Thursday, January 29, 2009

Quick Overview of My Intro to Urology Clinic

The first clue about the maturity level of your typical urologist, can be gained from seeing, on the door of the doctors' lounge, a labelled picture of the handsome animal featured above. These urologists strike me as the future incarnations of Kumar, the guy from that White Castle movie.

In contrast to the bawdy behavior of the urologists, one of our patients, Mr. Smith, was the quintessential "gentleman." He thanked us for taking the time to see him. Whenever he referred to any portion of the male anatomy, he said "Sorry, to the ladies, I don't mean to be impolite talking about these things." He was fully aware of his prior condition, and had followed his previous doctors' advice. The juxtaposition becomes especially absurd, however, when you notice the patient's right leg that is cuffed to the bed, and the two police officers sitting in the corner, mindlessly surfing the web, Berreta 92s intimidating from their holsters. The patient has scars on his back and legs, all from multiple previous gun shot wounds. Based on the manners of most of the patients who head over from County Jail, I can only assume that Cotillion is scheduled between recreation and lockdown.

No kid grows up dreaming of becoming a urologist. Even medical students tend to not think of it (I want to work with urine!) The thing is, however, unlike the "stereotypical" image of a surgeon, who might be seen angry and annoyed, the urologists love to make jokes, have fun, and really get along with their patients, all the while doing a cool fusion of medicine and surgery. The two attendings whom my group assisted today are volunteers, who spend one day a week away from their private clinics, just to teach us lowly Second-Year-Know-Nothing-Medical Students. They showed us the procedures for inserting a Foley catheter, doing sonogram assisted prostate biopsies, and performing a cystoscopy. They were all so eager and excited to teach us whatever they could, and we were all having a blast. It's kind of like an old boy's club, but one where young boys and all girls are invited, too.

Response to Comments on My Last Post (Yikes This Can Go on Forever!)

Hello “Schwartz,”

Thanks for your comments. I’m going to try to quickly respond. Sorry that the sources are messily scattered throughout. I'm aiming to get this done before 6 a.m. Urology clinic.

Adina,Your method of debate is a refreshing change from the usual vitriol. Thank you.I have a couple of initial questions I'll get out of the way first:
“1) Do have experience in statistical analysis or epidemiology?”

I freely admit that I am not nearly an expert in the subjects of statistical analysis or study design. However, when discussing these topics, I hope you will focus on the content of my arguments, rather than on my degrees or qualifications (please note that I do believe degrees are important for some things). In other words, I don’t care if you graduated from clown college. If you make good points, I will afford them the same respect that I would to those of a statistician. As an aside, I have taken non-graduate-level courses in biostatistics, epidemiology, economics, and math. Additionally, I worked for a clinical research study (for only one year).

Did you read the details or any critical reviews of the epidemiology you broadly reference?”

I made sure to read the major components of every paper I referenced. In terms of critiques of the study design, I have read many thorough (unconvincing) rebuttals to a number of the studies I presented at and

There are some much better-reasoned review articles available, which address the drawbacks of various studies. For example, this article compares a number of epidemiological studies, addressing the purported link between autism and vaccination. They find that Heron’s study fulfills 5/8 epidemiological criteria, and the research of both Hviid and Verstraeten each fulfill 6/8 criteria. In other words, they are strong, but not flawless studies (there are extraordinarily few epidemiological studies about anything that would fulfill all 8/8 criteria). The Geiers’ study, the only one that found a link between vaccination and autism, fulfilled 0/10 criteria. The methodology used in this article review article appears quite sound.

(Parenthetically the third world application of Rota vaccine is relevant but so is the fact that it is currently recommended as a childhood vaccine in the US. The US recommendation is justified as a reduction in cost due to reduced hospitalization, not death. This is far more relevant to your readers when considering the risks.)

CDC: “The number of intussusception cases reported to date after RotaTeq administration does not exceed the number expected based on background rates of 18-43 per 100,000 per year for an unvaccinated population of children ages 6 to 35 weeks.”

"However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.)"
In order to support the notion that the claims of damage have been vaccinated, you would have to produce case studies or at least detailed follow-up for the affected group OR at least you have to illustrate that enough study of children with similar risk profiles were studied en masse. Neither you or Dr. Offit have provided them so right off the bat, the definitive statement that the topic has been studied is not justified in my opinion. In general, you will find that in the cases of vaccine damage very little documentation is available and there certainly is no large cumulative study of affected children. That alone should raise red flags in a system that mandates a medical intervention.

I’m not sure what you mean by similar risk profiles. Do you mean studying patients in a case-controlled study, rather than the current practice of conducting longitudinal cohort studies? (In other words, finding kids who are already known to have autism, and then finding out about their exposures, rather than recruiting kids with known exposures, and then following them to determine if they were later diagnosed with autism).

I’m not 100% sure what kind of study you’re referring to, but if it is a case-controlled study, then I feel that such a study would have little value. A case-controlled study, in this situation, is susceptible to information bias (Differential reporting of past exposure information based on disease status), Selection Bias (Controls and/or cases chosen in such a way that they are systematically more (or less) likely to be exposed than the population from which they were drawn), Confounding. (Failure to measure and adjust for all potentially confounding factors can lead to invalid associations), and Temporal Relationship Problems. (Can’t be certain the exposure preceded the onset of the disease). (Sources of bias copied from Epidemiology Lecture notes created by Dr. Christopher Haiman).

It shouldn't be a surprise that Hannah Poling's case was actually investigated in detail likely only because her father was a neurologist with both the power and wherewithal to ensure her case was studied in detail"In terms of the Vaccine Court, the fact that those girls got money from the Vaccine Compensation Fund is not particularly relevant, because the cases are not judged based on scientific evidence" “

I might have missed it, but I don't see anywhere they state that the decisions are not based on scientific evidence. Medical records and expert assessment were provided in this case, and certainly expert assessment qualifies as scientific evidence. Your definitive statement here is not justified.”

I’m having trouble with this argument. Do you think that if we went to court to resolve a dispute about evolution vs. creationism, then the findings of the court would be scientifically relevant, so long as the judges heard the testimony of experts? I am not sure if you are saying that courts ought to be recognized as legitimate arbiters of a scientific debate, but if so, I must disagree. Courts might invite scientists to testify about their research, but the court itself has no meaningful role in determining of the scientific merit of such testimonies. Because courts must make legal decisions, the public hopes that the courts will do their best to be objective and weigh already discovered evidence appropriately, as well as figure out which witnesses are most credible. Ultimately, however, the legitimate value of scientific findings is determined by the scientific community through the scholarly writing and peer review.

Additionally, I am pretty confident the percentage of “experts” who testified that vaccines cause autism was dramatically larger than the percentage of scientists, in the general population, who agree with that notion. Court cases are misleading, because disproportionate representation leads to an assumption that there is widespread debate about a given issue, when opposition might actually exist among only a small fringe group.

"A team of lawyers (called "special masters") with no medical background, rather than a judge, jury, scientists, or medical professionals, preside over the cases." The Poling case was conceded after a review by the HHS scientists. It never went to a hearing before the Special Masters. The HHS scientists examined the scientific evidence presented and determined that a hearing was not required, as they concluded the act of vaccination contributed to her brain damage (encephalitus) leading ultimately to a diagnosis of Autism. Your own statements don't match the facts and display the bias of Dr. Offit's opinion pieces (where it is difficult to evaluate the level of bias).

