A RESPONSE TO JP
In my last post, I offered a critique of Paul Offit’s interview on Autism One Radio. That post prompted the following comment from “JP,” who maintains a site called SupportVacination.org. JP’s comment reads as follows:
I started to compose a reply to JP in the comments section, but I soon realized there was enough to say for a whole new post.
First of all, JP’s comment that the astounding increase we saw in ASD over the course of 10 years results from changes in diagnostic criteria and availability of services is an argument that even the most tireless vaccine apologists are beginning to abandon. Note that in Dr. Offit’s interview, he acknowledged that autism “has apparently become more common.” I hate to parse oral statements, but Dr. Offit did not say that “reported cases of autism have increased.” Granted, the use of the word “apparently” leaves a little wiggle room, but Dr. Offit’s phrasing is consistent with what we hear from public health officials who, even though they do not wish to give credence to a vaccine connection, admit that there seems to be a rise in the incidence of ASD. Genetics cannot account for that rise. For a less scientific confirmation, simply ask any elementary school teachers who have been on the job for more than 15 years if they see more kids on the spectrum. (I should note that statements attributed to Dr. Offit have been all over the board on the issue of whether there is an epidemic.)
Epidemiology can get us to the one in 166 number, but it can not show the impact of the increased exposure to thimerosal (or the combined impact of thimerosal-containing and live-virus vaccines) after a large number of vaccines were added to the schedule. Only clinical and biological studies can show that, and Dr. Offit’s insistence that epidemiology can definitively provide and answer leads me to question either his intellectual honesty or his scientific competence.
With regard to the Verstraeten report, let me quote the author: “The bottom line is and has always been the same, an association between thimerosal and neurological outcomes could neither be confirmed nor refuted and therefore more study is required.” Dr. Verstraeten did not say that his study indicates a lack of an association, but it needs to be replicated. Rather, he said his study was inconclusive.
I believe that in making that statement, Dr. Verstraeten showed more intellectual honesty as a full-time employee of a vaccine manufacturer than Dr. Offit has ever displayed as a part-time consultant. Dr. Verstraeten knew that limiting the scope of his study to a strictly defined definition of autism as opposed to the full scope of ASD, together with including a cohort too young to be diagnosed with autism, dramatically altered the outcome of his report. It went from showing a probable association to being “neutral.”
While I have not spoken to anyone at the CDC as JP claims to have done, my understanding is that the raw datasets are gone. At least that’s what the CDC indicated when a member of Congress looked into the matter. What may be available are the final “archived” sets that do not include all data that was examined. Moreover, anyone who wishes to examine the data is given very limited access, reportedly on privacy grounds, even though all personal identifying information has already been removed. The only means of either replicating or refuting Dr. Verstraeten’s published “findings” is to have access to the original raw data with the same unhampered access as Dr. Verstraeten had.
The Danish and Swedish studies Dr. Offit finds so convincing as replication have no relevance at all to the Verstraeten report. First, the level of thimerosal exposure in those countries was far lower than the exposure to our children here in the United States. Moreover, the use of different populations in the “before” and “after” numbers provides a textbook example of data manipulation.
I can only assume that the “Faroe Island” studies to which JP refers are the same studies Dr. Verstraeten described as being “as comparable to our issue as apples and pears at the best.” He fought against using those studies as part of his report despite the fact that “many experts, looking at this thimerosal issue, do not seem bothered to compare apples to pears and insist if nothing is happening in these studies then nothing should be feared of thimerosal.” Of course, Dr. Verstraeten wrote that before he left the CDC for the greener pastures of Glaxo-SmithKline. One cannot help but wonder how Dr. Verstraeten’s report would have ended up had he not opened it up to the “suggestions” of others with vested interests.
JP correctly argues that a single reductionist study cannot control public policy. But that is the nature of reductionist studies; they each comprise a single part of a larger puzzle. When enough pieces of the puzzle come together, one can see the whole picture. Enough of those pieces are coming together now that we can see the plausibility of a link, but Dr. Offit -- and apparently JP as well -- will not put the pieces together.
For example, I cannot argue with JP’s statement that the Burbacher study, in itself, does not show the harmful impact of inorganic mercury in the brain. But it does show that inorganic mercury can accumulate in the brain, if ethylmercury is not excreted. And the Jill James study shows the plausibility of some children being genetically hampered in their ability to excrete ethylmercury. Moreover, I can’t help but be reminded that Dr. Offit’s primary criticism of Richard Deth’s in vitro studies of ethylmercury was that there was no evidence that ethylmercury crossed the blood-brain barrier. That answer was supplied by the Burbacher study. Dr. Deth’s study shows a probability that ethylmercury is every bit as dangerous as methylmercury. But again, one has to put the pieces of the puzzle together by looking at a number of reductionist studies, something Dr. Offit apparently does not have the patience to do.
