Mr. Burton. I want to thank the panel. We will now go to our questions. Dr. Offit, you talk about collaboration, I guess, with the Merck Pharmaceutical Co.? Dr. Offit. Yes. As I disclosed in my written report, I have been in collaboration with Merck and Company on the development of a rotavirus vaccine since 1992. Mr. Burton. Do you do any traveling around, speaking on behalf of Merck or Merck products? Dr. Offit. I travel and speak about vaccines, and those talks are supported by unrestricted educational grants from either pharmaceutical companies or from universities. Mr. Burton. So they pay for your expenses and that sort of thing? Dr. Offit. They have an interest in educating physicians about vaccines, and it is good that they do, because physicians need to be educated about vaccines. Mr. Burton. I understand. And they produce the MMR vaccine, don't they? Dr. Offit. Yes, they do, yes. Mr. Burton. Thank you. Dr. Taylor, in your Lancet paper, you omitted to mention the Catch-Up Campaign. That is the vaccination of children over 1 year of age when the vaccination was introduced. Yet you appear to have included these Catch-Up children in your analysis of the step-up hypothesis. So you consider that to be methodologically--do you think that is a correct analysis? Dr. Taylor. Basically, that statement is not true, Mr. Chairman. We did include the children involved in the Catch-Up Campaign in our analysis, as is clearly stated. To suggest otherwise--and I suspect the suggestion comes from Mr. Wakefield--is malicious. Mr. Burton. Well, was it included--was it not omitted in the original paper that you submitted? Dr. Taylor. No. All cases were included who received MMR vaccine. All cases--we will submit additional analysis with all cases who received any measles-containing vaccine---- Mr. Burton. Didn't some of those 36 children receive the MMR vaccine after the---- Dr. Taylor. I think what you are referring to is the reply which we put to Mr. Wakefield's criticism of our paper in the Lancet. I have to say that his is the only criticism of our paper which we have received on a scientific basis. All other reports have been constructive and supportive. Mr. Burton. Well---- Dr. Taylor. What we looked for there were the children who had received MMR vaccine, which we had included in our analysis. There were 36 such children, and in 29 of them, there was evidence regarding when the parents became concerned about their child's development. In all cases, this was before they received the MMR vaccine. Mr. Burton. We have an epidemiologist in the audience, and--where is he? Would you mind coming up? I would like to have you sworn in real quickly. Dr. Spitzer. Yes. [Witness sworn.] Mr. Burton. Thank you. Can you explain the importance of properly counting these children born before 1988 who were given the Catch-Up vaccines? STATEMENT OF DR. WALTER O. SPITZER, PROFESSOR EMERITUS OF EPIDEMIOLOGY, MCGILL UNIVERSITY, AND MEMBER, NATIONAL ACADEMY OF SCIENCE OF THE UNITED STATES, CORPUS CHRISTI, TX Dr. Spitzer. Well, as implied by Professor---- Mr. Waxman. Point of order, Mr. Chairman. Point of order, if you will suspend your answer to that question. I want to make a point of order. Mr. Burton. The gentleman will state his point of order. Mr. Waxman. The rules of this committee require that ``Witnesses appearing before the committee shall, so far as practicable, submit written statements at least 24 hours before their appearance, and, when appearing in a nongovernmental capacity, provide a curriculum vitae and a listing of any Federal Government grants and contracts received in the previous fiscal year. Identification of witnesses are to be provided to members of the committee.'' Suddenly, we have a witness being called forward, and Rule 2 says ``Every member of the committee or the appropriate subcommittee, unless prevented by unusual circumstances, shall be provided with a memorandum at least 3 calendar days before each meeting or hearing explaining 1) the purpose of the meeting or the hearing, 2) the names, titles, background and reason for appearance of any witness. The ranking minority member shall be responsible for providing the same information on witnesses whom the minority requests.'' Suddenly, we have a witness being called forward. We have all of these people testifying, and we have now a witness coming up--I do not know who he is. It just seems to me that this is in violation of the rules. Mr. Burton. I think as you were reading there, where there are ``unusual circumstances''--and I believe you can go back and read that again--or whenever ``practicable'' was another term that was used in there--so the chair--excuse me, let us suspend for one moment. [Pause.] Mr. Waxman. Mr. Chairman, if I might be heard---- Mr. Burton. No---- Mr. Waxman [continuing]. And I am going to withdraw my point of order--but I do want to say that there are procedures for the conduct of hearings which provide for opportunities for all points of view to be expressed. And for a witness to be brought out of the audience because the witnesses before you did not give you testimony that fit with your preconceived theory seems to me to turn a congressional hearing more into a circus than a genuine fact-finding opportunity. But I will not object if you want to call this witness. I do want to also point out that we have rules on the time allocated to members, and I would insist that that time be observed or that all members be given the same open-endedness that I see about to come in your questioning, because the clock that usually keeps time for our questioning has been deliberately stopped. I will not object, but I do think it is inconsistent with the rules of this committee to bring witnesses out of the audience when you have a panel here that just testified, with whom we ought to pursue our questions. Mr. Burton. The parliamentarian has just informed me that where there are extenuating circumstances, the chair has the ability to bring a witness forward--and this is not the first time this has happened. [Applause.] Mr. Burton. That is the first thing. The second thing is that this is one of the most important hearings I think we have had, because we are talking about an epidemic of autism that is taking place in this country, and if there is information that is being given to the committee that is going to be in the Congressional Record that is not accurate, it needs to be corrected as quickly as possible so the American people and people from around the world who may want to look at the record of this committee have the facts. Now, if we have an epidemiologist here who has expertise about a report and can cite that information about this report where there might be an error, then we ought to correct it right now, instead of waiting until a report is filed, goes out to the American people, and then try to correct it where there might be a misunderstanding. So---- Mr. Waxman. Well, we do have an epidemiologist on this panel, and perhaps you ought to question her, or this other witness should have been asked to testify. No one would have objected to having anybody who had anything pertinent to say to us to have an opportunity to present what they have to say. Mr. Chairman, let us proceed, and let us keep the rules on time, or acknowledge the open-endedness of questions, because we will have a lot of questions as well. Mr. Burton. Dr. Spitzer. Dr. Spitzer. Very briefly, Congressman Waxman, your points are well-taken, and I respect them. I will say now to Professor Taylor that those additional cases in the Catch-Up Campaign may well have been included in the paper but were not clearly segregated or identified or enabled peers to evaluate the possible impact of including them or not, so the findings may have been misleading until we reanalyze them taking that into account. Moreover, the use of the case series strategy of analysis is unconventional, not accepted by mainstream scientists, and leaves the paper at best as a hypothesis-generating study and not something with which he or anyone can categorically say this proves that there is no relationship. It just shows and emphasizes what he said himself, that we need to study it further. So we have a compelling reason to have a blue panel, an international