The only document relating the Poling case that is provided on the Vaccine Court's website is at
It states,
“The undersigned [special masters] directed respondent to file a status report after reviewing Dr. Zimmerman’s expert report that addressed respondent’s position regarding petitioners’ claim that Hannah’s seizure disorder was vaccine-related. Petitioners filed the expert report from Dr. Zimmerman after the status conference. Respondent’s review of Dr. Zimmerman’s expert report…On February 21, 2008, respondent filed a Supplemental Rule 4 Report addressing. The respondent stated that “[h]aving reviewed this additional evidence, medical personnel at the Division of Vaccine Injury Compensation, Department of Health and Human Services (DVIC)] now recommend compensation for Hannah’s seizure disorder as sequela of her vaccine-injury in accordance with 42 U.S.C. § 300aa-11(c)(1)(C)(ii).” Id. at 2. Based on respondent’s concession, a damages determination is now underway in this case.”

Please note that the report states that a single respondent, rather than a team of DHHS experts, was asked to review the case (using the files provided by Hannah’s doctor0. The document does not mention the identity of this respondent. He or she could be a member of ARI or Generation Rescue, for all I know. Then the special masters made the final decision. Your account of what happens does not correspond to the account written in the document (See page 2). However, there may additional documents that I cannot locate, so I will look at those, if you know of any.

You seem to make more factual errors about the case of Andrew Wakefield: "Many of Wakefield's co-writers testified in court that he had falsified data, and 10/13 authors retracted their names from portions of Wakefield's most significant study, stating "We wish to make it clear that in this paper no causal link was established between the MMR vaccine and autism, as the data were insufficient.""I am interested in which trial of Dr. Wakefield anyone testified that data was falsified? I suspect you're incorrectly referring to the Omnibus hearing (which you yourself stated was unscientific) which did not involve Dr. Wakefield at all. Allegations against him were made despite the fact he was not a participant in the hearing, and thus he had no opportunity to rebutt the accusations. It would be good for you to clear up this allegation of yours, because as it stands, your statement does not match the facts that I am aware of. Given the diligence of most of your post, you seem to be making quite a few errors around the legal and personal aspects. I can only assume that you have been swayed by the many biased writings of these events without actually understanding the details of the events that unfolded. Wakefield is currently undergoing a GMC fitness hearing in the UK but no transcripts have been published and no verdict delivered so your conclusions appear a bit premature.

You are correct. I apologize for the error, and have placed a correction it in my previous post. Chadwick had testified at the Omnibus Hearing, not at a trial related to Andrew Wakefield. (I confused this case with the hearing for professional misconduct that Wakefield is currently undergoing at the General Medical Council in the U.K.) The extraordinarily detailed testimony against Wakefield, by the primary researcher who had carried out the experiments is quite damning, nonetheless. Please see part of the transcript at
There were other testimonies of many major problems in Wakefield’s research. For example, according to the testimony of Dr. Stephen Bustin, the now defunct diagnostic center that Wakefield used, Unigenetics, claimed to have “detected measles gene using a type of PCR that could detect only DNA." (Offit 171)” The measles virus doesn’t contain DNA, only RNA. Please read about the findings of the 2004 investigation of Wakefield’s laboratory at

You also make two further misleading statements: First, your wording infers that the retraction was significant despite the fact they only retracted the interpretation not for scientific reasons, but public relational ones as they noted in the section of their statement that you ommited. Second, you infer that the lack of a causal finding between MMR and autism was a new revelation, when it was already explicitly stated in the original paper (discussion section page 641). Your selective quoting makes a big deal out of very little just like the misleading press releases on the topic.

Wakefield was very smart in trying to have it both ways: Always saying that nothing can be known for sure (so that no one can pin anything on him), but then making frightening statements about vaccines to the public. Wakefield et. al. were careful to write “We did not prove an association between measles, mumps, and rubella vaccine and the syndrome described. Virological studies are underway that may help to resolve this issue… We have identified a chronic enterocolitis in children that may be related to neuropsychiatric dysfunction. In most cases, onset of symptoms was after measles, mumps, and rubella immunization. Further investigations are needed to examine this syndrome and its possible relation to this vaccine.”

Every researcher is aware that no medical study can “prove” anything, so it is silly to write “we did not prove,” in a paper. They seem to imply that they have significant evidence, but that this evidence just doesn’t qualify as “proof.” If you believe this argument is just a petty focus on semantics, then please note that Wakefield used every public opportunity, following the article’s publication, to imply that his findings were indeed significant. In an interview following publication of the article, Wakefield says:

“It is our suspicion that there may well be [a link between MMR and what he refers to as “this syndrome”] but that is far from being a causal association that is proven beyond doubt… Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines…. Again, this was very contentious and you would not get consensus from all members of the group on this, but that is my feeling, that the, the risk of this particular syndrome developing is related to the combined vaccine, the MMR, rather than the single vaccines…Well, the interesting thing is that the damage, the behavioural or developmental change tends to occur quite soon after administration, and this is where, why parents or GPs or paediatricians have been able to make the link, the association with MMR.”

These sound like pretty ominous warnings for an article whose authors are extraordinarily cautious and humble about the significance of their findings. Wakefield even held a press conference about this issue, which prompted segments of the British public into mass hysteria. Vaccination rates fell dramatically, and the incidence of deaths from measles rose.

We may disagree about the significance of the retraction. There were multiple flaws in the study, with or without the retraction. Because you feel that I was omitting information, here is the portion of the paper, to which you refer:
“We wish to make it clear that in this paper no causal link was established between MMR vaccine and autism as the data were insufficient. However, the possibility of such a link was raised and consequent events have had major implications for public health. In view of this, we consider now is the appropriate time that we should together formally retract the interpretation placed upon these findings in the paper, according to precedent.”

"However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.)"
Going back to this quote, I want to continue driving into the studies you reference through Dr. Offit. First, I'm surprised at your use of such a definitive statement (doesn't cause autism) that really can't be supported by any scientific studies of epidemiology. The conclusion that doesn't cause Autism isn't even that interesting really. We want to know if it contributes to damage including autism (or other problems). The case of Hannah Poling is a great illustration that vaccination alone did not cause the damage, but it certainly appears to have triggered and exacerbated it.

I only addressed the autism issue. If you feel that autism is only of many disorders caused by vaccination, and that autism is the least “interesting” among them, then I guess it’s the anti-vaccinationists' lucky day, because I have no energy to refute the link between vaccines and dozens of different disorders. Yes, you are correct. The studies did not (and cannot) conclude “thimerosal doesn’t cause autism.” I intended to say that we have an extremely low level of uncertainty that vaccines do not cause autism. Please read my last post, in which I spoke about how one can never reject a proposed null hypothesis. See my Xenu example.

This is particularly pertinent with Thimerosal and this leads to my original questions at the top. If you read the details of these studies, you'll find that the two founding components are data on the prevalence of Autism and the estimated cumulative exposure of Thimerosal during infancy. I hope you've read critical reviews of the studies quoted by Offit, and the data they're based on. If you aren't aware, there is wide disagreement on the reliability of the Prevalence data, and there are significant known issues with the Danish Registry, the UK's GPRD, and the US databases over the period of time studied. I recommend at least finding and reading some of the statistical arguments against the use of prevalance numbers in these studies. As you should know, the role (and bias') of the statistician is critical in influencing the outcome because numerous assumptions and adjustments must be made in these studies which are already subject to a high risk of false positives and negatives. When working with difficult, inconsistent, or incomplete data (sometimes withheld from independent public analysis) the knowledge of conflict of interest is quite important.

Yes, I read the critical review on the Danish study of 500,000 children (see links above). Just yesterday, Italy released a study stating that there was no link between autism and vaccination. I don’t believe that the statisticians in all of the different countries, for in all of the different studies are part of some vast conspiracy. Of course, in any discipline (perhaps excepting math), there can be biases introduced in a study. However, these studies generally feature good epidemiological study design. I don’t understand how people who oppose vaccination can be so demanding about the standards of these studies, when they rely primarily on case reports or research from faulty databases (Such as the Geiers’ use of the VAERS database) There is no flawless epidemiological study that shows smoking causes lung cancer. However, I’m sure we can agree that the epidemiological data from around the world have added up to demonstrate clearly that smoking causes lung cancer. Now all of the studies are adding up, and they refute a vaccination/autism link.

