[House Hearing, 107 Congress] [From the U.S. Government Publishing Office] VACCINES AND THE AUTISM EPIDEMIC: REVIEWING THE FEDERAL GOVERNMENT'S TRACK RECORD AND CHARTING A COURSE FOR THE FUTURE ======================================================================= HEARING before the COMMITTEE ON GOVERNMENT REFORM HOUSE OF REPRESENTATIVES ONE HUNDRED SEVENTH CONGRESS SECOND SESSION __________ DECEMBER 10, 2002 __________ Serial No. 107-153 __________ Printed for the use of the Committee on Government Reform Available via the World Wide Web: http://www.gpo.gov/congress/house http://www.house.gov/reform ________ U. S. GOVERNMENT PRINTING OFFICE 84-605 WASHINGTON : 2003 ____________________________________________________________________________ For Sale by the Superintendent of Documents, U.S. Government Printing Office Internet: bookstore.gpo.gov Phone: toll free (866) 512-1800; (202) 512-1800 Fax: (202) 512-2250 Mail: Stop SSOP, Washington, DC 20402-0001 COMMITTEE ON GOVERNMENT REFORM DAN BURTON, Indiana, Chairman BENJAMIN A. GILMAN, New York HENRY A. WAXMAN, California CONSTANCE A. MORELLA, Maryland TOM LANTOS, California CHRISTOPHER SHAYS, Connecticut MAJOR R. OWENS, New York ILEANA ROS-LEHTINEN, Florida EDOLPHUS TOWNS, New York JOHN M. McHUGH, New York PAUL E. KANJORSKI, Pennsylvania STEPHEN HORN, California CAROLYN B. MALONEY, New York JOHN L. MICA, Florida ELEANOR HOLMES NORTON, Washington, THOMAS M. DAVIS, Virginia DC MARK E. SOUDER, Indiana ELIJAH E. CUMMINGS, Maryland STEVEN C. LaTOURETTE, Ohio DENNIS J. KUCINICH, Ohio BOB BARR, Georgia ROD R. BLAGOJEVICH, Illinois DAN MILLER, Florida DANNY K. DAVIS, Illinois DOUG OSE, California JOHN F. TIERNEY, Massachusetts RON LEWIS, Kentucky JIM TURNER, Texas JO ANN DAVIS, Virginia THOMAS H. ALLEN, Maine TODD RUSSELL PLATTS, Pennsylvania JANICE D. SCHAKOWSKY, Illinois DAVE WELDON, Florida WM. LACY CLAY, Missouri CHRIS CANNON, Utah DIANE E. WATSON, California ADAM H. PUTNAM, Florida STEPHEN F. LYNCH, Massachusetts C.L. ``BUTCH'' OTTER, Idaho ------ ------ EDWARD L. SCHROCK, Virginia ------ JOHN J. DUNCAN, Jr., Tennessee BERNARD SANDERS, Vermont JOHN SULLIVAN, Oklahoma (Independent) Kevin Binger, Staff Director Daniel R. Moll, Deputy Staff Director James C. Wilson, Chief Counsel Robert A. Briggs, Chief Clerk Phil Schiliro, Minority Staff Director C O N T E N T S ---------- Page Hearing held on December 10, 2002................................ 1 Statement of: Baskin, David, M.D., professor of neurological surgery, Baylor College of Medicine, Houston, TX; Mark Geier, M.D., Ph.D., Genetic Consultants of Maryland, Bethesda, MD; and Walter Spitzer, M.D., M.P.H., F.R.C.P.C., emeritus professor of epidemiology, McGill University, Montreal, Canada..................................................... 30 Midthun, Karen, M.D., Director, Office of Vaccines Research and Review, Food and Drug Administration, Rockville, MD; Stephen Foote, Ph.D., Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health, Bethesda, MD, accompanied by Christopher Portier, Ph.D., Director, Environmental Toxicology Program, National Institute of Environmental Health Sciences, Bethesda, MD... 122 Letters, statements, etc., submitted for the record by: Baskin, David, M.D., professor of neurological surgery, Baylor College of Medicine, Houston, TX, Lancet article.... 34 Burton, Hon. Dan, a Representative in Congress from the State of Indiana, exhibit 3...................................... 150 Clay, Hon. Wm. Lacy, a Representative in Congress from the State of Missouri, prepared statement of................... 172 Foote, Stephen, Ph.D., Director, Division of Neuroscience and Basic Behavioral Science, National Institute of Mental Health, Bethesda, MD, prepared statement of................ 143 Geier, Mark, M.D., Ph.D., Genetic Consultants of Maryland, Bethesda, MD, prepared statement of........................ 51 Kucinich, Hon. Dennis J., a Representative in Congress from the State of Ohio, prepared statement of................... 10 Maloney, Hon. Carolyn B., a Representative in Congress from the State of New York: Washington Post article.................................. 16 Prepared statement of.................................... 20 New York Times editorial................................. 14 Midthun, Karen, M.D., Director, Office of Vaccines Research and Review, Food and Drug Administration, Rockville, MD, prepared statement of...................................... 125 Spitzer, Walter, M.D., M.P.H., F.R.C.P.C., emeritus professor of epidemiology, McGill University, Montreal, Canada, prepared statement of...................................... 109 VACCINES AND THE AUTISM EPIDEMIC: REVIEWING THE FEDERAL GOVERNMENT'S TRACK RECORD AND CHARTING A COURSE FOR THE FUTURE ---------- TUESDAY, DECEMBER 10, 2002 House of Representatives, Committee on Government Reform, Washington, DC. The committee met, pursuant to notice, at 1:30 p.m., in room 2154, Rayburn House Office Building, Hon. Dan Burton (chairman of the committee) presiding. Present: Representatives Burton, Weldon, Waxman, Maloney, Kucinich, Tierney, and Green. Staff present: Kevin Binger, staff director; Pablo Carrillo, counsel; S. Elizabeth Clay and John Rowe, professional staff members; Blain Rethmeier, communications director; Allyson Blandford, assistant to chief counsel; Robert A. Briggs, chief clerk; Robin Butler, officer manager; Joshua E. Gillespie, deputy chief clerk; Michael Layman, Susie Schulte, legislative assistants; Nicholis Mutton, deputy communications director; Leneal Scott, computer systems manager; Mindi Walker, staff assistant; Corinne Zaccagnini, systems administrator; T.J. Lightle, systems administrator assistant; Sarah Despres, minority counsel; Ellen Rayner, minority chief clerk; and Jean Gosa and Earley Green, minority assistant clerks. Mr. Burton. Good afternoon. A quorum being present, the Committee on Government Reform will come to order. I ask unanimous consent that all Members and witnesses' written and opening statements be included in the record. And without objection so ordered. I ask unanimous consent that all articles, exhibits and extraneous or tabular material referred to be included in the record. And without objection so ordered. Because my good friend Mr. Waxman has to leave at 2 and because my opening statement is going to include a couple of clips on video, I've asked him if he'd like to go ahead and make his opening statement first, and he'd like to do that. So we'll let him start off and then I'll go into the details I want to go into in my opening statement. Mr. Waxman. Mr. Waxman. Thank you, Mr. Chairman, for the courtesy of allowing me to go first in the opening statements. There is a Democratic Caucus meeting at the same time as this committee hearing and it's unfortunate the scheduling conflict exists. So I wanted to make my opening statement. I unfortunately won't be able to be here for the testimony of many of the witnesses. Mr. Chairman, in my lifetime polio has gone from every parents' fear to being a distant memory. Measles epidemics are few and far between. Congenital rubella, which can cause blindness, deafness, and autism, is increasingly rare. In just the last decade the most common causes of bacterial meningitis in young children have been controlled. We have vaccines to thank for these incredible accomplishments. While millions of American children have been protected by immunization, no vaccine is 100 percent safe. The government must ensure that these vaccines are as safe as they can be, insist that vaccines are only administered when the benefit greatly outweighs the risk, and provide those who are injured with quick and fair compensation. Today's hearing will focus on the allegation that routine childhood immunizations cause autism. Too often in this debate, though, solid public health information gets lost among sensational allegations or in recent days disgraceful political acts that are intended to protect special interests. This committee, unfortunately, has played a role in sowing confusion. Mr. Chairman, I think you've been well intentioned in your efforts and genuine in your convictions, but often your theories have just been wrong. Two years ago, for instance, this committee publicized allegations that the measles-mumps- rubella, MMR, vaccine causes autism. This allegation frightened many parents. But the allegation has been disproven by scientific evidence. Studies in Europe and here in the United States by the Institute of Medicine have concluded that the MMR vaccine is not associated with autism and there should be no confusion about that. Mr. Chairman, you've repeatedly, and rightly in my view, asked for more scientific studies so that we can know as much as possible about any adverse health consequences from vaccines. But it's important for our committee to pay attention to those studies once they are completed. In fact, it's important that parents know about two recently concluded peer- reviewed research reports. The first, which appeared in a recent issue of New England Journal of Medicine, examined the theory that the measles-mumps-rubella vaccine causes autism. Concerns about a potential link have terrified British parents and have resulted in measles outbreaks in the United Kingdom because of the children who are not getting vaccinated. At previous committee hearings some Members and witnesses have called for a comparison between vaccinated and unvaccinated children in testing the safety of this vaccine. Well, this comparison is exactly what the New England Journal of Medicine study provides. It found no increase in autism among those children who were vaccinated compared to those who were not. The commentary that accompanied the study said that this study should put to rest parents' concerns over the safety of the MMR vaccine. A second peer-reviewed research report was published in the Lancet 2 weeks ago. This study addressed the theory that thimerosal, a mercury based vaccine preservative, causes children to suffer neurological damage, including autism. In this study researchers measured the amount of mercury in the bloodstream of recently vaccinated infants. They found that this level does not exceed safe values in any child. The commentary that accompanied this study said it provided, ``comforting reassurance.'' It should be reassuring to parents that thimerosal has been removed from all routine vaccine immunizations except for the recently recommended flu vaccine and that additional studies on thimerosal are under way. These two research reports, with more research under way, are good news for public health. And I ask that these studies and the commentaries be included in the record. Mr. Chairman, if I---- Mr. Burton. Without objection. Mr. Waxman. Thank you. The vaccines are an essential part of child health and parents should know that leading experts such as the CDC and the American Academy of Pediatrics continue to recommend that children receive all vaccines currently approved for routine use. Now, I know that we have witnesses today who are going to include--the list of witnesses are going to include some scientists that dispute these findings. Now, that's appropriate for them to dispute the findings. And in fact many of them dispute the findings at the peer-reviewed meetings that resulted in these two studies. If scientists have scientific arguments, they should take it up with their scientific peer members. That's how scientific evaluation proceeds: Theories, evidence, contradictions, discussions, and then a consensus and then a challenge to that consensus. But this committee and politicians in the Congress are not the ones to make scientific decisions. And those who are in the minority and disagree with the scientific conclusions of their peers should challenge their peers by additional scientific arguments in evidence. I want to make that point very, very clearly, because what we have in this hearing is one of a series of hearings where we had a political argument that's being made which seems to be refuted by the scientific evidence, and the answer to that is more political arguments and hearings, and I fear that these hearings only scare people without scientific arguments to back them up. Now, the bad news for vaccine safety--the good news is these two studies reassure us about the vaccines, but the bad news for vaccine safety, however, has come on the political front. During the recent passage of the homeland security bill the Republican leadership snuck in two vaccine-related provisions that help industry and do nothing to help people who are injured by vaccines. The first of these provisions gave manufactures of the smallpox vaccine and hospitals that administer the vaccine virtually complete immunity from lawsuits but does nothing to compensate people who suffer vaccine-related injuries or death. The net result is that Republicans have managed to protect everyone but those who need the protection the most. Imagine an emergency room worker who is vaccinated against smallpox in order to protect the rest of us in case of a bioterrorist attack. If this hero or heroine on the front lines become incapacitated by the vaccine, he or she has no guarantee of compensation for his or her sacrifice. This is completely unacceptable. Republicans also snuck in another vaccine-related provision into the homeland security bill that has no bearing on homeland security whatsoever. It provides liability protection for Eli Lilly, a manufacture and distributor of thimerosal. The provision was cherry picked from a list of recommendations made by an expert panel that overseas the Vaccine Injury Compensation Program. Not included in the homeland security bill were those recommendations made by this same expert panel that helped families and children, including increasing the death benefit, doubling the statute of limitations for the program, and allowing the program to pay for family counseling. Here's a telling fact: The Republican leadership is so embarrassed by what they did that they won't even admit about what they've done. After the thimerosal provision was put in the bill, House Majority Leader Dick Armey said the provision was put in at the request of the White House. But when I wrote to the White House about this the White House claimed the idea originated in Congress. But to this day, not a single Member of the Republican leadership will admit responsibility for this provision. I don't know what kind of values these actions represent, but they are not the values that I want to have any part of. They put the interests of powerful and wealthy special interest ahead of families with children suffering from debilitating illnesses. This is an embarrassment to the Congress and to our great country. As we revisit these issues in the next Congress I hope that Republicans when considering changes to the Vaccine Injury Compensation Program do not forget that the purpose of the program is to help families not just to reduce the liability for industry; I also hope that the politics of vaccine safety reinforce rather than undermine the success of immunization. The lesson from the homeland security bill is not that people should fear that the smallpox vaccine is always dangerous or believe the allegations that thimerosal causes autism; the lesson is that protecting industry alone is unacceptable, both as public policy and principle. I thank the witnesses that are going to be here today--I know this is a hearing where they've been asked to testify. I'm going to have a chance to review the record of the testimony. And I'll look forward to reviewing the record but I want to underscore again scientific issues should be decided by scientific principles and evidence, not by politics and not by presenting discredited minority views that have not yet been able to prevail in scientific evaluation as if they were fact and as a result scare a lot of people to do something that would be more harmful than helpful. Thank you very much, Mr. Chairman, for your courtesy in allowing me to make this statement, and I'll look forward to reviewing the record. Mr. Burton. Let me just say before Mr. Waxman leaves he's been a big help in trying to change the vaccine injury compensation fund to be more responsive, and I do appreciate that. The one thing that I would like to say though is that Mr. Waxman does have a lot of other responsibilities and as such he has had to leave a number of times before we go into the details about scientific research that shows conflicting information. And I know that he reads these documents but I think sitting here and hearing the scientists from around the world that we've had come before us might give you a little different perspective, and I'm very sorry that you're not going to be able to be here today and have not been here for some of the witnesses that I think might have piqued your interest, maybe dissuaded you from some of the positions you've taken. Nevertheless, you're my buddy. I'm glad you work with me. Mr. Waxman. Will you yield to me? Thank you very much for your comments. I have had a chance to review the testimony of witnesses. I've had my staff very much involved in this issue. I've been involved in vaccine issues for at least 20 years in the Congress of the United States. And if you come in with a preconceived idea and hear witnesses say what you believe to be the case, I'm sure it reaffirms your views. But I think still these issues of science ought to be decided by the scientific method. That's the thing that's going to protect us. I thank you for letting me make the statement. Mr. Burton. I will send to your office, it will only take you about 20 minutes, I have a couple of tapes I would like for you to take a look at. I will let Mr. Weldon go next and I'll let my colleagues speak as well because I am going to take a little bit of time about my opening statement. I don't want to be discourteous to them. So Dr. Weldon. Mr. Weldon. Thank you, Mr. Chairman. And I want to commend you for calling this hearing and I specifically want to commend you for your willingness to explore this issue. If scientists behaved purely like scientists and did purely objective research all the time, then the comments made by Mr. Waxman would be valid. The reality is scientists and medical researchers operate with a system of biases that frankly can be very, very politicized. And the claims that were made by the ranking member that these issues essentially have been put to rest I don't believe are valid. Specifically when you look at the issue of the MMR, the Danish study, the data from the Danish study which he was referring to, which I'm sure we're going to hear more about today from our witnesses, was valuable but it didn't really get at answering the question of really looking at kids with regressive autism. I don't think the opinion of this committee has ever been that mercury per se or the MMR per se causes autism, and I think the general consensus of scientific opinion is that this is probably a multifactorial disease. And while the Danish study provided some valuable information, really it didn't answer the question, I think, of regressive autism. And the other thing that was very disturbing about the Danish study is they documented a tenfold increase in the incidence of autism in Denmark. There's absolutely no comment in the New England Journal about that issue. And let me just say I share Mr. Waxman's sentiments on vaccines. Vaccinations and septic systems have probably done more to save hundreds of millions of lives in the civilized world than anything else, and we all need to be very, very grateful to these tremendous breakthroughs in vaccinations. But there's, I think, some very, very troubling issues that have not been resolved. The thing that I continue to find extremely disturbing is the fact that the CDC still does not allow researchers access to the vaccine safety data. If everything was so objective and any scientist at all can look at this stuff, it would be one thing, but they continue to deny people access to this information. And until we get a free and open dialog within the scientific community, I don't think, for one, I will ever be satisfied that there isn't some data suggesting that some children may have serious side effects from some of these vaccines that is really going undetected, unnoticed and they may actually cause autism. Let me just conclude by saying that the issue with the MMR that got all this started was a clinical study, and the Danish study is again another epidemiologic study. And a clinical study is very, very cheap and easy to do but nobody seems to want to do it. We had somebody at one of our previous hearings, a Dr. Kriegsman from New York, who had replicated some of Wakefield's work showing that these kids are developing inflammatory bowel disease, and then he wanted to do the next step, he wanted to actually do the pathologic analysis on these biopsy specimens, and the institution that he worked at said, no, they don't want to get into it, this is too controversial. So if everything was so objective and scientific like Mr. Waxman is saying, why do you have a major institution in New York City saying, no, we don't want to get into that? You know, to a certain extent the problem is we're trying to investigate a sacred cow. For a lot of people in the medical community, there's this tremendous fear. If you say anything negative about vaccines, then parents will stop vaccinating their kids and then you'll have all these outbreaks of these diseases. I don't think parents are that stupid. I think parents will continue to vaccinate their kids. We have a responsibility to them to really find out if there's truth in all this. I don't think the answers are in, and I don't think this mercury study really helps us that much either. It provides--let my just say it's a great study and we're going to hear more about the mercury study because it gives us data in an arena where we had no data, so I'm thankful for that, but basically studies 40 kids. We don't know if the kids that get autism in response to mercury are kids who don't handle the mercury properly. And I don't think the ranking member was accurate at all to say that this puts this issue to rest. Frankly, I've been very, very surprised at his attitude in all this because before I got here I had an image of him as being somebody who would really go after all these toxin issues and all these pollution issues, and ethyl mercury, which is what thimerosal disassociates into, is chemically very, very similar to methyl mercury in its structure. It's very, very bothersome when you follow the vaccine--well, it's not in the vaccines anymore, but a few years ago when you followed the vaccine schedule you were giving kids doses 10, 20, 30 times the toxic dosage for these kids. And the recent--I guess it was in the Lancet study that looked at these kids and looked at excretions, I think it was a very valuable study but it doesn't answer the question that the kids that become autistic may be the kids that don't process the thimerosal properly, and that study only had 40 kids in it. So I say to you, Mr. Chairman, keep it up. I would like to see you get a subcommittee chairmanship in the next Congress and I'd like you to continue pushing this vaccine safety issue until we get answers to some these questions, until the CDC starts opening up that VSD data to independent researchers. You know, in Florida we have this thing called a sunshine law. What everybody says is sunshine is the best antiseptic. The best way to get answers on the vaccine safety data is to open it up and let objective scientists come in and look at it. If these vaccines aren't that