panel, to go back to that data base, look at the raw data, and be able to come up with a second assessment that is verifiable by the scientific community and the relevant community. Thank you, Mr. Waxman, Mr. Chairman. Mr. Burton. Thank you very much. Mr. Tierney. Point of order, Mr. Chairman. Dr. Taylor. Mr. chairman, can I comment on that? Mr. Burton. Stop the clock. The gentleman will state his point of order. Mr. Tierney. Is Mr. Taylor going to be given an opportunity to respond at this point in time? Dr. Taylor. May I comment? Mr. Tierney. I think it might be helpful to those of us who are sort of surprised by this new witness. I would like to hear what Mr. Taylor has to say in response to that. I think it would be educational. Mr. Burton. I have no objection to him responding, but I have some more questions of Dr. Wakefield, so---- Mr. Tierney. Well, Mr. Chairman, my point of order is can we have them nearer in time to each other so we can get the full benefit of it, rather than go back and forth. Mr. Burton. I will yield to the gentleman next. He can have the time next, or Mr. Waxman can, and he can yield to Dr. Taylor. Dr. Wakefield, would you come back up, please? Dr. Wakefield, would you clarify the difference of opinion that you have from your colleague? Dr. Wakefield. My anxiety, Mr. Chairman, is that if you test a step-up hypothesis--that is, those children who should be the first to receive the vaccine at the age of 1 year, born in 1987, because the vaccine was introduced in the UK in 1988, and therefore they would have been 1 year old, then the take- off, if there were a relationship between MMR and the vaccine, should have occurred at that point. The paper illustrated the point that the take-off occurred before those born in 1985 and 1986. What took place when the MMR was introduced was the Catch-Up Campaign, where all children of 1 to 4 years of age were targeted. It was an aggressive campaign--I know that, because one of the authors on the paper that we published in the Lancet was in charge of that campaign for Hackmey in Northeast London. If you give the vaccine to children over the age of 2, then it will cause the take-off to occur before 1987, and that is exactly what occurred. Now, at the very least, those cases should have been mentioned, because the reviewers, in the absence of those data, cannot give a valid interpretation of the paper when they make a recommendation for it to be published or not, and they should have been excluded from the analysis so we could see how the graph looked without them, and that did not occur, and that is a major anxiety. Mr. Burton. Dr. Taylor, do you want to respond now? Dr. Taylor. It does seem slightly surprising that at one moment, we are accused of excluding them and therefore that upsets the results, and now we are accused of including them, and that upsets the results. I have to say the time relationships, the step-up part of our paper is the least important part of our findings. The direct findings, the time series analysis, is much more important, which is the direct evidence that the individual children did not develop symptoms of autism within various defined periods after they received the MMR vaccine. If I could just comment on Dr. Spitzer's comment, he describes our analysis as unorthodox. We used the highest standards of epidemiological and statistical analysis in our handling of this data, and this data has been reviewed by numerous experts, both prior to publication and since. Last week, our research was the basis of a detailed debate at the Royal Statistical Society, where there was no criticism of the statistical techniques that we used, and the conclusions of our paper were accepted by this very expert group. The testimony which you received from Dr. Elizabeth Miller, who is an epidemiologist, and Dr. Patty Farrington, who is an expert statistician, is tabled for the committee's consideration. Mr. Burton. Would you mind, since there is a strong difference of opinion between you and Dr. Wakefield, and I presume some others, providing the data for your study to the committee, the complete data? Dr. Taylor. I will have to take advice on that from both my colleagues and the others. I would be required to decide whether the committee is an appropriate body for this information, which was collected, as you know, by the Medicines Control Agency, which is a branch of the Department of Health in the UK. In principle, I have no problem, but in practice, I would need to check---- Mr. Burton. Well, we would be very happy to write to the Department of Health in the UK and ask that you be able to release that information to the committee in total so that we could have somebody who is totally nonbiased, hopefully, on this issue to analyze it. Dr. Taylor. Yes. I think it would need to be done by more than a selected statistician. If it is to be reanalyzed, it should be reanalyzed by independent individuals--which, of course, is the problem with much of Mr. Wakefield's research, that it has never been independently verified. No one anywhere in the world has been able to reproduce any of his studies, and it seems possible, and it is only going to be a matter of time before this most recent information is also found to be inadequate. Mr. Burton. Well, my time has expired, but let me just say that I believe that Dr. Wakefield and Professor O'Leary and others would be willing to give us the documentation in the study that they did, and we would like to have yours as well so we can look at all of that. Mr. Waxman. Mr. Waxman. Mr. Chairman, because I believe autism is such a serious problem, I am troubled by this hearing. This hearing was called and structured to establish a point of view, and it is the point of view of the chairman. The chairman believes a particular point of view, and that is the connection between autism and vaccinations. You can look at it by the first panel, where we had five parents, all of whom believed the same thing that the chairman believed, and the way we just had the handling of the questions a minute ago. What also bothered me was when we asked that we have the American Medical Association or the American Public Health Association or the National Network for Immunization Information or the former Secretary of HHS, Dr. Louis Sullivan--real experts in addition to those we have before us-- we were told no, they cannot fit in. I think hearings like this have a real danger because if you sensationalize the idea that there is a connection between immunization and autism, immunization rates will drop. That is what happened in Great Britain after Dr. Wakefield published his first study. Immunizations dropped. Autism rates did not drop, but measles rates increased. I was impressed by the statement that we had a drop of just 10 percent in measles immunizations in 1990, and then we had 11,000 people hospitalized from measles. This can cause brain retardation and death. We know we can prevent that. Why should we then scare people about immunizations until we know the facts? I fear that what we have in this hearing is a sensationalization by the chairman in order to get all these cameras to report to the American people that there is this connection because he believes it, and many other people believe it, and therefore a lot of others who watch this will think, ``I will not immunize my children.'' Dr. Wakefield came out with a report in England, and the first group that examined his claims was the Medical Research Council, which is the British equivalent of the NIH, and they found no evidence to indicate any link between the MMR vaccine and bowel disease and autism. After they did their work, the Chief Medical Officer of the United Kingdom issued a letter to doctors in 1998, stating, ``Based on the previous material that I have seen and on the opinion of experts present at the Medical Research Council, I have concluded there is no link between measles, measles vaccine, or MMR immunization,'' etc. Then, the World Health Organization looked at his study, and they came up with the following statement: ``Given our view, the previous scientific claims made by Dr. Wakefield and colleagues lack scientific credibility, and his present study does not meet the requirements for establishing such a causal