The other issue is that these studies only look at the cumulative exposure over a long period of time. We know that the timing toxic exposure to virus' (CRS is a great example) or toxins in fetus' or infants can be quite significant in determine the outcome of damage. We also know that very low levels of heavy metal exposure can also have a significant effect neurological outcomes (ex. lead: None of these factors are even remotely considered in these studies, yet you and others including Offit make definitive statements like "doesn't cause Autism". They only studied cumulative dose to be the defining factor, an assumption that does not hold up all the time on it's own. Another aspect that is often ignored (and Contrary to Dr. Offit's published opinion in peer-reviewed journals) the concomitant application of vaccines (MMR and Thimerosal containing) are not actually required study for pre-regulatory approval and generally remain unstudied from a safety perspective. (

No matter when the vaccination occurs, if vaccinations indeed caused autism, we would find a difference between the vaccinated group and the control group. Even if we miss a lot of diagnoses by failing to follow everyone to late adulthood, the cases missed should be equal in both groups (or perhaps even greater in the control group- parents of kids who have vaccines are more hypervigilant, due to their concerns, and would likely notice autism symptoms earlier), so this wouldn't skew the results toward the null.

Thus, I don't think that following vaccinated people for a very long time is necessary, unless you believe that vaccines are only responsible for autism diagnoses that become apparent after childhood. In that case, we would see a difference in autism rates, only if we followed children all the way to adulthood. Sounds far-fetched.

Or perhaps you're implying that, even if mercury doesn't cause autism, it does cause neurological disorders that are only apparent adulthood? These new claims about non-autism related neurological disorders are a whole different topic. I don't know why there is a new idea about vaccines every day! Anyway, the absence of a link between vaccination and (non-autism) neurological disorders have been addressed in at least three studies (see Offit 247)or H. Frankel. "Report finds no link between thimerosal and neurodevelopmental disorders." The Lancet, Volume 358, Issue 9288, Pages 1163-1163

In reference to the notion that metals and other hazards are all around us, I don’t see how that would influence the results. Both vaccinated and unvaccinated kids would be exposed to such metals, so we would still need to see an increased incidence of autism for vaccinated kids. Your premise would require that vaccinated kids are subject to fewer “heavy metals” in their daily lives, and that this is the reason why the incidence of autism is equal in the vaccinated and non-vaccinated groups (i.e. the non-vaccinated group got all of their “heavy metal poisoning” from the environment, but vaccinated kids got their's from vaccines, so now the incidence is equal). This sounds farfetched, and is practically irrelevant, because it doesn't matter what would "cause" one's autism, if the chances of "acquring it" are the same, no matter the ubiquitous exposure.

Honestly, I wasn’t aware of the brand new suspicion (i.e. it’s not MMR that causes autism, nor thimerosal that causes autism, but only using the two of them together). After a claim is debunked, it doesn’t follow that a study must be made to investigate an “updated” conjecture. As I said in my last post, whenever new evidence comes along, the proposed causes always seem to keep change.

In terms of environmental exposure, data from the Minamata Bay mercury disaster show that no increased number of children developed autism, which even Aposhian was forced to admit at the omnibous hearing. (He then said that this is because mercury toxicity isn’t dose dependent, and that “This is an ancient form of quotation that until recently we taught in medical schools…we no longer believe that the dose makes the poison”) See Offit 166 and

From my perspective that type of language is unsubstantiated by the reality of the limitations of the studies. The fact that Dr. Offit regularly makes public statements of this type (in addition with factual error that require correction) significantly hurts his credibility and I argue exposes his bias. Overstating the conclusions of scientific study, especially ones based on weak data is a reccuring issue. As for MMR, I suggest you read the Cochrane systematic review of MMR studies from 2005/2006:
After reviewing an extensive list of "definitive" MMR studies performed over several decades, they concluded that the study of both efficacy and safety was inadequate. If you read the details, (I suspect you'll find several of Dr. Offit's references in there) you'll see findings of serious methodological issues with seemingly "credible" study also heralded historically by regulatory bodies as "definitive". From this perspective you might understand why I remain skeptical of definitive claims issued by the likes of Dr. Offit.

You are correct that none of the 139 articles fulfilled all of Cochrane’s inclusion criteria. I don’t know how you think a better epidemiological study could be designed, which would adequately fulfill the exacting criteria. No study that is currently being proposed by anti-vaccinationists could possibly suffice, so we would be wasting money if conforming the Cochrane standards was their primary goal. Epidemiological studies have a lot of disadvantages, in comparison to controlled environments with drosophila insects or rats. The Cochrane study does recommend vaccination and says, “Exposure to MMR was unlikely to be associated with Crohn's disease, ulcerative colitis, autism or aseptic meningitis (mumps) (Jeryl-Lynn strain-containing MMR). We could not identify studies assessing the effectiveness of MMR that fulfilled our inclusion criteria even though the impact of mass immunization on the elimination of the diseases has been largely demonstrated… No credible evidence of an involvement of MMR with either autism or Crohn's disease was found.”

Overall, I think there is plenty of justification of continued study. None of these studies you referenced ever examined the long term effects of either MMR or Thimerosal exposure in any RCTs (or as close as we can get given ethical limitations). We know from recent history (HRT being a prime example) that large long term studies often reveal unexpected negative outcomes in treatments assumed and shown to be safe by previous regulatory studies.

There are lots of claims we haven’t studied. In a world of unlimited abundance, I'd say, sure let’s have continuous studies about everything. A million studies. Regardless, NIH-funded studies are currently underway to examine this issue, and many more are planned, so it is a mute point.

"As I wrote on my other post, learning about the experiences of my patients and their families will be crucial for my providing good care, but is not relevant to science-based medicine (excepting in the use of case studies, which have limited value, and which are generally only used to develop hypotheses)."
This is an interesting opinion which I would like to examine outside of the vaccine discussion. Expert opinion still plays a role in evidence based medicine (which is what I assume you meant when using the term "science based medicine"). Cumulative clinical experience forms the heart of expertise. I am concerned that you also dismiss the value of clinical experience in detecting problems. It is exactly the detection of patterns of anecdote that usually lead to further study of issues. The other important factor is that repeated follow-up into similar individual cases may reveal biological mechanisms which can (and should) also be used to form a hypothesis. The fact that disease reporting is mandated by law, yet pharmaceutical adverse event follow-up outside of research settings is voluntary are rife with error is a sad reflection on our priorities in my opinion.

You are incorrect that I dismiss the value of clinical experience in detecting problems. Gaining clinical skills in how to recognize signs and symptoms, in order to form a diagnosis is quite different than assuming to know the etiology of an insufficiently studied disease. A good doctor might develop the clinical skills to recognize autism, but this does not mean he has any knowledge what caused it. Recognizing this requires some humility on the part of the clinician. Yes, I’ve mentioned that case studies, or any other observations, can be used to form a hypothesis.

Again, thank you for bringing a refreshingly politeness to the discussion. I wish you success in your studies. My only suggestion is to drill into the details of the assumptions underlying the evidence you use to justify closing the door on further research. Given the significant challenges facing our newer generation of doctors, I think you should drill into the well documented issues (plenty of peer review studies on this topic) with industry funded peer-review studies, and into the details of the impact that bias can have on statistical analysis. You might find (like I did) that the conclusions you're quoting are based on a lot more assumptions and questionable source data than you would like. (the latter not the fault of the authors, but on the lack of interest/diligence by medical regulatory authorities).
Potential Bias: I have two healthy NT children, one partially vaccinated (older), one unvaccinated (younger)

Thank you “Schwartz.” If you respond to this, I’m going to have to let you have the last word. My adventures in autism blogging are putting a cramp my non-school-related life.

