Dan Burton

Mr. BURTON of Indiana

Mr. BURTON of Indiana. Mr. Speaker, the gentleman from Minnesota (Mr. Gutknecht), the gentleman from Maine (Mr. Allen), the gentleman from Vermont (Mr. Sanders), and the gentlewoman from California (Ms. Watson) and myself are going to be talking this hour about the problems that we have in this country with exorbitant pharmaceutical prices. We all believe in the free enterprise system, and we believe that private industry ought to make a profit, but we also believe the American people ought to get the best bang for their buck. Unfortunately, the pharmaceutical industry has been taking advantage of Americans for a long, long time, and it is just now becoming evident. The gentleman from Minnesota (Mr. Gutknecht) made this chart up originally, and this chart, I know it is difficult for my colleagues to see, but it shows the disparity between pharmaceutical products purchased in the United States and those purchased in Canada. In some cases, products, pharmaceutical products manufactured here in the United States that are sold in other parts of the world, sell for one- tenth the price that they sell for here in the United States; and yet the American people, when they try to buy those products abroad through the Internet, are being criticized for that, and the Food and Drug Administration, hiding behind the veil of protecting the public from products that might harm them, are saying that they are not going to allow these Internet sites to sell these products. The very same products sold here in the United States, they are not allowing them to be purchased from Canada or other countries so the American consumer can save as much as 50 percent of their pharmaceutical costs. I have a constituent who was paying $1,300 a month or $1,200 a month for pharmaceutical products, and he bought the very same products on the Internet from Canada for less than half that amount, so he was saving $7,000 a year by purchasing them from Canada. And now the FDA, along with the pharmaceutical companies, are trying to stop him from doing that. We have over a million people in this country, probably closer to 2 million, who are buying their pharmaceutical products from Canada over the Internet. But the pharmaceutical companies and the FDA are trying to stop the American people from saving money and getting the products at a fair market price. Today, in the New York Times there is an article, and I do not quote from the New York Times very often, but there is an article talking about the exorbitant amount of money that the pharmaceutical industry is going to be spending over the next year to influence Congress, State legislators, government agencies and so forth to keep the prices of pharmaceutical products very high in the United States and prohibit the importation or reimportation of their products from other countries where they are selling them much cheaper. In 1990, PhRMA spent $2.3 million in that cycle here in Washington and around the country. In 1992, it more than doubled to $4.9 million. In 1994, it went to $5.2 million; and in 1996 it went to $9.2 million. In the year 2000, it jumped up to almost $20 million, and it was over $20 million in the year 2002. Let me read what was in the New York Times today. ``Lobbyists for the drug industry are stepping up spending to influence Congress, the States and even foreign governments as the debate intensifies over how to provide prescription drugs benefits to the elderly, industry executives say.'' The article goes on to say, ``The documents show that the trade association, the Pharmaceutical Research and Manufacturers of America, known as PhRMA, will spend at least $150 million this year. That represents an increase of their total budget of 23 percent over last year which was $121.7 million. Directors of the trade association approved the new budget, together with an increase in membership dues, to pay for an expanded lobbying campaign at a meeting last week. They have over 600 lobbyists in Washington, D.C.'' Here is what they say: ``Unless we achieve enactment this year of market-based Medicare drug coverage for seniors, the industry's vulnerability will increase in the remainder of 2003 and in the 2004 election year,'' and it will demonize the industry if they do not get this done. Now, we are for market-based pricing. The gentleman from Minnesota (Mr. Gutknecht) has said that many, many times. But that should be across the spectrum, not just here in the United States of America. I mean, in Canada if you can buy a product for $70, why should it cost $122 here in the United States right across the border, just a mile apart? And the reason is they are charging an exorbitant amount of money to the Americans, and they are loading the research and development and everything else on the back of American consumers instead of spreading it across the world. If they are talking about market-based drug coverage for seniors, then the burden should be spread equally across the spectrum, not just here in the United States but across Canada and Europe. If we did that, the price for all Americans would go