relationship.'' I do not know whether that is true or not, but that is what the scientists in England said when they evaluated it, as did Dr. Taylor when he evaluated Dr. Wakefield's study. Now, Dr. Wakefield has testified he has some new information. Fine. Let us get the new information out there. Let us let the epidemiologists evaluate it. Let us let scientists explore where the truth may be. But to put this out in a congressional hearing and scare people from getting immunizations--we know that without immunizations, dreaded diseases will occur, deaths and mental retardation and disability will occur among our children, and we can prevent that. What we do not know, and we have a lot of information to the contrary, is that autism will result from that immunization. Dr. Taylor--well, let me ask Dr. Boyle. You are an epidemiologist. Suddenly, we had to pull out of the audience an epidemiologist. But you are an epidemiologist. What do you have to say about this debate that we are seeing back and forth? Have you evaluated any of this information that is now being presented as if it were fact? Ms. Boyle. I think that the scientific data currently does not show an association between the MMR vaccine and autism. We have heard from Dr. Taylor. We also know that there is a study in Sweden by Dr. Gilberg and associates, who have been monitoring--Sweden is actually the only country that has been monitoring the rate of autism over time--and they looked at pre-MMR immunizations and post-MMR immunizations and found no changes in the rates of autism. Mr. Waxman. Well, I cannot tell you what is true or not, but I do not think our chairman can tell you what is true or not either, and I feel that when we had the hearings on whether there were campaign abuses by Democrats, a lot of people's reputations were ruined, and I thought the hearings were unfair. But those were political. The consequences of an unfair hearing on autism connected to vaccinations can cause people to die, and I worry about that, and I think we should get the facts before we make the assertions and not make the assertions and then throw out the witnesses who tell us information that does not fit those allegations. I yield back the balance of my time. Mr. Burton. The gentleman's time has expired. Does the gentlelady from Florida wish to question the panel? Ms. Ros-Lehtinen. Thank you so much, Mr. Chairman, and I thank you for holding this hearing. Rather than asking questions, because I am needed for a caucus in my other subcommittee, I want to thank you, Mr. Chairman, for holding this important hearing and for highlighting the need for further research as we explore the possible causes, interventions, strategies, counseling and other services to help families who are living with autism. We need to keep in mind that a person with autism is indeed a person first and not a behavior. These posters, which I would like to have the audience and the panelists see, show constituents from my Congressional District, Bonnie and Willis Flick, two beautiful children in my district who are living with autism, and, indeed, the whole family lives with autism. Bonnie and Willis are fortunate to be able to afford treatment and therapy, but so many other families are not as fortunate. So I thank you for the opportunity to hear from researchers and from parents and people who cope daily with this disease, and I commend you for your initiative, Mr. Chairman, in seeking answers to help those individuals with autism and for the opportunity to learn from experts and researchers. I especially want to thank you for allowing Dr. Cathy Pratt, the director of the Indiana Resource Center for Autism to come today and share her expertise on what we as policymakers can do to help families deal with autism. Approximately 50 percent of Florida's children with autism reside in my community in south Florida, so I am delighted to have you take this leadership role, Mr. Chairman, and have your committee address this issue so that 1 day, we can find prevention and methods and a cure to help us all cope with this rising curse of autism. I thank you very much, Mr. Chairman. Mr. Burton. Will the gentlelady yield to me? Ms. Ros-Lehtinen. Yes, Mr. Chairman. Mr. Burton. Let me just ask Dr. Wakefield, because I want to conclude with this panel and move on--would you be willing to give us all of the information on your study so it can be reviewed? Dr. Wakefield. Certainly. Mr. Burton. You will? Dr. Wakefield. Yes. Mr. Burton. Thank you very much. Professor O'Leary, would you be willing to give us all the information on your study so that we can review it? Dr. O'Leary. Yes, sir; no problem. Mr. Burton. I cannot hear you. Dr. O'Leary. Yes, sir. Mr. Burton. OK. Dr. Singh, would you be willing to give us all the information on your study so we can review it thoroughly? Mr. Singh. Yes, absolutely, without any hesitation. Mr. Chairman, if there is a moment, if I may have a chance, I would like to raise some interesting points later on. Mr. Burton. Yes, but just 1 second. Mr. Singh. Yes. Thank you very much. Mr. Burton. Now, then, Dr. Taylor, will you give us all the information on your study so we can review it along with the others? Dr. Taylor. In principle, I have no problem, but I would need to discuss that with my employing authority, University College London, and with the Department of Health, who funded this study. Mr. Burton. Who funded your study, Dr. Wakefield? Dr. Wakefield. We did. We have a small charitable contribution, but---- Mr. Burton. A charitable organization did; I see. Dr. Wakefield. We found it a little difficult to get funding---- Mr. Burton. And yours was done by the Government? Dr. Taylor. It was funded by the Medicine Control Agency, which is the body charged with responsibility for the safety of vaccines and other treatments. Mr. Burton. Well, I would be happy to work with the ranking Democrat, Mr. Waxman, to get an independent group of doctors/ scientists that we mutually agree upon to review all of your work to come to some kind of a conclusion if that is possible. So, since Dr. Wakefield and Professor O'Leary and Dr. Singh have all agreed, we would sure like to have yours, and I will be happy to write a letter, as I said before, to the authorities in England asking for your report, and hopefully, we will get that along with the others so we can review them side-by-side. Mr. Waxman. Mr. Chairman, on that point--and I want to agree with you. Mr. Burton. Sure. Mr. Waxman. Mr. Waxman. I drafted a letter, and I am going to share it with you, and I hope you will join with me on this letter to Secretary Shalala. We say in this letter: ``Because of the vital public health importance of childhood immunization as well as the growing concerns over the prevalence of autism in the United States, we urge you to convene, under the auspices of the National Institutes of Health, the Centers for Disease Control and Prevention, and the Food and Drug Administration, an expert panel of leading scientists and clinicians to review whether there is any causal association between vaccines and autism. Given the grave possibility that immunizations against life-threatening childhood diseases may decline is a result of unsubstantiated allegation of vaccine-induced autism, I would want her to act as expeditiously as possible.'' Perhaps you will join me in this letter because I think the only proper thing to do is to get the experts to evaluate all of these conflicting claims. I would not want the American people as a result of this hearing to stop being immunized if these claims are not---- Mr. Burton. Let me reclaim my time and say nor would I, but one of the concerns--the time is right there; it is on the clock--let me just say that the Department of Health and Human Services and Donna Shalala and the others have some very competent people over there. We have been checking into all the financial records of the people at FDA, HHS, and CDC, and we are finding that some of those people, even on the advisory panels, do have some possible financial conflicts, as was expressed in the New England Journal of Medicine just recently, on their front page. As a result, I will join with you to get an independent panel to review all of these studies, but I want to make sure