JP’s argument about the pervasive risk from methylmercury is almost word-for-word the same argument we often hear from Dr. Offit. Certainly potential exposure from methylmercury is a risk factor, and can present a possible envoironmental trigger for all sorts of things, including ASD. But the bolus dose of ethylmercury my child received in any of his thimerosal-containing vaccines exceeded the exposure of methylmercury from other sources, especially considering the ethylmercury was injected directly into his body. Mercury poisoning just doesn’t get any more efficient than that.
JP may be willing to take Dr. Offit’s claim that he does not take money from vaccine manufacturers at face value, but I think he is hopelessly naïve to do so. Dr. Offit acknowledged that he has been a consultant for Merck, although he has refused to say what remuneration he receives for his services. Dr. Offit and his partner received a $350,000 grant from Merck for the development of their rotavirus vaccine, and then got to keep the patent. In essence, Merck paid to have the option to use the patent. Merck purchased 20,000 copies of Dr. Offit’s book, Vaccines: What You Should Know, to distribute to physicians. There is nothing dishonest about entering into these arrangements, but to pretend that the relationship doesn’t exist is wrong.
Of course, Dr. Offit’s grasp on the concept of a “conflict of interest” is a little shaky. He served on the Advisory Committee for Immunization Practices for the CDC. While on the committee, Dr. Offit voted three times in favor of adding a Wyeth vaccine for Rotavirus to the national vaccine schedule. Because his association was with another manufacturer, he saw no reason to cast a vote on the issue even though the first vaccine’s approval would make it easier to gain later approval for alternatives like Merck’s vaccine. It was not until the committee met again -- after the Wyeth vaccine killed 10 children in a two-week period -- that Dr. Offit thought that the appearance of impropriety might be enough to prevent him from voting on the vaccine’s removal from the schedule.
I practice in a profession that takes conflicts of interest pretty seriously. I should be thankful for people like Dr. Offit, because his actions make shady lawyers look relatively honest.
Let us suppose for the sake of argument that Dr. Offit did not have close ties to the industry, and that he speaks out simply because he believes so very much in a vaccine program that has saved countless lives. (Indeed, that is the reason JP gives for his own involvement in the debate.) The arrogant statements Dr. Offit has made, such as “full disclosure can be harmful,” from a New York Times Magazine article, show his attitude toward patients and parents. Look at the following quote from the interview he gave David Kirby for Evidence of Harm:
I can picture Dr. Offit on the witness stand, shouting out: “You can’t handle the truth!!!”
Dr. Offit’s stated concern in making those statements was that parents were being deterred from having their children vaccinated. That concern may be laudable, but I would submit that Dr. Offit has done far greater damage to the vaccine program by making it easier to conceal the truth than would have been done if the problem would have been openly acknowledged. In his view, it may be better to hide some of the truth and sacrifice a minority of the children for the greater good. I have a hard time seeing that greater good, because I live with one of Dr. Offit’s sacrificial lambs.
JP says that we “have every ability in the world” to prove he is wrong. I am not sure what planet JP lives on, but here on Earth, research takes a lot of money. As long as men like Paul Offit provide cover for politicians and bureaucrats, some of whom benefit from the contributions of vaccine manufacturers, it will be difficult to convince government to allocate the necessary resources to definitively determine the causal connection between vaccines and autism. So the inquiry will take much longer than it should. Still, JP, tell Dr. Offit not to get too comfortable. It may take some time, but we’re going to find the answer.
Wade,
Again, I believe you're off-base on a few comments.
As I've stated numerous times on my blog - if you're trying to ask the question of whether vaccines (or mercury in vaccines) played a role in moving the needle towards the 1 in 166 number we see today, epidemiology is the ONLY way to answer that question. So I think Offit's right in that regard.
I haven't heard Offit's interview, but I don't think that's necessarily inconsistent with saying that autism might have an environmental component, but that component isn't necessarily vaccination. I personally think that's a real possibility - there are MANY factors at work with the increase in autism throughout the years. Some of them are expansion of the ASD criteria and availability of services. Some of them may be external.
I disagree with your assessment of the Burbacher study. The Burbacher study illustrated that ethylmercury clears the body faster than methylmercury, but leaves more inorganic mercury behind. In the study itself, Burbacher doesn't necessarily say that the inorganic mercury left behind is dangerous or even meaningful, because nobody knows if it is or not. (other than one study that postulates that fact) So Offit's again, right on that point.