safe then that will be validated. I think I've gone more than 5 minutes, Mr. Chairman. I want to thank you. I yield back. Mr. Burton. Just to followup on what you said, the Justice Department filed a motion asking the Special Master to keep all information secret, and that follows along with what you're talking about. That's very disconcerting to me. Mr. Weldon. Mr. Chairman, if I could just interject one other point. I objected to the language that was put in the Homeland Security Act on protecting the vaccine producers. And you know, Mr. Waxman just said that these studies show that it's safe and then he criticized us for protecting, he criticized Republican leadership for protecting the manufacturers. If what he said is true, that they're safe, then why should he be critical of us protecting the manufacturers? The truth is that language shouldn't have been in there. I objected to it and I think you objected to it as well, and it was a Member of the Senate who put that language in there. And I'm ready to work with Mr. Waxman and all the other Members on the minority side when we try to move that vaccine safety bill in the next Congress. I know Senator Snowe is very, very interested in doing something about this, and I think we can fix this issue. And the one thing that Mr. Waxman said which is correct is that we need to make sure the kids are protected. But I might say that if mercury isn't a problem and if MMR isn't a problem, then, you know, why should he be concerned that language was in there? I think the language should be changed. I'm ready to work with you, Mr. Chairman and Mr. Waxman, to try to fix it. Mr. Burton. Very good. Mr. Kucinich. Mr. Kucinich. As I listen to the debate and have listened to it over this past year between two individuals who I respect most highly in this Congress, Chairman Burton and Mr. Waxman, it causes me to reflect on how is it possible that you can get two people who care so much about this country and whose dedication to the people is unquestioned and revered, how Mr. Waxman, for example, who's been the champion in Congress in challenging the tobacco companies, long before anyone thought about it, understood the health questions that were involved, and built a national reputation around that. And on the other hand you have Chairman Burton, who I happen to believe has been far ahead of the rest of the country in raising issues about the safety of vaccines, and rightly so, how is it you can get this kind of conflict. Here's how I think it happens: There are really profoundly different philosophical views on how knowledge is organized and I think it is reflected here, and I think it's worth thinking about when we think about the debate that goes on here. One approach deals in allopathic medicine, another one respected holistic medicine. One approach is linear, the other one is nonlinear in its thinking. One is rational, the other one is intuitive. The one approach is deductive, the other one is inductive. Neither is wrong. They're just simply different ways of looking at the world. They often can lead to the discovery of matters that are urgent to the public interest, which is why I'm here to state my support for the efforts of Chairman Burton. He's been courageous and he has gone forward with dedication and persistence, and his commitment to the search for a cause for autism has provided leadership toward a goal that will eventually help not only his own family but also thousands of individuals with autism throughout the world. I want to thank the witnesses who have researched studies and experienced firsthand the effects of autism. As you know, autism spectrum disorders present a significant problem to our youth. The Centers for Disease Control estimates almost 400,000 children are affected by autism. Equally disturbing are estimates by the International Child Development Resource Center that autism-related costs will exceed 1 trillion in the next 50 years. $1 trillion. As the rates of autism appear to be increasing in many States, autism presents a problem of profound significance to all of us. It is essential that we continue to address this issue. The NIH has taken significant steps to find answers with an international effort that brought together researchers from Canada, Britain, France and Germany to study causes and mechanisms of autism. From this research theories about the connection between autism and vaccines are being developed, providing possible clues that bring us closer to the answers we seek. The NIH should be applauded for these efforts. At the same time we must recognize the research is ongoing. It is by no means complete. The Institute of Medicine reports that the report that was published last year concluded, ``the evidence is inadequate to accept or reject a causal relationship between exposure to thimerosal from vaccines and neurological development, disorders of autism, ADHD, speech and language delays.'' It also called for more research. From this report and other recent research it could be possible that thimerosal is a contributing factor in autism. And unless we have forums like this, there is no way to move that discussion and that effort forward. With these conclusions in mind, it's unjust that an exemption has been provided to vaccine manufacturers in the homeland security bill in sections 1714 to 1717. This exemption will effectively shield vaccine manufacturers from lawsuits from claimants that allege injury from thimerosal containing vaccines. Even those claimants involved in pending litigation will be forced to drop their lawsuits and begin a new process through the Vaccine Injury Compensation Program. While I believe that the Vaccine Injury Compensation Program is largely a good program, it is in need of reform and I support the chairman's legislation to make needed reform, H.R. 3741. The exemption that slipped into the homeland security bill will deny many thimerosal injury claimants redress because the current law governing the Vaccine Injury Compensation Program imposes a 3-year statute of limitations. This will restrict the number of claimants that can seek redress for their injuries. The overall effect of the sections 1714 to 1717 will be that many claimants will be prevented from seeking recourse through the judicial system and some claimants are prevented from any sort of redress. Meanwhile, manufacturers that are ultimately responsible will be shielded from that responsibility. Both the substance of these provisions and the process in which they were added were wrong. I know, Mr. Chairman, you share my concerns. You addressed these passionately on the floor of the House and addressed to the House on the day that the House passed the homeland security legislation and emphasized over and over these same points. This committee has investigated this issue in depth over the past 3 years. Should this committee have introduced legislation to repeal sections 1714 to 1717? And I hope the committee takes the lead on this issue. Well, sections 1714 to 1717 may be just one issue of the many that this committee has investigated relating to autism. I look forward to reading the testimony of the witnesses as it relates to several vaccines and the work of a number of government agencies. I thank the witnesses for their work, hope to continue to improve the way our government addresses autism and want to say that I am proud to be on a committee that is chaired by Dan Burton and I'm proud to be brought to this committee by my dear friend Henry Waxman. Thank you very much. [The prepared statement of Hon. Dennis J. Kucinich follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. Thank you very much. Mrs. Maloney. Mrs. Maloney. Thank you, Mr. Chairman. I'd like to thank you and Ranking Member Waxman for focusing on this important issue. I would especially like to thank you, Chairman Burton, for your determination, courage and long time commitment to investigating an issue that I know is very personal to him, autism. May I also say that I have often been on the other side of issues with Chairman Burton. We don't always agree, but I have seen his dogged determination firsthand and if anyone can get to the truth on this issue, he can, and I applaud your effort, Chairman Burton. I have understood from the Republican staff that in his opening statement the chairman will detail a chronology of events surrounding autism research and the role of the Federal Government. But I do not believe that his presentation will include what I think was an outrageous abuse of legislative power, the Majority Leader Dick Armey's gift to Eli Lilly that added last minute provisions in the Department of Homeland Security bill. These provisions that were added in the dark of night deny families of autistic children the right to file suits seeking compensation from manufacturers of thimerosal. Let me be very clear the new law blocks pending litigation against the manufacturers of this mercury based preservative, thimerosal, being brought by the families of autistic children. The new law forces families to seek relief from the Vaccine Injury Compensation Program. The New York times called the leadership's late addition, ``an abuse of congressional process.'' And I believe this is an understatement and I request unanimous permission to place in the record the editorial from the Times. Mr. Burton. Without objection, we'll do that. [The information referred to follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mrs. Maloney. Another quote was included in yesterday's Washington Post. Donna Brinker, the mother of an autistic son named Thomas, said, ``I believe in protecting our homeland but it petrifies me to think that our nation would protect any industry at the expense of our children.'' And, Mr. Chairman, I would like to add yesterday's Post story likewise to the record. [The information referred to follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mrs. Maloney. The Homeland Security bill was not the right place to change existing law governing vaccines and certainly not vaccines that have absolutely nothing, absolutely nothing to do with homeland security, and it certainly isn't the way to change existing law. Rewriting public policy in the middle of the night without proper notice, without regular order, without hearings, real legislative policy should not be made this way. It is inexcusable and flies in the face of the principles of open and just government. Another part of the scandal, and I considered it a scandal, is for days we couldn't find out how this happened. At least and finally Mr. Armey finally came forward days later and claimed credit for the inclusion of the language at the request of the White House. I would not want to claim credit for what one editorial called, ``sneaky, backhanded and anonymous.'' But what I would really like to know and to learn from these hearings is what is Eli Lilly, this pharmaceutical company, so worried about? Why do they need this new protection? Hopefully we will learn some of what they are worried about today from our distinguished panelists and scientists. Autism and the growing rates of autism among our children is a serious issue that deserves sincere deliberation and attention from this Congress. I am proud to have been part of a bipartisan commitment and coalition that has worked for the past 5 years to double the funding for the National Institutes of Health, the research arm for health. We worked to double it from $13.6 billion in fiscal year 1998 and when we finally get a budget in 2003, if it goes forward as planned, it will have climbed to $27.3. The hope is that these strong investments in biomedical research will spur scientific advances that will ultimately translate into better health care for the American people, including a better understanding of autism and vaccine safety. We do not have a consensus in the scientific community as to the cause of autism. More research and funding is needed to investigate this troubling health issue. I wholeheartedly support Chairman Burton's quality call for a White House conference on autism. We need continued robust research for the sake of our children. We need to know more. And I congratulate your efforts on focusing on this important health issue. Thank you, Mr. Chairman. I yield back the balance of my time. [The prepared statement of Hon. Carolyn B. Maloney follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. Thank you, Mrs. Maloney. My good friend down there at the other end, Mr. Tierney. Mr. Tierney. Thank you, Mr. Chairman. Once again I thank you for holding hearings that are both relevant and important to our country. Mr. Burton. Before you start I want to thank you and your colleagues from Massachusetts for being so hospitable to us when we were up there recently. Mr. Tierney. We were happy to do it. That is just one of the topics that we dealt with recently under your leadership in dealing with the FBI and its culture and conduct and the importance of making sure that agency is in fact protecting the interest of the American people and not working against them. Similarly here you've shown some great leadership in bringing this issue to the forefront of the American public's consciousness. Everywhere we've seen an increase in the number of incidents of autism, and my community is no different than any others. We've seen a tremendous increase, oftentimes concentrated in very particular areas, inexplicably so. While that awareness has led to a great community response, and we have many people that have been working on this issue trying to support the families that have to care for people with autism, making sure that centers are established and facilities are available and people are there to work with the families and with the children, and the children, in particular as the children get older, in dealing with the situation of what happens with their future, that's not enough. Obviously we have an obligation to try and find out as a government, encourage and support the scientific research and try to find out what is the cause, must determine that, to educate families so that the research is available to deal with autism within their family and to find either a cure or some way to prevent autism from impacting us in the extent that it has. The resources to do this have to match the proportion of the situation. I'm not sure at all that they do. And I think, Mr. Chairman, that you're right to raise that question, where have we been on this issue, are we projecting forward enough so that we give it the attention that it needs? Are we doing the right kinds of studies and has our government been doing historically what it needs to do to address these situations and will it be equipped to move forward as we look into the future? I think these are all important questions. This is obviously a growing concern to many communities. For those of us that won't be able to stay for the whole hearing I want to thank our witnesses for their written testimony, which will be reviewed and which will inform us, I'm sure, in the direction we take. I want to close just again, Mr. Chairman, by thanking you for your hard work in this area. I know it's a great personal concern to you. I think that you've moved beyond your own personal concern to embrace the concern that it has for many people across this county, and I thank you for that. Mr. Burton. Thank you, Mr. Tierney. Before you leave, at the end of my opening statement I was going to show two clips, but I'd like for you to see them before you leave. It will just take a few minutes. I'd like for you to start off by showing the clip of what happens to brain tissue when it comes in contact with just a minute amount of mercury. Can you start with that one? Then I want you to show a brief tape showing what happens to a child who becomes autistic. [Tape played.] Mr. Burton. Now that was a very low level of mercury that was introduced into that study. And we continue to inject or we have been continuing to inject our children with thimerosal, which does contain mercury. I don't know how anybody who could watch that and know that has validity could doubt that there's a very strong possibility that has had a debilitating impact not only on children but on senior citizens. Scientists believe, as was stated in that show, that it's a contributing factor to Alzheimer's, which has grown dramatically in recent years. With that I want to show you, because a lot of people don't know before I make my opening statement, I want you to see what happens to a child who becomes autistic. I want you to bear in mind why I feel so strongly about this, because my grandson was a normal child and 2 days after he got nine shots in 1 day, several of which contained thimerosal, mercury, 40 some times the amount that was tolerable in an adult, he started exactly like this child. This is what parents are going through all across this country and they have no recourse. The Vaccine Injury Compensation Fund has a 3-year statute of limitations. If they don't know within that 3-year period that their child may have been affected by these vaccines, they're out of luck, and they have no place to go but the courts. And the language that my colleagues talked about that was put in the homeland security bill blocks them from ever getting restitution. And those people, some are selling their homes, they're spending their life savings, working day and night trying to take care of their kids, and it's just wrong, and our government has to 'fess up to this. And if the pharmaceutical companies are responsible, then some way they have to aid in the compensation of these people, either through additional moneys going into the victims' Vaccine Injury Compensation Fund or some other way. And the Vaccine Injury Compensation Fund needs to be revisited very soon so that these people have access to it. To leave them high and dry is criminal, in my opinion. Now I want you to see what these parents are going through with these kids. [Tape played.] Mr. Burton. I could let you watch more of that but I think you get the general idea. Now my grandson and thousands of children across this country were normal kids and they got vaccinated with multiple vaccines. And mercury in the brain has a cumulative effect; all scientists will tell you that it doesn't wash out easily. It gets in the fatty tissues and it stays there so it has a cumulative effect. And yet we continue to get reports that say there's no scientific evidence that mercury causes autism. They don't say it doesn't, they say we can't conclusively prove that mercury causes autism. They don't say it doesn't. I was on television today, on CNN, and they had a scientist who incidentally has a 9-year-old child who's autistic. She said that there's no scientific evidence that mercury in vaccines cause autism. And I said, can you categorically say that mercury does not in any way cause autism? And she jumped all over the table trying to say, well, you know there's no studies that show it and everything, but she would not say and I have yet to find any scientist who will say that there's no doubt, no doubt, that the mercury in vaccines does not contribute to autism. Now, they'll say there's no scientific evidence, there's no studies or anything that proves that yet. But turn that around, there are no studies that disprove it either. And so they're skirting the issue. Now, the pharmaceutical companies are involved in a great deal of research, and I think that's good, and vaccines are important. They've given us the highest quality of health of any country in the history of mankind. And I am for vaccines, but they need to be properly tested. We had the Rotoshield virus that affected children in their stomachs. And we had an advisory committee that tested the Rotoshield vaccine and they said that it was ready to go on the market. There were several people who dissented in that even in that advisory committee. But they put the Rotoshield vaccine on the market and a couple of children died, several were injured, several had to have surgery. So they took it off the market in about 11 months. The guy who headed that advisory committee had a stock in a company that was making the Rotoshield virus vaccine. Shouldn't have done it. He had a tainted point of view. But nevertheless he did. Now, I asked the FDA how many times they do not agree with the findings and accept the findings of the advisory committees, because that's all they are, are advisory committees. Do you know how many times? 100 percent. 