down dramatically. The drug trade group plans to spend $1 million for an intellectual echo chamber of economists, a standing network of economists and thought-leaders, to speak against Federal price control regulations through articles and testimony, and to serve as a rapid-response team. A rapid-response team, that sounds like a military action. Well, we want to make sure that we do not have to have price controls. If we had fair pricing across the spectrum, around the world, then I think the Americans would get a fair price when they buy their products. But unfortunately, the products are a lot lower in other countries, in Europe, in Germany, in France, in Spain, in Canada, in Mexico; much, much less than they are here. Yet they want to keep those prices higher here in the United States so they can keep their profits high. The trade association and its tactics have become an issue. In debate on the floor of the Senate last summer, Senator Durbin, Democrat of Illinois, said PhRMA, this lobby has a death grip on Congress. After seeing what I have seen over the past month, month and a half, I am not so sure he is wrong. The influence that the pharmaceutical industry has in the halls of Congress and in the executive branch mystifies me. We are supposed to be sent here to represent the people of this country, to make sure they get a fair shake across the board. Yet the pharmaceutical industry has been loading huge, huge profits on the backs of the American people while making much smaller profits right across the border in Canada by selling their products at a more competitive rate. If Americans try to buy them up there now, now they are trying to stop them. The day after the pharmaceutical giant GlaxoSmithKline said they were going to pull out of Canadian pharmacies that were selling across the border through the Internet, the FDA I think the next day or the day after said there may be a concern about the safety of these pharmaceutical products. And so they were marching in lockstep with the pharmaceutical industry to stop Americans from getting these lower- priced pharmaceutical products, the same products they can get here, from Canada. Dues from the pharmaceutical industry will go to $144 million, an increase of 24 percent or $28.3 million over this year's dues. In its budget for the fiscal year that begins July 1, the pharmaceutical lobby earmarks $72.7 million for advocacy at the Federal level directed mainly at, you guessed it, the Congress of the United States. $72.7 million to lobby us; $4.9 million to lobby the Food and Drug Administration. I do not know if they have to spend that much because I think the FDA is pretty much in their pocket already. And $48.7 million for advocacy at the State level. In addition, the budget sets aside $17.5 million to fight price controls and protect patent rights in foreign countries and in trade negotiations. The PhRMA budget allocates $1 million to change the Canadian health care system and $450,000 to stem the flow of low-priced prescription drugs from online pharmacies in Canada to customers through the Internet here in the United States. I think it is kind of funny. They are going to spend $73 million to lobby Congress and only a million to do it in Canada. I think that is because they feel like it is a lost cause up there. In a memorandum for the PhRMA board, it says the industry is on the defensive, facing a perfect storm whipped up by several factors, expanding government price controls abroad, resulting in politically unstable crossborder pricing differences; increasing availability of medicines from abroad via Internet sales; State ballot initiatives to make drugs more affordable in the United States; increasing State demands for drug discounts in the Medicaid program; and false perceptions that drug prices are increasing by 20 percent a year. I do not know whether they are going up 20 percent a year, but they are a heck of a lot more here than they are in Mexico, in Canada, in Spain, in Germany, in France and elsewhere. Let me go into this breakdown a little bit further, and then I will yield to my colleagues. At least $2 million, and perhaps $2.5 million, in payments to research and policy organizations to build intellectual capital and generate a higher volume of messages from credible sources sympathetic to the industry. They are going to hire a bunch of people to be their mouthpieces that are supposedly credible to convince us that we ought to let the American people be saddled with these huge prices while these same products can be sold elsewhere for a lot less. $9.4 million for public relations, including $1 million for inside- the-Beltway advertising. $555,000 for placement of op-eds. They are going to buy the op-ed pieces in the newspapers? $555,000 for placement of op-eds and articles by third parties. They are going to hire people to put these articles in and pay them $555,000. I suppose if I wanted to, I could write an op-ed on behalf of the pharmaceutical industry, and they would pay me to do it. $600,000 for polling; $1.3 million for local publicity in 15 States. I suppose that is