they are not controlled by the health agencies of this country that may have some people who have some possible conflicts of interest. It has already been expressed in the New England Journal of Medicine, and we believe that that also possibly exists with some of the agencies of our health services here in the United States. So I will join with you, and we will pick them together, and we will try to make sure that we have some people who are totally unbiased. Mr. Waxman. Well, ``independent'' means no conflict of interest. I would not want a panel that had people with a conflict of interest, but I do want a panel of experts, and I think that the NIH and the CDC and the FDA can give us a panel that can do this evaluation. [Laughter.] I do not know why some people find that amusing, but I think---- Mr. Burton. So long as we find there is no conflict of interest, we would not have any problem with that. Mr. Tierney. Mr. Tierney. Thank you, Mr. Chairman. I have to say that I am a bit disturbed with the nature of this hearing and the direction that it has gone, only because I have a considerable number of people in my district who have not only children with autism, and they deal with it every day, but we have a number of institutions that have been working hard to give people the kind of support they need to deal with this situation, and I find this hearing taking on a lot different tone than a hearing that would like to look at some solutions and work together in a cooperative way to find out just what we can do. I do note that Representative Michael Bilirakis from Florida has some legislation filed, and one of the provisions would authorize funding for the NIH to establish Centers of Excellence that would conduct basic and clinical research into the causes, diagnosis, detection, prevention and treatment of autism. I congratulate the members of this panel who are cosponsors on that legislation and hope that that is the direction in which we will proceed, because I think we need to find out what the causes are. First, Dr. Boyle, you are an epidemiologist. Given your background, have you examined the evidence that autism is increasing in the United States? Ms. Boyle. We do know that the rates of autism appear to be higher than previously thought. As I said in my testimony, they range from 10 to 15 per 10,000. But that is really from studies from other countries. We have not had prevalence studies conducted in the United States. There were two done in the eighties that found very low rates, with perhaps methodologic reasons for that. At CDC, we have begun to develop a monitoring program at CDC which is only for the Atlanta area. We have our first year of data collected, and we are in the process of reviewing the information on the children with autism, and we hope to have a rate fairly soon. And we would like to see similar activities in many other locations. We have a wonderful model on birth defects. They are many years ahead of us in terms of trying to understand the causes of birth defects, and there are about 35 States that monitor birth defects on an ongoing basis. That does not happen for developmental disabilities, and we need to make that happen. Mr. Tierney. There are people in my district, particularly in the Merrimac Valley area, who seem to have at least acknowledged an increased number of reported cases, if not of autism itself, of one of the related diagnoses. Have you heard of---- Ms. Boyle. It is a difficult issue because the diagnosis for autism has changed considerably. The first studies were based on fairly narrow criteria from the way it was originally described. The more recent studies have actually used criteria that are much broader, and there is increased recognition. So we really do not know. There have been a number of investigators who have tried to see whether the increase in rates over time, or the higher rates in more recent years, is really due to a real increase or sort of a redefinition and better awareness. It is not an easy question to answer. Mr. Tierney. I bring that up only because in one instance, at least, a group of very active parents of children with autism worked with the school system and some other researchers and heightened the awareness of identification and found a marked increase in the number of cases that were beginning to be identified in the area, so people had not really appreciated these symptoms, including some doctors, pediatricians, who looked at it. Does that sound right to you? Ms. Boyle. The one study that has addressed this is the study by Gilberg which I mentioned earlier, which looked at trends over time. If you look at the range of functioning of those children over time, it appeared that the increase was in children who were higher-functioning as well as children who were lower-functioning. So the classic group seemed to remain constant. Now, why that is happening, we do not know. That is what we hope to do the research to understand. Mr. Tierney. Well, I agree that we ought to do this research and do it soon. I am a little bit concerned about what might be the message taken from this hearing by people and what we want to take on this. Dr. Boyle, if you had young children today, would you vaccinate them? Ms. Boyle. I do have children, and they are both fully vaccinated, and I would vaccinate them again. Mr. Tierney. Dr. Offit, how about you? Dr. Offit. Yes. I have a 7-year-old son, Will, and a 5- year-old daughter, Emily, and they are both fully vaccinated. Mr. Tierney. And you would do it again? Dr. Offit. Of course. I want them to be protected against the viruses and bacteria that can cause serious disability and death. I am fortunate, actually--I was a little boy in the early 1950's, and when I was a little boy, there were four vaccines--diphtheria, pertussis, tetanus and smallpox. I was fortunate that I was not killed by measles or paralyzed by polio. My son, hopefully, did not have to be as lucky, but hopefully, as we move into the 21st century and can develop vaccines against respiratory virus and para flu, children will not have to die from those diseases. Mr. Tierney. Dr. Boyle, you wanted to add something. Ms. Boyle. I did want to mention one thing. We do monitor the trend of other serious developmental disabilities in Atlanta, and just based on my own experience over the last 10 or 15 years, we used to see children who were deaf due to congenital rubella or who had mental retardation due to hemophilus influenza Type B. We no longer see those children in our program. Mr. Burton. The gentleman's time has expired. Mr. Tierney. Thank you, Mr. Chairman. Mr. Burton. I just have a few more questions, and then we will go to the next panel--I think Mr. Waxman has a few as well. Dr. Boyle, why did the CDC ignore the pleas of the parents of Brick Township when they begged CDC to look at the vaccine issue? Ms. Boyle. Actually, the study of Brick Township is sort of our first step, which is to look at the prevalence of---- Mr. Burton. Did you check into the vaccine issue, though? The parents there wanted the vaccines looked into as well. Did CDC---- Ms. Boyle. The concern with the parents from Brick Township in a number of meetings that we had with parents was related to environmental concerns. Mr. Burton. They did not---- Ms. Boyle. We have been working with the Agency for Toxic Substances and Disease Registration---- Mr. Burton. But didn't they also ask that the vaccines that had been given to their children also be investigated? Ms. Boyle. That is not my understanding. My understanding is that their initial concern was to answer the question, is the rate of autism in their community higher than what they thought---- Mr. Burton. Well, the information that we have is that the parents of Brick Township were very adamant that they wanted the vaccines checked because so many of their children had become autistic. And evidently, that is not one of the things that CDC is looking into, and I would like to pose the question to you and have you answer it in writing--why? Why didn't CDC include as one of the things they were investigating the possibility that some of these vaccinations may have caused the autism increase? Would you check that out and let me know? Ms. Boyle. I would be happy to. Mr. Burton. OK.