100 percent of the time they accept those findings and go ahead with it. So we may have some conflicts of interest here that need to be explored. Now you may say, well, that's subjective. You're not really sure about that. What about the homeland security bill? We have a class action suit, and I'm no friend of the trial attorneys, but we have a class action lawsuit with hundreds of families that are suing because they think their children are being damaged by mercury in vaccines and our committee wrote most of that bill. We were the committee of jurisdiction, primary jurisdiction. We should have been notified of any change in the bill because we wrote most of it, but what happened? The leadership stuck in at the last minute under the cover of darkness the amendment that we've talked about today. I support my leadership, I think they're great. I think they've done an outstanding job. But that should never have happened because it cuts off the access of a lot of families who have had damaged children from any source of compensation for their child's injury, and it's just wrong and it was designed to protect the pharmaceutical industry, and that's not right. Now, you say, well, if it was designed to protect the pharmaceutical industry and it was stuck in there, nobody really knows who did it, you can't find anybody in that gang that got it done that's going to own up to that, then there must be some concern that the suit might be successful. And so they're throwing those kids out in the cold and their parents who are mortgaging their homes and losing their life savings trying to take care of a child like that so they can protect their company. Now, I want to tell you, I want to protect the pharmaceutical companies. I voted for the Vaccine Injury Compensation Fund, which was to put money out of each shot that was given to people into the fund so that if there was damage they could go to that fund and get restitution, get some help for their kids or whoever was damaged by the vaccine. But it's not a nonadversarial program. We've got people who have waited 10 years. And then they've been threatened by the Justice Department in some cases if they say anything about the problems and the roadblocks they've run into. They'll extend that time before they get compensation for another year or two or three, and they need the money desperately for their kids. Is that the way government should operate? I think not. Now, if we have to say to the pharmaceutical companies, OK, we are going to extend the Vaccine Injury Compensation Fund for a longer period of time so that the fund parents have access to it, who missed the boat, then so be it. If we have to say to the pharmaceutical companies that you're going to have to put a little bit more money out of each vaccination that's given into the Vaccine Injury Compensation Fund so these kids are protected, then so be it. If they would do that, I'd get off their back and our committee would get off their back and the Congress would get off their back. But, no, what do they do under the cover of darkness? They try to block every attempt for these parents to get restitution, and that is wrong. It's wrong for our government to participate in that, and it's wrong for the pharmaceutical companies to participate in that. It's wrong to throw those people out in the cold who have been damaged. And it's not just a few; it used to be one in 10,000, and now it's one in more than 250 kids that are being damaged in this country that are autistic. Now, those kids are going to grow up. They aren't going to die. It's not like a lot of diseases where they get infected and they drop dead. They're going to live to be 50, 60 years old. Now, who do you think's going to take care of them? It's going to be us, all of us, the taxpayers, and it's going to cost, I think, as you said, Mrs. Maloney, trillions of dollars. So we can't let the pharmaceutical companies and our government cover this mess up today, because it ain't going to go away, and it's going to cost the taxpayers trillions more if we wait around on it. And for our FDA and HHS and the health agencies to continue to hide behind this facade that there have been studies that conclusively prove otherwise is just wrong, too, because not one of them is going to tell you that there's no doubt whatsoever that mercury in vaccine does not cause or contribute to autism; and the same thing is true with the MMR vaccine. We need to have conclusive evidence, and that means, don't say we can't prove that it causes it. Turn that argument around. We can't prove that it doesn't, so we're going to study it and we're going to find out. And you in the health field, you who run our health agencies in this country who are sitting here today, you have an obligation to these kids that you just saw there, to make sure that these studies are complete, thorough, so that everybody knows that we have all the facts. And you don't have that. And when you come up to testify today from HHS, I want you to tell me that you are absolutely sure 1,000 percent that the mercury in the vaccines has no impact whatsoever on autism. If any of you will tell me that, I want you to prove it to me, and if you can't, then, damn it, get on with doing another study. I have been fighting this battle for 3 years, as has my committee, and we are tired, but we're not nearly as tired as all these families that are watching their kids grow up, banging on the walls and having chronic diarrhea and constipation and other things. You shouldn't let that happen, and you should get to the bottom of it. Now, I know you people over at HHS and CDC don't like me much, and I really don't care. I care about these kids, and I care about my grandson; and I'm not going to be chairman anymore, and a lot of you people think, well, he's not going to be chairman anymore so we'll have him off us. You will not have me off your back. I'm going to be a subcommittee chairman and I'm going to make absolutely sure that I'm going to have under my control the investigations of our health agencies because of this very issue. And so I'm not going to go away and neither is this committee, and we are going to continue. And the new chairman, I'm going to talk to him when necessary about subpoenaing you back before the subcommittee to talk about this issue. So, please, for the sake of these kids, and for your own sakes if necessary, study this thing thoroughly. Study the thiomersal in the vaccines. If you want to protect the pharmaceutical companies because you have been getting, indirectly or directly, money for grants and stuff for scientific research, that's OK. I don't like it, but that's OK. Just make sure that the Vaccine Injury Compensation Fund works and that the parents who have had damaged kids will be able to go to that compensation fund and get restitution without having to mortgage their homes to pay for legal fees that aren't paid until the end, because they can't do it. And there's a lot of lawyers that won't even take those cases because they want to get their money as they spend their time. So I think I have said enough. I'm just telling you, I feel so strongly about this because I've seen these mothers and these fathers come forward with tears in their eyes, crying, saying, we've got this terrible problem and we have nowhere to go, nowhere to turn; and our kids were damaged, and they changed right after they got these vaccines. And it ain't right, it's just not right. So I have said enough. Our first witness, and I'm sorry I didn't read all of the opening statement today. I know my staff worked real hard on it. First panel is Dr. Baskin, Dr. Geier and Dr. Spitzer, and we'd appreciate it if you'd approach the witness table and stand to be sworn. [Witnesses sworn.] Mr. Burton. Dr. Baskin, would you like to start with an opening statement? STATEMENTS OF DAVID BASKIN, M.D., PROFESSOR OF NEUROLOGICAL SURGERY, BAYLOR COLLEGE OF MEDICINE, HOUSTON, TX; MARK GEIER, M.D., PH.D., GENETIC CONSULTANTS OF MARYLAND, BETHESDA, MD; AND WALTER SPITZER, M.D., M.P.H., F.R.C.P.C., EMERITUS PROFESSOR OF EPIDEMIOLOGY, McGILL UNIVERSITY, MONTREAL, CANADA Dr. Baskin. Yes, sir. Mr. Chairman, distinguished members of the committee, colleagues, ladies and gentlemen, my name is David Baskin. I'm a professor of neurosurgery and anesthesiology at Baylor College of Medicine. I'm a neurosurgeon. I do complex spine and brain surgery, about 350 cases a year. I have also been involved in research, looking at ways to protect the nervous system from damage and to reverse damage, for over 20 years, and have over $1 million in Federal funding, both from NIH and BIA, as well as State funding and private funding from foundations, to look at a variety of issues in terms of brain damage. In fact, our group was involved in the discovery of the drug that could reverse paralysis in spinal cord injury, which has now become the standard of care. So I've been working in this area for over 20 years. I also serve on scientific advisory boards for NIH, as well as the Cure Autism Now Foundation, the largest private funder of autism research in this country, which funds over $7 million a year. Now, as you said, Mr. Chairman, autism is exploding. This is a recent cover of Time magazine talking about the fact that over--now, it looks like one in 150 children suffer from some form of autism. What is autism? It's a lifelong brain disorder with very severe problems communicating, responding to surroundings and forming relationships. Most of these children, as you say, will grow up and will require lifelong care and cannot live independently. Horrible fact, over one-half will never speak. Many of them will never be even able to look at their parents and tell them they love them. It's worse than Alzheimer's disease. There's been a tremendous focus on Alzheimer's disease, but these children never had a chance to enjoy life before they lost it. Let's look at some medical definitions. What's a preservative? I looked it up in Stedman's medical dictionary, and it says a preservative is a substance added to a product for the purpose of inhibiting or destroying microorganisms. What's a poison? A poison is a substance that, when injected in a relatively small amount, causes damage to structures or disturbance of function. Now, while there's going to be quite a bit of debate this afternoon over dosages, make no mistake, there is the intent to put a preservative in these vaccines to prevent the growth of microorganisms that has gone awry, because the preservative that was used ended up being a poison. There is no debate in the scientific literature that mercury is a potent neurotoxin. We've known that since the late 1890's. The debate only comes to degree and extent and that sort of thing. So I don't think in the course of your deliberations today you should confuse that fact. We are talking about a known poison, neurotoxin, that's been added to these vaccines with the initial idea that it would function as a preservative. Mercury has a long history of medical misadventures. In 1890, ethyl mercury was synthesized in London, and it soon became a popular treatment for syphilis. The saying went, ``A night with Venus and a lifetime with mercury.'' In fact, in 1927, the Nobel prize was awarded because it was felt you could improve outcome by adding treatment with mercury. Many of these patients developed serious neurological disorders, but it was thought initially this was due to the syphilis, when it turns out that a lot of these cases, retrospectively reviewed, had evidence of mercury toxicity. Thimerosal was placed in vaccines in the late 1930's; and guess what: Three years later Tanner first described the syndrome of autism--never ever been described before in the medical literature. The neurotoxicity of mercury has been very well established in terms of brain injuries since the 1960's, as you'll see. In 1956 and 1960, there were massive outbreaks of mercury poisoning in Iraq, and the reason this happened was that ethyl mercury was used as a fungicide. The grain was treated with this fungicide, the idea being that you could plant this grain, it would grow, the crops would flourish. But I would imagine, because of poverty, a lot of this grain was just taken and made right into bread and people ate it. So they ate these doses of mercury. And there were hundreds of cases, both in Iraq and then there was a similar outbreak in China. A number of these cases just had really severe, horrible brain damage, but what came out of this work, there was a much more mild syndrome with developmental delays and neurodevelopmental disorders, problems with language, problems with communication. Some of the descriptions of these kids looked just like your videotape. So there was a--pretty early in the 1960's it was known there was a direct relationship of the dose of mercury received and the severity of the injury, and as early as the late 1960's, the scientific literature said the fetal and infant brain is clearly more sensitive than the adult brain. The brain damage in these cases was studied, and it's interesting that the type of brain damage seen was the loss of the Purkinje cells, which are cells in the cerebellum, and the loss of the cortical column, which is the part of our brain that is involved in complex thought. And guess what: At the recent meeting for autism research at the Society for Neuroscience, this exact same histopathology has been described in autism. There were other outbreaks elsewhere, so we've known about this scientifically for a long time. There is no debate that this is a toxin that causes brain injury. Now, there was a study trying to look at lower-dose exposures conducted in the Faroe Islands beginning in 1987, and what this did was it looked at 1,000 children and it followed them from birth to age 7. It tested them very specifically for neurodevelopmental disorders. It measured blood levels of mercury in the umbilical cord, and it found an association between very low doses of mercury and neurodevelopmental disorders just like autism, and found that mercury here actually wasn't as predictive as the blood levels, which is the gold standard. The Environmental Protection Agency established, as a result of primarily these horrible problems in Iraq, a standard for what was a maximum safe level of ingestion of mercury, which was 0.1 microgram per kilogram per day, and they called this, ``a level of daily exposure that was likely to be without an appreciable risk.'' They based this on 81 children in Iraq. They looked at symptoms very much like autism--problems talking, problems with mental cognition, problems with walking; and as recently as 2000, our National Research Council reviewed this data and supported these limits, said these are the right limits to use not only based on the Iraqi experience, but also based on the Faroe Islands experience. Let's look at what the children actually received. This can be a source of debate. There are a lot of different ways to calculate these numbers, but what I have done here is simply taken the FDA's numbers as they prevented them published by Leslie Ball in 2001; and if you look at the various numbers, you see that a child, by 6 months, receives somewhere between one-and-a-half to three times the maximum safe EPA dose of mercury. If you take into account that mercury is preferentially taken up into the brain at five times the concentration, these kids are getting somewhere around 12 to 15 times the maximum dose, and that is the most conservative estimate. Making lots of assumptions that many scientists wouldn't agree with, they're overdosed. Yet the last formal review by the FDA was in 1976, and they said, ``No dangerous quantity of mercury is likely to be received from biological products in a lifetime.'' Mind you, this is 16 years after the experience in Iraq with all the mercury poisoning, and also the outbreak in China. Dr. Ball in 2001 said, ``Reassessment of the risk is appropriate.'' I think that was a nice thing to say, but I think that really--consistent with prior testimony before this committee, I think there is a concern that perhaps the FDA was asleep at the switch for decades, as was stated in an internal e-mail, that it really does only take eighth-grade math to see that they're beyond the maximum safe levels. The pity about this is thimerosal is not an essential component for vaccine. The argument with thimerosal is not an antivaccine argument. Vaccines are wonderful. They're here to stay. They save lives. The argument is that you don't need to put a toxic poison in them in order to deliver them. But it's worse. The incidence of autism is increasing, and we don't know why. As you said, nobody can explain this. There are many other sources of mercury exposure in the environment; so that if we're going to inject our kids with a neurotoxin, and they're already being exposed to a certain amount of mercury, this just adds insult to injury. We clearly know infants' brains are more sensitive. We know the blood brain barrier, the barrier to drugs between the blood and the brain, is virtually gone in infants. We know there is probably at least a five-times preferential uptake into the brain. And we know about lead. You know, lead has been around for a long time. In one of the NIH study sections that I served on, there was a proposal to study lead and juvenile delinquency rate, and the consensus was, why do we need another study to know that lead exposure in infancy can relate to juvenile delinquency rate in adults; we already know this is the case. This is accepted science. So the idea that a metal can cause a very specific brain injury has been around a long time. I'm going to turn my attention a moment to the article that was published by Dr. Pichichero and his colleagues in Lancet in November 2002 since this was just referred to. [The information referred to follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Dr. Baskin. This was a study of 40 infants, age 6 or younger, in which they measured blood, urine and stool mercury levels. The conclusion was that administration of that change containing mercury did not seem to raise blood concentrations of mercury above the safe values. The data are the data, and I think, as you said, Dr. Weldon, it's good to have some data, but interpretation of data is paramount. In my residence, we teach residents and we teach young doctors how to be neurosurgeons. We spend a night a month pouring over the medical literature and make the important distinction that while the data in the papers are probably correct and true, the way you interpret the data, the way you look at that and come to a medical conclusion is often subject to interpretation; and I'm going to show you and talk to you about the fact that while the data are the data, I think the conclusions are not borne out. First of all, I was shocked when I read this study that there was no disclosure of conflict of interest. As an NIH scientist, anytime anybody funds my research for any reason, I have to disclose the conflict of interest. Yet these authors have vaccine patents, have received numerous funding for studies by drug companies that make vaccines; and I was surprised that Lancet took it. I'm sure it's not over with. Whether or not there's a true conflict of interest, they certainly should have revealed it. The sample size, as you said, Dr. Weldon, was small. Autism occurs in one in 150 kids. So if a child had some different tendency in their blood to absorb more mercury or have it remain in the blood longer or be more sensitive in their brain, if they only checked 40 kids, they may well not have found even one kid with a predisposition to autism. So it's a meaningless study without a larger sample size. The sample wasn't random. They didn't take kids from different portions of the population in different areas. If there's some metabolic difference based on race or sex or where you live or other things, they wouldn't have found it. They didn't even talk about the preferential uptake of mercury into the brain, which is fivefold. But they did find a very high stool level of mercury, and one kid had 81.3 nanograms. If you again go to the very conservative FDA data, a 50 percentile kid receives 20.7 nanograms per gram. So somehow the mercury went from the injection, ended up in a much higher level in the stool. And obviously, the mercury gets to the stool by traveling through the blood; there's no rectal administration. If you put gasoline in your car that has lead in it and somebody comes by and scrapes your tail pipe and says we have a high lead level, it got there by traveling through the system. So what happened here is, we know the stool levels were high, but if you look at when they actually measured the blood levels, they said it was somewhere between 3 and 27 days later. The peak mercury levels after injection occur within hours or at least within the first 24 hours. So if they were drawing blood later than that, and much later than that, of course the levels weren't going to be high. But the mercury doesn't jump from the injection to the stool; it goes through the blood. At some point it was high because it was high in the stool. And because they didn't measure the peak levels, they can't even talk about what they did, which is the pharmacal kinetics, which basically means the way the drug is metabolized; and they drew a bunch of fancy curves. You can't do a pharmacal kinetic study if you don't have the peak level. They clearly didn't have the peak level because they have high stool mercury, and they have low blood mercury--doesn't make sense. So they described this as a descriptive study, and that's exactly what it was. It provides some interesting information, it's a start, but the interpretation is inaccurate--as what we would say in neurosurgery, ``The operation was a success, but the patient died.'' Let me turn to some studies that we're doing at Baylor College of Medicine. We have the opportunity to actually grow human frontal cortex cells in cell culture. So these are cells from the front part of the brain that grow in culture. We incubate these cells with thimerosal at various doses, and we use a number of very sophisticated techniques to detect cell death and cell damage. It turns out that every cell has a program inside of it to commit suicide. The reason we have this in our bodies is, when we're babies we have webs between our fingers, but when we're born, we don't have these webs. These cells are eliminated by activating a genetic program, so there's no inflammation and there's no scar tissue. We basically start out with many more cells than we end up with. We kind of prune ourselves into shape, and this process is called apoptosis. Well, it turns out that toxic substances, including mercury, turn on this suicide program in the brain. Here are some pictures from our cell culture experience, and you can see the arrows pointing to those little knobs sticking off the cell. These are the cells committing the suicide program and breaking themselves into tiny little pieces with a very low dose of mercury. Here is a slide where you see a lot of blue cells. This is a blue dye that normal cells don't take up. In order for something to turn blue, the cell has to have holes punched in their membranes. And guess what: At an extraordinarily low dose of thimerosal, most of the cells are blue. It means that this stuff grabs ahold of the membrane and punches holes into it, so that the dye can penetrate, not only into the cytoplasm but into the very center of the cell, the nucleus, where all the DNA exists. This is a fascinating slide. The center of the cells are blue, which means there have been holes punched into the membranes so the dye gets to the center of the cell. The rest of the cell is green which is the release of an enzyme that only gets released during the suicide program. So these cells are turned on to commit suicide or go into apoptosis. We found this to be dose- and time-dependent. We found that 101 nanograms per gram is the lowest dose we've studied, and it's toxic. And we didn't even expect this to be toxic, yet if you consider a five-times preferential uptake and you use FDA numbers, infants receive 380.5 nanograms, three times the dose that we found to be toxic to brain cells. Don't forget, we did this in adult brain cells. Remember that infant brain cells are much more sensitive, so there's a real cause for concern. In addition, there was discussion that there's no scientific data or evidence. I don't agree with that. At the recent International Meeting for Autism Research at the Society for Neuroscience, a number of investigators around the world are finding similar things. At Columbia University, there's now a model in mice who were injected with low doses of thimerosal very similar to what's given in human vaccines. These mice develop neurological deficits that look like autism, and when you take their brains out and you analyze them, they have the same type of brain damage. There's evidence that thimerosal not only binds to the proteins you saw in the cartoon, but also binds to sulfur groups which are pretty essential groups for the membrane. So this is probably how it punches holes in the membrane. This is work at Northwestern, and the very important work that is coming out of a number of NIH-funded centers is that if you give patients thimerosal, you can take their lymphocytes and make them killer lymphocytes and trigger the onset of autoimmune disease, which also may be part of what's happening in terms of brain damage. So science has come a long way. We've gone from caveman clubs, and now we're at ICBM missiles, and I would be very optimistic that in the next few years, Mr. Chairman, you're going to see a tremendous amount of scientific data supporting the fact that this is a horrible toxin that shouldn't ever have been in these vaccines. Well, what can you do? What can Members of Congress do to try to make this better, to do something to improve the situation? First of all, as a physician, I probably prescribe a pound of drugs a week and, you know, I always rely on the FDA. I don't go through and test the safety data of each drug myself; I assume it's safe. Somewhere along the line, the process failed. Mercury is a known neurotoxin, and you know what: It's still being given today in flu vaccines, to pregnant mothers and to children. Why? It's not necessary. So I think one thing you can do is compel the CDC and the FDA to do their jobs. Insist on properly managed accountability. Insist on conflict-of-interest disclosures. I live in Houston. We sure learned a lot from Enron, and I hope that we can avoid similar unfortunate circumstances. I think you should consider this a problem very similar to September 11th--it's interesting, we talk about homeland security, it's