Take Care,

Tuesday, January 27, 2009

Response to Anti-Vaccination Parent

Ginger Taylor, the parent of a six-year-old son with autism, wrote a lengthy response to my previous post, "The Disappointment of Hearing 'Your Results Don't Matter.'" Ms. Taylor sounds like a woman who is truly dedicated to her son's successful development. However, I still find a number of Ms. Taylor's contentions to be unfounded. I am responding to her comments, albeit with a bit of hesitation. I am not an expert on the subject of autism, and do not wish to misrepresent the scientific community. If there are any mistakes, they are solely my own. Here goes:

You seem to have made an assumption here, that certainly would be a reasonable one if Paul Offit and his compadres are your main source of information on biomedical intervention for autism. And that seems to be that just because Jenny McCarthy didn't present the kind of evidence you are looking for to prove the efficacy of the treatments she used when she was on Oprah, and just because Offit says there is none, that they don't exist.

Perhaps it's true that there is better evidence than that which Jenny McCarthy presents("My science is Evan, and he's at home. That's my science1"). However, I honestly haven't seen such evidence. I've read a lot of anecdotal accounts of "miraculous" recoveries, "immediate" personality changes following administration of the MMR vaccine, and emotional appeals to the public's sense of outrage, but nothing that comports to the standards of science. Advocacy groups, such as Autism Speaks, the Autism Research Institute, and Generation Rescue, all feature many studies of very poor quality, and I can only assume that what they present is the "best evidence they've got."

I am the mother of a 6 year old that regressed into autism following his 18 month vaccinations and have gotten him about halfway back with the evidence based interventions that Offit has derided.
How do you know that you haven't gotten him "back" (I assume you don't mean "cured") simply due to good parenting? Effective behavior modification techniques? A good social environment? There is no way to know if your child improved due to any specific intervention. Don't sell yourself so short. I'm sure that your son's success has a lot more to do with the time and devotion you dedicate to him than to anything that anybody's selling you. There is a long history of blaming autism on "bad mothering2."Parents should feel pride in their children's progress, rather than (unfounded) guilt due to a feeling that they've exposed their children to something harmful.

Offit is not a good source on autism treatment (he does not even treat children with autism, he is an infectious disease specialist), and his vast conflicts of interest should be raising huge red flags for you.

-He is a vaccine patent holder who won't say exactly how many millions he made from RotaTeq, but says it was like "winning the lottery".

-He was reprimanded by Congress for his ethical breaches and conflicts of interest when as a member of the ACIP failed to abstain, but rather voted to put RotaShield on the CDC schedule, effectively creating a market for his own vaccine by insuring that it would go directly into doctors offices nationally the day after it was approved.

-RotaTeq is arguably the least important vaccine on the schedule for children to receive as Rota virus represents a minimal health threat to American children. (CDC's web site recommends that it be treated with rest and Pedialite). If Jenny's message that kids are getting "Too Many, Too Soon" is taken seriously and adopted, and the vaccine schedule is paired down, certainly RotaTeq will be the first to go as it has been confirmed that it causes Kawasaki's disease and fatal Intussusception.

-He has been publicly and repeatedly corrected for spreading misinformation and inaccurate statements about the cases in the vaccine injury compensation program, most notably this past year in both the Wall Street Journal and the NEMJ.

-He is currently being sued for libel by at least one person he wrote about in the book.

-Although he is quoted at least weekly claiming that vaccines have no relationship to autism, he almost never discloses that he is a vaccine patent holder and has major conflicts of interest. CBS News even did a piece on his failure to disclose (Along with AAP and Every Child By Two. And it turns out Amanda Peet is even being paid by Wyeth for her vaccine promotional spots).

-He routinely makes outlandish and irresponsible remarks such as his famous, "theoretically a baby can receive 100,000 vaccines at once safely" absurdity (I wrote to him the first time I saw this in print and was sure it was a misquote, and asked for a corrected quote from him. He replied that it was a correct quote and "that is probably a conservative number".)

(To be frank, we can't under stand why anyone takes him seriously, and suspect that it is his mere bravado that has prevented people from cluing in to the fact that he is not responsible physician.)

So given all the potential for bias here, don't you think that it might be wise to take a hard look at the other side and make sure that the information he is giving you is reliable and complete?

Perhaps Offit is a mean, greedy man, who enjoys slandering people, and who is simply trying to make more money from his Rotavirus vaccine. I don't know him personally, so I have no specific objections to these claims. The problem is, I don't care about Offit's personality or accomplishments or lack thereof. My only concern is whether or not the statements about autism that he states in his book are factual. Luckily, if I'm suspicious about potential conflicts of interest, I can investigate all of his claims independently, as Offit has provided 32 1/2 exhaustive pages of footnotes in his book, all of which refer me to all of the relevant papers and transcripts. If you can show me a place in his book where Offit

1) Falsifies information from these references AND
2) Such falsification is so damning that it undercuts his basic argument (i.e. invalidates the heap of evidence that he provides in the other 246 pages in his book),

then I would certainly take this objection seriously. But none of the arguments presented above satisfy either of those conditions, as they only address why Offit might want to falsify information, not whether or not he actually did so.

(Parenthetically, please know that intussusception occurs
spontaneously in approximately 1 out of 2,000 healthy young infants and children per year. The fact that Rotateq may cause intussusception (bowel obstruction) in 1 out of 12,000 patients must be weighed against the fact that the vaccine is generally administered in developing countries, where approximately 475,000–580,000 children die from rotavirus infection each year, according to the WHO. All treatments (and human actions) have costs. You must compare these costs to the corresponding benefits).

Because it is not like you have just one mom, Jenny McCarthy, standing up in public and claiming that she recovered her son from autism using these methods, the same year that her book came out, 2007, the Autism Research Institute documented more than 1,100 cases of kids loosing their autism diagnosis following biomed.

The plural of anecdote might not be data, but is a hell of a clue that any honest, earnest, evidence based loving clinician would be remiss not to examine, to put it politely. Criminal might be a better characterization.

Unfortunately, the studies propagated by the Autism Research Institute do not nearly satisfy the conditions of evidence based medicine. Let's look at one oft-cited ARI-sponsored article: "Effect of pioglitazone treatment on behavioral symptoms in autistic children4" in Journal of Neuroinflammation, written with co-contributors Stephen Edelson and James Adams of ARI.

Even after a cursory reading of this article, I find that the study included only 25 children, with no indication about whether the research subjects were recruited randomly or from a population that already subscribes to the researchers' theories. Most importantly, the study featured no control group. Scientific Method 101 says that you can't test a hypothesis without having a control. P values were not reported, so there is no way of determining whether the findings were statistically significant or simply occurred due to random chance. In fact, the authors themselves only conclude only that there should be "further testing," a viewpoint that they presumably shared even before writing the article.

Some people outright deny that the scientific method is a meaningful means of testing alternative medicine. In certain ways, I find the "research" of the ARI to be more pernicious. Their work has the cloak of science, and would seem quite convincing to someone who has no background in basic study design. I probably just prefer the people who outright claim that the scientific method is irrelevant, because at least they're being honest about their beliefs.