congressional districts. For instance, in my district this last week, PhRMA went into Kokomo, Indiana, and talked to one of the writers; and they went to the Louisville Courier Journal, on both ends of my congressional district, to try to make the case that I did not know what I was talking about and that I was hurting the people of this country by trying to make sure they get a fair shake on these pharmaceutical prices, and they did that to try to discredit me and hurt me in my congressional district. I have to tell you something, PhRMA PR people, you are making a big mistake. A big mistake. The Federal affairs staff at PhRMA has quadrupled since 1999. The organization plans to spend $5 million for outside lobbyists at the Federal level. In their campaign contributions, drug companies have favored Republican candidates, but PhRMA has retained a diverse group of lobbyists to ensure access to Democrats as well. I am sure of that. I will not go into who some of their lobbyists are, but my colleagues in the House know that we have a lot of our former colleagues out there that are on the payroll of the pharmaceutical companies. Big, big bucks. The State government affairs division of PhRMA will spend $3.1 million to retain more than 60 lobbyists in 50 States. The number of State legislative proposals dealing with prescription drugs has doubled since 1999. The drug industry says many of these bills are seriously negative, have a high probability of enactment, and require major attention on our part. They want to get it stopped. They hire 600 lobbyists here in Washington, D.C. That is more lobbyists than we have in Members of the House and the Senate. That is overkill. They only need one for each one of us. What are they going to do with the other 65? I guess they will all go to lunch, have a triple martini lunch. I hope PhRMA is watching this. I really do. PhRMA said it would spend $12.3 million to develop coalitions and strategic alliances with doctors, patients, universities, and influential members of minority groups. The organization has earmarked several million dollars to foster ties with groups like the National Black Caucus of State Legislators; the National Hispanic Caucus of State Legislators; and the National Medical Association, which represents the interests of African American doctors. The budget includes $500,000 for efforts to educate and activate Hispanic-Latino organizations at a State and Federal level. In other words, my colleagues, and I think my colleagues who are here on the floor tonight already know this, they are pulling out all the stops to keep their profits very high here in the United States, to saddle the American people with huge prices while they are selling these pharmaceutical products for a lot lower elsewhere, and they are going to lobby us to death to try to make sure those profits remain high. I am a free enterprise advocate. I believe in keeping our nose out of the private sector as much as possible; but when an industry starts beating American taxpayers to death and American consumers to death with exorbitantly high prices while at the same time they are selling these same products around the world for less and still making a profit and then they say, we cannot buy them abroad and they threaten the people who sell them to us from abroad with closing them down, then that is wrong. That is bullyism and that is something that cannot be tolerated. The free enterprise system, God bless it, should not tolerate that kind of activity from any industry. I will say to the pharmaceutical industry right now and I believe the pharmaceutical products have given us the highest quality of health care in the history of mankind, and God bless you for that; but you have gone too far when you start raping the American people; and that is what is going on with these prices right now and it ain't going to work. The Internet is here to stay. If you push in on one side of the balloon, it is going to pop out someplace else and you better get with the program. Make a profit, but make sure it is fair for everybody. Make sure it is fair for everybody. If you do that, I will be one of your biggest supporters as I have been in the past, and I am sure my colleagues will as well. We have the gentleman from Maine (Mr. Allen) here, the gentleman from Vermont (Mr. Sanders), the gentleman from Minnesota (Mr. Gutknecht), and the gentlewoman from California (Ms. Watson). Let me get this straight here. I want to make sure that everybody that is paying attention in their office understands this. Congressman Allen is a Democrat. I am a Republican. Congressman Sanders is an Independent. I am a Republican. Congressman Gutknecht, God bless him, is a Republican. I am a Republican. I like you a lot. And Congresswoman Watson is a Democrat from California. But we all see eye to eye on this. This is not a partisan issue. That is why I think the pharmaceutical industry spending hundreds of millions of dollars ain't going to win this battle because they cannot beat us when we are united. With that, let me yield to my colleague, the gentleman from Maine (Mr. Allen).