a severe problem--it's chemical poisoning at home, and it's very similar. I was in a cab today, and the radio was talking about the FBI, the CIA and lack of communication that might have avoided the terrible problems of September 11th. Well, you know, the EPA knew this for a long time. All of these agencies had pieces of this data, but they don't seem to talk to each other; there doesn't seem to be any sort of coordination, very similar to the issues with homeland security. I think another thing you can do is support the NIH. The NIH has done a great job recently trying to catch up. The NIEHS particularly, but some of the other institutes as well, has really put together first-rate scientists and first-rate programs to do this. You could help by proposing specific funds to be set aside by NIH. NIH has something called ``request for application,'' which means we are entertaining applications only on this subject, and then they pick the very best ones. They don't have the money to do that too often, but if you can give them a small extra pot, that would bring the very best research in this country along very quickly. Allow science and the press and our legal system unfettered access to the issue: This is the only way the truth is going to come out, and particularly in science, if we couldn't read and critical-review each other's data, we would go nowhere. I think you have to insist on that, and by doing that, consider reversing the relevant provisions in the homeland security bill, as was discussed, and stand up for our Nation's children and their rights. In conclusion, Plutarch said, ``The mind is not a vessel to be filled but a fire to be kindled.'' Please do everything you can to ensure that our Nation's most valuable resource, our children, have their rights protected and can grow and flourish to their full potential. Thank you. Mr. Burton. Dr. Baskin, I'm going to send your presentation to everybody I possibly can, because it was so thorough, and you're to be congratulated for all that hard work. I just think you summed it up so well, and I'm going to make sure we send that over to the FDA and CDC to make sure they take a look at it. Dr. Geier, you're recognized. Dr. Geier. Thank you for inviting me, Mr. Chairman and other members of this committee. Vaccines are one of the greatest triumphs of the 20th century, resulting in the virtual eradication of most infectious diseases. Vaccine producers should be commended for their efforts, but one must openly acknowledge that, on occasion, vaccines are indeed responsible for adverse reactions. The U.S. Government judiciously established the Vaccine Compensation Act in 1986 as one of its provisions. The Vaccine Adverse Events Reporting System data base was created. The VAERS data base has been maintained by the CDC in Atlanta, GA, since 1990, and vaccines suspected of adverse reactions are to be reported to this data base as mandated by U.S. law. The reporting of serious adverse reactions to VAERS requires written and telephonic communication by the CDC. The CDC follows up serious adverse reactions 1 year later to determine whether the patient has recovered, and the FDA inquires into deaths reported to the VAERS data base by contacting the patient's health care provider and physician. Despite the continuing insistence by the FDA and the CDC that the VAERS data base is subject to severe limitations, the FDA, CDC, David Geier, my son, and I analyze and publish from the VAERS data base. The VAERS data base provides a prospective about vaccine adverse reactions unobtainable by any other means, as it contains almost 200,000 adverse events, following almost 50 different vaccines resulting from more than 1 billion doses of vaccine administered in the United States. It is biologically plausible that thimerosal, contained in vaccines, contributes to childhood neurodevelopmental delays, but there are few epidemiological analyses that study the effects of thimerosal contained in vaccines. We analyzed the incident rates of neurodevelopmental delays reported to the VAERS data base following thimerosal-containing diptheria, tetanus and acellular percusses, called DTaP, in comparison to thimerosal-free DTaP vaccines. The CDC provided us with a number of doses manufactured and distributed each year of each type of vaccine, manufactured by each manufacturer, but in so doing, we had to agree to withhold the identities of the vaccine manufacturers because the CDC considers this information proprietary. Thus, we are prohibited from releasing data on which company makes a safer vaccine, when two or more companies make the same vaccine. We feel that it is essential that this information not be denied to doctors or patients. The CDC and FDA also knows the number of doses of each lot manufactured. We feel it is important that this information be released so that analysis of potential so-called ``hot lots'' can be carried out. This slide shows that autism and mental retardation were approximately six times statistically significantly more likely, and speech disorders were two times statistically significantly more likely following thimerosal-containing DTaP vaccines in comparison to thimerosal-free DTaP vaccines. Further, the details of our study---- Mr. Weldon. Dr. Geier, can I just interrupt you, is that published data? Dr. Geier. That's been submitted and accepted with revision, but it's not finally accepted. So it has not been published yet, but shortly we hope. Mr. Burton. I don't want to interrupt you either, but I think it's very important at this point. We talked to the health agencies about the VAERS being made public and being made available to any researchers, completely available; and you're telling us that you still can't that get information? Dr. Geier. We can--well, there are a number of problems with VAERS. First of all, VAERS is maintained by CDC in Atlanta on a data base that's proprietary. So it's very difficult to access. We get it accessed, and a computer programmer takes it off and puts it--makes it available so that Microsoft Access can work on it. This allows everybody to work on it. My son has also figured out a system to put their--I think it's seven different data bases together to make one, however, so we can get access. But you can't just call up this site and get useful access; you get some data, but it's not useful. But in addition to that, in order to interpret VAERS, you need to know the denominators, you need to know how many doses were given; and we've been given the information of how many doses of each type of vaccine were given each year. Additionally, in order to do these calculations, you need to know the number of doses produced by each vaccine manufacturer. We were given that with the provision that we were not allowed to tell which vaccine companies are which. So we can do the study we did up there because, you notice, all we said is we compared the relative risk of one that contained thimerosal with a similar vaccine that didn't, didn't tell you which company. But it really hurts us to see--when we see two or three manufacturers of a particular vaccine where one is far worse than the other, that we can't publish which one is worse. And, in fact, CDC has published a paper showing, I think, a sixfold increase in serious reactions of one manufacturer versus another, and they call them manufacturer A and manufacturer B. I think that the American public are entitled to know which manufacturer is which, so they can choose the better vaccine for their children. Mr. Burton. Well, I don't want to interrupt anymore of your testimony, but what I'd like to do is have you give us a list of the problems that you're having in getting this information, and we'll try to see what we can do to lift the veil of secrecy so that you can get on with your work. Dr. Geier. We would appreciate that very much. The doses of mercury children were receiving from thimerosal on a given day following vaccination in comparison to the EPA, AFDR and FDA limits of exposure to mercury are summarized in the next slide, and this is similar to a slide that Dr. Baskin showed. This is what's in each one. This calculates the risks, the amount of the excess the children received, and the way that Dr. Baskin did it was very, shall I say, ``charitable'' toward the production. Children actually receive from a ten- to a hundredfold excess of mercury from their childhood vaccination on the days of immunization in comparison to the guidelines. The daily dose of mercury children received was equal to or exceeded the guideline even when averaged out for 10 days following vaccination. Further details are provided in the packet that I submitted to the committee. The IOM analyzed the mercury dose children received at 6 months of life and averaged it over every day in a child's life, that is, 180 days, showing that the dose received by the child was only in slight excess of the EPA limits. This type of averaging makes no scientific sense. As an example, if I were given a lethal dose of mercury and my dose was averaged over my more than 50 years of life, I would not have received a dose exceeding the limits, despite the fact that I would be dead. Realistically, children are receiving large doses of mercury at intervals that far exceed all the Federal agency guidelines and not by fivefold but by over a hundredfold. This slide summarizes the CDC's VSD data regarding the relative risk of autism versus the mercury dose that the child received. When we saw this, we were very, very disturbed. Despite the fact that our study had shown that two populations, one population had received a vaccine with thimerosal and the other didn't, were statistically different, this is more powerful data because this is a plot of the amount of mercury that a child received versus the amount of autism, and it turns out that this plot is not linear. In fact, it goes up faster and faster with increasing mercury doses from childhood vaccines. And again, the packet I submitted has quite a bit more on these graphs. But we did--each point in their analysis was barely significant, but the graph on the whole is very significant, and there's an interesting trick used in presenting their data. Their data had data for each of the first two points. The third point said greater than 62.5 exposure. It's kind of hard to plot greater than 62.5, and therefore, you can't do this analysis, but when we looked at it, greater than 62.5 has to be 75; there's no other possibility. So we replotted it with 75. I mean, that's just the way the vaccines are given. And when you replot it with 75, you get a very, very good curve fit, and it's statistically significant, and it fits for several different disorders. And it's very disturbing, because this is a kinetic study. You know, if you compare two things and one is bigger than the other, well, maybe even though the statistics show it is unlikely, maybe it was chance, but when it goes up as you go up with dose, and it goes up faster and faster as you go up with more and more dose, this is very disturbing. Also, the relative risk at the top top is 2.5. That means that of these children, who belong to the Kaiser plans, a very large segment of the autistic children were related to the thimerosal. I mean, there are two issues. One is, can thimerosal cause autism; and another is, does it cause a significant part? I mean, maybe it only causes 1 percent of autism. This tells you that it causes a very significant part of the autism. Now, I'd like to go into a little bit of what you asked me in the question. You asked me about the VAERS data base, and I wanted to talk to you about the VSD data base. As described in the packet that I submitted to the committee, despite correspondence between myself and the CDC, originally dating prior to the CDC's press release to open the VSD to the public, I have not been given access to the VSD. This has been ongoing for more than 4 months, and my last proposal was more than 150 pages long. Mr. Burton. Let me interrupt you here just a second. Now, the VSD, we were told by our health agencies that was going to be made available to any researcher completely; and you're telling us you're still not getting it? Dr. Geier. Let me go through my experience. And I gave Dr. Weldon the complete documentation of all of our exchanges. It's available, but it's so difficult to get--I think we're in a very good position among independent researchers to ask for it, and we have little hope; and let me go over some of the barriers they've put in our way. We've been doing this for 4 months. My last proposal was more than 150 pages long, and despite the fact that I've published approximately 30 peer-reviewed scientific studies analyzing VAERS, I still haven't been able to move beyond the first hurdle of gaining access to the VSD. And I had a very simple solution to their question of what do you want to study. I simply said, well, let's do something really easy. Let's study whether VSD has the same kind of results as the VAERS. And you know my studies are valid because they have been peer-reviewed and published by 30 different journals, such as the Annals of Internal Medicine and Rheumatology and various other journals. So rather than going into a whole big study design, let me see if we can confirm our results with the VSD. This didn't please them, and they required that we ask every single possible question and make various predictions, and we came up with a 150-page proposal. However, that didn't satisfy them because, first of all, they seemed to put up continually additional steps, fees and hindrances and seemed to make the realistic possibility of ever gaining actual access to the VSD remote. Basically my understanding is, after we get them to agree to our study, which we have to describe every possible thing we want to test, then we have to go before each of the Kaiser boards in order to get their permission; and CDC does not even know what Kaiser boards will require. If we go to each Kaiser board and ask that we be able to use their Kaiser data and it's approved, then my understanding is it goes back to the CDC for approval. After the CDC approves it, then I get limited access in a little town in Maryland. This happens to be near where I live, but anybody else would have trouble, because they're going to give you like 5 minutes of access a week, so you'd have to fly in here from, say, California. In addition, when you go there, we've been told that we can't take cell phones. We can't copy anything. We can't take any data out. We're going to be searched. All of this in the name of confidentiality when, in confidentiality, all you have to do is what VAERS does, just take the names off. And as far as validity of the studies, if the studies are valid, I'm going to submit them for peer-reviewed publication. If they're published, they're valid. I don't need them to review the validity of the studies. Mr. Burton. Would you ask excuse me 1 second.I think Michael Crane is here. Mr. Crane, would you raise your hand real quickly. I'd like to talk to you after this hearing is over to find out why these impediments are put in front of these people. OK? [Witness sworn.] Mr. Burton. Thank you. Dr. Geier. Finally, there's a constant mention of fee, and we've asked for the amount of the fee on several occasions, and we're told repeatedly there's a fee and they don't know the amount of the fee. My suspicion is no one is ever going to get that far, but we're independent and we don't have any outside support. We do this because we care about the children. So if they ask for $1 million fee, we have no granting fund to pay the fee. Turning to another subject. I've been asked to comment on the Lancet article which measured mercury in blood, urine and stool, which was commented on by Dr. Baskin, in infants 3 to 28 days following thimerosal-containing vaccines in comparison to infants receiving thimerosal-free vaccines. The findings of low-level mercury in the blood is only indicative of measuring too late. If they wanted to see it, they should measure 3 to 24 hours after the shot, and it does nothing to assure that these children were not exposed to potentially damaging levels of mercury. We know, in fact, these children received by injection more than 100 times the daily permissible dose of mercury, and the mercury would be more damaging in the brain than the blood. It's almost as if they want you to read the study and think, well, I guess they didn't get any mercury. But we know they got the mercury. So why is it supposed to be reassuring that they measured later, and it's not in the blood; that means it could be in the brain. So that study, to me, has no validity. It has some interesting data, but no validity on the question of whether thimerosal causes problems. I've also been asked to comment on the recent New England Journal of Medicine study done in Denmark, which failed to find a correlation between MMR vaccination and autism. This study attempted to compare children vaccinated with MMR to a comparable control group of children who were not vaccinated with MMR. The author's own analysis showed that the two groups were statistically different in most respects even before being vaccinated, making the results dubious. You want to have match controls. Basically they adjusted them; I have no idea on which way to adjust. For example, if the control group and the vaccinated group differ by how their income--what their income level is, I don't know whether to raise it or lower it. Neither do they. So they just changed it in such a way that it evened out the numbers. Even overlooking the weakness in the study design, the study would have only shown MMR to be statistically linked to autism if MMR caused a rather large proportion of all autism in the population being studied. This already was known not to be the case. HHS itself has published that there is a causal relationship between MMR and permanent brain injury. Our study using VAERS, contained in the submitted package-- this is another study we've submitted for publication--shows that MMR increases the relative risk of autism, but its contribution to autism in the whole population is relatively small since much of the autism seems to be linked to thimerosal which, of course, is not contained in the MMR vaccine. So their study doesn't say that MMR didn't cause 10 percent of the autism. It just said it didn't cause 60 percent of the autism, and--because you'd have to have a large percentage the way they looked at it. In conclusion, these two recent studies do little to alleviate the fact that the scientific data indicates that thimerosal in vaccines and from other sources, such as RhoGAM, a product containing thimerosal, given during pregnancy to RH- negative women, appears to cause or contribute significantly to the recent dramatic increase in the rate of autism seen in the United States. As far as RhoGAM goes, I practice as an obstetrical geneticist. I do amniocentesis. I give RhoGAM. I was not aware that RhoGAM contained thimerosal. It no longer does, but it did for a number of years. The reason I wasn't aware of it is that I've never seen a multidose vial of RhoGAM. If it's ever been made, I have never seen it in my 22 years of practicing, and yet, they put thimerosal in it as a preservative. What the heck are they preserving? And there are studies by clinicians who take care of these children, who find that a very high proportion of these children are born to women who are RH-negative, who had RhoGAM during the pregnancy. I see no reason in the world--if they have to put thimerosal in single-dose vials, are they afraid that they don't know how to make things sterile? Are we to assume that sterility testing is not good? Ideally, vaccines should be killed, single antigen, highly purified and checked to determine if any of the epitopes they contain are cross-reactive with human lymphocytes. They should come in single-dose, sealed vials, so the preservatives are not necessary; and they should contain enough antigenic materials so that adjuvants are not necessary. History has written that the fall of Rome may well have been related to lead poisoning from newly invented lead pipes. Let it not be written that our great society poisons itself with mercury preservatives. Thank you. [The prepared statement of Dr. Geier follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. I think Dr. Weldon has a quick question for you, Dr. Geier. Mr. Weldon. I think you answered my question. Thimerosal was in single-dose RhoGAM injections? Dr. Geier. Yes. That's the only kind of RhoGAM injection I've ever seen; and I have bought it from several companies, and they're always single-dose. They come in a syringe, prefilled, and they contained, up until recently, a year or two ago, thimerosal. Mr. Burton. Thank you very much. Dr. Geier, that was an excellent presentation, as well. We'll try to make sure, along with Dr. Baskin's, this gets to everybody. I'm going to send this to Secretary Thompson over at HHS. I hope I can convince him to watch this whole presentation. Dr. Spitzer. Dr. Spitzer. Thank you, Mr. Chairman. In the interest of time, I will focus on the Danish study, as requested. There are somewhat related matters that I will go over a bit more quickly, but the main focus is on the Danish study, and the paper was the New England Journal paper appearing on November 7th, which itself focused primarily on MMR. And the hypothesis declared in the paper in the New England Journal was about a relationship and association between the vaccine and autism, simply expressed as that, by a Danish group, about which I'll say a bit more in a moment. So, in evaluating the hypothesis that MMR vaccination and autism are associated, they came through enlightened policy of the Danish Government to link data bases of the--data bases I have on the projection here, which are, from my experience of the Saskatchewan data base, perhaps one of the best, to look at relationships between disorders and risk factors, however they might be exposed, properly done. I'll emphasize that the linkage was with computerized data bases. Also, I will mention it again, they were created for other purposes, and they were well linked. Madsen has a good reputation in Europe. I worked in Europe for 4 years on epidemiologic studies and know their work by reputation. I have not met Madsen or any of the coinvestigators. I have no interest one way or another in terms of that team. It was sponsored and funded by the Centers for Disease Control and Prevention. I'll have more to say about that. Let me read the conclusion from the abstract, which is very similar to the conclusion later in discussion of the paper: ``this study provides strong evidence against the hypothesis that MMR vaccination causes autism,'' and the emphasis is mine. The category of the study, it is a cohort study which was, as a cohort study, well done, the followup being from January 1991 to December 1998, 8 years, and there were over 500,000 children in the cohort, 440 having received MMR, or 82 percent; and they translated this to personal years because of the difference in time of followup of different children. That was appropriate to do; it was the right thing to do in what was a dynamic cohort--that is, opposed to fixed. You don't start with, say, 100,000 children today and follow them together in the future. The children were introduced to the cohort as they were born, we call it a dynamic, and followed forward in time to determine whether the outcome of interest, in this case, several subgroups of--several manifestations of autism appeared or not during that period of time, although the followup went on for