave young cancer victim being further victimized by a greedy insurance company. And Evanthia Pappas is no doubt brave, and no one could read about her plight without rooting for her to beat the odds. The problem is that no consideration was given to just how unlikely this incredibly expensive treatment was to benefit her and whether it was even ethical to be doing such a study in which the patient bore over $200,000 of the cost for a treatment that was indeed experimental and being studied in an uncontrolled clinical trial. There are some very thorny medical, ethical, and financial issues there indeed.

Perhaps the reason Dr. Sampson’s post resonated with me was because it reminded me of a story that was extensively discussed last year, so much so that I saved the link to it. The story (Cancer Patients, Lost in a Maze of Uneven Care) appeared on the front page of the New York Times last summer. The article in question starts out by telling a truly sad story about a 35 year-old woman who, after giving birth, was diagnosed with Stage IV colon cancer as the human interest “hook” with which to represent what is described as a systemic problem with cancer care in this country:
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Posted in: Cancer, Medical Ethics, Science and Medicine, Science and the Media, Surgical Procedures

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Jenny McCarthy, Jim Carrey, and “Green Our Vaccines”: Anti-vaccine, not “pro-safe vaccine”

Jenny McCarthy & Jim Carrey at Green Our Vaccines

Last week, there was a rally in Washington, D.C. How many people actually attended the rally is uncertain. The organizers themselves claim that 8,500 people attended, while more objective estimates from people not associated with the march put the number at probably less than 1,000. Of course, such wide variations in estimates for the attendance at such events are not uncommon. For my purposes it is irrelevant whether 500 or 8,000 attended because even if the lowest estimate is closer to the true number this march represented the largest march on Washington ever for this particular cause, the previous largest having occurred three years ago.

Fortunately for public health interests, the organizers’ timing was very bad (for them, at least) in that they marched last Wednesday, the very day after Barack Obama clinched the Democratic nomination. The media were rife with coverage of the history-making nomination of the first African-American as a nominee of a major party, as well as speculation about when and whether Hillary Clinton would concede and endorse Obama. Drowning out most other news, Obama’s nomination led to almost nonexistent news coverage of the rally, aside from a handful of television appearances by one of its celebrity organizers. Its relative lack of success notwithstanding, however, all who support science- and evidence-based medicine should nonetheless remain concerned about this rally, because it was a dagger aimed at the heart of the most effective public health innovation ever conceived by the human mind, an intervention that has arguably saved more lives over the course of human history than every other medical intervention combined. That this dagger turned out to be a toothpick is fortunate indeed but by no means a reason to dismiss the movement that spawned it as irrelevant.

I’m referring, of course, to the antivaccinationist movement, and the rally was known as the “Green Our Vaccines” rally, led by the celebrity couple Jenny McCarthy and Jim Carrey and organized and funded by Talk About Curing Autism (TACA), Generation Rescue (upon whose board McCarthy now sits), and a panoply of other groups that promulgate the myth that either vaccines containing mercury in the form of their thimerosal preservative or vaccines themselves cause autism.
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Posted in: Neuroscience/Mental Health, Politics and Regulation, Public Health, Science and the Media, Vaccines

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Early detection of cancer, part 2: Breast cancer and MRI

Note: If you haven’t already, you should read PART 1 of this two-part series. It defines several terms that I will be using in this post, and I don’t plan on explaining them again, given that they were explained in detail in Part 1. Of course, if you’re a medical professional and already know what lead time bias, length bias, and stage migration are, then it goes without saying that you should still read Part 1 for its scintillating prose.

ResearchBlogging.orgWhen last I left this topic three weeks ago, I had discussed why detecting cancer at ever-earlier stages and ever-smaller sizes is not necessarily an unalloyed good. At that time, I discussed in detail a landmark commentary in the New England Journal of Medicine entitled, Advances in Diagnostic Imaging and Overestimations of Disease Prevalence and the Benefits of Therapy. The article, although nearly 15 years old, rings just as true today in its cautioning doctors about whether ever-increasing diagnostic sensitivity that imaging technology and new blood tests were (and are) providing was actually helping patients as much as we thought it was. Before we dive into this problem as applied to breast cancer, let’s review what Drs. Black and Welch had to say about screening tests for breast cancer 15 years ago, as way of background and linking my last post and this one:

Before the widespread use of mammography, most breast cancers were discovered on physical examination, as palpable lumps. In one of the few studies to assess directly the accuracy of physical examination in screening for breast cancer, only 27 percent of tumors more than 1.0 cm in diameter and 10 percent of those less than 1.0 cm in diameter were detected by physical examination. However, the mean size of breast cancers detected by state-of-the-art screening mammography is about 1.0 cm, and many of the cancers detected as microcalcifications are only a few millimeters in size.