Mr. BURTON of Indiana. I thank my colleagues, and we will be taking special orders in the future. I hope they will join with me when we do that, and I look forward to even the gentleman from Ohio (Mr. Brown), if he has the time, to come to our hearing, which is a week from Thursday, because it is going to be a very important hearing on this entire subject.

Mr. BURTON of Indiana. One-sixth.

Mr. BURTON of Indiana. Before the gentleman departs, let me just say there are five of us here tonight, and I hope that we will all use our influence to educate the rest of our colleagues who are not as conversant with this problem as we might be. You, being one of the leaders on the Democrat side, I hope you will talk to your colleagues, along with the gentleman from Vermont (Mr. Sanders) and the gentlewoman from California (Ms. Watson.) I yield to the gentleman from Minnesota (Mr. Gutknecht).

Mr. BURTON of Indiana. Mr. Speaker, I thank the gentleman for coming down and joining us. We hope that he, along with a lot of our colleagues on both sides, will join with us in this fight to get this job done. We are just about out of time. If the gentleman from Minnesota (Mr. Gutknecht) needs time, I will yield to him. Let me just say one more time to the PhRMA people, if they happen to be following this discussion tonight, the people in the pharmaceutical industry, we all agree that they have done a great deal for mankind and they have given us the highest quality of health in the history of man; but at the same time, there is a limit to how much they can expect out of our veins as far as the price of pharmaceutical products, especially when we know those products are being sold for a lot less elsewhere. This fight is not going to end until we obtain victory. I want to tell them there are a lot of people here, besides those tonight, who are committed to making sure that we get these prices of pharmaceutical products down to a level that is acceptable for the American people, as they are in other parts of the world. No matter how much money the pharmaceutical companies spend or PhRMA spends, they ain't going to win this battle. So I think they need to get with the program instead of trying to stop Niagara Falls with a sieve. It is not going to work. I think Lincoln said it the best. He said, ``You can fool all of the people some of the time and some of the people all of the time, but you cannot fool all the people all the time,'' and this is so transparent the American people are going to get it and they are going to get it very quickly. I now yield to the gentleman from Minnesota (Mr. Gutknecht).

Mr. BURTON of Indiana. I think maybe that would be a good idea. Mr. Speaker, I think that it is a great idea to make the FDA respond by having a GAO study that does exactly what the gentleman is saying, to show how many people have suffered or died or worse because they could not get the prescription drug benefits. So that should be in our request to GAO. Mr. Speaker, I yield again to the gentlewoman from California.

Mr. BURTON of Indiana. We are just about out of time, but the gentleman from Ohio (Mr. Brown) came down to the floor and requested a few minutes.

Mr. BURTON of Indiana. Mr. Speaker, I thank the gentleman from Vermont (Mr. Sanders), and I would like to say to my colleagues that not this Thursday but next Thursday we are going to have a hearing in the Subcommittee on Wellness and Human Rights of the Committee on Government Reform. I anticipate and hope we will all be there, because we are going to have some witnesses come in from the pharmaceutical industry, and more witnesses come in from areas that can show that these products will be safe coming into the United States. We are going to have people from HHS and FDA there. I think it will be a very illuminating meeting; plus, we have some surprise information that will be coming out of that meeting, as well. The gentlewoman from California (Ms. Watson) has been very patient. I thank her very much for being with us. She has been a leader in California on a number of issues involving health. I am happy to say she is my ranking member on our committee, and she does a great job. I yield to the gentlewoman from California (Ms. Watson).

Mr. BURTON of Indiana. Mr. Speaker, while the gentlewoman was talking, I talked to the gentleman from Minnesota (Mr. Gutknecht), and one of the things in the law that the gentlewoman cited was that the FDA had to show that the products coming in were safe. Why do we not turn that around by amendment and say that the FDA has the burden of proof placed upon it to prove that pharmaceutical products coming into the country are not safe? And if we did that, that would open up the borders so people could buy these pharmaceutical products, and the FDA would have the burden of proof on its shoulders to prove they are not safe in order to stop them from coming in.

Mr. BURTON of Indiana. I will have a bill drafted; and if Members would be willing, I would like them to cosponsor this change.

Mr. BURTON of Indiana. Mr. Speaker, let me say to my colleague, who has been the leader on this issue for a long time, we all appreciate your hard work. And I understand your saying, shame on us. But the Food and Drug Administration, which we pay for with taxpayers' dollars, should not be protecting the pharmaceutical industry and making sure that these exorbitant profits are made year in and year out, and then coming to the rescue of the pharmaceutical industry when they are trying to stop the reimportation of pharmaceutical products from Canada by saying that there is a safety issue. It is unconscionable what they are doing over there, and we need to keep the heat on them. So maybe not, shame on the pharmaceutical industry by itself, but shame on them and the FDA and us for not being more responsive.

Mr. BURTON of Indiana. I think that needs to be dealt with along with the prescription drugs benefits we are going to talk about. I do not want to pass a prescription drug benefit that is going to guarantee the taxpayer paying for these huge profits being realized by the pharmaceutical industry. Let me go to my colleague, the gentleman from Vermont, Mr. Sanders, and then go to the gentlewoman from California (Ms. Watson). The gentleman from Vermont (Mr. Sanders) has been working on this for a long time as well.