one more year; and then I just show here how--visually how that happens. Now, this was a major strategic advance in epidemiology. You have heard me say here before words to the effect that most, if not all, of the epidemiology until now has been clearly shoddy. People think that because the discipline is in adolescents, maybe infancy, you can afford to be shoddy. In fact, you should pursue as high a standard as possible. And it's also the first epidemiological study published to be adequately controlled, an adequately controlled observational study. An important attribute of linked national data bases, or provincial ones like Saskatchewan, is that there is no selection bias. This is especially true in Denmark where well in excess of 97 percent of the people and the children of the country, however they entered, by immigration or birth and so on, are there. It's not matter of representivity. They're all there. So there is no selection bias. That's very hard to accomplish in epidemiology when you don't have this advantage. Now, unfortunately, the important strategic advance was not matched by some important, detailed methodological tactics in the execution of the study. That vitiates the strength of the authors' conclusions, which I found unusual considering what came out in the data, which I'll summarize in a moment, and in this presentation, I'll review some of the methodological problems without being exhaustive. Let me share with you that much of what I have here is as a result of conversations of colleagues, some seniors, who have written to the New England Journal. There hasn't been enough time yet to accept the things, and I need to respect confidence. I myself have forfeited my letter because I think it's more important, more socially sensitive that it be presented here, but I cannot assume that of any colleague; and on one or two occasions that I have asked permission, it's been denied and understandably so. They might get promoted. I can't. Now, the key result to be published here, which leads to public statements of reassurance from authorities not only in this country, but in Europe and elsewhere, is a relative risk of 0.92 with confidence interval there, which shows no significance, as it wouldn't if there is no difference--that's for autistic disorders, one of the two major subgroups here; and for other autistic spectrum disorders, 0.83, again with that confidence interval. And unlike the CDC study that I discussed at an earlier meeting, Mr. Chairman, the power here is high. Remember, it's only 12 percent in Davis' study. Here, it's 80 percent to detect an authorization of 1.5, and I remind you that in OR, an observation of one shows no association, and the key results we have here with the confidence intervals overlap 1, and there's the power which is quite adequate. In fact, it's superior. You don't often see that high a power obtained. It's curious. They never give it to you. You have to calculate it yourself, but that's the way it is. Now, going to some of the more detailed problems--and if I went into everything I'd be here for 2 hours, Mr. Chairman; I wouldn't be too popular even with you. But the first thing I'd like to say and perhaps the most important point, that of the numerator, the affected cases here, only 13 percent were reviewed. That is very inadequate, especially if done for validity purposes, just for validity. To fail to examine all the records among the 787 children in the numerators of the cohort, or 738 in Table 2, that are similar, and without using a clinical and epidemiologic and large statistical multidisciplinary approach, it leaves the project wide open to errors and misclassification. They said that because it was validity and it's a psychiatric diagnosis in Denmark, they had to use psychiatrists. Well, that's the last reason I'd use psychiatrists. I want validation from other health professionals, appropriately involved clinically and otherwise in the situation. If they say it was too much work, in a self-selected group of affected children in Britain, with which I have been working with Professor Leary, among others, and so on, we did nearly 500 children, 493 children, looked at their lifetime histories with seven colleagues, including psychologists and pediatricians and so on, in about a month. In later collaboration, also of 62 of the involved, for reasons they became involved in laboratory study, one-third of them, 28, or 45 percent, which is artificially high; but nevertheless, we could clearly show they were regressive; and with a bias against it, because we forced the situation where you waited 30 days--not just 3 or 4, as can happen, but we took 30 days to be very conservative--and it was in that little period we call them ``unconfirmed.'' The probable proportion in general populations--we could get it in Denmark, but they didn't do it--is between 10 and 15 percent. Now, my questions are, were clinical psychologists and other clinicians involved in the Danish exercise? Was noncaseness validated, the controls? Was there a definition of zero time for any manifestation? They talk about diagnoses, but zero time is when you first observe by a competent clinician the signs or symptoms related to the condition. It may take years for you to get the diagnosis, especially by a psychiatrist, and the average in our studies was about 2.2. Other British studies go up to averages of about 5.2. Regressive autism, I asked the question, but I don't think it was demarcated and whether there would be prolonged exposure to MMR when they were doing the review. Now, I'm going to make the most important point of the presentation, in case you need to cut me short a little bit down the line. Assume hypothetically--and I'm doing everything conservative--that there is a vulnerability to MMR-induced disease in a subgroup of 10 percent of the autistic cases. Mr. Burton. Should this be a new slide? Dr. Spitzer. Sorry. So we assumed that there's 10 percent and we assume further that in the main autism group, 80 percent had been vaccinated, which is similar to the 82 percent we've seen in the paper and 95 percent vaccinated in the subgroup of autistics, all of it being plausible. And I stress this is hypothetical. Now, if you did a nested case control study within these cohorts, which I'll explain in a minute, and did that design in those Danish cohorts, the odds ratio for MMR in that subgroup of 10 percent would be 4.17, which is appreciably high for preventive or therapeutic medicine in pharmacal epidemiology. Now, combining all the autistics, the OR becomes 0.97, so that the 90 percent mask what's happening in that 10 percent. Here I show briefly--this will be distributed--how the calculations will be done. And I assume--and I stress it's hypothetical. That's why we don't give confidence intervals. It would be contrived. Now, is 10 percent trivial? Conservatively, very conservatively, perhaps this is half. Ten percent would represent approximately 50,000 children in the United States alone, perhaps a little less, with the yearly burden of one point--I'm sorry, with a lifetime burden, it would be of 1.25 billion for just that 10 percent. It isn't trivial. And as a public health doctor, I hope MMR can be ruled out. There are those that say I am biased, and I will admit it, but let me tell you that my bias as a public health doctor is a profound desire that we can exonerate this effective vaccine, because it is one of the most effective interventions for important problems we have. But the failure to demonstrate safety so far means I cannot recommend it, even after the Danish study, for my own grandchildren. So there is the--there is the trivial figure for the 10 percent. Next slide. Two slides--another slide, I'm sorry. Now, next slide. At the core of the methods problem is that the workers described a very important subgroup in the introduction of their paper but did not examine it specifically. They did not or could not test the most relevant hypothesis as proposed by Wakefield. In other words, they were looking for a question to be appropriate for the question they were putting and ignoring what Wakefield and others have published over the last few years from clinical and laboratory and not epidemiology. Next slide. Now, there are also analytic issues, and these are the ones that I am reticent to give too much--you will see it in the literature within days or, at most, weeks. Now, one strength here is that Madsen and her colleagues used person years. That's what you do in a dynamic cohort situation. I've seen it criticized, and I don't understand it because that's a strength. However, they had allocation of cases to subcohorts of exposed and nonexposed which are difficult to understand. That's one of the two examples that I gave. There is an unusual distribution of ages in the cohorts to which you alluded to, Dr. Geier, and they have problems with measurement of clinical phenomena, and their censoring rules are surprising or are inappropriate. These are just five or six of the statistical issues over and above that main issue of failing to protect against hiding a phenomenon in a subgroup by looking at the 90 percent, if you wish. Next slide. So the questions I have first is, why did Madsen and IOM do an adjustment to the subcohort that removed six autistic and a total of 13 cases of progressive developmental disorder cases from the vaccinated subcohort and then place them in the unvaccinated one? This single adjustment reduces relative risks of autism due to MMR vaccination by 17 percent, from 1.26 to 1.09. Next slide. Why did Madsen not simply exclude all cases involving earlier, that is, nonregressive, diagnosis of autism? If they had removed all cases diagnosed before 2 years of age from both subcohorts, the relative risk would have risen from 1.26 to 1.28. Next slide. Now, another problem is difficult to understand. I'm not saying they are wrong, but I still haven't quite figured out what they did and why and how they adjust it. To age cohorts coming close to the end of the study or the end of followup, we have an average inception of the disease. It's about 3 years. If you only follow them for a year and a half, you are going to miss an awful lot of autistic cases among those exposed. So the censoring is difficult to understand, how they adjusted for it. I'm still in the process of figuring out and may well write an article on that with colleagues in the relatively near future. Next slide. Now, the classical problem of computerized data bases as they had, as we had in Saskatchewan, and I did a big study on beta agonists in Saskatchewan in--almost exactly 10 years ago, published in the New England Journal, the most cited paper in the literature that year. These data bases can and are useful, but there the data are gathered for other purposes, and when you go into those data bases, sometimes you just cannot get the data you need because it was never gathered or it was never archived. That may almost certainly be the case here, and certainly variables could not be considered. There has been very, I would say, wise discussion of mercury and the implications a few moments ago. There was nothing about mercury in all of this and nothing mentioned. Next slide. I think we will skip this. This has to do with what I have from Wakefield in the literature, the fact that this is multifactorial. It involves interactions between potentially enabling factors, triggering factors such as mercury and MMR working in concert, subgroups genetically. You know, I don't know much about genetics, and I don't know--I don't--can't appreciate well how far we have gotten there, but I really hope we never discourage the pursuit of genetic information because it's likely to be an interactive, multifactorial profile which we don't understand yet. Next slide. Now, the fourth issue is research management tactics, which refers to some of the issues that you directly or indirectly mentioned earlier, Mr. Chairman, you and some of the colleagues. The concerns are about the process of funding, the interaction of sponsors with protocol formulation and approval, compliance with protocol, the role of the investigators vis-a- vis sponsors in the actual conduct of search and the input of the CDC epidemiologist in the preparation of the report with its conclusions. Now, sponsors should stay out of it except through clear, ethical accountability patterns. Sponsors should not be involved in the research. Was there a protocol? Next slide. Next slide, please. Was there a protocol? Who approved it? Were there any changes in the protocol? Who approved the changes? Who monitored the work in progress? Who approved the final report? Was there a scientific advisory board? What exactly was the role of the CD and its professionals? That I don't know, and it's not in published literature, and it's not been the appropriate thing, for now, for me to approach Dr. Madsen. Next slide. Now, I would like to point very quickly to epidemiologic research priorities based on computerized data bases. The Danish one is excellent, it really is, for that kind of data source. And we don't have it in the United States. We only have it in Saskatchewan in Canada, maybe to a lesser extent in Quebec, a few other places, perhaps Sweden. But in Sweden the confidentiality is so high that they destroy your letters before they read them. As I said, heavy metals and the developing immune system, all those issues, were not touched on for reasons I said. Forgive me for going on ahead. Next slide. Next slide. Likewise, we have heard here, and earlier testimony which I heard, synergistic adverse effects upon the immune system of susceptible children could not be studied here. The triggering phenomenon couldn't be studied in any manifestation of autism. Next slide. There is no mention of heavy metal as a likely multifactorial causal association. And it's not the fault of the investigators. I don't want us to go away and thinking badly of Dr. Madsen and her colleagues. They are good scientists. We don't know the pressures they had upon them, whether yes or no, from outside agencies. But this cannot be done with the Danish link data bases, as good as they are. It just can't be done. Mr. Burton. Doctor, sir, are you near---- Dr. Spitzer. I'm almost--2 minutes or so. Mr. Burton. Thank you, sir. Dr. Spitzer. Next slide. Now, it's my view and that of others that the Madsen group should replicate, extend, and perform complementary designs of the recent work. One should also explore whether it is feasible to do the same in Saskatchewan, Canada. Next slide. The hallmark of science is replication, verification, and corroboration. One study proves nothing. In any of these national preventional data bases, one can do cohort studies that are extensions and corroborations and--but the methods must be declared for analysis in advance. And unless the case control study goes into this representative two subcohorts, takes all the cases as cases and takes the probability representative sample of the controls as the controls, and then you have all the advantages of both cohort and case control in one study and at about a tenth of the cost, for that matter. Next slide. Now, there must be total transparency, considering the things that I've heard from distinguished members from both parties of the committee. There must be a scientific advisory board monitoring all phases, especially protocol changes in progress, proposed publications. The majority should be epidemiologists and biostatisticians. Ethics and conflicts of interest for reasons that are self-evident and may ultimately-- should be under surveillance, perhaps by a community advisory board as we did in Alberta. And the main protocol should be published in advance. We should be able to critique that protocol in the peer-reviewed literature. In major studies, that's what my group at McGill do and what many groups in Europe are doing as well, even in North America. Next slide. A significant first step has been taken in epidemiology. It is imperative that the whole feasible road of research be taken. One study proves or disproves nothing in any field, or two, if you take the lines, that one that you described. Thank you for your attention. Mr. Burton. Thank you, Dr. Spitzer. We appreciate your comments as well. [The prepared statement of Dr. Spitzer follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. I think I will let Dr. Weldon start off. Doctor, would you have any questions? Mr. Weldon. Yes, Mr. Chairman. I have a question for Dr. Geier. You said the CDC or the FDA has the data as to which manufacturers produce which vaccines that contain thimerosal and which ones don't. And the VAERS data shows that some of them have a higher incidence of these neurodevelopmental disorders, and--but you just can't disclose that? Is that correct? Dr. Geier. Yeah. There are three levels of denominators. One level is, how many doses of each type of vaccine were made per year? Which we have and can disclose, although that seems to be not generally available, but we have managed to get it. The second one is broken down by company, which we have under agreement that we not disclose which company. So we can do a study like the one I presented and compare one with and one without, but I couldn't say such and such a company makes a vaccine and another company makes a vaccine, and the first company is five times worse than the second company. And then the third level that they also have--and this is all published by them if they have it, is that they have the number of doses per lot number. So with that information you could investigate the possibility of a bad lot. I looked in my VAERS data, and I find some lots that have far more reported reactions than others, but I don't know how big the lots were. If I knew how big the lots were, I could tell you, yes, there was a bad lot of particular vaccine made in such and such a year or, no, there wasn't. And that information I've been unable to get with or without any agreements. Mr. Weldon. So what you are saying is if it is an average- sized lot but there's a higher incidence of side effects---- Dr. Geier. Well, I don't know. I mean, let's say I look at two lots, and one of them has 100,000 reactions and one of them has 10,000 reactions. It could be that the 100,000 was a 10 times bigger lot. If I average them, that's not valid. I have to know. And they know exactly how many doses were in each lot. And if they release that, we could look lot by lot through the VAERS data and say, well, there was a bad lot. Boy, it had 20 times--and we could do statistics to see whether it was just by random choice or chance or whether it was real that a particularly bad lot was made. There has been a lot of literature on bad lots. In fact, in the 1980's the FDA used to keep a list called the ``hot lot'' list, and they also had trouble getting the numbers. But they have the numbers now to do it, and they won't release these to any scientists, and they won't allow people to discuss which vaccine company makes a worst vaccine when they're two of the same vaccine made by the same company, and I think consumers are entitled to that kind of information. It's sort of like, you know, we get an automobile crash test and you find, gee, one car is a lot safer than the other when it runs into a wall, but we are not going to tell you which kind of car. Well, they tell us which kind of car, but they won't tell us which vaccine producer. They won't allow it to be released which vaccine producer makes a safer vaccine. And I think with our children and our lives it's critical that we have that information. Mr. Weldon. Dr. Spitzer, I always find it very interesting to hear you speak. It's frequently a little hard to follow, though, not being a biostatistician or an epidemiologist, so I just want to make sure I understand you correctly. You said the Danish study, the Madsen study, is a good study. But is what I said in my introductory remarks accurate, that it did not--is it the case that if MMR was causing the majority cases of autism, that the study is good, but if it's causing a percentage less than 50 percent, then the study is not valid? Is that what you were basically saying? Dr. Spitzer. Well, what I would like to stress is that the Madsen study in a sense broke a barrier in being the first properly controlled epidemiological study ever done and new avenues which can be followed and also had the advantage of an extraordinarily good data base with the disadvantages---- Mr. Weldon. And I understood all that. Dr. Spitzer. Now, what I'm saying is, they just didn't go far enough, first of all, with inadequate evaluation of the cases, both in terms of a small sample and in terms of how much within each case was looked at. We don't have the details of that. And, second, I'm just saying they cannot rule out with the decisiveness that they imply, they cannot rule out an association. They can for the totality, but they can't say there is no subgroup that conceivably could be affected. Mr. Weldon. So is it correct---- Dr. Spitzer. And so that's--it just didn't go far enough, even though it's a major advance in the study of autism epidemiologically in the last decade. Mr. Weldon. Is it correct to read it and interpret that MMR does not cause the bulk of autism in Denmark, but it may cause--it could cause---- Dr. Spitzer. You can infer that if you take them as a totality and look at them that way. It's not detectable should it be happening in a subgroup. Mr. Weldon. But if MMR is causing a percentage--let's say a percentage well below 50 percent, then that study didn't answer that question---- Dr. Spitzer. No. Mr. Weldon [continuing]. Correct? OK. Mr. Burton. Can I followup on that, please? Would the gentleman yield? Mr. Weldon. I would be happy to yield. Mr. Burton. In layman's terms, so that everybody understands, you are saying that it could cause 10 percent, 20 percent of the autism cases, 30 percent. Is that right? Dr. Spitzer. When you get up to 30 percent, it's--but 20 percent or below is a concern. Mr. Burton. Well, see, that's something that a lot of us-- you went right over our heads with all those statistics. But you are saying that it's possible that 20 percent of the autistic cases could be as a result of the MMR vaccine? Dr. Spitzer. Yes, and cannot be ruled out by this study. Mr. Burton. Thank you. Dr. Spitzer. I'd use the figure 10 percent to be conservative rather than 20, although it could be 20. But 10 percent is what we tested hypothetically and I'd like to speak to. Mr. Burton. Well, 10 percent is still a considerable number of children. Mr. Weldon. Dr. Baskin, you are a clinician, I understand. Have you looked at the research data done by a Dr. Wakefield from England on the issue of MMR and autism? Are you familiar with that at all? Dr. Baskin. Yes, I'm familiar with that. I've actually met Dr. Wakefield and conversed with him. Mr. Weldon. OK. One of the things that I have been very concerned about since I've been working with the chairman on this issue, and it's about 3 years now, I think this is now the third epidemiologic study. There were two out of England and then there was this--maybe it's the fourth one. I think there was a U.S. study, if I'm not mistaken. Dr. Spitzer. There is the Finnish study as well. Mr. Weldon. OK. But nobody has made an attempt to duplicate a clinical study like the original Wakefield research. And can you honestly refute Dr. Wakefield's clinical data with all these epidemiologic studies, particularly in light of the conversation I just had with Dr. Spitzer, that the study only-- the best study we've had so far can only be used to say that MMR does not