Dr. Paul Offit and Dr. Jon Poling: New England Journal of Medicine
By Anne Dachel
Managing Editor's Note: You can click into the NEJM to read the two pieces referenced. The body copy also runs at the bottom of the post.
On August 7, the New England Journal of Medicine published the opposing opinions of Dr. Jon Poling, father of Hannah Poling, and Dr. Paul Offit, Infectious Disease Specialist from Children's Hospital of Philadelphia, on the Vaccine Court case in which the federal government conceded that vaccines were a factor in the development of autism in Hannah. Titled, Vaccines and Autism Revisited, the letters run in the "Correspondance" section of NEJM. (Click HERE to read the August 7th piece)
In the May 15 NEJM Perspective section, Offit split every hair he could to try and lessen the impact of the Poling case. He tried to convince the public that there was no scientific basis for the concession. (Click HERE to read the May 15th piece.) Offit's remarks led to the August 7 response by Dr. Poling.
In his August 7 piece, Poling went after Offit's opinion about his daughter's case using phrases like "Offit misrepresents my position," "Offit confuses issues," and "His opinion is unsupported by clinical trials."
Poling also said that he agreed with the remarks made by former head of the National Institutes of Health, Dr. Bernadine Healy, on CBS News, who said, 'I don't think you should ever turn your back on any scientific hypothesis because you're afraid of what it might show. . . . If you know that susceptible group, you can save those children. If you turn your back on the notion there is a susceptible group . . . what can I say?'
The fair and balanced NEJM then allowed Offit to respond to Poling at the bottom of the article. Offit defended his remarks by claiming that the science is on his side and the facts support his view. He made one stunning comment. He brought up Healy's remarks about the need for further study of a subgroup of children who might be damaged by vaccines. Offit wrote, "Now, Poling and Healy are standard-bearers for the poorly conceived hypothesis that children receive too many vaccines too early. As a consequence, some parents are choosing to delay, withhold, or separate vaccines."
That was really a low blow. To claim that one of the top doctors in the U.S. was promoting a "poorly conceived hypothesis" and that "the public airing of that hypothesis caused thousands of parents to avoid the MMR; many children were hospitalized and several died from measles as a result," was really pitting doctor against doctor in the vaccine war. (Amanda Peet just told us on Good Morning America, "Please don't listen to me. . . . Go to the experts." Well, here they are and they don't agree!)
I had to go back to the remarks made by Healy on CBS Evening News (Click HERE) on May 12 to figure out what exactly she said that could be described as a "poorly conceived hypothesis." Soft-spoken and reasonable in her conversation with CBS reporter Sharyl Attkisson, Healy called for more studies on vaccines and autism. She said that we need to do the studies to find out if there is a subgroup of children who are susceptible to a particular vaccine, to vaccines plural, or to components in vaccines. She urged scientists "to take another look at that hypothesis, not deny it."
Healy said nothing to undermine that vaccine program. She told the public, "A susceptible group does not mean that vaccines aren't good." She firmly stated that she didn't believe "the public would lose faith in vaccines."
We have the most heated controversy in medicine today over vaccines and Healy addressed it by saying, "It is the job of the public health community and of physicians to be out there and to say yes, we can make it safer because we are able to say, this is a subset. We're going to deliver it in a way we think is safer."
Sharyl Attkisson then brought up the fact that health officials will deny there is a link between vaccines and autism. They say there's no evidence.
Healy, shaking her head, firmly stated twice, "You can't say that."
Why? Because they haven't studied "the population that got sick."
Healy said that she hasn't seen "major studies that focus on 300 kids who got autistic symptoms within a period of a few weeks of getting a vaccine."
Healy noted the primate and mouse studies that have been too quickly dismissed. She challenged the conclusions of the IOM Report of 2004 where we were told not to "pursue susceptibility groups." Healy said, "I really take issue with that conclusion. The reason they didn't want to look for those susceptibility groups was because if they found them, . . . that would scare the public away."
Offit might think that the endless epidemiological studies have settled the question, but Healy made it clear, "Populations do not test causality, they test associations. You have to go into the laboratory."
Healy chided the medical community by saying, "The fact that there is concern that you don't want to know that susceptible group is a real disappointment to me."
She ended a chilling comment about vaccines and the link to autism: "The question has not been answered."
From his remarks, it's pretty obvious that Offit is opposed to any open scientific inquiry. Healy didn't say that all children were receiving too many too soon, as Offit claimed. She said we need to find that subgroup of children.
