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."
Here's the body copy from NEJM:
Vaccines and Autism Revisited
by Offit, P. A.
To the Editor: In his Perspective article on a possible connection between vaccines and autism, Offit (May 15 issue)1 speculates about my daughter, Hannah, and repeats inaccuracies from a March New York Times opinion piece that was officially corrected by the Times and our April 5 letter.
By omitting critical information from my March 6, 2008, statement, Offit misrepresents my position. I said, "Many in the autism community and their champions believe that the result in this case may well signify a landmark decision as it pertains to children developing autism following vaccinations. This still remains to be seen, but currently there are almost 5,000 other cases pending."
Offit's remarks about Hannah's case are not evidence-based. He has no access to my daughter's personal medical records, legal documents, or affidavits. In contrast, physicians from the Department of Health and Human Services (DHHS) who studied this information recommended that the government concede Hannah's case. The clinical history Offit presents contains significant inaccuracies, and the resulting conclusions are consequently flawed.
Offit confuses issues by comparing Hannah's case with unrelated decisions in "vaccine court." The Office of the Secretary of DHHS, through the Department of Justice, conceded Hannah's case. There was no courtroom hearing and no decision from the "unusual vaccine court."
Offit is frequently cited regarding the "biologically plausible" theory that simultaneous administration of multiple vaccines is safe. His opinion is unsupported by clinical trials, much less investigations in potentially susceptible subpopulations.
Despite the high frequency of mitochondrial dysfunction in autistic children,2 studies have not established primary or secondary roles. To explore this question, we need an immunization database for children with metabolic disorders to establish safety guidelines3 and improve vaccine safety for minority subgroups of children.
I agree with the statement of Bernadine Healy, former director of the National Institutes of Health, 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?"4 Also commendable is the new 5-year research plan of the National Vaccine Advisory Committee, which will entail the study of minority subpopulations, including patients with mitochondrial disorders.5
A strong, safe vaccination program is a cornerstone of public health. Misrepresenting Hannah Poling v. HHS to the medical profession does not improve confidence in the immunization program or advance science toward an understanding of how and why regressive encephalopathy with autistic features follows vaccination in susceptible children.
Jon S. Poling, M.D., Ph.D.
Athens Neurological Associates
Athens, GA 30606
Dr. Poling is the father of Hannah Poling and reports receiving consulting or lecture fees from Pfizer, Eisai, Ortho-McNeil, Biogen, Teva, Immunex, and Allergan. No other potential conflict of interest relevant to this letter was reported.
Offit PA. Vaccines and autism revisited -- the Hannah Poling case. N Engl J Med 2008;358:2089-2091. [Free Full Text]
Oliveira G, Ataíde A, Marques C, et al. Epidemiology of autism spectrum disorder in Portugal: prevalence, clinical characterization, and medical conditions. Dev Med Child Neurol 2007;49:726-733. [ISI][Medline]
Brady MT. Immunization recommendations for children with metabolic disorders: more data would help. Pediatrics 2006;118:810-813. [Free Full Text]
CBS News. The "open question" on vaccines and autism. May 2008. (Accessed July 18, 2008, at http://www.cbsnews.com/blogs/2008/05/12/couricandco/entry4090144.shtml.)
Draft ISO Scientific Agenda for NVAC Vaccine Safety Working Group. Centers for Disease Control and Prevention's Immunization Safety Office scientific agenda: draft recommendations. April 4, 2008. In: Scientific review. Washington, DC: National Vaccine Advisory Committee Vaccine Safety Working Group, April 11, 2008:30. (Accessed July 18, 2008, at http://www.cdc.gov/vaccinesafety/00_pdf/draft_agenda_recommendations_080404.pdf.)
The author replies: Poling implies that by omitting his phrase "many in the autism community and their champions," I unfairly attributed the notion that vaccines might cause autism to him alone. However, Dr. Poling's public announcement of the DHHS concession to the press and his subsequent appearances on national television and at autism conferences suggest that he is, at the very least, a vocal centerpiece of that community.
Poling claims that I didn't have access to his daughter's medical records. 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.
Poling states that my assertion that the administration of multiple vaccines is safe is an "opinion . . . unsupported by clinical trials." 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.
Poling agrees with Healy that "you should [n]ever turn your back on any scientific hypothesis because you're afraid of what it might show." However, scientists have not been afraid to test the hypothesis that vaccines might cause autism. Far from it: the ill-founded notion that the measles–mumps–rubella (MMR) vaccine caused autism was tested in 10 epidemiologic studies. Unfortunately, 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.1,2,3,4 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. The problem here is not a failure of scientists to consider hypotheses; rather, it is a failure of the media and the public to distinguish hypotheses from scientific evidence.
Paul A. Offit, M.D.
Children's Hospital of Philadelphia
Philadelphia, PA 19104
Mulholland EK. Measles in the United States, 2006. N Engl J Med 2006;355:440-443. [Free Full Text]
McBrien J, Murphy J, Gill D, Cronin M, O'Donovan C, Cafferkey MT. Measles outbreak in Dublin, 2000. Pediatr Infect Dis J 2003;22:580-584. [CrossRef][ISI][Medline]
Jansen VAA, Stollenwerk N, Jensen HJ, Ramsay ME, Edmunds WJ, Rhodes CJ. Measles outbreaks in a population with declining vaccine uptake. Science 2003;301:804-804. [Free Full Text]
Smith MJ, Bell LM, Ellenberg SE, Rubin DM. Media coverage of the measles-mumps-rubella vaccine and autism controversy and its relationship to MMR immunization rates in the United States. Pediatrics 2008;121:e836-e843. [Free Full Text]
Anne Dachel is Media Editor of Age of Autism.