cause all autism cases in Denmark and that the study does not exclude the possibility that MMR is causing a percentage of them? Dr. Baskin. The answer is, no, I can't refute that. While thimerosal is my major research base as a clinician, and after conversations with Dr. Wakefield, one of his great concerns is regressive autism, the fact the child starts out normal and then gets worse, and another one of his great concerns is the second shot, none of these studies have actually looked at these subgroups in any detail. Mr. Weldon. I have some more questions, but I would like to yield back to the chairman for the moment. Mr. Burton. Thank you. Let me start with you, Dr. Baskin, and you, Dr. Geier. Because thimerosal--although MMR is a very important issue as well and important to me, I am interested in the thimerosal issue because it has been given to literally millions of people since the 1930's, and it's been given in more and more greater quantities in recent years because of the number of vaccinations involved. Do you personally believe from your studies that the mercury is a contributing factor to the cases of autism we have in this country? Dr. Baskin. Yes. Mr. Burton. Do you think it's a large contributing factor, or do you have any percentages? I mean, I know this is a tough question and everything, but you have done a lot of research. Dr. Baskin. I think it's hard to look at a percentage. I think that, as NIH is focusing on, there is probably an environment gene interaction. In other words, a lot of children get the injection and don't become autistic, and so there must be something specific or different about the way a certain subgroup of children are able to handle toxins which, as I alluded to earlier, is known for other toxins. I mean, that is not a foreign concept. I don't think we yet know the answer to that. I think that one of the striking things is over the years at NIH and NICHD the idea of regressive autism was not well accepted. It was sort of originally preached that you were sort of autistic from birth and actually there weren't that many children who have regressive autism. But the NIH with good data and with good science has actually reversed its position quite a bit on that, and this group seems to be increasing. So up to somewhere between 30 and 40 percent of children in very conservative studies seem to have this regressive autism. In other words, it doesn't seem like they are starting out abnormal. Something happens to them, and they backslide. So I think if you want to take a conservative estimate and you want to take those conservative numbers, because there are other studies that say 60, 70 percent of autism is regressive, I think that it's a very good chance it's more likely than not that it contributes or causes autism in about 40 percent of children who are autistic. Mr. Burton. Would you say that a child like my grandson who got nine shots in 1 day, seven of which contained thimerosal, would you say that they had a greater risk of getting a neurologic--creating a neurological problem like autism than-- -- Dr. Baskin. Yeah, absolutely. I didn't touch on that. I tried to be very conservative with my analysis. But, as you pointed out, these EPA guidelines are a small amount per day. These kids are getting an enormous amount all at once. And you say--you could say you could average the amount of a lethal injection over your lifetime and say, well, you never in any 1 day got a lethal dose. The only trouble, you'd be dead and 6 feet under the ground. So, yes. I mean, those are the most concerning cases, children who were OK, who got worse, and whose parents can link this to a single or a set of--a serial set of exposures to mercury. And that sounds like the absolute typical case that we would be most concerned about. Mr. Burton. Dr. Geier, I think you indicated that in some cases kids are getting 100 times the amount of mercury that would be tolerable at one time. Dr. Geier. Yes. In fact, some of those calculations are over 100 times. Mr. Burton. So a child that got multiple vaccines in 1 day could conceivably be getting more than 100 times the amount, according to EPA, that's a tolerable level of mercury in one fell swoop? Dr. Geier. Yes. And their levels are actually conservative, because they meant by ingestion, not by injection. So their studies were not usually by injection. Mr. Burton. So the injection would be actually---- Dr. Geier. It's worse. Mr. Burton [continuing]. Worse, much more lethal, so to speak. Dr. Geier. Yeah. I mean, there is no question that these children are overdosed. Mr. Burton. Would either one of you take nine shots in 1 day, knowing that seven of them contained mercury, at the same time? And--or would you allow that to happen to your kids or grandkids, whether they are healthy or not? Dr. Baskin. You know, a mercury thermometer broke in my house, and I cleared everybody out of the house and went to my lab and got these really bioresistant gloves, and cleared it up like a toxic spill. No, of course not. It's a really bad toxin. Dr. Geier. I wouldn't. And I had a different situation. I run a laboratory that does chromosome analysis, and we had a mercury vapor bulb break. And we were located near the NIH, and we cleared the building and had the NIH guys come in with full body suits to clean out the area. Dr. Baskin. And I think we've dramatically underestimated what's been in the literature for the entire last century, that this is a highly toxic compound. The more we look into it, the worse it gets. Mr. Burton. And it shouldn't be injected into human beings. Dr. Baskin. Absolutely not. Mr. Burton. But one of the things--one other thing I want to talk about, and this is not related to my personal problems, I hope. And that is that older people are coming down with Alzheimer's at a more rapid rate than in the past. Do you attribute that in any way to the levels of mercury that they are ingesting, either through their amalgams in their mouth or the vaccinations that they are getting or the food that they are eating that contain mercury? Dr. Baskin. I think that's a less well-studied area. But this work that you described, which I was aware of, of the fact that as these cells die from mercury they form these kind of plaques and tangles like we see in Alzheimer's disease is very intriguing and certainly suggests this may well be a contributing factor. Mr. Burton. And should be studied. Dr. Baskin. Absolutely should be studied. Mr. Burton. Dr. Geier. Dr. Geier. I agree. I think it's well-studied, could be studied, but is very plausible. Mr. Burton. I don't want to alarm everybody in the United States, but the Members of Congress have been getting flu vaccines that contain thimerosal for several years. And I want you to know that I don't think that's one of the reasons we have made bad decisions up here, although somebody might ask that question. Dr. Weldon, do you have any more questions of this panel? Mr. Weldon. Yeah. I have a couple of questions for Dr. Baskin about ethyl mercury versus methyl mercury. I have had some people say that data on methyl mercury is fairly good, but we don't have good data on ethyl mercury. I take it from your testimony there is actually quite a bit of data on ethyl mercury and that it's as toxic as methyl mercury. Dr. Baskin. There is more data, more and more data on ethyl mercury. The cells that I showed you dying in cell culture are dying from ethyl mercury. Those are human frontal brain cells. You know, there has been a debate about, well, ethyl versus methyl. But from a chemical point of view, most chemical compounds that are ethyl penetrate into cells better than methyl. Cells have a membrane on them, and the membrane is made of lipids, fats. And ethyl as a chemical compound pierces fat and penetrates fat much better than methyl. And so, you know, when I've began to work with some of the Ph.D.s in my laboratory and discuss this, everyone said, oh, gosh, you know, we've got to adjust for ethyl because it's going to be worse; the levels are going to be much higher in the cells. So, I mean, I think at best they're equal, but it's probably highly likely that they are worse. And some of the results that we are seeing in cell culture would support that. Mr. Weldon. Now, you said several times in your testimony that uptake in the brain is probably much higher than in other tissues. What do you base that statement on? Dr. Baskin. Well, the literature on methyl mercury is much better than ethyl on this issue. And if you look at the studies, the brain is 2 percent of the body weight but took 10 percent of the exposure. So that's a fivefold preferential update. Mr. Weldon. This was based on people who died? Dr. Baskin. Right. And also on animal studies, both. Mr. Weldon. Animal studies? So the brain--what did they do---- Dr. Baskin. The brain seems to take five times more the exposure than it should. In other words, if you assume that you give methyl mercury and it goes everywhere in the body equally---- Mr. Weldon. You should get the same level. Dr. Baskin [continuing]. You should get the same level everywhere. But the brain takes five times as much as it should have. Mr. Weldon. And that was based on methyl mercury? Dr. Baskin. Methyl mercury. Correct. Mr. Weldon. The Lancet study, only 40 infants. You agree that's much too small a sample size to really make any conclusions? Dr. Baskin. Right. I mean, there are a number of problems with the Lancet studies as I mentioned. But certainly, if the disease occurs in one in 150 children and you only test 40, you may miss that child, very easily miss the child who had the problem, or at best maybe only catch one. Not to mention the other things that have been discussed by several of the panel, the most significant one being they drew the blood much too late. They drew the blood days to weeks later, whereas we know the peak level of methyl mercury---- Mr. Weldon. Three to 28 days. Dr. Baskin [continuing]. Occur within hours, within 24 hours; yet they drew the blood up to 27 days later. As a matter of fact, to me it's very worrisome. They are still finding some mercury in the blood that far out. It should--you know, you would think it might be gone. Mr. Weldon. Is there any---- Mr. Burton. Would the gentleman yield? Would that be the reason that some families see a very, very rapid change in their children shortly after these vaccinations are given in large numbers? For instance, in our family it was just a matter of a couple days and--boom. Dr. Baskin. Correct. All of the data on both methyl and ethyl mercury suggests that the peak level--in other words, the highest level in the blood--is either achieved within hours or at least within 24 hours. So that's--and, again, if it gets in the blood, the blood goes to the brain. We know it has a preferential tendency to be sucked into the brain or to cross into the brain in excess, and so you would expect to see something fairly quickly. As a matter of fact, if somebody said 3 months later something happened, I would say that's probably not related. Mr. Burton. Can I followup with one question here? Mr. Weldon. Sure. Mr. Burton. In animal studies, as I understand it, the animals evidently didn't become ill for 14 days after the injection of the mercury. Are you familiar with that study? Dr. Baskin. It depends on which study you are talking about. There's a variety of different studies. Mr. Burton. Well, it's a rat study that was done in the 1950's by the Eli Lilly company. Are you familiar with that? Dr. Baskin. I'm not familiar with that particular study. But, you know, in general, remember that if you are doing studies on rats and mice, you have to have very sensitive behavioral screens. As long as they are getting up and eating, I mean, they might be acting weirdly and you wouldn't know it. So I--without knowing what study you're referring to, it would be hard for me to comment on it. Mr. Burton. Thank you. Mr. Weldon. Is there any kinetic studies on the clearance of ethyl mercury that are available that could allow you to make conjectures as to what the peak levels might have been based on the blood levels that are available in the Lancet study? Or is that information not known? Dr. Baskin. It's known to a limited extent. There's a study in pre-term infants that received vaccinations. So they--you know, by kind of people not thinking about it, their weight is very small and they receive the same dose, and so it was a very high level. And they looked at some of that data. But, frankly, there is not enough. I think one of the points in the Lancet study is they drew all these complicated curves saying that they knew what the pharmacokinetics were, which refers that they knew how the drug was taken up, how it was absorbed, how it was distributed, but they never caught a peak level. And, of course, you can't even make a comment about pharmacokinetics unless you know the peak level. So, I mean, I think the short answer is there is some--some data available but not enough. Mr. Weldon. Dr. Geier, when this issue was first brought to my attention 3 years ago, I was very disturbed about the mercury issue. Then the CDC study that you referred to where you drew those curves came out; and, frankly, I was somewhat relieved with that data. Not being a scientist or an epidemiologist, I accepted it at face value. There was some initial data suggesting that some of the kids had language and speech development problems, and then they added more numbers and said that association went away. I'm very disturbed by these curves that you drew, though. So you're saying that--I just want to make sure I understand you correctly--that when you plot out the data like that, you can actually do a calculation and it is statistically significant? Dr. Geier. Yes. When you--if you allow us to remove that greater than 62 point---- Mr. Weldon. Well, I want to ask you about that. You say it's got to be 75. Is that based on the immunization tables and the known amount of---- Dr. Geier. Yes. Mr. Weldon [continuing]. Thimerosal in there? So they couldn't have gotten 150 or 200. It had to be 75. Dr. Geier. Right. It had to be 75. And when you allow that point, then you have a curve-fitting program that tries to fit the best curve. And it tells you how well the curve fits to that, and it fits in greater than 95 percent to a logarithmic curve. Mr. Weldon. Not being a scientist, I can't honestly--but I just know what it's like. You know, I'm going to get the CDC people in my office after all this is over, and I'm going to say, OK, how do you respond to all of this? And I don't think they are here today, right? They are not in the second panel, Mr. Chairman? Which I'm very disappointed by. But I would assume they are going to say that's not kosher, so to speak, what you did; that's not a valid scientific technique. Dr. Geier. No, I think they're going to be upset that we used their intermediate data before they added all these young children to dilute it out. And even when they diluted it out, by the way, it's still there. It just became more dilute. As far as, you know, doing the curve, I think they'd have to agree that, you know, if you analyze a single point and then you compare that to analysis of several points as they go up, you add more likelihood that it's significant. I mean, just intuitively, what's the odds that three go up in a row? I mean, just supposing something is random, forget about even how much they go up or even what shape they go up, the odds of three going up in a row are not so good if they were from a random subject. So it's obvious that to intuitively that--but--and as well as mathematically that when you go to a kinetic curve like that, the curve can be significant even if each individual point is only, as I think they said, marginally significant. You get three marginally significant curves that fit like that, it becomes very significant. But maybe Dr. Spitzer, who is our epidemiologist and mathematician, can comment on that. Dr. Spitzer. Well, it's--trying to say it in nontechnical terms--but it is a finding that's being observed by appropriate rules of handling the data in the main. It's usually preferable that it be declared in advance, and that 75 that he said, not in the course of analysis and so on, but that this is not likely to happen by chance, at least at the 95 percent level, or chance alone. That's the basic principle. It's a finding where the role of chance has been excluded to the extent of 95 percent. Mr. Weldon. I believe I understand. I could really go on much further, but I was just reminded we actually have a second panel, and we have been at it for 2\1/2\ hours, so I will yield back. I'm sorry, Mr. Burton. Mr. Burton. No, that's fine, Dr. Weldon. You ask more poignant questions than I, because you have that experience and background. Before I recognize Congressman Green, who I believe is Dr. Baskin's Congressman--is that correct? Dr. Baskin. Yes. Mr. Burton. Is he a good one? Dr. Baskin. He is very good. Mr. Burton. OK. Well, I just thought I'd ask. Dr. Baskin. He is a good patient, too. Mr. Burton. That's unsolicited testimony. Before I recognize him, let me just ask you one quick question here. Do you, all three of you, think that our health agencies have done enough in the research of this very, very important issue of the epidemic of autism? Dr. Baskin. My opinion is this: I think that the NIH now is galvanized and is doing more. And if, as I said earlier, if more funds could be set aside for this specific issue, they have the capability and the interest to do it. Mr. Burton. Have they in the past? Dr. Baskin. Not in the past, no, but I think they are now. Mr. Burton. So we have an epidemic, and up to this point they haven't been doing enough. Dr. Baskin. Right. I think so. I think so. But I think, to be fair to NIH, a lot of this information wasn't really made available; like I talked about agencies not talking to each other. Mr. Burton. What about CDC? Dr. Baskin. I think the CDC is not. The CDC, in my opinion, has been obstructionist. Mr. Burton. OK. How about the FDA? Dr. Baskin. The FDA, as they said in their own e-mails, I think have been asleep at the switch for decades. Mr. Burton. Asleep at the switch. OK. Dr. Geier. Dr. Geier. I think--it's Geier. Mr. Burton. Geier. Dr. Geier. I think that they've been asleep, and I think that we found that out when we did a midline search on thimerosal. There are over 1,500 articles listing problems with thimerosal. And that doesn't go back--the midline search goes back to 1967. Actually, the problem goes back farther than that. If there are 1,500 articles that are implying problems with thimerosal and the FDA and CDC knew that it was in the vaccines, something should have been done, more than just ignoring it. Mr. Burton. Thank you, Dr. Geier. Dr. Spitzer. Dr. Spitzer. Well, as I mentioned before, on this whole matter, particularly as it concerns MMR, I call myself a worried agnostic. If I, from the FDA or some of the sister major agencies around the world, could get assurances that we have the same quality information on safety of this product as we have on efficacy or effectiveness--and that is good--my worry would go down a bit, or go down quite a bit. It's gone a little bit down with the Danish studies. But that's what I have not been able to find, Mr. Chairman, is adequate, scientifically admissible evidence on the safety of the products as opposed to efficacy. Mr. Burton. And at this point you wouldn't give your grandkids the MMR vaccine? Dr. Spitzer. Not yet. No. Not in the foreseeable future, I don't think. Mr. Burton. Thank you. Well, let me just end my comment here by saying that the FDA and CDC and our health agencies have an awful lot of questions that need to be answered. But the one thing they could do to make the situation a lot better is if they get on--get on with admitting there is a problem if there were 1,500 articles--and start really getting down to the business of studying this thing and devoting the amount of resources that are necessary to get the job done. And I want to thank you guys very much for your help. And, with that, Congressman Green, it's good to have you with us. Mr. Green. Mr. Chairman, I did serve on this committee three terms ago and I moved to the Energy and Commerce to deal with health care. It's interesting; I walked back in the office from a meeting and saw Dr. Baskin, who, one, is a great friend and great neurosurgeon, and I'm going to ask him to sign an affidavit that, yes, a Member of Congress does have a brain. But---- Mr. Burton. Did you get a flu shot this year? Mr. Green. I did get a flu shot in. Mr. Burton. Well, it has mercury in it. Mr. Green. OK. Mr. Weldon. You know, he has brain cells he's growing in his lab. I was wondering if he would sell some to Members of Congress. Mr. Green. You know, we could use them. We could use them. But the issue--because we were just responding in our office to a letter of a family with a child with autism. And on my Subcommittee on Health Care, that our good doctor is also on, this is an issue. And I want to thank you for holding these hearings to help us as Members of Congress go further. But again, I just came in to say hello to my good friend Dr. Baskin. Dr. Baskin. Thank you. Mr. Burton. Before you leave, let me just say that---- Mr. Green. Thank you. Mr. Burton. Thank you. Before you leave, I just want to say that we have a bill that I've talked to Congressman Bilirakis, the chairman of your subcommittee about, that would go a long way toward helping solve the problem with the vaccine injury compensation fund, and I really would appreciate if you'd talk to him and take a look at that bill. Mr. Green. OK. Glad to. Mr. Burton. Thank you very much. Well, gentlemen, thank you very much. We have gone way beyond what we normally would, but I thought it was very important to let you really lay out the whole story. And with that, we will go to the next panel. And thank you for your service. Mr. Burton. The next panel is, we have the FDA and the NIH, Dr. Midthun, Dr. Foote, and Dr. Portier. Would you please come to the witness table? Please stand up so I can swear you in, please. [Witnesses sworn.] Mr. Burton. Dr. Midthun, do you have an opening statement? Dr. Midthun. Yes, I do. Mr. Burton. OK. You are recognized. STATEMENTS OF KAREN MIDTHUN, M.D., DIRECTOR, OFFICE OF VACCINES RESEARCH AND REVIEW, FOOD AND DRUG ADMINISTRATION, ROCKVILLE, MD; STEPHEN FOOTE, PH.D., DIRECTOR, DIVISION OF NEUROSCIENCE AND BASIC BEHAVIORAL SCIENCE, NATIONAL INSTITUTE OF MENTAL HEALTH, BETHESDA, MD, ACCOMPANIED BY CHRISTOPHER PORTIER, PH.D., DIRECTOR, ENVIRONMENTAL TOXICOLOGY PROGRAM, NATIONAL INSTITUTE OF ENVIRONMENTAL HEALTH SCIENCES, BETHESDA, MD Dr. Midthun. Thank you. Mr. Chairman and members of the committee, I am Dr. Karen Midthun, Director, Office of Vaccine Research and Review of the Center for Biologics Evaluation and Research at FDA. Mr. Chairman, as a physician and a parent, I want to express to you, the members of this committee, and to parents and physicians that I appreciate the devastating effects of autism on children and their families. I am here to assure you that we are working diligently to help ensure that the vaccines we license for use in the United States are shown to be safe, pure, and potent. I appreciate the opportunity to participate in this hearing on autism and to respond to the committee's concerns regarding a potential link between vaccines and autism. The Office of Vaccines regulates the investigation and licensure of vaccines. FDA's regulatory process for licensing vaccines has for decades served as a model for other countries. To date, the existing data do not demonstrate a causal relationship between vaccines and autism. Nonetheless, I want to assure this committee, the public, and especially parents, that FDA continues to take these issues seriously. One concern that has been raised relates to the use of thimerosal, a mercury compound, as a preservative in some vaccines. FDA recognizes and supports the goal of reducing exposure to mercury from all sources. Consistent with this goal, FDA has encouraged manufacturers to develop new vaccines without thimerosal as a preservative and to remove or reduce the thimerosal content of existing licensed vaccines. As required by section 413 of the FDA Modernization Act, FDA conducted a review of the use of thimerosal in childhood vaccines. Our review showed no evidence of harm caused by thimerosal used as a preservative in vaccines except for local hypersensitivity reactions. Of the U.S.