I know that you believe that it is "criminal" not to further investigate the claims of people who believe in the vaccine/autism link, because of the shear number of complainants. However, these claims have been investigated (Ten studies to show MMR doesn't cause autism. Six that show thimerosal doesn't cause autism, etc.) 5 More importantly, even if there hadn't been so many studies, I reject the notion that "any honest, earnest, evidence based loving clinician would be remiss not to examine" this issue, simply because many people believe in it. I will not "investigate" the claims of HIV denialists. Mass hysteria is a common historical phenomenon. If you are interested in reading an account of hundreds of people who were (erroneously) so convinced that they had been infected by a virus, that they actually began to experience symptoms of nausea and vomiting, please refer to Desenclos, J.C., Gardner, H., & Horan, M. (1992). "Mass Sociogenic Illness in a Youth Center." Revue D'Epidemiologie et de Sant, Publique, 40, 201-208.

Even if i had not reviewed some of the relevant literature, one hint to me that these vaccination claims are baseless would be the fact that the proposed pathophysiology constantly changes, while the culprit remains the same. Originally, it was proposed that the virulence of MMR stems from an infection caused by harmful proteins from the attenuated measles virus that reach the brain6. Others then said that MMR induced autism via an "autoimmune phenomenon7." Then others started to relate autism to thimerosal, saying it was due to mercury neurotoxicity, or perhaps thimerosal's binding to testosterone, which leads to hyperandrogenism8. Today, many activists acknowledge (or at least don't deny) that the vaccines are generally safe, but say that they just should not be administered to kids below a certain age, or that too many vaccines should not be administered during a short period of time (i.e. "Too Many, Too Soon"). The proposed mechanism and subsequent recommendations constantly shift and adapt with new evidence, but never actually disappear.

"her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic."

So ask yourself, if Offit and CDC and AAP and the vaccine industry are so keen on insuring vaccines don't cause autism, and why have then not take Evan and those 1,100 kids, put them in a long list and compare them to patients of a similar demographic? (Why is there no study comparing kids with an autism diagnosis who undergo biomed with those who don't to see how functional they are at age 10 or so?) Jenny has repeatedly called CDC and asked them to examine her son and all the kids like her son, yet they have never contacted her or ARI or any of the parents who have before and after videos all over the internet showing their recovery stories.

Does that lack of curiosity raise any red flags for you?

Do you think that if one medical practice (much less several dozen) announced they had 1,100 cases of people who recovered from HIV/AIDS, all with evaluations, test results, medical records and videos to prove it, that CDC et all would collectively yawn, quote Brinner, claim it is not data and never even pick up the phone to see if an actual cure had been found? Even for just some cases of HIV/AIDS?

Not in a million years.

(...and if that ever happened, San Francisco would burned to the ground by protesters).

So why is it that with all the claims of vaccine regression and subsequent recovery, are you satisfied with the "no association, no know cause or cure" line from the very people, Offit, HHS, CDC, AAP et al, who would be held responsible and be out of their collective posteriors for causing the autism epidemic if it turned did out to be the vaccines?

Especially when they are not showing up in our community to evaluate our claims and examine our kids?

Especially when they are doing everything possible to prevent REAL vaccine research from being done. Like just three days ago when the Federal members of the IACC voting NOT to study vaccine causation" with the funding from the Combating Autism Act (in opposition to the community members, autism parents, who wanted the research done), one of the regional intents of which was to study the possible association between vaccines and autism.

Ask yourself, why won't health authorities do a simple study comparing vaccinated and unvaccinated children, to look for overall health out comes and see if kids vaccinated according to the CDC schedule have more autism, ADD, asthma, diabetes, arthritus and other neurological and immune disorders?

Why does a Congresswoman have to propose a bill to force NIH to do the study? Shouldn't they want to do it? Certainly there are more and more unvaccinated kids out there to study, and if in fact Offits claim that there is absolutely no association is true, then it can only improve vaccination rates to put a study out that can make the claim with authority.

And why... when no such study exists, can anyone make the claim that vaccines don't cause autism? Vaccines as a whole have never been studied, merely a few different aspects of the vaccine program. And they have been studied quite poorly in many cases.

I do not know why you believe the vaccination-autism claim has not been and is not being investigated. The NIH currently has four studies being performed on the subject, in addition to the many studies that already have been performed in a number of different countries. Many thousands of records have been analyzed, with every study concluding that there is no link between autism and MMR or autism and thimerosal. Japan, when it discontinued the use of MMR, did not see any subsequent decrease incidence of autism diagnoses.9 Additional studies might be initiated when the six “Centers for Excellence in Autism Research" are created with money from the Children's Health Act of 2000. Millions and millions of dollars have been and will be spent to investigate this unfounded assertion. This money could be better spent on studies that would investigate credible "leads" about the causes of autism (such as the excellent work of the Autism Genome Project).10

If you feel that these studies are still insufficient, all I can say is that there is only so much money we can use to chase after every proposed claim. If we performed studies to investigate each person's purported "cancer cure," we'd be left with non-useful confirmations of what we already know (i.e. that virtually all of these claims are bunk). Such studies have enormous opportunity costs, as they take away potential funding from plausible hypotheses that stem from prior research and well-reasoned pathophysiological mechanisms, rather than from conjecture. For example, it is a waste of money to study whether or not diluted duck liver cures the flu, (as homeopaths contend)11. At least eating duck liver is harmless. Non-vaccination has led to numerous preventable deaths in developed countries in the 21st century.

I erred when I said, "her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic," because I implied that it would make sense to now add Evan's case to a scientific study. A good study would be double-blind randomized, controlled, trial including a random sample of kids with autism, rather than a cherry-picked selection of kids whose parents oppose vaccines, or whose parents who have already used alternative "treatments." Certain information can be obtained from a cohort study (a study where random children with certain conditions who have or have not had certain exposures are simply "followed" to determine outcomes), but these more necessarily require repeated investigation others, as they introduce a greater number of potential sources of error than randomized control trials.

Numerous randomized controlled trials have been conducted on kids with autism to test "natural," "biological" materials. These include the gluten-free casein-free “special diet" (which has only shown to cause bone density loss),12dimethylglycine13, and (hot off the presses, published just last week!) human immunoglobulin therapy 14. Needless to say, none of these treatments have proven to be effective. An NIH-sponsored study is underway to study the effects of cod liver oil, Vitamin B6, and Magnesium on kids with autism 15 (These vitamins are currently repackaged and sold -with a trumped up price- as "
Super Nu Thera," to parents of autistic children).

You assert that the testimony of thousands of parents satisfied with "biomed" treatment should be more discomfiting to clinicians. However, thousands of parents swore by "facilitated communication," as well as by secretin, and those thousands of parents were proven to have been influenced by the placebo effect (I am not blaming parents. Nearly everyone, including myself, are at least somewhat influenced by the placebo effect). At least 15 studies were performed to test secretin therapy, a treatment once heavily promoted by the Autism Research Institute.16 All randomized controlled trials demonstrated that the hormone caused no improvement in autism symptoms, in comparison to the placebo.

Some studies simply cannot be performed, because the proposed intervention is already known to be potentially lethal. For example, chelation therapy can be dangerous, even for someone in an acute condition who is already known to be suffering from heavy metal poisoning. When used on healthy children with autism, who have no measurable increase of "heavy metal toxicity," we put children at risk for the fate of Abubakar Tariq Nadama. Indeed, the NIH
extensively planned to perform a randomized controlled trial of chelation therapy, and called it off only when the initial animal testing demonstrated that the treatment caused extensive brain damage in rats.

As for the challenge of how we can "make the claim that vaccines don't cause autism?," my answer is we cannot make this claim, just as no one can make any claim with 100% certainty. We use science-based medicine to diminish our levels of uncertainty, until they become extraordinarily low. The fact that we can not, in any study, conclude that the "null hypothesis (in this case, that vaccines don't cause autism) is accepted," does not mean that it makes any sense to favor the alternative hypothesis (i.e. that vaccines do cause autism). For example, let's say someone made a claim that "Xenu...was the dictator of the "Galactic Confederacy" who, 75 million years ago, brought billions of his people to Earth in DC-8-like spacecraft, stacked them around volcanoes and killed them using hydrogen bombs17." My null hypothesis would be that this event didn't happen. However, I can never affirm this null hypothesis with 100% certainty, just as I can never state "vaccination doesn't cause autism" with 100% certainty.