Mr. BURTON of Indiana

Mr. BURTON of Indiana. Mr. Speaker, I submit the following report prepared by the staff of the Subcommittee on Human Rights and Wellness, Committee on Government Reform. This report is the result of a three- year investigation initiated in the Committee on Government Reform. Mercury in Medicine--Taking Unnecessary Risks I. Executive Summary Vaccines are the only medicines that American citizens are mandated to receive as a condition for school and day care attendance, and in some instances, employment. Additionally, families who receive federal assistance are also required to show proof that their children have been fully immunized. While the mandate for which vaccines must be administered is a state mandate, it is the Federal Government, through the Centers for Disease Control and Prevention (CDC) and its Advisory Committee for Immunization Practices that make the Universal Immunization Recommendations to which the majority of states defer when determining mandates. Since the early to mid-1990s, Congress has been concerned about the danger posed by mercury in medical applications, and in 1997, directed the Food and Drug Administration (FDA) to evaluate the human exposure to mercury through foods and drugs. In 1999, following up on the FDA evaluation and pursuant to its authority, the House Committee on Government Reform initiated an investigation into the dangers of exposure to mercury through vaccination. The investigation later expanded to examine the potential danger posed through exposure to mercury in dental amalgams. This full committee investigation complemented and built upon the investigations initiated by two of its subcommittees. In January 2003, the investigation continued in the newly formed Subcommittee on Human Rights and Wellness. A primary concern that arose early in the investigation of vaccine safety was the exposure of infants and young children to mercury, a known toxin, through mandatory childhood immunizations. This concern had been raised as a possible underlying factor in the dramatic rise in rates of late-onset or ``acquired'' autism. The symptoms of autism are markedly similar to those of mercury poisoning. Significant concern has been raised about the continued use of mercury in medical applications decades after the recognition that mercury can be harmful, especially to our most vulnerable population--our children. This report will address one form of mercury in medical applications, Thimerosal, as a preservative in vaccines. In July 2000, it was estimated that 8,000 children a day were being exposed to mercury in excess of Federal guidelines through their mandatory vaccines. One leading researcher made the following statement to the Committee in July 2000: ``There's no question that mercury does not belong in vaccines. ``There are other compounds that could be used as preservatives. And everything we know about childhood susceptibility, neurotoxicity of mercury at the fetus and at the infant level, points out that we should not have these fetuses and infants exposed to mercury. There's no need of it in the vaccines.'' The Food and Drug Administration's (FDA) mission is to ``promote and protect the public health by helping safe and effective products reach the market in a timely way, and monitoring products for continued safety after they are in use.'' However, the FDA uses a subjective barometer in determining when a product that has known risks can remain on the market. According to the agency, ``at the heart of all FDA's product evaluation decisions is a judgment about whether a new product's benefits to users will outweigh its risks. No regulated product is totally risk-free, so these judgments are important. FDA will allow a product to present more of a risk when its potential benefit is great-- especially for products used to treat serious, life- threatening conditions.'' This argument--that the known risks of infectious diseases outweigh a potential risk of neurological damage from exposure to thimerosal in vaccines, is one that has continuously been presented to the Committee by government officials. FDA officials have stressed that any possible risk from thimerosal was theoretical: that no proof of harm existed. Upon a thorough review of the scientific literature and internal documents from government and industry, the Committee did in fact find evidence that thimerosal posed a risk. The possible risk for harm from either low dose chronic or one time high level (bolus dose) exposure to thimerosal is not ``theoretical,'' but very real and documented in the medical literature. Congress has long been concerned about the human exposure to mercury through medical applications. As a result of these concerns, in 1997, Congress instructed the FDA to evaluate the human exposure to mercury through drugs and foods. Through this Congressionally mandated evaluation, the FDA realized that the amount of ethylmercury infants were exposed to in the first six months of life through their mandatory vaccinations exceeded the Environmental Protection Agency's (EPA) limit for a closely associated compound methylmercury. The FDA and other Federal agencies determined that in the absence of a specific standard for ethylmercury, the limits for ingested methylmercury should be used for injected ethylmercury. The Institute of Medicine, in 2000, evaluated the EPA's methylmercury standard and determined that based upon