Again, prevalence depends on the degree of scrutiny. According to the Connecticut Tumor Registry, clinically apparent breast cancer afflicts about 1 percent of all women between the ages of 40 and 50 years. In a recent medicolegal autopsy study, however, small foci of breast cancer were found in 39 percent of women in this age group. Most cancers were in the form of ductal carcinoma in situ. Furthermore, over 45 percent of the women with cancer had two or more lesions, and over 40 percent had bilateral lesions. Although it has been argued that such small in situ lesions are not detected by and are therefore irrelevant to screening mammography, about half the lesions in that study were detected, usually as microcalcifications, on postmortem plain-film radiography of the resected breasts. Because of continual technical improvements and increasingly broad criteria for the interpretation of mammograms, the detection threshold for breast cancer has fallen considerably since the time of the Breast Cancer Screening Project of the Health Insurance Plan of Greater New York (1963 to 1975). This can explain the increased prevalence of cancer on mammographic screening, from 2.717 to 7.614 per 1000 examinations (with the incidence increasing from 1.517 to 3.214 per 1000 examinations). The lower detection threshold can also explain the increase in the percentage of carcinomas in situ (stage 0) among all mammographically detected cancers — from 12.7 percent to over 30 percent. The principal indication for biopsy has changed from suspicious mass to suspicious microcalcifications. This can explain why the reported incidence of breast cancer has increased and why most of the increase is in smaller lesions, particularly ductal carcinoma in situ.

About a year ago, three major articles hit the medical press that made me start thinking about this more than I had in the past. It’s my job, after all, because breast cancer surgery is a large part of my practice, and I do breast cancer lab-based research. What also tweaked me not to put off doing part 2 of this series is that, just two days ago, there was an abstract presented at the American Society of Clinical Oncology Meeting (where I still am today) that also serves to highlight just how difficult this question of integrating a test as sensitive as MRI into a screening regimen for and preoperative evaluation of breast cancer is and how MRI should fit into in this regimen can be.
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Posted in: Clinical Trials, Public Health, Science and Medicine, Science and the Media, Surgical Procedures

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A real “Era III Emergency Room”

Due to the holiday, I have not had time to compose the usual lengthy and analytic post that readers have come to know and (hopefully) love. However, Dr. Atwood’s Weekly Waluation of the Weasel Words of Woo #6 so perfectly brought a famous (or infamous) parody back from the depths of my memory that I had to go straight to YouTube and find it. I think our readers will appreciate if they haven’t seen it before. The quote that inspired me to resurrect this gem is:

This new era is composed of a blend of the best of what we know of physical, material-based medicine (”Era I”), mind-body medicine (”Era II”), and the caring, compassion, and consciousness that characterize “Era III.” A compelling example is given in the use of all three levels of caring in the “Era III Emergency Room.”He vividly shows us a new kind of emergency department in which an auto crash patient is not only stabilized and sutured but has the suggestion of relaxation imagery along with the lidocaine and nylon. Meanwhile, caring healers take a moment to pray and visualize a positive outcome based on the scientific evidence of the effects of nonlocal mind, employing a network of nonlocal healers as they work.

No, this is the real “Era III Emergency Room”:

The sad thing is, I fear that the above video is not too great an exaggeration of the way medicine is going.I will return next Monday (possibly even sooner) with new material.

Posted in: Humor, Science and Medicine

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Monkey business in autism research

NOTE: I had originally planned on posting Part II of a series on cancer screening. However, something came up on Friday that, in my estimation, requires a timely response. I should also inform readers that, because next Monday is a holiday here in the U.S., I haven’t yet decided whether I will be doing a post next week or not. Stay tuned and check back.