So... at the conclusion of my long winded comment, I would like to call your attention to Bryan Jepson's book, "Changing the Course of Autism: A Scientific Approach to Parents and Physicians". I would like to encourage you to read it and then look back at Offit's book and see if he actually is taking apart the case for biomedical research or just going after the easy targets like McCarthy, while ignoring the actual biomedical approach to autism and the science to back it up.

You owe it to your future patients to have actually teased out the truth on this for yourself rather than just swallowing what those who quite obviously and transparently protecting professions and individual careers tell you the truth is.

Upon your recommendation, I read parts of Jepson's book. To buttress his arguments, Jepson heavily cites the work of Dr. Andrew Wakefield. Many of Wakefield's co-writers testified in court [CORRECTION 1.29.09: It was not a court trial but an omnibous proceeding for the Vaccine Injury Compensation Program, for which Wakefield was not on trial. I confused this with the British General Medical Council, which is holding a hearing to examine charges of professional misconduct] that he had falsified data, and 10/13 authors retracted their names from portions of Wakefield's most significant study, stating "We wish to make it clear that in this paper no causal link was established between the MMR vaccine and autism, as the data were insufficient." One witness at Wakefield's trial, Nicholas Chadwick, was the research assistant who had actually carried out the tests for the Wakefield's 1998 Lancet paper. He testified in court that, despite the fact that he informed Dr. Wakefield of the negative PCR test results, Dr. Wakefield reported positive findings in his paper.18 There were a number of such testimonies, despite the fact that Wakefield gave $30,000-$180,000 to expert witnesses who testified on his behalf19.

(Parenthetically, Wakefield is also under investigation for subjecting children to unnecessary and risky tests, such as lumbar punctures and colon biopsies, which would be inappropriate for any study, so long as these procedures were not medically indicated. An associate affiliated with the study ended up perforating a child's colon in a number of places.20 Some of the actions that Mr. Wakefield is accused of performing, such as handing out cash to children who attended his son's birthday party, and then collecting their blood as samples, are downright bizarre. He failed to use a random sample of children in his studies, using mostly clients of a trial lawyer, Richard Barr, from whom Wakefield had received, on his own admission, at least $50,00021).

In other words, I do not find Jepson's book, which heavily references Wakefield's papers (as well as the work of the Geiers, who also performed poor research), to be particularly reliable.

You clearly, clearly want to make the right decisions for your patients. What if the right decision for some of your patients was not to vaccinate them according to the current CDC schedule (clearly it was the wrong decision for Hannah Poling, Madison Hiatt and the thousands of others who have received a billion of dollars from the Vaccine Injury Compensation Fund)? And the right decision for some of your patients with ASD was exactly what Jenny McCarthy did for her son? And what if you never looked into it because Offit etc told you not to bother?
In terms of the Vaccine Court, the fact that those girls got money from the Vaccine Compensation Fund is not particularly relevant, because the cases are not judged based on scientific evidence. A team of lawyers (called "special masters") with no medical background, rather than a judge, jury, scientists, or medical professionals, preside over the cases. The court's guidelines state that “special masters are not bound by formal rules of evidence” and that both sides should “be creative” in presenting their arguments “quickly and less expensively22.”

The court had no way of verifying whether or not Hannah Poling's autism (caused by an underlying mitochondrial disorder) was indeed aggravated by vaccination. Even Poling's doctor, John Shoffner, an expert in mitochondrial disease, was
"genuinely puzzled" by the verdict. As far as I'm concerned, the findings of this court have little to do with science.

Bottom line, if you don't look all sides on this and make your own decision (rather than just joining the Orac insult-o-rama), then you risk taking on their crime of injuring children and withholding needed treatment if 'my side' is right.

I urge you, while you are still very early in your career, to take this subject very seriously and listen to autism parents and see if their concerns, questions and challenges are actually being answered by those you are taking your advice from currently. Are they really dealing with them, or just setting up straw men and knocking them down?
I (and many other parents) would be happy to talk to you about what we have learned and experienced and why we believe as we do, should you earnestly want to investigate autism causes and treatments on your own.
As I wrote on my other post, learning about the experiences of my patients and their families will be crucial for my providing good care, but is not relevant to science-based medicine (excepting in the use of case studies, which have limited value, and which are generally only used to develop hypotheses).

I know that "look at all sides on this" sounds neutral and unbiased, and that I should not "risk taking on their crime of injuring children and withholding needed treatment if 'my side' is right." The problem is that I am confident that I would cause more harm if I spent time to "look at all sides on this" and continued to pore over everyone's counterpoint for these debunked claims. I can spend a lot of time investigating whether or not HAART causes AIDS, or whether oleander defeats cancer, and any other medical claim ever proposed. Nobody can independently investigate every contention. However, doing so would detract from learning to read EKGs or chest X-rays, or performing other tasks that are crucial to avoiding future medical errors and providing excellent patient care.

Every one needs a gestalt about which resources to trust, and on what basis to accept information. A method may occasionally fail, but one chooses it because, compared to all other strategies for acquring information, it provides the greatest accuracy for the most important issues, with the greatest efficiency. To me, trusting a random website would be quick, but unreliable. Doing my own experiments on every issue might be reliable, but extremely inefficient. The best method available for clinicians to acquire scientific information is to use books and journals edited by people whom we know subscribe to a similar epistemoligical approach (i.e. commitment to the scientific method), and whom we know are held accountable for their claims, by the scrutiny of peer review. Will people sometimes falsify data or make errors? Yes. However, after a while, repeatability of experiments stops bad or mistaken research in its tracks.

I figure you might think that this is just a battle of "my favorite studies" versus "your favorite studies," and that the abundance of conflicting papers means that we can't know who is correct (which would theoretically render scientific research to be quite useless, on the whole). While controversy and uneven results can indeed be frustrating, I must say that this isn't a matter of my preferentially selecting studies that would help my case. The scientific method requires "appropriate design and analytic methods...critical to achieve meaningful results." Such methods include "definition of exposures and outcomes, validation of developmental diagnoses, provision of sample size calculations and/or discussion of study power, and statistical methods including techniques to control for potential confounding." One study compared a number of epidemiological cohort studies that investigated a possible vaccination-autism correlation, and found that only the study by the Geiers, (which was also the only study that reported a correlation between vaccination and autism) fulfilled zero out of eight epidemiological criteria. There are a lot of seductive "studies," that we may hope to rely upon, but we can still distinguish the good from the bad, especially with the power of repeatability.

Good luck, Ms. Taylor, and I hope your son's development continues to be successful. I have a family member with an autism-spectrum disorder, and I have observed firsthand the amazing dedication and love that parents put in to careing for these wonderful kids.