Mr. Burton. Dr. Taylor, you have shown the measles virus in
the intestine, and you have in your laboratory--or
``laboratory,'' as they call it in your country--you have gone
through and checked those samples that were sent to you by Dr.
Wakefield that show that there definitely was measles in the
gut of these children who became autistic. I think Dr. Singh
verified the same thing.
Did you check any of that, Dr. Taylor, why there was
measles in the guts of those children? Did you take a look at
any of that?
Dr. Taylor. I am sorry, I have not had a chance to look at
this paper. It is interesting information. However, in terms of
Mr. Wakefield's history, in all of his initial results, he has
found the cure for, first of all, Crohn's disease, and he has
found the cure for----
Mr. Burton. Let me just ask you this--I do not want to go
into those other things--Dr. Wakefield showed us on his slides
that there was measles in the guts of these children who were
vaccinated with the MMR shot. Professor O'Leary verified it in
a separate laboratory----
Dr. Taylor. Not in a separate laboratory; that was the same
laboratory. That, I think, is the critical point.
Mr. Burton. Well, it was----
Dr. Taylor. This information does have to be verified by an
independent laboratory.
Mr. Burton [continuing]. It was sent to him--and Dr. Singh,
I think, verified it as well. You have not, though, looked into
the problem with the measles in the gut of these children,
though?
Dr. Taylor. I do not know quite what you mean. That is not
my area.
Mr. Burton. You have not checked into that; OK.
Professor O'Leary, did you want to say something?
Dr. O'Leary. Sir, can I make a comment, please? What I
presented is evidence, direct evidence, cell-based and tube-
based. It was done at a separate laboratory from Dr.
Wakefield's.
If Professor Taylor has a beef with me, he should say that.
My work is completely independent. I stand over it. I have come
here to tell the truth. There is nothing for me to be gained in
not telling the truth.
Mr. Burton. Dr. Singh, you had some more comments, and I
want to yield the balance of my time to you to respond.
Mr. Singh. Yes, just a couple of things. Basically, I want
to raise the issue that when we think about epidemiological
studies, what are these individuals really looking at. All they
do is they take numbers from previous, old records of what-
have-you. They do not even pay any attention to the fact that
old-time vaccines were made based on old immunology. Today,
immunology is so different; it is almost a difference of day
and night. So we need to take into account that new research
should really be evaluated by so-called expert epidemiologists.
The second thing----
Mr. Burton. Well, let me just say one more thing. I want to
ask Dr. Boyle one last question, and that is do you believe
anybody who is getting funds from Merck or any of the other
pharmaceutical companies should be on advisory panels that are
making judgments about pharmaceuticals coming from those
companies, or do you believe that that is a conflict of
interest?
Ms. Boyle. I think that is a difficult question to answer.
Mr. Burton. Wait a minute. Let me get this straight. You
think it is a difficult question to answer. If somebody is
getting funding of some type from a pharmaceutical company, for
them to sit on an advisory panel that is approving or giving
their approval to a new drug that is coming on the market, you
do not see that as a conflict?
Dr. Schwartz. Mr. Chairman, I am Dr. Schwartz. I am a
colleague of Dr. Boyle and am the acting director of the
Epidemiology and Surveillance Division in the National
Immunization Program, and we appreciate your indulgence in
allowing me to testify and to help with answering questions
about immunization.
The Advisory Committee on Immunization Practices is a
chartered advisory committee under the FACA regulations. There
are very strict guidelines regarding the participation in votes
of members who may have conflicts of interest that will help
assure that those potential conflicts of interest, those
potential financial conflicts, do not affect the votes and the
decisions of the advisory committee.
The reason why individuals who may potentially have
conflicts are included in the committee is to assure that we
get the best expert advice possible so that we can make the
best vaccine recommendations possible, and frequently, the best
experts are those who may have done research or may have
provided information to some of the vaccine manufacturers--but
their role in the committee and in the voting process is very
strictly defined.
It is also important to point out that recommendations for
vaccination are made independently by the American Academy of
Pediatrics and the American Academy of Family Physicians, and
those recommendations are virtually always in harmony with the
recommendations from the Advisory Committee on Immunization
Practices.
Mr. Burton. Well, I am going to go ahead--my time is
expired, but I am going to come back to you on that. I will
take another round on that.
Mr. Waxman.