As to whether methylmercury exposure is more dangerous than ethylmercury exposure, well, there is the pesky fact that methylmercury is everywhere. We can't get away from it. It's in the food we eat, the water we drink and the air we breathe. If mercury is a cause of autism, it would be logical to assume that methylmercury is the prime culprit. You are correct in saying we have no studies to know that for sure, but it's a reasonable hypothesis.
And as I said above, Offit giving more weight to epidemiology IS appropriate. It's how you're going to make decisions about population-based issues. Reductionist studies aren't going to help shape public health policy. They can't, they're not powerful enough, they're not right often enough.
As to the Verstraeten study - while Verstraeten did classify the study as "neutral", I've now talked to three different folks involved with the study who disagree with that assessment. They all agree, however, that a more probative study (and there's one being conducted based on a similar Faroe Islands study several years ago) is necessary.
And as I said on my blog (and confirmed by two different individuals involved with the CDC) the data used in the Verstraeten study IS available for anyone who wants to use it. I've heard that fallacy of the "data is missing" so long now that it's become almost a given, which is a shame.
And as to your claim in a previous comment that Offit has deeply entrenched "vaccine industry ties" - I guess I'd like to see some actual proof of that. Offit himself has said, on numerous occassions, that he does NOT take money from drug companies. I've yet to see someone counter with hard evidence that he does, other than the claims of Merck hush money or misuse of "unrestricted educational grants" that is to date unfounded.
Wade, all in all, I think that Offit's position - while anathema to you - has a fair amount of validity. And as I told Ginger Taylor a while back - you have every ability in the world to prove me wrong. Epidemiological studies. Clinical trials of chelation therapy. Rather than rush headlong into curing kids with treatments that are of questionable validity and effiacy, why not do the due dilligence to know you're right first?
I started to compose a reply to JP in the comments section, but I soon realized there was enough to say for a whole new post.
First of all, JP’s comment that the astounding increase we saw in ASD over the course of 10 years results from changes in diagnostic criteria and availability of services is an argument that even the most tireless vaccine apologists are beginning to abandon. Note that in Dr. Offit’s interview, he acknowledged that autism “has apparently become more common.” I hate to parse oral statements, but Dr. Offit did not say that “reported cases of autism have increased.” Granted, the use of the word “apparently” leaves a little wiggle room, but Dr. Offit’s phrasing is consistent with what we hear from public health officials who, even though they do not wish to give credence to a vaccine connection, admit that there seems to be a rise in the incidence of ASD. Genetics cannot account for that rise. For a less scientific confirmation, simply ask any elementary school teachers who have been on the job for more than 15 years if they see more kids on the spectrum. (I should note that statements attributed to Dr. Offit have been all over the board on the issue of whether there is an epidemic.)
Epidemiology can get us to the one in 166 number, but it can not show the impact of the increased exposure to thimerosal (or the combined impact of thimerosal-containing and live-virus vaccines) after a large number of vaccines were added to the schedule. Only clinical and biological studies can show that, and Dr. Offit’s insistence that epidemiology can definitively provide and answer leads me to question either his intellectual honesty or his scientific competence.
With regard to the Verstraeten report, let me quote the author: “The bottom line is and has always been the same, an association between thimerosal and neurological outcomes could neither be confirmed nor refuted and therefore more study is required.” Dr. Verstraeten did not say that his study indicates a lack of an association, but it needs to be replicated. Rather, he said his study was inconclusive.
I believe that in making that statement, Dr. Verstraeten showed more intellectual honesty as a full-time employee of a vaccine manufacturer than Dr. Offit has ever displayed as a part-time consultant. Dr. Verstraeten knew that limiting the scope of his study to a strictly defined definition of autism as opposed to the full scope of ASD, together with including a cohort too young to be diagnosed with autism, dramatically altered the outcome of his report. It went from showing a probable association to being “neutral.”
While I have not spoken to anyone at the CDC as JP claims to have done, my understanding is that the raw datasets are gone. At least that’s what the CDC indicated when a member of Congress looked into the matter. What may be available are the final “archived” sets that do not include all data that was examined. Moreover, anyone who wishes to examine the data is given very limited access, reportedly on privacy grounds, even though all personal identifying information has already been removed. The only means of either replicating or refuting Dr. Verstraeten’s published “findings” is to have access to the original raw data with the same unhampered access as Dr. Verstraeten had.
The Danish and Swedish studies Dr. Offit finds so convincing as replication have no relevance at all to the Verstraeten report. First, the level of thimerosal exposure in those countries was far lower than the exposure to our children here in the United States. Moreover, the use of different populations in the “before” and “after” numbers provides a textbook example of data manipulation.