1. Jenny McCarthy on Oprah. Interview by Oprah Winfrey, Oprah Winfrey Show, NBC, September 18, 2007. Source from Offit, Paul A. Autism's False Prophets (Columbia: New York, 2008).
2. Bettelheim, Bernard. The Empty Fortress: Infantile Autism and the Birth of the Self (New York: Free Press, 1972). Source from Offit.
3. Offit. 110-111.
4. Boris, Martin and Claudia C. Kaiser, et. al. "Effect of pioglitazone treatment on behavioral symptoms in autistic children." Journal of Neuroinflammation 2007, 4:3.
5. Please see the pages-long list of studies in Offit 256-7 and 266-7.
6. Letter from Dr. Wakefield to journalist Brian Deer. 12.2.04.
7. Waisbren, Burton A. "It is time to face up to the problems of MMR vaccination and its possible relationship to Autism."
8. Geier, David A. and Mark R. Geier. "The Biochemical Basis and Treatment of Autism: Interactions between 3 Mercury, Transsulfuration, and Androgens." Autoimmunity Reviews. Retracted by publisher before publication. Available at
9. Honda, Hideo and Yasuo Shimizu. "No effect of MMR withdrawal on the incidence of autism: a total population study" Journal of Child Psychology and Psychiatry. 46:6. 572-579. Source from Offit.
10. The Autism Genome Project (AGP) Consortium. "Mapping autism risk loci using genetic linkage and chromosomal rearrangements." Nature Genetics. Published online: 18 February 2007, doi:10.1038/ng1985.
11. Vickers AJ, Smith C. "Homoeopathic Oscillococcinum for preventing and treating influenza and influenza-like syndromes.", Cochrane Database Syst Rev. 2006, Issue 3. Art. No.: CD001957.
12. "Autism in Celiac Disease: Failure to Validate the Hypothesis that a Link Might Exist." Biological Psychiatry. 42(1997):72-75. See other sources in Offit 270.
13. 5. Bolman, William N., John A Richmond. "A Double-Blind, Placebo-Controlled, Crossover Pilot Trial of Low Dose Dimethylglycine in Patients with Autistic Disorder," Journal of Autism and Developmental Disorders 29:3 (1999) 191-194
14. 7. Handen, Benjamin L. and Raun D. Melmed. "A Double-Blind, Placebo-Controlled Trial of Oral Human Immunoglobulin for Gastrointestinal Dysfunction in Children with Autistic Disorder," Journal of Autism and Developmental Disorders
DOI 10.1007/s10803-008-0687-y.
15. "Treating Oxidative Stress and the Metabolic Pathology of Autism" Arkansas Children's Hospital Research Institute. Identifier: NCT00572741.
In recruitment stage.
16. A.D. Sandler, K.A. Sutton, et. al. "Lack of Benefit of a Single Dose of Synthetic Human Secretin in the Treatment of Autism and Pervasive Developmental Disorder," New England Journal of Medicine 341 (1999):1801-6. See other studies mentioned in Offit 251-2.
17. Wikipedia article on the Scientology figure, "Xenu."
18. United States Court of Federal Claims. Docket Number 98-916V
19. Full Legal Services Commission Report obtained by Brian Deer via Freedom of Information Act. Available at
20. R. Ellis, "₤500,000 Payout for Autistic Boy Left Fighting for Life After Being Used as an MMR Guinea Pig." Daily Mail. December 8, 2007. Source from Offit.
21. MP3 audio available at and sources cited in Offit page 258.
22. "Guidlines for Practice Under the National Vaccine Injury Compensation Fund." The Office of Special Masters. United States Court of Federal Claims. Available at Source obtained from Grant, Andrew. "Inside the 'Vaccine Court.'" Scienceline.

Friday, January 16, 2009

The Disapointment of Hearing "Your Results Don't Matter"

I am not categorically opposed to "alternative medicine," provided that each accepted treatment is properly tested in an ethical and scientifically sound manner (but I just call using acidic Vitamin A to treat acute promyelocytic leukemia plain old "medicine"). However, friends will sometimes advocate for a particular alternative therapy, be it a tincture, muscle manipulation technique, or adjunct cancer treatment, with the the promotion "My relative tried it and she had great results." To which I usually just respond with, "Cool, Thanks."

I respect the intelligence of my friends, and thus usually speak up and engage them in conversation, when I find something they say to be questionable. However, I keep mum when facing a statement about a close one's personal recovery. There is simply no polite way to say "The experience of your relative does not matter."

I am certainly happy if a friend's loved one recovered successfully from his or her illness. But the fact of his recovery has a less than minuscule effect on my views concerning the value of the treatment. I have no idea if the recovery was because of the treatment, despite the treatment, or for some completely unrelated reason. I say a "less than minuscule", rather than a non-existent effect on my confidence in the medication, because the anecdote does teach me "At least one person was able to recover from his illness while (but not necessarily as a consequence of) using this treatment (Treatment A)." The practical effect of this knowledge would be that, were I placed in a hypothetical situation, in which I had to quickly save someone by choosing between said Treatment A or Unknown Treatment B, I would probably preferentially grab Treatment A. I don't anticipate facing such a "deserted island"-like scenario in my lifetime, so I can safely say that I would be no more or less likely to use Treatment A in practice.

I wonder if the harshness of the objection is what makes some people resistant to evidence-based-medicine. What we are basically saying that no matter how much someone suffered, and no matter the magnitude of her eventual breakthrough, her case is scientifically irrelevant, so long as it was not added to long list of comparable patients of a similar demographic. People want to feel like their experiences matter. Nobody wants to simply be a statistic.

The problem is that treating people as individuals, and caring deeply about the welfare of one patient, both requisite components of empathy-based-patient care, are not pertinent components of evidence-based medicine. It is when we take the good intentions of the former, and impose them upon the cold calculations of the latter (or vice-versa), is when we start to provide medical care that is less efficacious, and less empathic, respectively. Empathy requires a dogged commitment to the patient and his relatives, science involves an exacting focus on anonymous people whose names will never be disclosed. Perhaps it is this intense desire to celebrate the personal, rather than the abstract, that drives us to make crucial cognitive mistakes.

While I am angry that Jenny McCarthy's "advocacy" work may harm many children, her biases seem to stem from natural human feelings that arise to deal with uncertainty, to maintain control over our environment, and, most of all, to find personal meaning in our experiences.
I am currently reading Paul Offit's wonderful book, "Autism's False Prophet's," which transcribes Jenny McCarthy's statements on Oprah, including this response to a question:

"My science is Evan, and he's at home. That's my science." [Loud, thunderous applause].

I honestly am not mocking Ms. McCarthy when I say that I wish I could point to the difficult experiences of loved one's illnesses and call them "my science." But no matter my sympathy of the motivations, it is irrational, nonetheless. And it could potentially cause enormous harm.

Paul Offit also presents the transcription of a doctor name Dr. Geier, who testified against vaccinations in court, and who had been peddling his own untested autism medication called "Lupron." Dr. Geier said,
"We presented a new idea on how to treat autism and how to treat mercury poisoning, because these kids aren't autistic, they're mercury poisoned. Although I'm not happy with trying it on children without further research, these people are desperate and there have been some remarkable responses."

"Remarkable responses," "Try it: He had good results," "My family is my science": All of these are erroneous statements that are damaging to health care. One must develop the humility necessary to accept the limited applicability of one's experiences and observations. This is a difficult bias to overcome. But to do so is necessary, because, as Roger Brinner brilliantly quipped, "The plural of anecdote is not data."

Wednesday, January 14, 2009

Adding Worse Doctors, Getting Better Medicine?

Edwin Leap worries that, if doctors no longer earn a decent profit, the best and brightest will find no good incentive to enter the healing profession.

He writes:

Physicians have to be paid well in order to continue to practice medicine. It wasn’t always this way. Because, there was a time in modern medicine when the rewards of the practice of medicine were considered higher than mere cash. Why did early physicians expose themselves to epidemics and death? Why did they go to battlefields and learn surgery? Why did they labor with the miserable and poor? Because they sensed the value of human-kind. They were taught, and believed, that every life was valuable in God’s eyes, and that if they ignored their calling, and ignored suffering, they would face God’s wrath. They also believed that if they did right, if they endured under hardship, if they died of the diseases they fought against, they would be rewarded by their Creator.