Mr. Waxman. I want to say to the parents in the audience
and to others, family members, who are here that I do not want
you to think that I am in any way trying to minimize what you
have gone through or to in any way challenge the depth and
sincerity of your feelings. I think that is a separate question
from the scientific question of whether there is a causal link.
And because it is so important, it is essential that through
sound science, we determine this fact--not through emotionalism
and not through sensationalism.
I did not come here to say one side is right or one side is
wrong, but I want us to have the best scientific information we
can have.
Now, Dr. Offit's integrity has been challenged, presumably
because he has a point of view that does not quite fit with the
chairman's point of view. Dr. Schwartz started to indicate why
he thought your situation, even though you have a relationship
with Merck, did not put you in a conflict.
Let me ask you directly, Dr. Offit, do you have a conflict
of interest, and if ``No,'' why not?
Dr. Offit. No, I have no conflict of interest. What I have
is an apparent conflict of interest, and that is why I
disclosed that at the beginning of every ACIP meeting, and that
is why I disclosed it in my written report.
If I could just explain this a little bit, I have been
doing research for 20 years on rotaviruses. What I have done in
my laboratories is try, with my colleagues, to understand what
the genes are that cause diarrhea and what the genes are that
help the body fight infection. That led to a patent on a
vaccine for rotavirus. Rotaviruses kill 13 children a day in
this world, and rotaviruses cause 1 out of every 75 children
born in this country to be hospitalized. It is a serious, and
in developing countries often a deadly, infection.
It would be an advance if we could prevent that disease.
Merck and Company has made a commitment to developing that
vaccine, and hopefully, if we can develop a safe and effective
vaccine, we can prevent a lot of disease and death.
Mr. Waxman. I think that everyone here should agree that we
want a safe vaccine, or a vaccine that is as safe as possible.
Merck did not hire you to come up with a particular position,
did they? Did they tell you they wanted your research to have a
certain outcome?
Dr. Offit. No. This work was all done--frankly, it was
funded by the National Institutes of Health, and it was funded
by research that we did as a basic--I am an immunologist--that
is my expertise.
Mr. Waxman. There is an organization--and I am going to put
this in the record--called the Autism Autoimmunity Project. I
have a letter from its president urging people to give money to
it, because this project is going to fund research that is
going to show the connection between vaccines and autism and
other diseases. And they proudly say they fund Dr. Wakefield
and Dr. Singh. Is that true?
Mr. Singh. Yes.
Mr. Waxman. Is that true, Dr. Singh?
Mr. Singh. Yes. I just received some money from that
foundation, oh, about 2 months ago. My research has been going
on on this issue for the last 15 years.
Mr. Waxman. Yes--and I am not saying there is anything
wrong with it----
Mr. Singh. I just wanted to make a point on that.
Mr. Waxman [continuing]. Although this organization seems
to have a particular point of view. How would you think they
would feel if your research came up with a different conclusion
from what they wanted to achieve in their--because they have a
position----
Mr. Singh. Mr. Waxman, I am a very honest, decent human
being--unlike, perhaps, some other people that you might know
of--and I can tell you that if I found a connection which was
not existent or if my results did not support what this
foundation wanted, I would even return the money to that
foundation.
Mr. Waxman. Even though they want a particular point of
view----
Mr. Singh. They never asked me to do any research----
Mr. Waxman [continuing]. You are an independent scientist,
and you have integrity.
Mr. Singh. What I am----
Mr. Waxman. Just answer yes or no, because I do want to
ask----
Mr. Singh. I beg your pardon?
Mr. Waxman. My question to you is they have a point of
view, but they fund you, you have integrity, and you are going
to do your work based on science. Is that your answer?
Mr. Singh. My answer is that I am getting funds from
private sources because national agencies continue to decline
my research grant proposals when I submit. Where else am I
going to go to get the funding?
Mr. Waxman. Have you been turned down by NIH?
Mr. Singh. I am trying to raise funding independently, on
my own, not necessarily----
Mr. Waxman. Have you been turned down by NIH?
Mr. Singh. Three times, I have attempted--three times, I
have written grants, and NIH has not given me a single dime.
Mr. Waxman. I want Dr. Wakefield to be able to answer the
same question very briefly.
Dr. Wakefield, you acknowledge you have received money. Do
you feel that that in any way raises expectations that your
research come out with a result that this organization wants?
Dr. Wakefield. We are funded to test hypotheses, and we
present the data whether the hypothesis is correct or not. And
we have done that, we have gone on record as doing it. We
publish negative studies in association with measles and
Crohn's disease. That does not mean it is not there; it means
that our hypothesis was wrong in terms that we could not find
it using the technology. So we have gone on record as
publishing both positive and negative data.
Mr. Waxman. I ask unanimous consent that those documents
from the Autism Autoimmunity Project be put in the record, and
I would note, Mr. Chairman, that you are also associated on the
board of this group.
Mr. Burton. Without objection. That is no problem.
[The information reAutism and Childhood Vaccines Hearing Testimony:
Mr. Burton. I see this as a little bit different situation.
The pharmaceutical companies who are producing jobs--and they
do a great job for the country--but they have a financial
interest in getting things approved.
The New England Journal of Medicine has recognized this in
a recent publication, on the front page. They said that they
had some people on their advisory committees who had made some
comments and made some recommendations that had financial
interest, and they had not scrutinized them properly, and they
apologized for it and said it would not happen again.
So what I asked Dr. Boyle and what I am inferring here
today is that there can be a bias if people are being paid or
reimbursed by pharmaceutical companies when they start making a
decision or a recommendation on an advisory panel.
Now, you said that if they represent Merck or Bristol
Meyers or some other laboratory, they will probably excuse
themselves from voting, and there may be a requirement for
that. That does not alter the fact that they are sitting on
that panel, and they are talking to everybody else on that
panel, and they have influence on that panel, and they do have
a tremendous impact on whether or not certain things are
approved or disapproved. And I think that that is a conflict of
interest. I do not see why we cannot have people on advisory
panels who have no financial interest whatsoever with
pharmaceutical companies when they are approving those, because
we are talking about the health of the Nation. And that is
something which ought to be investigated very thoroughly by
this Congress.
We are talking today about autism, but there is something
of as great stake here as the autism question and whether or
not the MMR vaccine and other vaccines may be contributing to
autism, and that is are we letting pharmaceutical companies
have too great an influence on the decisionmaking process that
affects very one of our lives?