I can only assume that the “Faroe Island” studies to which JP refers are the same studies Dr. Verstraeten described as being “as comparable to our issue as apples and pears at the best.” He fought against using those studies as part of his report despite the fact that “many experts, looking at this thimerosal issue, do not seem bothered to compare apples to pears and insist if nothing is happening in these studies then nothing should be feared of thimerosal.” Of course, Dr. Verstraeten wrote that before he left the CDC for the greener pastures of Glaxo-SmithKline. One cannot help but wonder how Dr. Verstraeten’s report would have ended up had he not opened it up to the “suggestions” of others with vested interests.
JP correctly argues that a single reductionist study cannot control public policy. But that is the nature of reductionist studies; they each comprise a single part of a larger puzzle. When enough pieces of the puzzle come together, one can see the whole picture. Enough of those pieces are coming together now that we can see the plausibility of a link, but Dr. Offit -- and apparently JP as well -- will not put the pieces together.
For example, I cannot argue with JP’s statement that the Burbacher study, in itself, does not show the harmful impact of inorganic mercury in the brain. But it does show that inorganic mercury can accumulate in the brain, if ethylmercury is not excreted. And the Jill James study shows the plausibility of some children being genetically hampered in their ability to excrete ethylmercury. Moreover, I can’t help but be reminded that Dr. Offit’s primary criticism of Richard Deth’s in vitro studies of ethylmercury was that there was no evidence that ethylmercury crossed the blood-brain barrier. That answer was supplied by the Burbacher study. Dr. Deth’s study shows a probability that ethylmercury is every bit as dangerous as methylmercury. But again, one has to put the pieces of the puzzle together by looking at a number of reductionist studies, something Dr. Offit apparently does not have the patience to do.
JP’s argument about the pervasive risk from methylmercury is almost word-for-word the same argument we often hear from Dr. Offit. Certainly potential exposure from methylmercury is a risk factor, and can present a possible envoironmental trigger for all sorts of things, including ASD. But the bolus dose of ethylmercury my child received in any of his thimerosal-containing vaccines exceeded the exposure of methylmercury from other sources, especially considering the ethylmercury was injected directly into his body. Mercury poisoning just doesn’t get any more efficient than that.
JP may be willing to take Dr. Offit’s claim that he does not take money from vaccine manufacturers at face value, but I think he is hopelessly naïve to do so. Dr. Offit acknowledged that he has been a consultant for Merck, although he has refused to say what remuneration he receives for his services. Dr. Offit and his partner received a $350,000 grant from Merck for the development of their rotavirus vaccine, and then got to keep the patent. In essence, Merck paid to have the option to use the patent. Merck purchased 20,000 copies of Dr. Offit’s book, Vaccines: What You Should Know, to distribute to physicians. There is nothing dishonest about entering into these arrangements, but to pretend that the relationship doesn’t exist is wrong.
Of course, Dr. Offit’s grasp on the concept of a “conflict of interest” is a little shaky. He served on the Advisory Committee for Immunization Practices for the CDC. While on the committee, Dr. Offit voted three times in favor of adding a Wyeth vaccine for Rotavirus to the national vaccine schedule. Because his association was with another manufacturer, he saw no reason to cast a vote on the issue even though the first vaccine’s approval would make it easier to gain later approval for alternatives like Merck’s vaccine. It was not until the committee met again -- after the Wyeth vaccine killed 10 children in a two-week period -- that Dr. Offit thought that the appearance of impropriety might be enough to prevent him from voting on the vaccine’s removal from the schedule.
I practice in a profession that takes conflicts of interest pretty seriously. I should be thankful for people like Dr. Offit, because his actions make shady lawyers look relatively honest.
Let us suppose for the sake of argument that Dr. Offit did not have close ties to the industry, and that he speaks out simply because he believes so very much in a vaccine program that has saved countless lives. (Indeed, that is the reason JP gives for his own involvement in the debate.) The arrogant statements Dr. Offit has made, such as “full disclosure can be harmful,” from a New York Times Magazine article, show his attitude toward patients and parents. Look at the following quote from the interview he gave David Kirby for Evidence of Harm:
… you did more harm than good in sort of, quote/unquote, allowing the parent to be fully informed. There’s no politically correct way to say this, but being fully informed is not always the best thing.
I can picture Dr. Offit on the witness stand, shouting out: “You can’t handle the truth!!!”
Dr. Offit’s stated concern in making those statements was that parents were being deterred from having their children vaccinated. That concern may be laudable, but I would submit that Dr. Offit has done far greater damage to the vaccine program by making it easier to conceal the truth than would have been done if the problem would have been openly acknowledged. In his view, it may be better to hide some of the truth and sacrifice a minority of the children for the greater good. I have a hard time seeing that greater good, because I live with one of Dr. Offit’s sacrificial lambs.