The CDC studies that are always being promoted in the press haven't settled a thing. The public is growing increasingly skeptical of health officials and their claims. They don't want to risk the health of their children by giving them vaccines with possibly damaging side effects. Healy's was the refreshing voice of reason in this debate. Too bad Offit refused to listen.
Perhaps the ending of the Poling/Offit pieces said it all. After Poling's remarks, he listed his conflicts from the lecturing and consulting fees he had received from different pharmaceutical companies. At the end of Offit's, all we see is "Children's Hospital of Philadelphia."
The current one-size-fits-all practice within the context of these unanswered questions is basically willful neglect and / or reckless endangerment. Even if the questions were answered today, and regardless of the answers, how do they spin the interim behavior into something either noble or necessary?
Posted by: Randy | August 08, 2008 at 01:17 PM
Thank you for this latest addition to your effort to promote a rational examination of the issue of whether or not vaccines cause autism or other neurodevelopmental disorders.
It is not only Dr. Healy who believes the question remains utterly unanswered.
In his May 12, 2008 sworn testimony before the vaccine court Dr. Sander Greenland, one of the world's premier epidemiologists, stated categorically that none of the published epidemiological studies have even addressed the question of whether or not there exists an association between thimerosal and "regressive autism." Dr. Greenland's view, largely uncontested, is completely consistent with Dr. Healy's observation that our public health authorities have failed to look at the population of children who got sick.
The question remains unanswered despite the loud but unsubstantiated claims of public health authorities or extreme promoters of vaccination like Dr. Offit.
Robert J. Krakow, Esq.
Posted by: Robert J. Krakow | August 08, 2008 at 10:49 AM
Sorry in my previous post I wrote:
"Offit was able to turn up 3 deaths from the Dublin outbreak of 1990 (not UK)"
This should have read "2000" not "1990".
Posted by: John Stone | August 08, 2008 at 04:02 AM
...and Offit got how much for the royalties on RotaTeq?
The amount alone is a disgrace, considering there are children who have suffered from that and other vaccines, but the fact that he "off-ed it" so the liabilities don't fall on his shoulders is truly the level of sleaze of which he is capable.
He's a paid mouth piece. PERIOD. Just a little Pinocchio with rhinoplasty. Dance, Paulie, Dance! Nod your little wooden head on command. Happy in his career choice, unattached to this world by anything but puppet strings.
The real tragedy here is that news media continue to allow their people to even have his number on their call-list.
Posted by: GrammaKnows | August 07, 2008 at 07:41 PM
Offit was able to turn up 3 deaths from the Dublin outbreak of 1990 (not UK), which may be something to do with compromised health and economic migrant communities (very little to do with Andrew Wakefield). The UK auhorities keep on mentioning two deaths from measles in immune compromised, unvaccinated subjects, but they don't publicise 18 others in the last 15 years, who were presumably vaccinated:
http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733835814
There are also serious anomalies in the most recent report of a measles death in the UK, since the unfortunate subject only seems to have tested positive for the presence of the virus, without having the symptoms of the disease. Enquiries of our Health Protection Agency (HPA) have so far not met with acknowledgement (five weeks after Freedom of Information requests were submitted):
http://www.jabs.org.uk/forum/topic.asp?TOPIC_ID=2169
with regard our Dr Salisbury there was a very helpful blog today by Alan Golding of CryShame:
http://alan-golding.blogspot.com/
However, it is also essential to point out that one of the key reasons why we are having outbreaks of measles in the UK is simply because the vaccine is not working - for which reason our the HPA (who cite Offit as authority) are double vaccinating infants:
http://www.ageofautism.com/2008/05/double-mmr-jabs.html
Posted by: John Stone | August 07, 2008 at 05:10 PM
Offit was able to turn up 3 deaths from the Dublin outbreak of 1990 (not UK), which may be something to do with compromised health and economic migrant communities (very little to do with Andrew Wakefield). The UK auhorities keep on mentioning two deaths from measles in immune compromised, unvaccinated subjects, but they don't publicise 18 others in the last 15 years, who were presumably vaccinated:
http://www.hpa.org.uk/web/HPAweb&HPAwebStandard/HPAweb_C/1195733835814
There are also serious anomalies in the most recent report of a measles death in the UK, since the unfortunate subject only seems to have tested positive for the presence of the virus, without having the symptoms of the disease. Enquiries of our Health Protection Agency (HPA) have so far not met with acknowledgement (five weeks after Freedom of Information requests were submitted):
http://www.jabs.org.uk/forum/topic.asp?TOPIC_ID=2169
with regard our Dr Salisbury there was a very helpful blog today by Alan Golding of CryShame:
http://alan-golding.blogspot.com/
However, it is also essential to point out that one of the key reasons why we are having outbreaks of measles in the UK is simply because the vaccine is not working - for which reason our the HPA (who cite Offit as authority) are double vaccinating infants:
http://www.ageofautism.com/2008/05/double-mmr-jabs.html
http://www.jabs.org.uk/forum/topic.asp?TOPIC_ID=2169
Posted by: John Stone | August 07, 2008 at 05:07 PM
I don't have the time to do research on this right now, but if my memory serves me right, Dr. Offits following assertation is a gross misrepresentation of what FDA actually requires as part of vaccine licensing studies (disclaimer: I have never actually been involved in vaccine research or testing, but I have been involved in *licensing* studies for other medical interventions):
"But studies of concomitant use, which are required by the Food and Drug Administration before licensure to show that new vaccines do not affect the safety or immunogenicity of existing vaccines or vice versa, have clearly shown that multiple vaccines can be administered safely."