Right now, we are talking about the anthrax vaccine. They
are going to inoculate every one of our military personnel, and
there are all kinds of questions about the anthrax vaccine, all
kinds of them. We have had all kinds of side effects that we
have talked about, and I have talked to people who have had
them. And the former chairman of the Joint Chiefs of Staff is
on the board of that company that makes the anthrax vaccine.
They are manufacturing millions of doses of this vaccine, and
every member of the service will have to get six shots of that.
If the decisionmaking process involves people who have a
financial interest in it, and that outweighs the potential side
effects of any drug, then I think there is something amiss.
So I have great concerns about that, and I would just say
to you that HHS and CDC and FDA and all of them ought to take a
hard look at whether or not they have people on their advisory
panels who have a potential conflict of interest by getting
money or something else from a pharmaceutical company that they
represent.
Now, I was not trying to impugn the integrity of Dr. Offit,
but I did want to point out that he does get money from Merck
and gets some benefits from Merck. So for anybody to say that
he can be totally unbiased is questionable. Maybe he would be
totally unbiased, but it is questionable.
So I think that this whole issue of whether or not the MMR
vaccine is a problem--the measles vaccine has been found in the
gut, it has been verified, and we still have this problem, and
the question was whether or not it goes from the gut up to the
brain and is a contributing factor to autism--but the companies
that make the MMR vaccine have people on the advisory boards
who are participating in the decisionmaking process.
So it makes me wonder whether we are going to really get to
the bottom of it unless we go to outside entities--and that is
not questioning anybody's integrity. It is just saying that if
I am paying somebody money for some product or something, and
there is something else that I am going to make money off of,
and they are on a board that is going to participate in a
decisionmaking process, to say that they do not at least think
about me and think about where the money is coming from just
boggles my mind, and I think it would most people.
With that, do I have any further questions? Let us see what
else we have here.
[Pause.]
Mr. Burton. OK. Dr. Boyle, for your information, at a
public meeting in Brick Township in January 1997--and you
should know this--with CDC and others present, several audience
members asked about the vaccines and the possible autism link,
and they asked that vaccines be checked. That is from Andy
Napoli, the legislative director of Representative Chris Smith.
So, I again want to stress that we want to have an answer
from CDC. If parents from that township were wondering about
the possible connection between these vaccinations and autism,
why didn't CDC check on it? Why not? You are checking on
everything else, the other environmental concerns around there.
Why not check on the vaccine?
And I submit that maybe, just maybe, it is because the
pharmaceutical company that manufactures it had some influence
on the people who were in that meeting, and they said, Hey, we
do not want to get into that. And if that is the case, that is
damned near criminal.
With that, I will be happy to yield back the balance of my
time and let Mr. Waxman have his 5 minutes. Then we will go to
the next panel.
Mr. Waxman. Thank you, Mr. Chairman.
I would like to have Dr. Spiker come forward, if he would.
Dr. Spitzer. Spitzer. S-p-i-t-z-e-r.
Mr. Waxman. Oh. I am sorry. Dr. Spitzer, where are you----
Dr. Spitzer. I am a professor of epidemiology with the
Faculty of Medicine at McGill University in Montreal.
Mr. Waxman. When you came forward a moment ago, you
appeared to be reading from a prepared statement. Did you have
a statement written out that you read from?
Dr. Spitzer. Yes, I did. The circumstances are that I
personally learned of this hearing, and of related activities
very late in the game. I have been an honorary assistant to
2,100 families in the United Kingdom who have great difficulty
getting scientific help and cannot afford it. I have chosen on
this issue----
Mr. Waxman. Excuse me. Did you prepare that statement
yourself before the hearing?
Dr. Spitzer. Yes, I did.
Mr. Waxman. OK. And were you contacted or did you contact
Chairman Burton's staff before your testimony?
Dr. Spitzer. I did so indirectly, to the best of my
knowledge, through a person named Ms. Barbara Fisher.
Mr. Waxman. And could you identify Barbara Fisher? Is she
here?
Dr. Spitzer. She is here in the audience.
Mr. Waxman. Is she a staffperson for the committee?
Dr. Spitzer. No. She is in the vaccination----
Mr. Waxman. When did you talk to her? Was it today or
earlier than today?
Dr. Spitzer. I spoke to her yesterday and the day before
yesterday by telephone and met her here----
Mr. Waxman. And you met her here?
Dr. Spitzer. I met her this morning.
Mr. Waxman. But you talked to her yesterday and the day
before about coming here to testify?
Dr. Spitzer. Yes.
Mr. Waxman. Thank you very much.
Dr. Offit----
Dr. Spitzer. I am sorry. It was primarily for the press
conference, but with the possibility of being able to testify
as well.
Mr. Waxman. Yes--some extenuating circumstances for which
the rules did not have to be observed.
Dr. Offit, the chairman says he is not impugning your
reputation, but it sounds to me like your reputation has been
impugned. You get money from Merck. They make the vaccine. You
are on an advisory committee for the CDC about vaccines. That
is an apparent conflict of interest. Again, why isn't it a
conflict of interest?
Dr. Offit. Because as I sit on the Advisory Committee on
Immunization Practices and make recommendations for children in
this country, the only thing I consider is exactly how I would
treat my own children. I mean, I take the job very seriously.
So the recommendations that I make are based solely on a
careful review of the data that are presented to us, period. I
do not have any conflict with regard to that decisionmaking
process. It is simple in that sense.
Mr. Waxman. Dr. Boyle and Dr. Schwartz, what would happen
if you excluded people from your advisory committee who worked
in the area of research on vaccines or in some other area for a
pharmaceutical company?
Dr. Schwartz. Those with the greatest expertise on vaccines
and those who are best able to make recommendations that will
protect the health of American children have frequently done
research in vaccines. They are the ones who know the issues
best and who can make the best recommendations. By including
them on the advisory committee, but implementing appropriate
controls to make sure there are no apparent conflicts of
interest, the CDC feels that they get the best advice to make
the best public health recommendations.
Mr. Waxman. How about people who are funded by the Autism
Autoimmunity Project--have you ever heard of that group?