JP says that we “have every ability in the world” to prove he is wrong. I am not sure what planet JP lives on, but here on Earth, research takes a lot of money. As long as men like Paul Offit provide cover for politicians and bureaucrats, some of whom benefit from the contributions of vaccine manufacturers, it will be difficult to convince government to allocate the necessary resources to definitively determine the causal connection between vaccines and autism. So the inquiry will take much longer than it should. Still, JP, tell Dr. Offit not to get too comfortable. It may take some time, but we’re going to find the answer.
posted by Wade Rankin at 10/11/2005 10:24:00 PM
6 Comments:
Wade,
I'd like to respond to some of this...
First of all, JP’s comment that the astounding increase we saw in ASD over the course of 10 years results from changes in diagnostic criteria and availability of services is an argument that even the most tireless vaccine apologists are beginning to abandon.
That wasn't my statement. My statement was that a number of factors - some diagnostic, some service-availability driven, and perhaps some external - are responsible. IDEA and the widening of the autism criteria in the DSM-IV HAD to have accounted for some of the increase in cases during the 1990's. It's illogical to believe otherwise. Can it account for all of it? Perhaps not. But I see far too much dismissal of those factors for my taste.
While I have not spoken to anyone at the CDC as JP claims to have done, my understanding is that the raw datasets are gone. At least that’s what the CDC indicated when a member of Congress looked into the matter. What may be available are the final “archived” sets that do not include all data that was examined. Moreover, anyone who wishes to examine the data is given very limited access, reportedly on privacy grounds, even though all personal identifying information has already been removed. The only means of either replicating or refuting Dr. Verstraeten’s published “findings” is to have access to the original raw data with the same unhampered access as Dr. Verstraeten had.
While I would like nothing more than to forward the names and personal information of those I spoke to at the CDC, a lot of the information I got (including a number of choice tidbits about the Geiers and what REALLY happened, which I may at some point write about) was obtained on the promise of anonymity. I'm not going to betray that confidence. Suffice it to say that these individuals are well-connected with both immunization policy and the Verstraeten study, and I tend to think they have more credibility than, say, the Geiers - who are NOT epidemiologists.
The bottom line - the data IS available. Rather than assume it isn't available because Dave Weldon says it isn't or because some of the anti-thimerosal and anti-vaccine groups insist it isn't...why isn't someone trying to get the data for themselves? As far as I know, nobody on that side actually has.
JP correctly argues that a single reductionist study cannot control public policy. But that is the nature of reductionist studies; they each comprise a single part of a larger puzzle. When enough pieces of the puzzle come together, one can see the whole picture. Enough of those pieces are coming together now that we can see the plausibility of a link, but Dr. Offit -- and apparently JP as well -- will not put the pieces together.
I guess I'm confused as to what these "pieces" are, Wade.
The Burbacher study didn't show anything other than somewhat more inorganic mercury shows up in the brain after exposure to thimerosal.
The Deth study only shows what we already know - if you inject thimerosal directly into cells the cells are damaged.
The Horning study uses a mouse model, assumes autism is an autoimmune disease and assumes the behavior the rodents displayed were autistic in nature. (Self-mutilation, contrary to popular belief, is relatively rare in autistics.) James' study shows that autistics may have some methylation problems, but doesn't show that relieving those problems means anything in terms of improving the lot of those children.
As to Offit, and some of the specific points Wade made:
-Offit was "consulting" with Merck on a rotavirus vaccine. How much money Offit was receiving (or if he even received any) is unknown. It's no secret that Dr. Offit will profit if his rotavirus vaccine makes it to market, but Offit has also never disputed that point.
-Offit did not receive any money from Merck. Another researcher in his division did, for testing the vaccine. As to the 20,000 copies purchased by Merck - unless you know the business arrangement of the deal (some of those deals are done "at cost" and royalties are waived) you can't assume Offit profited.
-As to his voting to put Rotashield on the schedule - there's another entirely different angle to take on that. Wade doesn't understand that by voting to put Wyeth's vaccine on the schedule, he was creating a pretty tough scenario for Merck's version. Wyeth would have several years head start in creating relationships with state governments and medical suppliers. RotaTeq (Offit's vaccine) would have to play catchup in terms of the marketplace. Offit actually did Merck a big disservice by putting a competitor's vaccine on the market first.
Could you argue Offit shouldn't have voted in either scenario? Sure. If it was me, I'd have stayed out of it altogether for fear of trying to influence the decision one way or the other. But I can argue Offit's decision to stay out of the removal of Rotashield from widespread use was due to not wanting to seem like he was trying to "pave the way" for his vaccine to get back on the market.