-recommended childhood immunization schedule, the maximum cumulative exposure to mercury from thimerosal at the time of this review in 1999 was within acceptable limits for methyl mercury exposure set by FDA, the Agency for Toxic Substances and Disease Registry, and the World Health Organization. However, during the first 6 months of life, cumulative exposure to mercury could have exceeded the more conservative limits of the EPA in some cases, depending on the specific vaccine formulations used and the weight of the infant. Of note, all of these guidelines contain a safety margin and are meant as starting points for evaluation of mercury exposure, not absolute levels above which toxicity can be expected to occur. The clinical significance of exceeding EPA's limits is not currently known. Nevertheless, reducing exposure to mercury from vaccines is warranted and achievable in principle in the United States because it is possible to replace multi-dose vials with single-dose vials which do not require preservative. I am pleased to be able to report substantial progress in the effort to reduce thimerosal exposure from vaccines. Since early last year, all routinely recommended licensed pediatric vaccines manufactured for the U.S. market contain no thimerosal or contain only trace amounts of thimerosal in the final formulation. With the newly formulated vaccines, the maximum cumulative exposure from vaccines during the first 6 months of life is now less than 3 micrograms of mercury. This represents more than a 98 percent reduction from the previous maximum cumulative exposure of 187.5 micrograms of mercury from vaccines. In addition to the initiatives taken with regard to routinely recommended childhood vaccines, FDA has also worked with manufacturers to facilitate the removal or reduction of thimerosal from other vaccines. Two of the three influenza virus vaccines are now available in a formulation that contains only trace thimerosal. The manufacturer of the third influenza virus vaccine has announced that it will not manufacture this vaccine after this year. In 2001, the Institute of Medicine's Immunizations Safety Review Committee focused on a potential relationship between thimerosal use in vaccines and neurodevelopmental disorders. The Institute of Medicine concluded that the evidence is inadequate to either accept or reject a causal relationship between thimerosal exposure from childhood vaccines and the neurodevelopmental disorders of autism, attention deficit, hyperactivity disorder, and speech or language delay. Additional studies are needed to establish or reject a causal relationship, and we concur with that. The committee believes that the effort to remove thimerosal from vaccines was a prudent measure in support of the public health goal to reduce mercury exposure of infants and children as much as possible. In an effort to better characterize the potential toxicity that could have accompanied an exposure to thimerosal from vaccines, FDA nominated thimerosal to the National Toxicology Program for further study. The nomination was accepted by the review committee earlier this year. Reports of developmental delay following vaccination have been submitted to the Vaccine Adverse Event Reporting System, commonly referred to as VAERS. Although VAERS reports usually cannot establish a causal relationship between a vaccine and an adverse outcome, further study of these reports can sometimes provide important clues and suggest directions for further research. FDA takes these reports seriously and is conducting a followup study of VAERS reports of autism. Also, FDA is pursuing promising research involving the characterization and development of an animal model to study general biological principles for autism. By looking at ways to improve the safety of vaccines, we must keep in mind that childhood vaccines have contributed to a significant reduction of vaccine-preventable diseases, including polio, measles, and whooping cough. It is rare for American children to experience the devastating effects of vaccine-preventable illness. Although they provide a great public health benefit, vaccines, like all medical products, are not risk free, and FDA is committed to continuing its efforts to reduce these risks whenever possible. In conclusion, FDA continues to work diligently with manufacturers to eliminate or reduce exposure to mercury from thimerosal and vaccines. Since early last year, all routinely recommended licensed pediatric vaccines manufactured for the U.S. market contain no thimerosal or contain only trace amounts of thimerosal in the final formulation. Although no causal relationship between vaccines and autism has been established, FDA, along with other health and human services agencies, continues to pursue and support research activities to increase our understanding of any potential relationship between vaccines and neurodevelopment disorders. Although the prevention of disease through the use of vaccines is a tremendous public health accomplishment, there is more work to be done. I assure you that the Office of Vaccines and FDA will continue to make regulatory decisions and recommendations regarding vaccines based on the best scientific evidence to protect the public health. Mr. Chairman, I appreciate the committee's interest in this area, and look forward to continuing to work with you in the future. Thank you. [The prepared statement of Dr. Midthun follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. Dr. Foote. Mr. Foote. Mr. Chairman, members of the committee, I am Dr. Steve Foote, Director of the Division of Neuroscience and Basic Behavioral Science of the National Institute of Mental Health. I am accompanied by Dr. Christopher Portier, Director of the Environmental Toxicology Program at the National Institute of Environmental Health Sciences. I am the witness representing the National Institutes of Health today because I play several roles in the coordination, planning, and oversight of autism research at NIH. For example, I serve as a scientific program staff member of the NIH Internal Autism Coordinating Committee, a longstanding body that serves to coordinate autism research NIH-wide. Also, I have played a major role in organizing and implementing the NIH centers program called for in the Children's Health Act of 2000, which we have named the Studies to Advance Autism Research and Treatment, or STAART, Centers Program. Finally, I have served a leadership role in the establishment and operation of the Department of Health and Human Services' Interagency Autism Coordinating Committee that was created under a provision of the Children's Health Act of 2000. I appreciate the opportunity to talk with you about NIH's support of research on autism. I am a neuroscientist who has been interested in the brain and its disorders throughout my career, and, like others, I have found autism to be a particularly challenging mystery. My view of this disorder has been broadened and deepened by my continuing interactions with members of the families with autistic children and adults. I feel their urgency. An affected child cannot wait for research before growing up. Any potential improvement is crucial. I would like to acknowledge the important role of families and advocacy groups in our efforts. They have not only raised the visibility of autism and challenged assumptions; they have pushed for and often funded I might say, accelerated and expanded research activities. I testified before this committee earlier this year, but now there is even more recent progress to report. The basic research on autism that is sorely needed is moving forward at an ever-accelerating pace, as is continued genetic research and studies of the etiology of various autism spectrum symptoms, including communication disorders and interpersonal difficulties. Autism biomedical research is rapidly expanding as the scope and level of detail of scientific topics under active investigation is aggressively broadened. Several weeks ago, I attended the Second Annual International Meeting for Autism Research. This meeting was an exciting forum for this rapidly growing field. It was a meeting that just could not have even been imagined just a few years ago in terms of its scope and quality. Extremely important funding programs from voluntary organizations and other Federal agencies, along with very substantial increases in NIH funding that have occurred over the past several years, have provided financial support underlying this growth in volume and quality of research. Other driving forces have been the advances of closely related biomedical research fields such as genomics and neuroscience that have provided the necessary knowledge and tools for more powerful and promising insights into the biological nature of autism. In summary, biomedical research into autism is advancing rapidly and NIH is playing a major role in this progress. I am also pleased to report that as part of the enhanced activities in this area, NIH has made much progress in implementing the provisions of the Children's Health Act of 2000 that focused on NIH research activities related to autism. In terms of the requirement for a new centers of excellence program, NIH has issued a total of three requests for applications, RFAs, to implement on a fast track, the STAART Centers program. An RFA, as you know, is a clear statement to the scientific field, setting aside funds that NIH invites research in a particular area. The first RFA was for developmental grants. Those were reviewed. We funded six of those. The second RFA was for an initial round of competition for full center support. A number of applications were received, reviewed in March 2002, and two centers were funded. A second round of competition for full center support is in mid-cycle and the applications are being reviewed yesterday and today. And I was at those reviews all day yesterday and I was able to attend most of the reviews today, and they are going very well. When these successful applications from this round of competition are funded during fiscal year 2003, the full network of at least five centers stipulated by the law will be in place. The five participating NIH Institutes--NIMH, the National Institute of Neurological Disorders and Stroke, the National Institute of Child Health and Human Development, the National Institute on Deafness and Other Communication Disorders, and the National Institute of Environmental Health Sciences--have committed up to $12 million a year, including $8 million from NIH, to fund this network at that level for over 5 years--for up to 5 years. This is a commitment of $60 million minimum. Another component of the Children's Health Act was the establishment of an Interagency Autism Coordinating Committee, the IA CC as we call it. The Secretary of the Department of Health and Human Services delegated to NIH the authority to organize the IACC, and NIMH was asked to lead this effort. The IACC has been organized and has now had its first three semiannual meetings. It is actively pursuing its mandate to enhance communication and effective interaction among the several agencies that support or conduct autism-related research, service, or educational activities, and it has engaged family and advocacy groups largely through the public members that were appointed by the Secretary. In addition to these activities, NICHD and NIDCD have competitively renewed their longstanding collaborative programs of excellence in autism. The NIH is fully committed to this important program, and will continue its support for both CPEA and STAART programs for several years into the future. And yet another recent enhancement of the NIH autism research portfolio, NIEHS, has funded two centers focused on autism research. We at the NIH are at a heightened state of awareness concerning the need for more research on autism due to the clear magnitude of this major public health problem and due to the work of many people within and outside this room. We have been making progress. In fiscal year 1998, NIH support for autism research totaled about $26 million; by fiscal year 2001, which is the latest year for which we have official numbers, the total was about $55 million. To put this in perspective, the NIH commitment to autism research has more than doubled in these few years. In terms of the specific questions in your letter of invitation, there are a number of active and planned projects that address the concerns you raise. NIH recently furnished you with a summary of the research activities sponsored by the National Institute of Allergy and Infectious Diseases and by NIEHS designed to address questions about thimerosal, ethyl and methyl mercury, and the search for other environmental risk factors for autism. Another question you raised was about treatments, and several institutes are sponsoring numerous projects dealing with treatment interventions for autism, and the STAART Centers Program includes a primary emphasis on such studies. So to summarize and finish, NIH is on schedule in terms of implementing the letter and the spirit of all aspects of Title I of the Children's Health Act, including a broadly based increase in autism research support, the initiation of a new centers of excellence program, and enhancement of genetic and other research resources, and the establishment of the Interagency Autism Coordinating Committee. That concludes my testimony. And Dr. Portier and I would be glad to answer any questions. [The prepared statement of Mr. Foote follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Mr. Burton. Thank you. I just have a few questions here, and then I'm going to let Dr. Weldon ask some questions. But I will have a number of other ones that I think are relevant and important after he concludes. I believe Dr. Geier indicated that since the 1980's, there have been 1,500-plus articles written in scientific journals about the problems with mercury and thimerosal. Why haven't the health agencies of our government done something about it before now; 1,500 articles. Dr. Midthun. Dr. Midthun. The review that we did in response to FDAMA went over the literature that existed, and it was our assessment that certainly, as Dr. Baskin was saying, we all know that mercury itself in larger amounts is clearly a toxicant. But our assessment was that the amounts that were present in the vaccines, that there did not--there was--that those were safe and effective, and that certainly though our assessment was that whenever possible it's good as a precautionary measure to limit the exposure to mercury from any sources, and in the United States, since we do have the ability and principal to use to single-dose presentations that don't require a preservative, that would be the appropriate precautionary step to take. Mr. Burton. Why haven't we done that before now? I mean, in 1998, the FDA showed it was concerned about the neurotoxic effect of mercury from cumulative dosing. And if you look at exhibit No. 3--do you have that in front of you? [Exhibit 3 follows:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] Dr. Midthun. No, I don't. Could I please see those? Mr. Burton. Give that to them, would you please. I want to read you what--this is a memo from Dr. Marianne Gruber to Dr. Carolyn Hardegree and Dr. Norman Baylor of the FDA. It's dated September 17, 1998, and it's entitled ``Point Paper, Preclinical Reproductive Toxicity Studies for Vaccines.'' And on No. C there, if you are looking at it, it says--Dr. Gruber says, for investigational vaccines indicated for material immunization, the use of single-dose files should be required to avoid the need of preservatives in multi-dose vials as are required by the Code of Federal Regulations. Of concern here is the potential neurotoxic effect of mercury, especially when considering cumulative doses of this component early in infancy. All mercury-containing vaccine formulations should be evaluated in appropriate preclinical reproductive toxicology studies that include the assessment of postnatal, behavioral, and developmental end points. Read that? Dr. Midthun. I am sorry, I don't see point C on here. I am looking at exhibit 3, and I see A and B. Mr. Burton. It's on page 4. Dr. Midthun. Page 2--3. Mr. Burton. And these are some of your---- Dr. Midthun. I still--I'm sorry, don't see point C on page 4. I see the heading, the first bold heading. Mr. Burton. The last paragraph down at the bottom. Dr. Midthun. For investigational vaccines indicated for maternal immunization. That paragraph? Mr. Burton. Yeah. Dr. Midthun. OK. Let me take a look at that, please. Mr. Burton. All right. Dr. Midthun. This is a specific reference to maternal immunizations, specifically evaluating investigational vaccines to administer to pregnant women. Mr. Burton. Right. Dr. Midthun. And there, you know, the--obviously, again, as a precautionary measure to limit the exposure to mercury and also to evaluate any vaccine that is investigational that you are trying to evaluate for that particular use that these kinds of studies should be done. So this is a specific reference to vaccination of pregnant women, for vaccines indicated for them. Mr. Burton. So let me get this straight. There are 1,500 articles written about the problems with thimerosal and vaccines, we have had a 40fold increase in the number of children that are autistic, You had this statement regarding pregnant women, and yet you didn't think that there was any concern about children, infants, getting these vaccines that had thimerosal in them at that time? Dr. Midthun. Again, I haven't had an opportunity to look at this whole--this whole memorandum, but I think that clearly this relates to a time pursuant to the FDAMA--FDA Modernization Act of 1997--when a process was initiated to review mercury in general in all drugs and biologics, including, of course, vaccines. Mr. Burton. Do you think mercury is a bad thing to be putting in your body? Dr. Midthun. I think we recognize that mercury in large amounts clearly is harmful. Mr. Burton. How much is a large amount? Dr. Midthun. You know, there are different studies that have been done to look at that. And I think that some of the studies that came out of the Faroe Islands indicated that perhaps lower amounts could cause problems based on subtle year developmental observations that were seen in that study. Although my understanding was that some of the interpretations of that study were also somewhat confounded by the probable exposure to PCBs. Mr. Burton. Enough. Enough. That's enough. I just don't want to hear any more of that. Take a look at this slide that's up here, would you please. That shows the amount of money that is spent on diabetes at the top, AIDS next, and autism at the bottom. And autism is one of the fastest growing epidemics in the country. Why is it we're spending such a small amount on research? I know Dr. Foote says we're spending more. But even if we were spending the $55 million you're talking about we're spending $2,770,000 on AIDS and $845,000 on diabetes, not to diminish those, they're very important. But one of the fastest growing, if not the fastest growing epidemic in the country is autism. And we're spending just a minute amount on that when we're going to have these kids with us for life and they're damaged. Why is it more research hasn't been done before now? Mr. Foote. Well, as you know, these budget figures are the bottom line of a very complex set of processes. Certainly we are doing--we are engaged in a lot of activities designed to increase the number of investigators who are capable of constructively utilizing research funding to study questions about autism. And that's one of the major hopes we have for the autism centers program is that these will create sites at which young people can get intensive training in autism-related issues. And it is our full expectation that then they will become qualified and highly competitive investigators for NIH funds. Mr. Burton. How many studies are currently going on? Mr. Foote. How many autism-related research grants---- Mr. Burton. Studies, that the Federal Government is funding, how many are going on right now that are started? Mr. Foote. I don't think I can speak for the entire Federal Government, but there are five NIH institutes that fund autism research and it runs up into probably a few hundred grants. Mr. Burton. When does all this start, do you know? Mr. Foote. Well, as I indicated in my opening remarks, autism research has been going on in some substantial degree for at least a decade at NIH, but the exponential curves that we've been discussing certainly apply to the amount of money going into autism research, which has increased very dramatically over the past few years. Mr. Burton. Are there still vaccines in doctors' offices right now today that contain thimerosal that are being given to children? Dr. Midthun. I don't believe so, no. As I mentioned, all vaccines for the routine recommended childhood immunization series started 2001 have been manufactured either thimerosal free or with markedly reduced amounts of that thimerosal. Now, that's just the vaccines that are in the routinely recommended immunization schedule. As I mentioned, influenza vaccines which are not part of that recommended schedule but were encouraged to be administered by the ACIP, although they're not yet part of the routine schedule, those are now available in a thimerosal trace formulation for both of Evans vaccines and Aventis Pasteur vaccines. As I mentioned, Wyeth announced its intentions not to manufacture an influenza vaccine after this year. But the other two do offer this trace thimerosal presentation. However---- Mr. Burton. But they still have that thimerosal in them. Dr. Midthun. Yes, they still also have multi-dose vials that do contain---- Mr. Burton. Why don't they go to single-dose vials? Dr. Midthun. I know that they are considering the feasibility of---- Mr. Burton. Why don't you tell them to do that? Dr. Midthun. We consider these vaccines, which also contain thimerosal as a preservative to be safe and effective. However, we do consider that it's important to have vaccines---- Mr. Burton. Did you hear any of the testimony earlier from those people that were testifying, those scientists and doctors? Dr. Midthun. Yes, I did. Mr. Burton. Did you see the study from Canada there that showed the damage that's done when a very minute amount of mercury is given, put in proximity to brain cells. Dr. Midthun. I think it's hard to extrapolate that data to what actually happens in a clinical situation. Mr. Burton. You know, every study that's been done, Doctor, that you guys put forth showing that there's no correlation between thimerosal and autism doesn't say categorically that thimerosal doesn't cause