I do not recall any such requirement of studies into concommitant use of a new vaccine with existing vaccines. Unless he is paraphrasing (or taking out of context) what FDA requires for new COMBO vaccines. Yes, if a manufacturer wants to put out a vaccine that now contains A + B (while before the regimen was A and B in separate vaccines), then yes, the manufacturer needs to show that A+B combined in a new vaccine is safe and effective (but don't get too excited over what is needed to actually how that a vaccine is safe and effective..). However, this same manufacturer is NOT required to show that combination vaccine A+B is safe and effective if used in combination with already existing vaccines C and D and E and so on.
As I said, I am going from memory. I don't have time right now to dig through vaccine licensing studies in detail.
Posted by: Petra | August 07, 2008 at 04:34 PM
The idea that there is a susceptible subgroup of children that react badly to single or multiple vaccines is plausible. But, equally so is the hypothesis that it is a combination of various factors which lead to health disasters of one degree or another, i.e. the toxic tipping point hypothesis. If the former is correct, the genetics research might have merit/value. If the latter is correct, no one's genetics is going to keep them/theirs safe from harm. If forced to face the reality that many are harmed by vaccines, which hypothesis would be the most palatable for the powers that be to admit?
The complete failure of the CDC or FDA, or apparently any mainstream medical or govt organization to carefully investigate as many cases of apparent vaccine injury as possible, in hopes of identifying ANY threads of commonality, is, to me anyway, an indication that the powers that be are more interested in maintaining the status quo of the vaccine program, than in the truth, or in the health of individual people.
I had the opportunity to see a part of a CDC investigation into a possible food-borne illness outbreak. It was done too late, poorly conducted, and was highly unlikely to lead to any smoking food or bacteria (and did not), but at least they TRIED.
Real scientists are interested in facts, evidence, observations, and all available information that can lead to better understanding of something, and the truth. Arguments, disagreements, and conflicting data are part of the process, but any scientist who ignores and disregards all data or information that does not support his/her perspective or ideas can not claim to be a true scientist. Offit has some official degrees, but clearly he is not a scientist. Sooner or later, he will fail to be an effective mouthpiece because real scientists, and anyone who understands science, will eventually perceive that he has a small mind and is wearing blinders. The more he blathers on, the sooner that truth will out.
Sue
Posted by: Sue | August 07, 2008 at 04:11 PM
Okay, here is what I found in the June 11 issue of the Journal of American Medicine (JAMA)
...during January 1–April 25, 2008, a total of 64 confirmed measles cases were preliminarily reported to CDC, the most reported by this date for any year since 2001. Of the 64 cases, 54 were associated with importation of measles from other countries into the United States....
Fourteen (22%) patients were hospitalized; no deaths were reported.
So here are my questions: 1) Why does Offit say some people in the U.S. have died recently from measles? Who is he referring to?
If all these cases, as documented by JAMA, are arising through importation from other countries (the people traveled overseas and got the measles themselves, then brought it back and spread it to a dozen or so others who had not traveled), then why can't we even discuss creating a screening program for people who come to the U.S. from overseas? However much of a burden this might be for travelers, it would surely be far less expensive and burdensome than vaccinating every living person in the U.S. against dozens of viruses that are no longer present in the U.S. but are imported through travelers.
Posted by: lisa | August 07, 2008 at 03:03 PM
Garbo, Gardasil was not tested with Menactra. But VAERS has shown that when Menactra and Gardasil are administered together there is a significant increase in GBS. Could this be what you were thinking of?