There's an entirely different way to look at it IF you are willing to subscribe something other than base motives to Dr. Offit.
And as to this quote:
… you did more harm than good in sort of, quote/unquote, allowing the parent to be fully informed. There’s no politically correct way to say this, but being fully informed is not always the best thing.
I understand where Offit's coming from. Information is a good thing. Information with appropriate context is not a good thing.
What I hear anti-vaxers always say is "I'm not against vaccines, I just want parents to make an informed choice." In reality, what they want is for doctors to admit that vaccines do x, y, and z. They want the VIS to be five pages long and say that vaccines cause autism and SIDS and cancer. (ok, maybe not all of that)
Or you can find doctors that talk in scientific sounding terms that vaccines do all of these horrible things. To a layperson, it sounds credible. To someone with actual education in immunology or in public health, it's laughable. That's why - if you forgive me - I'm more willing to listen to an immunologist or an epidemiologist than a geneticist or an author or the plethora of "researchers" making the rounds.
And now to the final point:
JP says that we “have every ability in the world” to prove he is wrong. I am not sure what planet JP lives on, but here on Earth, research takes a lot of money. As long as men like Paul Offit provide cover for politicians and bureaucrats, some of whom benefit from the contributions of vaccine manufacturers, it will be difficult to convince government to allocate the necessary resources to definitively determine the causal connection between vaccines and autism. So the inquiry will take much longer than it should. Still, JP, tell Dr. Offit not to get too comfortable. It may take some time, but we’re going to find the answer.
This paragraph is, in many ways, troubling to me.
The anti-thimerosal group has every ability to prove me wrong. And it's not by testimonials or by Generation Rescue taking out full-page ads (at $100K a pop) in USA Today or the New York Times. It's not by impressive sounding science that - at best - tangentially proves your case.
It's by getting right to the heart of the matter and showing that kids who got thimerosal were more likely to be autistic than kids who weren't.
Or, in absence of that, showing that treatments that chelate heavy metals have an impact on a child's autistic symptoms.
Cave and Holmes started using chelation in 1995. There's been significant discussion about thimerosal in vaccines since at least 1999-2000. In all of this time - six years - there hasn't been one study done by any clinician or researcher that says (with any degree of certainty) that thimerosal plays a role in autism.
Not one.
Yet the Buttars and Bradstreets of the world charge $800 an hour for consultations and thousands of dollars per year for treatments that are at best unproven to work and in some cases may be dangerous. Yet J.B. Handley and Lyn Redwood convince us that autism=mercury poisoning and don't mind the fact that there are enough lawsuits out there to bankrupt drug companies for a theory that has minimal scientific support at best.
You can argue that the government is dragging their feet all you want. But that's obscuring the point, Wade. The harsh reality is that doctors are promoting treatments and not providing ANY evidence in ANY peer-reviewed journal that they work. And that's ok.
Yet government agencies and drug companies spend millions (if not billions) on research and development of vaccines, test them over and over, monitor their usage after licensure. But somehow, they're the bad guys because instead of doing primary safety research on thimerosal they did primary safety research on vaccines themselves.
You've fallen victim to the most common gambit of the "altie" - the "we don't have the time or money to do the research" gambit. As long as the anti-thimerosal movement can claim that the government is stifling their research intentions, they have a pass to not do the research on their own.
Rats and test tubes are nice, Wade, but if there's so little time to waste, shouldn't these studies be cutting right to the chase instead?
JP. Let’s get rid of the conflict-of-interest question. You say the Merck payment went to another doctor in the research group. In the past, I have heard the doctor described as a business partner of Dr. Offit’s, or as a member of Dr. Offit’s practice group (which ordinarily amounts to the same thing as a business partner). If that was the case, then Dr. Offit would profit, at least indirectly, from such a payment. Together with the book purchase, a pattern of indirect profit would be present. On the other hand, if the doctor receiving the funds had no such relationship, then Dr. Offit has my apologies on that one count. But that does not indicate the lack of a conflict. Dr. Offit has continuously admitted to being a “consultant,” a position that ordinarily carries with it some kind of financial remuneration. Moreover, if Dr. Offit granted Merck the right to manufacture a vaccine for which he holds the patent without any compensation for the initial granting of the right, then I would suggest that he find better representation.