I get e-mail.

Sometimes the e-mail is supportive. Other times, as you might imagine, given some of my posts, it is anything but. On Friday afternoon, I happened to notice an e-mail from an “admirer” of mine that said something like this:

You are a complete jack-ass.

- Generation Rescue

Appended to the e-mail was a link to this article on the Age of Autism blog.

Generation Rescue, as you may recall, is an organization that promotes the idea that vaccines cause autism, and this e-mail almost certainly came from the founder and head of GR, a man named J.B. Handley. In case you don’t know who he is, Handley is a man who is, even by the standards of antivaccinationists, incredibly boorish and possessed of a bull-in-a-china shop manner that alienates even some potentially sympathetic people, although parents who believe that vaccines cause autism seem to love him. He is also quite–shall we say?–flexible in his notions of how vaccines cause autism. Until about a year ago, the Generation website stated unequivocally:

Generation Rescue believes that childhood neurological disorders such as autism, Asperger’s, ADHD/ADD, speech delay, sensory integration disorder, and many other developmental delays are all misdiagnoses for mercury poisoning.

About a year ago, it changed to:

We believe these neurological disorders (“NDs”) are environmental illnesses caused by an overload of heavy metals, live viruses, and bacteria. Proper treatment of our children, known as “biomedical intervention”, is leading to recovery for thousands.

The cause of this epidemic of NDs is extremely controversial. We believe the primary causes include the tripling of vaccines given to children in the last 15 years (mercury, aluminum and live viruses); maternal toxic load and prenatal vaccines; heavy metals like mercury in our air, water, and food; and the overuse of antibiotics.

The kind interpretation is that GR was changing its hypothesis given that the data being published consistently and strongly refuted the myth that mercury in vaccines somehow cause autism. In reality, though, it’s fairly clear that GR was pivoting effortlessly to a hypothesis that not only was nearly completely unfalsifiable but also allowed GR to continue to blame vaccines for autism, which is what it’s really about. More recently, as I have pointed out before, antivaccinationist rhetoric has also pivoted even further and equally as effortlessly to blame unspecified “toxins” or “combinations of toxins” in vaccines. Be that as it may, having felt the love, I have to admit that Mr. Handley sure does know how to charm a guy. When he draws my attention to some abstracts so politely, abstracts that he clearly considers to be very important evidence, how can I refuse to take a look? After all, Mr. Handley himself apparently very much wanted to point me in the direction of these three abstracts, and it would be downright churlish of me to deny him and refuse to look at the studies with as open a mind as possible.
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Posted in: Basic Science, Medical Academia, Neuroscience/Mental Health, Politics and Regulation, Public Health, Vaccines

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The early detection of cancer and improved survival: More complicated than most people think

“Early detection of cancer saves lives.”

How many times have you heard this statement or something resembling it? It’s a common assumption (indeed, a seemingly common sense assumption) that detecting cancer early is always a good thing. Why wouldn’t it always be a good thing, after all? For many cancers, such as breast cancer and colon cancer, there’s little doubt tha early detection at the very least makes the job of treating the cancer easier. Also, the cancer is detected at an earlier stage almost by definition. But does earlier detection save lives? This question, as you might expect, depends upon the tumor, its biology, and the quality and cost of the screening modality used to detect the cancer. Indeed, it turns out that the question of whether early detection saves lives is a much more complicated question to answer than you probably think, a question that even many doctors have trouble with. It’s also a question that can be argued too far in the other direction. In other words, in the same way that boosters of early detection of various cancers may sometimes oversell the benefits of early detection, there is a contingent that takes a somewhat nihilistic view of the value of screening and argues that it doesn’t save lives.

A corrollary of the latter point is that some boosters of so-called “alternative” medicine take the complexity of evaluating the effect of early screening on cancer mortality and the known trend towards diagnosing earlier and earlier stage tumors as saying that our treatments for cancer are mostly worthless and that the only reason we are apparently doing better against cancer is because of early diagnosis of lesions that would never progress. Here is a typical such comment from a frequent commenter whose hyperbolic style will likely be immediately recognizable to regular readers here:

Most cancer goes away, or never progresses, even with NO medical treatment. Most people who get cancer never know it. At least in the past, before early diagnosis they never knew it.