And I second another poster's questions on Offit's reference to measles deaths? Clearly, he is not talking about the US or we would have heard about it. I believe he's referring to the death of an immuno-compromised boy in the UK several years ago.
Posted by: Sorsha | August 07, 2008 at 02:48 PM
We are currently having the same 'big push' underway in the UK to promote the MMR because of a surge in measles cases, apparently an epidemic is imminent. Astoundingly our Paul Offit equivalent David Salisbury said this morning on tv live on air that there is no proof, from any studies around the world linking vaccines to autism so we should just "park it there and move on".
These guys are entrenched up to their eyeballs in this, so much so, that charges should be brought against them as they are personally responsible for continuing and hiding the damage of children by vaccine. I personally know of three children who died after MMR.
There are now 19 new cases of autism every day in the UK (Govt's own figures) why that is not deemed an epidemic is truly scandalous! The MMR catch-up initiative, flu jab for two year olds and introduction of Cerverix in September in schools, all set underway this week will see more children consigned to autism as my son was. He eleven now unable to speak and still in diapers. Interestingly our Parliament is in recess until October so these edicts can be passed without a murmur as our media bow down to civil service and big business profits.
The case of Hannah Poling has bearly registered here and quite frankly we are in the dark ages once more. Our only blessing is the true determination I see in parents to stand up to this state oppression because they live with autism every day, we'll fight on with true purpose because we know what we saw.
H
Posted by: Allison Edwards Uk | August 07, 2008 at 01:59 PM
Dr. Healy made a point to say we must pursue this susceptible group no matter how large or how small.
That is the biggest question isn't it? How many Hannah's are out there?
Posted by: Andrea | August 07, 2008 at 01:47 PM
Once again and excellent piece from A of A. Offit better watch what he's saying about Hanna Poling...... it's inaccurate and can be construed as slanderous. Why doesn't anyone in the major media ever report his massive TIES to the pharmaceutical industry?? And now he's grasping at straws by trying to get a Hollywood "celebrity" to bolster his position to counteract Jenny McCarthy. (I personally never heard of Amanda Peet until she opened her big mouth and called us all parasites.)
I smell fear.....
Cindy
Posted by: cindy | August 07, 2008 at 01:37 PM
The concomitant studies mean very little. Here is the scope of quality control:
http://www.hhs.gov/nvpo/factsheets/fs_tableII_doc2.htm
"Manufacturers are required to submit the results of their OWN tests for potency, safety, and purity for each vaccine lot to the FDA. They are also required to submit samples of each vaccine lot to FDA for testing. However, if the sponsor describes an alternative procedure which provides continued assurance of safety, purity and potency, CBER may determine that routine submission of lot release protocols (showing results of applicable tests) and samples is not necessary."
They are not studying nervous system reactions/damage in detail, nor have they ever. Later in his response he states:
"My information was based on a verbatim transcript of the DHHS concession, which stated that his daughter had had frequent ear infections and a series of viral infections early in life. These infections, which are a far greater immunologic challenge than attenuated or inactivated vaccines, are not in dispute. "
Sounds like pseudoscience to me, considering there are no data which supports this assertion.
Posted by: unherdof | August 07, 2008 at 01:26 PM
If you look at the package inserts it always talks about testing them with another vaccine or two. But it only talks about whether or not the vaccine is still effective and basically just if the patient's arm doesn't fall off within 10 minutes of getting both shots it is considered safe to do them at the same time.
Posted by: Jack | August 07, 2008 at 12:29 PM
Paul Offit is increasingly looking like Bruno Bettelheim, the genius behind the 'refrigerator mom' theory. If more of our mass media had any spine whatsoever (thanks CBS!!) they would have taken off with a fury after the Poling case surfaced and Offit would long ago have been found to be what he really is, just another Bruno.
Slowly but surely he is coming down and his place in the medical history books will be one of the biggest shames the world has ever seen, bigger than Bruno himself.
Posted by: WE SHALL OVERCOME | August 07, 2008 at 12:02 PM
Cathy, re: FDA testing vaccines concommitantly, I'm pretty sure I remember reading that Gardasil was tested w/Menactra, tho I can't remember where I read it. Maybe that's what he's referring to. Of course that whole trial was rigged, and it hardly touches the tip of the iceberg of the shots that babies are routinely given all at once. I'm always shocked when I look at the injury reports in VAERS and see the number of shots some of the kids got at once. I find it impossible to believe that anyone has actually tested all those vaccines together or even two at a time. Or added up how much aluminum adjuvant is in all of them and what that combined level of adjuvant does to each viral component, and what those viruses do to each other. It's criminal negligence.