Dr. Schwartz. The ACIP meetings are all open public
meetings. They are all----
Mr. Waxman. What is ``ACIP?''
Dr. Schwartz. The Advisory Committee on Immunization
Practices meetings are all open meetings and are announced in
the Federal Register. If someone from that particular institute
wanted to come and share information or present to the ACIP,
they would certainly be welcome to do so.
Mr. Waxman. And would you feel they have a conflict of
interest if they are funded by an organization that wants to
have scientists establish a certain conclusion?
Dr. Schwartz. I think the most important thing that we need
to consider is the quality of the scientific data and whether
those data have been peer-reviewed, whether they have been
considered by other scientists, and whether they have been
replicated in other laboratories.
Mr. Waxman. So you think the most important thing is that
Dr. Wakefield and Dr. Singh ought to disclose if they are
funded by this group, and Dr. Offit ought to disclose if he is
funded by Merck.
Dr. Schwartz. I think disclosure is important, yes.
Mr. Waxman. And then you evaluate their science?
Dr. Schwartz. Yes.
Mr. Waxman. Because ultimately what is at stake are the
scientific questions that we want answered.
Dr. Schwartz. That is exactly correct, and preserving the
health of American children.
Mr. Waxman. Well, that, it seems to me, should be the goal
of all of us, and I hope that hearings like this are to try to
get to that result and not simply to further a particular point
of view which could well be wrong, and if it is wrong, as I
fear it may be, by advertising this particular point of view
and scaring the public, we could see a drop in immunization
rates. And we do not know if autism will drop--in fact, we have
evidence from Great Britain that it did not drop when
immunizations did----
Mr. Burton. I am allowing you extra time because I have one
more question. I am allowing you extra time.
Mr. Waxman [continuing]. I am getting extra time--for good
behavior--that when we do have an example in the real world of
sensational press about the link between autism and
vaccinations, vaccination rates dropped, and we knew that
caused an increase in measles, but we saw no decrease in
autism.
It is troubling to me. I appreciate all of the views that
have been expressed here, and I hope that we can get an
independent group to look at this, because I do not think this
committee is an independent group trying to reach an honest
conclusion.
I yield back the balance of my time to the chairman.
Mr. Burton. Let me just make one final comment, and that is
that the people who are doing the independent studies here do
not sit on any advisory boards that are making decisions on
what kinds of vaccinations we are going to be giving to the
people of the United States of America. The people who
represent the pharmaceutical companies and sit on those boards
do. That is the difference.
And let me just conclude by saying that I really appreciate
all of you being here. This is a very difficult issue. I think
it was unavoidable that there would be this kind of contention
today because we have a lot of parents and grandparents, like
myself, who feel very strongly about the life that our kids and
grandkids are going to have to lead; and on the other side of
the issue are the people who are saying there is no impact from
the shots that are being given to our kids.
So the bottom line is that there are going to be strong
differences of opinion, and we want to get all those
differences of opinion on the record, and then we will all go
out and have a cup of coffee together and debate it in private.
The American people need to know the facts. Lincoln said,
``Let the people know the facts, and the country will be
saved,'' and I think that is just as true today as it was at
the beginning of this Republic. So that has been our goal--not
to fight with everybody, but to get the facts out. And we are
all for vaccinations. It is just do we want to give a child
nine vaccinations in 1 day; do we want to give them 31 or 32 or
33 vaccinations between the time they are born and age 6? Isn't
that maybe a little bit of overload? That is the whole
question.
I want to thank this panel. We have one more panel. I
really appreciate all of you being here, even though we may
have some differences with some of you.
Thank you.
I apologize to the next panel for having to sit there for
so long.
While the next panel is coming up, we will take a couple-
minute break. The next panel consists of Dr. Bernard Rimland,
Dr. Michael Goldberg, Dr. Mary Megson, Dr. John Upledger, Dr.
Catherine Pratt, Dr. Deborah Hirtz, and Dr. Edward Cook.
We will start in just 1 minute.
Note/Warning:
Autistic people have fought the inclusion of ABA in therapy for us since before Autism Speaks, and other non-Autistic-led autism organizations, started lobbying legislation to get it covered by insurances and Medicaid.
ABA is a myth originally sold to parents that it would keep their Autistic child out of an institution. Today, parents are told that with early intervention therapy their child will either be less Autistic or no longer Autistic by elementary school, and can be mainstreamed in typical education classes. ABA is very expensive to pay out of pocket. Essentially, Autism Speaks has justified the big price tag up front will offset the overall burden on resources for an Autistic’s lifetime. The recommendation for this therapy is 40 hours a week for children and toddlers.
The original study that showed the success rate of ABA to be at 50% has never been replicated. In fact, the study of ABA by United States Department of Defense was denounced as a failure. Not just once, but multiple times. Simply stated: ABA doesn’t work. In study after repeated study: ABA (conversion therapy) doesn’t work.
What more recent studies do show: Autistics who experienced ABA therapy are at high risk to develop PTSD and other lifelong trauma-related conditions. Historically, the autism organizations promoting ABA as a cure or solution have silenced Autistic advocates’ opposition. ABA is also known as gay conversion therapy.
The ‘cure’ for Autistics not born yet is the prevention of birth.
The ‘cure’ is a choice to terminate a pregnancy based on ‘autism risk.’ The cure is abortion. This is the same ‘cure’ society has for Down Syndrome.
This is eugenics 2021. Instead of killing Autistics and disabled children in gas chambers or ‘mercy killings’ like in Aktion T4, it’ll happen at the doctor’s office, quietly, one Autistic baby at a time. Different approaches yes, but still eugenics and the extinction of an entire minority group of people.
Fact: You can’t cure Autistics from being Autistic.
Fact: You can’t recover an Autistic from being Autistic.
Fact: You can groom an Autistic to mask and hide their traits. Somewhat. … however, this comes at the expense of the Autistic child, promotes Autistic Burnout (this should not be confused with typical burnout, Autistic Burnout can kill Autistics), and places the Autistic child at high risk for PTSD and other lifelong trauma-related conditions.
[Note: Autism is NOT a disease, but a neurodevelopmental difference and disability.]
Fact: Vaccines Do Not Cause Autism.
International Badass Activists 