http://www.voiceamerica.com/voiceamerica/vepisode.aspx?aid=51243
The program begins with an interview with Dr Wakefield, in which he is given the chance to discuss his 1998 paper that was published in the Lancet in which he describes a new form of bowel disease (Lymphoid Nodular Hyperplasia) found in children with autism. This paper has been the eye of a tremendous storm of controversy, including the retraction of the paper by The Lancet as well as a hearing by the General Medical Counsel in Britain which Dr Wakefield was stripped of his medical license. At about 7 minutes into the interview, Teri asks Dr Wakefield to explain what the paper did and did not say. Here is his response:
“what it did was to take the clinical history, and findings in 12 children, whose parents came to us for clinical care- NOT for the purposes of litigation, but because their children were sick- they were symptomatic, in particular they had autistic regression and gastrointestinal symptoms that had not been investigated properly. When they were investigated properly, they were found to have a novel inflammatory bowel disease. A subtle, but nonetheless definite inflammatory bowel disease that responded to treatment. That was reported in the case series. This was not a hypothesis-testing study, it merely was a description of the clinical condition. It wasn’t even in that respect a scientific study. It was just a clinical case report.
The other thing it did was to faithfully reproduce the story given to us by the parents about what they believed precipitated their child’s problem. Now, had their child’s problem been precipitated by, um, natural chicken pox for example, had the child regressed into autism within a short space of time after chicken pox, then we wouldn’t be having this conversation Teri. But because it was a vaccine, it was absolutely unacceptable. Now we were asked at the time whether it was wise to put in the vaccine story. If we hadn’t have done, that would have been dishonest. That would have been a misrepresentation because we would be censoring the parents’ story for some political expedient and we weren’t about to do that. So, that was what was said, what was not said was that MMR vaccine causes autism. In fact, what we said was that this study does not prove an association- let alone a casual association- between the vaccine and the disorder, but it did call for further research. It was “that” that ignited the spark.”
Later in the program, he is given the chance to respond to the allegations made against him by Brian Deer in a recent article in the British Medical Journal. This is a detailed section, so I was not able to transcribe it, instead I'll provide a few highlights. One allegation is that the clinical histories in the children’s records, as recorded by their GPs, don’t match those in the study so therefore Dr Wakefield must have falsified the records in the study. Deer says that in child #1, there are signs of autism in the child’s records BEFORE he received the MMR. What he is referring to is that there are notes that the child had a hearing problem. What Deer fails to mention is that the notes also say that the child had discharge coming out of his ear at the time, so this was likely an ear infection. (As an aside here, this wasn't mentioned in the interview, but Deer never had legal access to the medical records of these children). Another allegation made against him by Deer is that Dr Wakefield himself had a vaccine patent on a competing form of MMR, so this was all an elaborate trick to ruin his competition. What he actually has a patent on is not a vaccine at all, but Transfer Factor, an OTC nutritional supplement, that in no way competes with the MMR vaccine.
The second person interviewed is Dr Vicki Debold, who has worked in the health care field for more than 30 years, as a nurse, administrator and health policy analyst, primarily focusing on pediatrics and patient safety. Currently she is a research scientist and affiliate faculty member at George Mason University in the Health Administration and Policy Department where she teaches health services research methods. Since 2008, Dr Debold has served as the consumer voting member of the FDA’s Vaccine and Related Biological Products Advisory Committee. Additionally, she has worked for the Vaccine Safety Working Group, Epidemiology and Implementation Subcommittee of the National Vaccine Advisory Committee. She also serves as the consumer representative to the Independent H1N1 Vaccine Safety Risk Assessment Working Group, and has been a consultant to the CDC Board of Scientific Counselors.
Teri focuses with her on the bigger picture of vaccine safety, and asks “is neurodevelopmental injury associated with vaccine components isolated?” (meaning is it an issue for vaccines other than the MMR). Dr Debold answers that no, neurodevelopmental and immune adverse reactions are not new and not limited to just one vaccine. Encephalitic outcomes (which can vary from temporary to deadly) have been seen in studies even early on, especially those involving Pertussis. Regression- loss of social, emotional, physical skills following vaccination has been documented for decades. These concerns have been around for a long time before there was any concern about a possible link between MMR and regression.