Now many people are diagnosed and treated, and they never get sick or die from cancer. But this would have also been the case if they were never diagnosed or treated.

Maybe early diagnosis and treatment do save the lives of a small percentage of all who are treated. Maybe not. We don’t know.

As is so often the case with such simplistic black and white statements, there is a grain of truth buried under the absolutist statement but it’s buried so deep that it’s well-nigh unrecognizable. Because we see this sort of statement frequently, I thought it would be worthwhile to discuss some of the issues that make the reduction of mortality from cancer so difficult to achieve through screening. I will do this in two parts, although the next part may not necessarily appear next week
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Posted in: Cancer, Public Health, Science and Medicine, Science and the Media

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Mercury emissions from coal-burning power plants and autism: Is there a correlation?

ResearchBlogging.orgOn April 30, outside the courthouse in Dallas, a press conference/rally was held. This particular rally was in response to a new study published by a group led by Dr. Raymond F. Palmer in the Department of Family and Community Medicine at the University of Texas Health Science Center in San Antonio, whose conclusion was that autism prevalence correlates strongly with proximity to mercury-emitting coal-burning power plants and other industrial sources of airborne mercury, the implication being that such sources of mercury may be causal or contributory to the development of autism. Unfortunately, the rally was reported by the media as though this study were slam dunk evidence that mercury environmental mercury is a definite contributor to the development of autism. For example, there is some video (also here) from local news sources of the rally, in the first of which it is stated as fact that mercury caused autism in the child featured in the story and in the second of which a mother who thinks that mercury causes autism is quoted credulously. This study has had much less play in the national news, but antivaccination activists, such as the ones at the Age of Autism website, a site whose main theme is that either mercury in the thimerosal preservative that used to be in childhood vaccines before 2002 or vaccines themselves cause autism, both promoted the rally and posted a glowing and credulous take on the study, as did “alternative medicine” and antivaccinationist website NaturalNews.com.

My first thought upon reading of this is that it is yet more vindication of the science showing that the claim that mercury in thimerosal-containing vaccines is a failed hypothesis. After all, as I have predicted time and time again, as the scientific and epidemiological evidence continued to mount that thimerosal is just plain not associated with autism or autism spectrum disorders, even the most diehard adherents to this belief are starting to realize that they were backing a losing horse, especially since thimerosal was removed from all childhood vaccines other than the flu vaccine in 2001, leaving only trace amounts from the manufacturing process and there is no sign that autism prevalence is falling. That’s why lately, their effort has shifted from primarily demonizing mercury to blaming other “toxins” in vaccines, even to the point that their efforts to demonize some ingredient–any ingredient–in vaccines often reaches ridiculous levels of blatant silliness, such as touting sucrose as one of those “toxins.” Indeed, I was puzzled. If environmental mercury is the new cause of autism, then the rationale antivaccinationists use to demonize vaccines and portray their children as “vaccine-damaged” is much less potent. Why on earth would they tout this study, which, even if a good study (and it’s not), would weaken their arguments against vaccines immeasurably and take power away from their whole new propaganda slogan “Green Our Vaccines”? The only reason I could think of is that perhaps they somehow think that if mercury in the environment can be linked to autism that maybe–just maybe–they can convince people that they were right about mercury in vaccines all along. Indeed, this seems to be the sort of tack that David Kirby took a year ago when he started arguing that mercury emissions from coal-burning power plants in China (which do reach California), coupled with mercury emission from crematoria in which cadavers with mercury fillings were burned, were contributing to the continued increase in the autism caseload in California despite the elimination of thimerosal in 2001.