Dr. Offit constantly protests that there’s no conflict of interest simply because we can believe him when he says his intentions are honorable. The impossibility of objectively judging intentions is precisely the reason we have standards for conflicts of interest. If there was good reason for Dr. Offit to recuse himself on the final vote on the Wyeth vaccine, those reasons existed on the three previous votes as well. Your echoing of Dr. Offit’s protests that he was actually voting against Merck’s interests is certainly appealing in a simplistic way, but the opposite analysis is equally, if not more, plausible. Getting a rotavirus vaccine -- any rotavirus vaccine -- on the schedule served Merck’s interest in the long run. While ceding some market share to Wyeth, Merck could be assured of a smoother approval process when they came out with their “new and improved” version of the vaccine.
As I stated previously, though, we can ignore the conflict-of-interest issue and assume that Dr. Offit speaks out merely because he believes so very much in the way in which this country’s vaccine program is run. I accept that as a plausible explanation for Dr. Offit’s comments. A plausible explanation, however, is not the same thing as an excuse for deceptive speech, whether the deception is directed to others or to oneself. I consider it entirely possible that Dr. Offit is so irrationally paranoid about the possibility of frivolous litigation that he will say just about anything to protect the vaccine industry. Your own comment seems to echo that paranoia. That opens up a subject that is too complicated for this comment, but I promise that my next post will look at that issue.
So let’s move on to your continuing accusation that those of us who believe in the plausibility of a causal link and the efficacy of biomedical treatment, are responsible for conducting research but we engage in a gambit that there is not enough time and money. The only time element that concerns me is whether my wife and I can wait for all of the scientific research to be completed before I take steps to intervene in our son’s condition. I don’t believe we can, so we weigh risks against potential benefits and take the action we deem appropriate. That decision, however, is totally separate from the issue of scientific research into causal connections between environmental factors -- including both thimerosal-containing and live-virus vaccines -- and the triggering of ASD.
I cannot believe that you are seriously suggesting that corners should be cut (or as you say, “cut to the chase”) in performing the research to determine whether a link exists. If those corners were cut, the results would be subject to criticism for not being thorough enough to have any validity. Good science does not lend itself to instantaneous answers. It takes time, and it takes money. Organizations like Safe Minds have done wonders in helping to fund some of the basic research that is laying the foundation for further study. But to put it bluntly, the resources available to the families of autistic children are simply insufficient to carry out the research that is still needed.
Your gratuitous mention of the reputed fees charged by Drs. Buttar and Bradstreet (and I certainly do not know how accurate you are) are completely immaterial to the question of funding basic research. Indeed, if I were one of those bloggers who revel in the gamesmanship of a debate rather than substance, I would call it a “red herring.”
Ordinarily, the type of research we are talking about is funded through either government or the industry that has the most to gain or lose by the research. Whys is this issue any different?
JP, you complain that we make out government and vaccine manufacturers to be “the bad guys because instead of doing primary safety research on thimerosal they did primary safety research on vaccines themselves.” I plead guilty as charged. I consider it disgraceful that the most technologically advanced nation in the world would allow an additive to be placed in a product designed to enhance the health and safety of children without conducting any serious study of the additive’s safety. And when you consider that the additive contains mercury, the word “disgraceful” can be replaced by the word “obscene.”
I apologize if I am departing at all from my custom of showing courtesy to anyone who leaves a comment at this site. You are always free to comment in any way you see fit, and to express any opinions you wish.
Wade,
It is clear that your problem with me is not my comments or the style in which I make my comments, but the position I take with regards to defending Paul Offit and vaccination policy. I'm a touch saddened by your tone, actually, but I do admit that at times I come off a bit abrupt - so I'll take at least some of the blame for that.
But let me reiterate a few things:
1. In the U.S., removing thimerosal from vaccines was a good idea. Why? Because we have the financial resources to do so. (I do differ from Dr. Offit in that regard.) However, in other parts of the world - a couple of dollars per dose makes a big difference. If it's a question of not vaccinating (or undervaccinating) a population, then at this point I think the real risk of those diseases in other parts of the world outweight the mostly theoretical risk of thimerosal in vaccines.
2. I don't think I'm "paranoid" about frivolous litigation against the vaccine industry. It isn't paranoia when the vaccine industry is under what I believe is an unfair attack. These lawsuits dwarf the entire worldwide market for vaccines. I'll say what I've said many times before - if we're going to go there and say that vaccines played a role in the rise of autism, we'd better make damn sure we're right.
Why? Because we can't undo the harm very easily if it turns out later that autism and vaccines were really unrelated. This isn't fen-phen or breast implants - it's an entire tenet of modern medicine that has unquestionably saved millions of lives. I'm suggesting we need a high standard of proof, higher than what's out there so far.
3. As to the use of biomedical treatments:
I understand the desire to "do something" to help their autistic child. Just as I would understand the desire to help any child who was struggling with any troubling condition.