autism. They never say that. Can you are tell me right now categorically without any doubt whatsoever that mercury in vaccines does not cause autism? Dr. Midthun. I think what I'd have to say is what the Institute of Medicine concluded is that the body of evidence neither---- Mr. Burton. I want you to give me a yes or no. Can you tell me, can you say right now just flat out, just say can you tell me without any doubt whatsoever that the mercury in vaccines does not cause neurological problems or autism? Dr. Midthun. We can neither accept nor reject a causal relationship. Mr. Burton. So what you're saying is you cannot tell me that, you cannot say categorically, can you? Dr. Midthun. We don't know one way or the other. Mr. Burton. So why are you keeping something in there if you don't know one way or the other when you know that there's an epidemic of autism? If there's an epidemic of something, why do you keep it in there when you're not sure? Because every study I've seen flatly says you're not sure. You say there's-- you can't say yea or nay. Dr. Midthun. I think you have to consider the benefit that vaccines confer. And there's a definite benefit from influenza vaccine and having an adequate supply of vaccine is very important. Mr. Burton. Let me followup on that then. Single-shot vials, does that need thimerosal? Dr. Midthun. No, they don't, but---- Mr. Burton. Why do we have single shot vials? Dr. Midthun. There are a lot of manufacturing issues associated with switching over. You need much more filling capacity for the lines. You need a lot more other kinds of things that need to be introduced, so although it can be done and both Evans and Aventis Pasteur have started to introduce that, it is not something that at present they have the capacity to do in entirety. Mr. Burton. Let me ask you this: Do these pharmaceutical companies that produce these vaccines had, in the past, the ability to produce, and have they produced single-shot vials? Dr. Midthun. Yes, they do. Because that's how Evans and Aventis Pasteur is doing it to right now. Mr. Burton. How about all of the pharmaceutical companies? Do all of the pharmaceutical companies pretty much have the ability to produce single-shot vials? Dr. Midthun. You know, I couldn't speak to that categorically. I don't know. But I do know certainly in the case of Adventis Pasteur and Evans they do have the ability because they are doing that. Mr. Burton. Then why hasn't the FDA, to be on the safe side, knowing that we're having one in over 250, and in some cases, one in 150 children becoming autistic, and there's a growing body of evidence that thimerosal and mercury is causing that, why wouldn't you go down the cautious road instead of coming up with these additional studies that say well, we're not sure, we can't say yea or nay, why not go to single-shot vials? Dr. Midthun. Because we believe that the multi-dose vials continue to be safe and effective and that they speak to having enough supply of influenza vaccine, which serves a very important public---- Mr. Burton. Let me end up by saying this. I'm a student. I studied at the Cincinnati Bible Seminary. I don't like to quote scripture very often, but there's none so blind as those that will not see. You just sit there and you keep saying over and over and over again that you think that there's not a real danger for having this mercury in these vaccines. There's been 1,500-plus articles written saying that there is a problem. We've got scientists from all over the world coming in here. You saw a demonstration from a Canadian tape showing the impact of a minute amount of mercury in brain cells. And yet you continue to say well, we don't think that a very small amount of mercury--but you don't know because there's no study that you've put out, not one that says categorically that mercury in vaccines does not cause neurological problems. You can't tell me that today. You've hedged all over that issue. You guys continue to keep coming up here and making excuses. And I don't know why. Why not just get it out of there? Dr. Weldon. Mr. Weldon. Thank you, Mr. Chairman. I want to thank all of our witnesses in this panel for being here, and I didn't get an opportunity to thank the previous panel. Dr. Midthun, as I understand it, according to what you've said, thimerosal is in multi-dose vials of the influenza vaccine for a variety of reasons. We do currently recommend that children at risk receive the flu vaccine injection, is that correct? Dr. Midthun. That's correct. Mr. Weldon. So though it is the case that thimerosal has been removed from all of the standard pediatric inoculations like MMR and DTPA, that some children may be getting thimerosal from the multi-dose vials that are still out there on the market, is that correct? Dr. Midthun. That's possible although I know that Aventis Pasteur, in speaking with them, they've tried very hard to target the trace thimerosal to the pediatric population, yes. Mr. Weldon. Well, I would recommend to the FDA that you issue a recommendation that the single dose thimerosal free influenza vaccine be the vaccine used in the pediatric population. Mr. Burton. Would the gentleman yield? Mr. Weldon. Yes. Mr. Burton. Because of the huge rise in Alzheimers and because they're putting thimerosal in the vaccines for flu for adults as well, and all the Members of Congress that get those shots are getting them, I wish you would amend that to take it out of all flu vaccines. Mr. Weldon. Well, Mr. Chairman I was going to get to that issue. What exactly is the problem, could you just explain it a little more detail, you know, if I were to offer an amendment on the Labor HHS appropriation bill, mandating that all thimerosal be removed from the market in the United States by a date certain, let's say July 2003 or December 31st, what is the problem with getting rid of this substance? Dr. Midthun. That is something that you know the manufacturers, you know, one would you have to say to them exactly---- Mr. Weldon. Manufacturing process? Dr. Midthun. It is that one has to remove the thimerosal from the product but then an even bigger issue is that you then have to fill multi-dose vials. And to fill multi-dose vials takes a lot more filling lung capacity than to fill multi-dose vials. So you have to have an infrastructure in place to be able to set that up. And I mean---- Mr. Weldon. So your concern is that such a mandate would result, if I understand your testimony correctly, in a possible shortage of available vaccine on the market. Dr. Midthun. That's correct. I believe that is the case. Mr. Weldon. OK. Dr. Midthun. I don't believe that a transition can be made that quickly without creating quite a shortage. Let me just mention one other issue, and we've all been aware of vaccine shortages over these last couple of years is that Wyeth did announce that they are leaving the influenza vaccine market. So the market which previously had four manufacturers back in 2000, Parke Davis left that year, that had us down to three manufacturers and that was the first year where we experienced the influenza shortage. Then last year we had somewhat of a delay there. Availability of the three remaining manufacturers worked very hard to make up for the shortfall of the fourth one who left. This year we'll be down to two. So I have concerns that taking that kind of a step, I don't believe it could be accomplished in that kind of a timeframe without leaving a vaccine shortage. I think one must consider the benefit that the vaccine conveys in terms of disease prevention against these other issues. Mr. Burton. Would the gentleman yield again? I'm sorry. The implication of your answer is that because of the problems with thimerosal and so forth, that's why they're not producing the flu vaccine, influenza vaccine again. Dr. Midthun. No. No. I do not know that. All I know---- Mr. Burton. Isn't it true they are going to single-shot vials for measles; is that right? They're going to a nasal flu vaccine instead, is that not correct? Dr. Midthun. There is a license application in for a live attenuated nasally administered influenza vaccine. That vaccine--and I can disclose that because that is public knowledge--that vaccine is being developed by Metamune. Mr. Burton. Will that contain thimerosal? Dr. Midthun. No, that's a live, attenuated vaccine. That does not contain thimerosal. Mr. Burton. Thank you. Mr. Weldon. I understand there is, under development, a nasal measles vaccine as well, is that correct? Dr. Midthun. You know, I don't know exactly what's been publicly disclosed here in open session. I can neither acknowledge or deny the existence of an IND. So I don't know what's been publicly disclosed in terms of any measles vaccines that might be under investigation or new drug application development. Mr. Weldon. OK. Mr. Foote, you know, I often wish I was Bill Gates and could just fund some research, I was originally made aware of Dr. Wakefield's work about 3 years ago when one of my constituents came in my office and contended that his child was well, developing normally with appropriate speech and eye contact, and then got the MMR and then proceeded to go down the tubes and got a second MMR years later and got even worse. And, you know, Dr. Wakefield's research was not expensive. You know, we throw billions of dollars around this town. What's the delay in getting this research done? And you know, we had a hearing back I think in July this fellow Kreigsman came in and on his own he has scoped all these kids and he's seen all the same exact findings that Dr. Wakefield has and he was real excited I've been talking to this guy, he's been biopsying all of these he's got all these little specimens and the IRP, Atlantic center hospital doesn't want to do the pathology on these things. They're just--I don't know if they're afraid or what, but you know, can't you find some way to just answer the doggone question so I don't to keep asking the same question year in year out. Am I going to be here in the 112th Congress asking NIH to answer me the question is Dr. Wake field a crack pot or is he on to something with the MMR? Mr. Foote. So, after that hearing which I was either a witness or I was accompanying, I've already been up here a couple of times this year so I can't remember exactly which one that was I initiated a conversation with Dr. Kriegsman. I gave Dr. Kriegsman my business card, I told him to contact me because NIH would be interested in receiving a grant application in this area, especially from someone who it seemed had pilot data, and in his case, I believe a group of control subjects, material from control subjects which was--which would be critical to a well-designed study of the Wakefield kind of phenomenon. So I did indeed have some phone conversations with him. We discussed this IRB issue. He was just at the point of interacting further with, I think--I think there was--there's some question in my mind about where exactly the IRB was located. I think this was part of the problem. But he explained some of these problems to me. I gave him whatever advice I could. I made clear that should he be able to resolve those difficulties, we would be very interested in receiving an application. When I attended, the meeting annual meeting of the Autism Society of America---- Mr. Weldon. Go ahead, I'm sorry. Mr. Foote. I was going to make one more quick point which is, when I attended the meeting of the annual meeting of the Autism Society of America in Indianapolis, I had a meeting with Dr. Wakefield and with some of his colleagues and so on. I made clear to them that I was willing to be a contact point within NIH for Dr. Wakefield or anybody else who was interested in submitting a grant application to---- Mr. Weldon. You know I'm not really interested in a grant to Dr. Wakefield. I would like somebody else to try to duplicate his work. And I think you could duplicate his work for $250,000 or less. And why can't we get that done? Mr. Foote. All I'm telling you is when I meet somebody who--there were others---- Mr. Weldon. You're saying if somebody applies, you'll look very favorably. Mr. Foote. I'll go further than that. I will help them figure out what the most effective--that is my job, I do it every day--what the most effective way is to approach NIH for getting funding for that research. Mr. Burton. Let me just ask a question. Dr. Kriegsman, now you've talked to him several times you said. Mr. Foote. I talked to him, I think, twice on the phone about these. Mr. Burton. You told him what now? Mr. Foote. I told him NIH, I would help him interface with NIH in terms of what kind of grant application to prepare, what kinds of review committees to institute---- Mr. Burton. What else did he have to do before you could help him? Mr. Foote. He told me that his problem was very similar to what Dr. Weldon indicated, it sounds like Dr. Weldon had some contact with him afterwards, also that he was having trouble with his institutional review for human subject studies. Mr. Burton. Down there at his hospital or his---- Mr. Foote. At his hospital or whatever IRP was responsible. Mr. Burton. Assuming that's the case and you realized the gravity of this situation, why doesn't our health agencies try to assist him in getting past that barrier? I mean, you know, it seems to me you say OK, if you can get past this barrier, and you know full well that there's a recalcitrance on the part of the Board of Governors of a hospital or health institution, it seems to me you would say, hey, this is significant enough that we really ought to help this guy instead of just saying when you get past that, give us a call. Can't you do something like that? Can't you guys initiate some help for some of these people? Mr. Foote. We have in terms of human subjects, animal subjects, ethical issues and so on, the model that is in place is that the grantee institutions assume responsibility for those issues. And NIH tries not to mandate or micromanage those issues at grantee institutions. Mr. Burton. So if a person---- Mr. Foote. There is a limit on me intruding or anybody else intruding into those types of considerations. Mr. Burton. Let me give you a hypothetical. Let's say we were going to have, in some part of the country, let's say major outbreak of smallpox. And let's say that we had an institution where a doctor or scientist had some kind of an answer to the problem. And he said he was running into because of insurance purposes or some other legal reason his board of directors from being able to get their support for this IRB. So you would say what let the epidemic spread or what would you do? Mr. Foote. Well, I would offer an alternative. Mr. Burton. What's the alternative you're offering him? Mr. Foote. He never called me back? Mr. Burton. Well, I'm telling you he's going to call you back, and I hope. Mr. Foote. That's just fine. This is what program staff at NIH do is help investigators in face with our organization. Mr. Burton. Does he know that you would help him find an alternative? Mr. Foote. I think I had, including at the hearing here, I think I had three or four very cordial conversations with him and encouraged him. Mr. Weldon. I just want to clarify with Dr. Foote exactly what's going on. He's done the endoscopies, he's biopsied the kids, he's got the specimens, he wanted to do duplicate the work that Dr. O'Leary did looking for the presence of measles virus RNA in the lymph follicles of these kids, and that's the nature of the patho physiologic conjecture that they're engaged in, and the IRB Atlantic cell said no, we don't want to go there, we don't want to mess with this. I just want to make it very, very clear. My area of concern is this: Is when you leave all these questions out there unanswered, it creates a lot of uncertainty. And the British have not handled this very well and they still continue not to handle it very well. And that we just have an open dialog and just absolutely pursue the data, it's in the best interest of the program in making sure the kids continue to get vaccinated. And I don't know what it will take to get the answers to this question, but I'm certainly ready to work with you. Mr. Chairman, I got to go apologize. I'd love to linger. Mr. Burton. God bless you, my son, go in peace. But let me just say to Dr. Foote, you will be getting a call from him in the next couple of days, I promise you that. And I probably will be on the phone with you in a conference call. Thanks, Dr. Weldon. I have to put on my specs here because vanity prohibits me from wearing them all the time like Cyrano de Bergerac, you have to read about him. Here is an e-mail, and this e-mail is from who? See, I want to read to you an e-mail we got yesterday from a father of an autistic child. Ray Gallup's son, he's 17, he's vaccine injured and an autistic child as a result. 17 years old. Our family is living in hell. With our 17-year-old son Eric, who is 6 feet tall and 150 pounds. Now, imagine 6 feet tall 150 pounds like that boy you saw on television or on the monitor a while ago. He attacked Helen, Julie my daughter, and myself. He head butted Julie and bit my wife on the head. Eric bit one of my fingers. This isn't the first time and it's getting worse. We have to help and I'm afraid for the safety of our family and our son. Eric was like he was 6 foot 5 and 300 pounds on Sunday when he had his tantrum. I held him down but he tried to bite me and kick and scratch me. I was so exhausted I couldn't breathe and I thought I would have a heart attack. When we closed the doors to lock ourselves from Eric--lock ourselves from Eric--he kicked on the door breaking some of the wood. I don't know what to do any more short of calling the police. We're at our wit's ends. This is our lot in life. We're trusting the medical profession that vaccines are safe. We're paying a bitter price for that trust. It is hard to have any holiday feelings when we see what has happened to our son and our family. Again, I'm sorry I couldn't attend but we are under siege. You know, Dr. Midthun, and Dr. Foote, and Dr. Portier, when you hear those stories, doesn't it bother you a little bit and you keep telling us you come up here week after week, month after month, year after year saying, well, mercury doesn't cause that. But when we read your reports it doesn't say that. It doesn't tell us anything. It says well, we're not sure. So you take the position since there's no scientific evidence for sure that the mercury is causing it, that we should go ahead and leave it in there or have been leaving it in there. But you don't take the other side, which is the side that errs on the side of safety. Let's go to these pharmaceutical companies and say OK, we know it's going to cost a little more for single-shot vials, but we want you to do it. We want to recall, recall all of the vaccines that contain mercury because it is a toxic substance, and we don't know all the answers. And until we do know all the answers, we want to err on the side of safety so we don't have anymore 6 foot 5 kids beating the heck out of their parents, biting their father, kicking in doors and injuring the mother and sister. But that's going to happen more and more. You know my grandson, who's autistic, is going to be 6 foot 10 according to the doctors. My father was 6 foot 8, his father--his grandfather on the other side was about 6 foot 8. So he's going to be a tall kid. Can you imagine when he's 16 years old trying to control him if he goes out of control? What are we going to do? What are all these families going to do? And yet we don't have a vaccine injury compensation fund that's responsive to these people. The language that was put in the homeland security bill blocks an avenue through the courts. And these families continue to fight this hardship with their own money because they have no place to go, and you continue to put, you continue to let this substance in there. I just cannot understand it. I just don't understand it. I have one question for you, Dr. Portier, and then we'll submit some questions for the records that I hope you'll answer for me. Dr. Portier, does the study recently published in The Lancet identify the effects of mercury on infants who are vaccinated with thimerosal? Does the study recently published in The Lancet identify the effects of mercury on infants who are vaccinated with thimerosal? Dr. Portier. No. Mr. Burton. It does not. Are you familiar with the CDC's vaccine safety data project evaluating thimerosal containing vaccines in children that found a weak signal between the receipt of these vaccines and neurological developmental delays and the attention deficit disorder? Dr. Portier. Not familiar enough with the study to give you any intelligent comment. Mr. Burton. Has the NIEHS and the NIH conducted any further analysis of the VSD data base? Dr. Portier. No, we have not, to my knowledge. Mr. Burton. Has the NIEHS evaluated why some children seem to hold on to mercury in their brains and their bodies? Or why some hol onto heavy metals rather than flush it from their bodies? If not, why not? Dr. Portier. That is one of the issues specifically for mercury and that's being looked at at our centers program. That's part of the research agenda of the National Toxicology Program and for other metals, that is certainly part of our research agenda. Mr. Burton. OK. Well, thank you. I think I'm going to submit questions to you. One more thing, and this is very important. I hope you will join with me as health professionals in urging the President to have a White House conference on autism which will bring parents in, scientists who have differing points of view as well as people from our health agencies in to discuss the problems with autism, what people go through, what the causes are and so on and so forth. This is such an epidemic, gone from 1 in 10,000 to more than 1 in 250 that it's something that we can't hide anymore. I'd like for to you join me in asking the White House to make this a real focal point by having this conference on autism. And I guess you can't probably give me an answer until you talk to your superiors, but I'm making that official request, an official request. I hope you'll do that and get back to us. Let me conclude by saying we will continue on with this subject. You have gotten mercury out of a lot of the vaccines. I berated you a lot in the past and a little bit today because it's still in some. But we have moved in the right direction. It's a shame that it has taken this long to get it out as much as we have. But I can tell you there's going to be a lot more Congressmen very concerned about there because we're start together tell all of them that when they get their flu shot, they're getting mercury in them. And that there's a growing body of evidence that mercury in vaccines may be a major cause of Alzheimers. And when I tell my colleagues that, there's going to be more and more of them wanting to raise Cain about this. And I know you don't want to have to deal with you know another 200 Dan Burtons, my God, that would be something even I wouldn't want to deal with. So I hope that you'll take this to heart and I hope we don't have to have too many more hearings like this, but we will if we don't see some real change and see some studies on this. With that we'll submit some questions to you for the record. I hope you'll answer them. Thank you for being here. We stand adjourned. [Whereupon, at 5:02 p.m., the committee was adjourned.] [The prepared statement of Hon. Wm. Lacy Clay, additional information submitted for the hearing record, and a complete set of exhibits follow:] [GRAPHICS NOT AVAILABLE IN TIFF FORMAT] -