But what does the study say itself? Is it good evidence that airborne mercury from coal-fueled power plants is an important contributor to the development of autism? I will argue no, because the study’s flaws are so innumerable that it is well nigh uninterpretable. For simplicity’s sake, to summarize its findings, I’ll quote a Science Daily press release about it:
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Posted in: Neuroscience/Mental Health, Public Health, Science and the Media, Vaccines

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The North Carolina Board of Medical Examiners, Dr. Rashid Buttar, and protecting the public from practitioners of non-science-based medicine

One of the most contentious and difficult aspects of trying to improve medical care in this country is enforcing a minimal “standard of care.” Optimally, this standard of care should be based on science- and evidence-based medicine and act swiftly when a practitioner practices medicine that doesn’t meet even a minimal requirement for scientific studies and clinical trials to support it. At the same time, going too far in the other direction risks stifling innovation and the ability to individualize treatments to a patient’s unique situation–or even to use treatments that have only scientific plausibility going for them as a last-ditch effort to help a patient. Also, areas of medicine that are still unsettled and controversial could be especially difficult to adjudicate. Unfortunately, with medicine being regulated at the state level, there are 50 state medical boards, each with different laws governing licensure requirements and standards for disciplining wayward physicians, our current system doesn’t even do a very good job of protecting the public from physicians who practice obvious quackery. The reasons are myriad. Most medical boards are overburdened and underfunded. Consequently, until complaints are made and there is actual evidence of patient harm, they are often slow to act. Also, in my experience, they tend to prefer to go after physicians who misbehave in particularly egregious ways: alcoholic physicians or physicians suffering from other forms of substance abuse; physicians who sexually abuse patients; or physicians who are “prescription mills” for narcotics. These sorts of cases are often much more clear-cut, but most importantly they don’t force boards to make value judgments on the competence and practice of physicians to nearly the extent that prosecuting purveyors of unscientific medicine does.

Dr. Rashid Buttar: Autism and cancer

The reason I’ve been thinking about this issue again is because last Friday it was announced that one of the most dubious of dubious physicians of which I have ever become aware, Dr. Rashid Buttar of North Carolina, was, after many years of practice, finally disciplined by the North Carolina Board of Medical Examiners. Basically, the Board restricted his practice so that he could no longer treat children or cancer patients (more on why those two particular restrictions were imposed below). Once hailed as a hero by antivaccinationists and even once having testified to the Subcommittee on Wellness & Human Rights on autism issues, he is now disgraced.

Dr. Buttar runs a clinic called the Center for Advanced Medicine and Clinical Research, which features on its front page this quote:

“All truth passes through 3 phases: First, it is ridiculed. Second, it is violently opposed, and Third, it is accepted as self-evident.”- Arthur Schopenhauer, 1788-1860.

I can’t resist mentioning that any time I see this particular quote, I know that I’m almost certainly dealing with someone who is far on the fringe, because what one first has to realize about the quote is that non-”truth” never makes it past phase one or two–and rightly so. Right off the bat, we can see that Dr. Buttar has a greatly inflated view of his own importance.
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Posted in: Cancer, Health Fraud, Medical Ethics, Neuroscience/Mental Health, Politics and Regulation, Vaccines

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Barriers to practicing science-based surgery

ResearchBlogging.orgMuch to the relief of regular readers, I will now change topics from those of the last two weeks. Although fun and amusing (except to those who fall for them), continuing with such material for too long risks sending this blog too far in a direction that no one would want. So, instead, this week it’s time to get serious again.

A few weeks ago, I wrote about factors that lead to the premature adoption of surgical technologies and procedures or the “bandwagon” or “fad” effect among surgeons. By “premature,” I am referring to widespread adoption “in the trenches,” so to speak, of a procedure before good quality evidence from science and clinical trials show it to be superior in some way to previously used procedures, either in terms of efficacy, cost, time to recover, or other measurable parameters. As I pointed out before, laparoscopic cholecystectomy definitely fell into that category. The popularity of the procedure spread like wildfire in the early 1990s before there was any good quality data supporting its superiority to the “old-fashioned” gold standard procedure of open cholecystectomy. Another example, although not nearly as dramatic because the number of patients for whom the procedure would be appropriate is much smaller, is transanal endoscopic microsurgery. However, the difficulties in practicing science- and evidence-based medicine don’t just include fads and bandwagon effects. The example of laparoscopic cholecystectomy notwithstanding (which was largely driven by marketing and patient demand), surgical culture is deeply conservative in that it can be very reluctant to change practice even there is very strong evidence saying that they should.
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Posted in: Basic Science, Cancer, Surgical Procedures

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