I would suggest, however, that one who engages in biomedical treatments must realize that there is no real way to determine an accurate risk/benefit ratio for said treatments at this point. How could there be, if there's no peer-reviewed science for one to make an informed decision about the true safety and efficiacy of said treatments for this purpose?
I mean, if I were to suggest that one vaccinate their child (for example) while having no peer-reviewed research to back up whether the vaccine is effective or even safe, I would be crucified. And rightly so. (We can argue whether the amount of peer-reviewed research for a particular vaccine was adequate, obviously, but the reality is that there is substantial research on vaccines done before they ever hit the market.)
So my feeling is that if one chooses to engage in those treatments, that's certainly their prerogative. Going to them with the idea that these are experimental and may not work is likely the right mindset.
But I would suggest that most purveyors of these treatments don't perceive them in that way. At least not the most vocal advocates of them, like the J.B. Handleys of the world. They're already convinced that chelation or vitamin supplmentation IS a viable cure for autism, and market and promote it in that fashion. So if one is already convinced that these treatments work, then it makes sense that they would charge $800 per consultation (see AutismDiva or Kevin Leitch's blog for specific examples of how much Buttar charges for a "consultation") for that treatment.
It's not a red herring to bring that up. It's part and parcel of the argument, because without peer-reviewed science the ONLY thing parents have to go on are the claims of the doctors involved. And those doctors have a lot to lose in these cases, I'd presume. Their professional reputations. In some cases, major sources of income.
So all of this goes back to the point about "cutting corners".
I steadfastly believe in the five to ten years that people have been researching chelation and autism somebody should be able to produce a peer-reviewed study in a credible journal about chelation's effectiveness in that regard. It may be a small study. It may be experimental and need to be replicated. But then that should be the impetus for being able to get that funding to do bigger studies at larger research institutions.
Because an equally plausible counter to the "government won't fund studies because they're afraid of the answer" argument is "government won't fund studies because the theory itself is a scientific dead-end". Not every avenue of scientific discovery discarded by the NIH is done so to protect the pharmaceutical industry. There's also the very real possibility that, well, thimerosal may not be the answer (or even an answer) after all.
I mean, I'm not asking for $10 million studies over several years involving thousands of kids. Just 20 kids who had chelation or vitamins against 20 kids who didn't, and what were the results? Who got better? Who didn't?
This is the kind of simple, basic research that could be done RIGHT NOW that would help make these treatments mainstream and more readily available. It would take it out of the realm of the DAN! doctors and othe doctors perceived to be on the "fringe" and make it available to anyone. Sure, some mainstream doctors might resist it at first. I bet most would. But at this point, there's no reason for them to accept it.
And if the treatments work, the basic science underneath will validate that claim down the line. Deth and Horning and James will all be vindicated. But finding a treatment that worked without knowing exactly why it works isn't exactly new, or novel.
That's why to me the focus shouldn't be on "basic science" but on the treatments being used today to help kids. If they really do work, there should be no fear or concern about publishing results (even very preliminary ones) in peer-reviewed journals for the scrutiny of the scientific community.
Wade, I really don't want you to misunderstand. If somewhere down the line we truly determine autism is caused in part or whole by vaccines, then I agree we should investigate everyone involved. We should do whatever we can medically and financially help these children, and the drug companies should bear the burden of that.
But we're not there yet. We're not even close, and I'd suggest that most of the best evidence to date suggests thimerosal is unlikely to be a causal factor in autism. At best, it may exacerbate certain related symptoms in a small percentage of autistic children.
If chelation or vitamins or secretin or anything helps kids with autism, we should pursue those avenues. With good scientific evidence to back them up.
wade,
maybe jp is saddened by your tone, but i think you were too easy on him. it's hard to believe that anyone who claims he doesn't have a horse in this race can be as zealous as him. aren't you the least bit curious as to how someone who claims to have no ties to either government or the pharmaceutical industry can manage to get secret sources inside the cdc?
Anonymous-
When I had questions about the Verstraeten study, or about certain other claims made against the CDC - I did something shocking.
I actually contacted them and asked them questions, to which they responded. The amazing thing I've found is that if you ask folks within those organizations questions in an honest fashion without coming off adversarial, they'll usually respond quite nicely and promptly and provide some pretty good insight.
The reason I'm zealous about this subject is that I suffered through some of these "benign" vaccine-preventable illnesses as a kid, and I'd hate to see the day these "benign" illnesses come back and affect my children.
Wade, your patient critique--which is from the Greek krino, "to separate, to judge, to decide"--illuminates the questionable thinking (and actions) by those who should know better. You are keeping us all honest! regards from Kristina
Post a Comment
<< Home