Posted by: Garbo | August 07, 2008 at 11:58 AM
Anne,
Excellent analysis! While reading it, the continual escapades of Offit just have me in disbelief. How is it possible that a doctor, a father, a human being, could let a susceptible group of children continue to be harmed? Then I remember that this person is capable of doing this because he does not care (and he has millions tied up in this denial). It is becoming more obvious that he will do and say whatever is necessary to continue the denial (keep the money).
It is like watching "Rear Window" (yes, I like to compare life to the cinema :)
http://www.imdb.com/title/tt0047396/
We are Jummy Stewart watching Raymond Burr as he continually attempts to cover up his crime. The climax is when Burr goes after Jimmy Stewart and Grace Kelly. The heroes are saved by their deductive thinking and perseverence.
We have thousands of children injured and it is STILL happening. Meanwhile, we watch Offit as he continually minimizes, denies, and lies about the vaccine issues. His brazen comments often do not match reality. Hooray that CBS, Dr. Healy and Dr. Poling (and many others)are not allowing his lies and disregard for human life to be perpetuated. Like Burr, going after the heroes may indicate desperation and the charade finally coming to an end.
Posted by: Teresa | August 07, 2008 at 11:17 AM
Offict says that several children have recently died after coming down with the measles. I have been following the story of measles outbreaks in the media. The stories I've seen report that some children have indeed required hospitalization, but that there have been no deaths. To what deaths is he referring? Does anybody know?
Posted by: lisa | August 07, 2008 at 10:55 AM
Dr. prOffit seems to be increasingly desperate. Which means we're making progress. Eventually the truth will out!
Posted by: ObjectiveAutismDad | August 07, 2008 at 10:43 AM
"But studies of concomitant use, which are required by the Food and Drug Administration before licensure to show that new vaccines do not affect the safety or immunogenicity of existing vaccines or vice versa, have clearly shown that multiple vaccines can be administered safely."
Can someone point me to these studies on Concomitant use of vaccines? I'm serious I'd like to read one of them and see what they these studies look like. Thanks, Cathy
Posted by: Cathy | August 07, 2008 at 10:42 AM
AnneS, of course he isn't open to it. He doesn't want anything to interfere with his sacred Cash Cow. Not only that, when the connection is found, he will more than likely lose his job, his license, and wind up in jail (well, we can wish that, can't we? I doubt he'll ever see a day in prison).
OMG, what a smug, elitist little prick he is. His whole attitude screams "I'm right. You cannot be right because I am right. Therefore, everyone who doesn't agree with me is wrong."
How Mary Holland and every who was at the press conference the other day could stand being in the same room with that slime astounds me. Seriously, those of you who were there; hats off to you. I couldn't have done it.
I still have some Lye soap to wash his stink off if you need it, though. Just let me know...I'm always willing to help a friend like that.
Posted by: Craig Willoughby | August 07, 2008 at 10:01 AM
"(Amanda Peet just told us on Good Morning America, "Please don't listen to me. . . . Go to the experts." Well, here they are are and they don't agree!)"
Touche' Anne!
This is a great article -- you tied it all together perfectly!
And yes, very telling that Dr. Poling states all his conflicts but Offit says nada.
Surprise, surprise! (Gomer Pyle style)
Posted by: Kelli Ann Davis | August 07, 2008 at 08:29 AM
You're right, Offit is not open to taking this into a lab and finding out if the vaccines are doing this. I bet he was the same way when it was discovered his vaccine was causing intussusception. He probably fought long and hard to say the epidemiology was just not showing that it was his vaccine damaging and killing infants.
Posted by: AnneS | August 07, 2008 at 08:06 AM
Evidently, the concept of susceptible subgroups of children prone to adverse reactions to vaccine is totally misunderstood/dismissed/not analyzed by Dr Offit. Neither The concept of the importance of the anecdotical evidence in detection and consideration of adverse reactions- very individualized. The trials on vaccines safety
never considered or studied clinically susceptible subgroups of children
Recent mnauscript on the issue
http://www.bmj.com/cgi/content/full/333/7581/1267
Posted by: María Luján | August 07, 2008 at 08:01 AM
Mind you, Anne, I don't think Paul Offit needs enemies when he has the president of the AAP saying that 3% collateral damage from the vaccination programme is acceptable. Has anybody asked what Renee Jenkins knows, and what the basis of the figure is?
Posted by: John Stone | August 07, 2008 at 06:11 AM