In 1999, the IOM (Institute of Medicine) published a report that said that there was a relationship between DPT and encephalopathy. If you look at the Vaccine Injury Compensation Program’s Table of Compensable Injuries it lists encephalopathy is a compensable injury for both pertussis- containing vaccines and MMR. There have been questions relating to other neurological problems that the IOM has tried to review over the past 15 or so years, but there simply wasn’t enough scientific evidence to determine whether or not a relationship exists. It sounds like she is saying that this has been true for half of the questions that the IOM has reviewed in regards to concerns about vaccine safety. She says “There is, you know, a very large gap in science about what we know and what we don’t know as it relates to adverse events following vaccination”.
When asked if there have be times in the past when physicians or researchers have been ridiculed and discredited for having unpopular and unorthodox views of medicine, Dr Debold answers that this has been a longstanding pattern in the history of medicine. As an example she points to Ingot Semmelweis, who was berated and fired for believing that incidence of childbed fever could be reduced if maternity doctors would wash their hands between examining patients and after doing autopsies. Examples of practices that were once believed to be safe, but later shown to be unsafe, include the use of various drugs during pregnancy such as thalidomide, radiation of tonsils that led to thyroid cancer, etc. What’s happening with Dr W now is nothing new- whoever first raised concerns about the safety of common health treatments, even when it turned out to be true, was vilified the same way.
This is followed by an interesting discussion about why this issue is coming up now. The public is more informed about medicine and that some medical interventions cause harm and death, they are taking more responsibility for their own health, they have increased access to medical research and information, and are asking more questions. There are biases in health research that the public is more aware of, including the fact that a lot of research is funded by pharmaceutical companies, those companies have influence over what gets published so that studies that support their products are more likely to be published, and negative studies can be “spun” to alter the conclusions.
Dr Debold goes on to discuss problems related to vaccine science and infrastructure. Pre-licensure studies for vaccines tend to be very small, they use only healthy children, and they are increasingly using an “active placebo” which means that the experimental group is not compared to a control group that receives an inert placebo, rather the control group receives either other vaccines or the other ingredients in vaccine, such as the adjuvant, without the actual antigen. These studies test for vaccine effectiveness- whether the test group develops the antibodies- but not for safety.
Post-licensure there are two systems to look at safety, VAERS (which is passive) and an active system that’s called VSD, which is closed to outside researchers. The VSD is too small to pick up unusual events and still doesn’t have unvaxed control groups. The VSD system is studied by researchers on contract with the CDC and since it is closed, findings cannot be independently replicated. The public is becoming increasingly aware that there are problems here and is less trusting of the system. She says that polls show that 90% of parents are saying that vaccine and medicine safety is there #1 concern, but doesn’t say number one concern amongst which options?
The next person interviewed is J.B.Handley of Generation Rescue. Amongst other things, he discusses the validity of the 14 studies that are used by the CDC to claim that vaccines are safe. The highlights of his section are the mention of Poul Thorsen, one of the lead researchers on the4 Danish studies, who embezzled millions of dollars. This has not been covered by the mainstream media, which is ironic as they have made such a big deal of the alleged ethical concerns regarding Dr Wakefield. Additionally, Mr Handly points out that the organization in Denmark that controls the vaccination data is also the organization that produces all of their vaccines so there is a conflict of interest. He also points out that it’s absurd to suggest that Dr W’s paper is the source of worldwide panic as the media has been doing. The media seems to be saying that all of the worry over vaccines was caused by him, and he’s a fraud, so none of the worry is true. There is no evidence to support this view.
Lastly, we hear from Wendy Fournier, of the National Autism Association, who points out that not only have the original findings of the 1998 Lancet paper not been challenged (the existence of Lymphoid Nodular Hyperplasia), but they have been independently replicated a number of times. The original study was reporting on a link between bowel disease and autism. This association has been shown to exist over and over again. Even the AAP has put out a consensus report noting this association. Additionally, Ms. Fournier is asked to talk about the evidence of a causal link between vaccines and autism based on the settlements in Vaccine Court. She says, of the 1322 cases of neurological injury that were settled outside of vaccine court and are therefore “off the record”, that according to a source at the United States Health Resources and Services Administration “we have compensated cases in which children have exhibited an encephalopathy or general brain disease, encephalopathy may be accompanied by medical progression of an array of symptoms including autistic behavior, autism, or seizures.”