We are too modern for all that, now, aren’t we? We don’t need mumbo-jumbo, irrational, anti-scientific theories about human worth. We’re post-moderns! We will do right, because it’s good for mankind and good for society and because our reward will be…well, it will be science and knowledge…I mean, it will be the survival of all the fittest for the collective good of mankind in a few eons…it will be…a good review from my boss and a nice retirement with a boat…it will be a vacation and a car and….well, some money will do nicely, if you please.

Reject transcendence if you will. But if you do, prepare large boxes of cash. Because doctors without a sense of temporal and eternal purpose will have to be rewarded financially in order to stay in a long, arduous educational system, in order to work all hours, in order to expose themselves to risks physical, emotional and legal and in order to come back day after day to a job that is sometimes amazing but often quite tedious and frequently quite maddening.

Given that it may make more sense, from a purely economic perspective to become a UPS driver than a doctor, and that the average GPA of pre-medical school matriculants is still about a 3.7, the risk of a sudden doctor dry-up is rather low. I am not sure if it is due to a continuous devotion to "transcendence," but Pre-meds are still undergoing Fear Factor level feats to contest for every last available medical school chair in the country. When all else fails, many pack their bags for four sunny years in Grenada.

The unaccepted applicants are, all things considered, less-qualified on average. Some unaccepted applicants bombed their MCATs, some got a C in Orgo Sophomore Year, some had a stain on their tie during their interviews, and some were simply "more average" all around.

Would these potential physicians be worse doctors than the current matriculants, assuming economic conditions lured the smartest college students to law, business, or package delivery? Perhaps. However, the brutal admissions process doesn't measure some of the most crucial skills necessary to become a doctor: Good patient rapport, observation skills, manual dexterity, superhuman ability to function without any sleep, a healthy self-esteem that can endure frequent criticism, and the motivation to keep up with the latest in science-based medicine (a criterion that automatically excludes many working spinal surgeons). There is no reason to believe that Team A possess these skills to a much greater extent than Team B.

Let's say, however, that the currently shut-out applicants would actually become inferior doctors. Maybe they'd miss a few more crucial diagnoses, screw up a few more procedures, or show up to work with that stained tie, every single day. . The fact is that the stuff they do right might outweigh the probability that they would make a few more mistakes. In other words, while medical errors are an enormous problem, many people do not even have the opportunity to be at risk of being victims of medical errors. They do not have doctors, period, and have no chance to be diagnosed and treated, altogether. If you see the slow-growing elephantiasis and massive tumors being sported in our ED's waiting room, you'd see what I mean.

Imagine a mediocre doctor who goes into a small town with no primary care physicians. The doctor misses a few diagnoses, but also recognizes a whole bunch, all of which would have been undetected otherwise. He administers a lot of STD tests, and performs tons of vaccinations. All things considered, I'd say it's a win.

In other words, we shouldn't only focus on the quality of doctors. Even the best doctors can only see so many patients. Those physicians should be doing the trickiest procedures, managing the most complex clinical cases, and addressing actual emergencies. But let's allow nurse practitioners, physician's assistants, and less-stellar doctors to take care of everyone and everything else. Because poor people without any medical care could really benefit from a lot more "good enough."

HT: Kevin, M.D.

Tuesday, January 6, 2009

Radiolab on Choice

Today I listened to a podcast of "Radiolab," the WNYC show hosted by Jad Abumrad, the voice and inflection clone of that other NPRish guy who does "This American Life (Does that voice trainer do some standard laryngoplasty on everyone?) The experimental music and sound effects alone provide a worthy opponent to TV, despite the inability to exploit one of our senses. The topic of the day was "Choices" and the potential psychological perils of its abundance.

People, like myself, who read lots of "happiness studies books" (which is distinct from reading self-help books. Not that there's anything wrong with that...) will recognize some of the usual players who are interviewed, most notably, Barry Schwartz, a professor of psychology at Harvard who wrote "The Paradox of Choice." Schwartz studies how the abundance of available options in developed countries commonly leads to self-doubt, regret, paralysis in decision-making, and an overall feeling of dysthymia. Schwartz believes that government should act to limit people's choices, by paring down, say, the hundreds of peanut butter options at Whole Foods.

Predictably enough, as a libertarian, I disagree with Barry Schwartz's prescriptions, if not his assessments. Even if, theoretically, government were justified in restricting choices without consent, and even if in practice did a decent a job ridding the public of some unnecessary choices, we'd still all have to cope with overwhelming options sooner or later. Schwartz, in his book, even provides strategies for doing so. Since Schwartz presumably doesn't believe in censorship, I'd still have millions of books listed on Amazon to devour. With some benevolent meddler paring down my reading list, I'd still mull over whether to read altogether to move on to cooking dinner instead (using a pared down list of recipes). In other words, people simply have to learn strategies of prioritization. Uncle Sam's wagging finger in the peanut butter aisle would simply help me avoid setting up the an internal Grand Supermarket Shopping Prioritization Strategy Task Force, a necessary step for learning to move on and get stuff done.

Abumrad interviews Oliver Sacks, who outlines his strategy to avoid deliberating on too many time-wasting decisions. He says, "I make a willful choice. Certain things I care about a lot and I worry over, and then there's a whole swath of my life that I just don't even choose." Every week, his housekeeper buys one half-gallon of soy milk, one half-gallon of prune juice, seven apples, seven pears, and several tins of sardines. She will then cook up a gallon of orange jello and a vat of tabbouleh, to be consumed for dinner each night, along with the sardines.

Sacks is so normalized to his menu, that he "never gets bored" with his food. Presumably, his main hedonic pleasure is music. To maximize time invested in such pursuits, he simply ignores other potential sources of joy, such as variety in food. Repetition, however, is not the same as denial: every day, he keeps exactly a dollar in his pocket, to buy a piece of 72% cacao chocolate at the chocolatier on his way home.

Later in the program, Abumrad highlights human irrationality in decision-making, through the concept of "risk aversion," or how our fear losing something overpowers our perceived joy of winning that same item. Mimicking a previously performed psychological study, the djs wandered around outside, offering random bystanders opportunities to play "heads or tails." The djs started out offering one dollar for the strangers' dollar (a proposition rejected by all), but then offered increasingly high amounts of money to match the bystander's dollar. Most people didn't accept the match until the djs reached about two dollars. On the show, the djs then speculate as to why, for most people, loss is twice as "painful" as gain.

Risk aversion is real, but I don't see how it is always irrational. For one, the dj's dollar is not worth the same amount as my dollar. My dollar is already in my pocket. His dollar has to sacrifice some pennies to pay for my trust that this stranger is good for the money, and this isn't just one big scam.

One guy, cited that he "was just not a gambler," and, for reasons other than religion, wouldn't even play if the odds were 100 to 1. Perhaps his view of gambling as different from other economic transactions is irrational (I avoid casinos, not because it's "gambling," but simply because I know my odds of winning are poor. I viewed my regrettable purchase of that "As Seen on TV" Super Slicer as simply a gamble with better odds). However, if the man is a conscientious objector to coin tosses, is that necessarily irrational? Perhaps, due to family history, he knows he may be susceptible to a gambling problem (thus making an irrational decision that is only rational, because it is used to combat an irrational compulsion). Maybe he just wants to die bragging that he never gambled. The problem with these studies, I find, is that the researchers just don't give their subjects enough credit.

Even if there were no doubts about the integrity of the djs, nor any personal opposition to gambling, a more serious error is to assume that a potential dollar won is worth the same as the dollar the person already has. In fact, I suspect Sir Oliver Sacks himself might have refused to play the game of chance. A hundred to one odds might allow the chance to purchase the fanciest products displayed in the supermarket. But he could also lose the opportunity to buy a piece of 72% cacao chocolate on the way home from work.

Update 1/7/09: The very day I wrote this post, I randomly came across this at the "Overcoming Bias" blog. I suppose the Baader-Meinhoff phenomenon is my personal bias of the hour.