scientific data that it, rather than the FDA's, was the scientifically validated safe exposure standard. Rather than acting aggressively to remove thimerosal from children's vaccines, the FDA and other agencies within the Department of Health and Human Services (HHS) adopted an incremental approach that allowed children to continue to be exposed to ethylmercury from vaccines for more than two additional years. In fact, in 2001, the Centers for Disease Control and Prevention (CDC) refused even to express a preference for thimerosal-free vaccines, despite the fact that thimerosal had been removed from almost every childhood vaccine produced for use in the United States. On three occasions in the last 15 years, changes have been made to vaccine policies to reduce the risk of serious adverse effects. First, a transition from oral polio vaccine to injected polio was accomplished in the United States to reduce the transmission of vaccine-induced polio. Second, an acellular pertussis vaccine was developed and a transition from DTP to DTaP was accomplished to reduce the risk of pertussis--induced seizures in children. And third, when the Rotashield vaccine for rotavirus was linked to a serious bowel condition (intersucception), it was removed from the U.S. market. Ethylmercury has been largely removed from every major childhood vaccine manufactured for use in the United States, except the influenza vaccine, which continues to contain trace amounts. This success, however, does not change the fact that millions of American children were exposed to levels of mercury through vaccines that exceeded comparable federal guidelines. Many parents, and a growing number of scientists, believe that this mercury exposure may have contributed to the explosive growth in autism spectrum disorders, and neurological and behavioral disorders that this country has experienced. The scientific evidence in this area is considered by some to still be inconclusive, in large part due to the lack of serious, effective inquiry by our health agencies. The federal government has an obligation to vigorously pursue the necessary research to determine the extent of the impact of these heightened exposures to ethylmercury on our population. A second concern that arose during the investigation was the continued use of mercury in dental amalgams. Mercury has been used as a component in dental fillings since the Civil War era. The American Dental Association and its member dentists have taken a position that the mercury in fillings, which are considered toxic until placed in the tooth, and is considered toxic when removed from the mouth, is completely safe while in the human mouth. This position seems counter even to the ADA-funded research that shows the daily release of small amounts of mercury vapors in the human mouth where dental amalgams are present, as well as minute chipping and swallowing of the mercury fillings over time. Babies and young children are exposed to this additional mercury. As developing fetuses, babies are exposed to mercury through the placenta. If pregnant women have mercury amalgams, they are unknowingly excreting low levels of mercury on a daily basis to their fetuses. Additionally, children who receive dental services through Medicaid are also potentially exposed to mercury. When these children need dental fillings, because of the low cost, only mercury amalgams are available for use. This concern remains under investigation by the Subcommittee on Human Rights and Wellness. II. Findings and Recommendations A. Findings Through this investigation of pediatric vaccine safety, the following findings are made: 1. Mercury is hazardous to humans. Its use in medicinal products is undesirable, unnecessary and should be minimized or eliminated entirely. 2. For decades, ethylmercury was used extensively in medical products ranging from vaccines to topical ointments as preservative and an anti-bacteriological agent. 3. Manufacturers of vaccines and thimerosal, (an ethylmercury compound used in vaccines), have never conducted adequate testing on the safety of thimerosal. The FDA has never required manufacturers to conduct adequate safety testing on thimerosal and ethylmercury compounds. 4. Studies and papers documenting the hyperallergenicity and toxicity of thimerosal (ethylmercury) have existed for decades. 5. Autism in the United States has grown at epidemic proportions during the last decade. By some estimates the number of autistic children in the United States is growing between 10 and 17 percent per year. The medical community has been unable to determine the underlying cause(s) of this explosive growth. 6. At the same time that the incidence of autism was growing, the number of childhood vaccines containing thimerosal was growing, increasing the amount of ethylmercury to which infants were exposed threefold. 7. A growing number of scientists and researchers believe that a relationship between the increase in neurodevelopmental disorders of autism, attention deficit hyperactive disorder, and speech or language delay, and the increased use of thimerosal in vaccines is plausible and deserves more scrutiny. In 2001, the Institute of Medicine determined that such a relationship is biologically plausible, but that not enough evidence exists to support or reject this hypothesis. 8. The FDA acted too slowly to remove ethylmercury from over-the-counter products like topical ointments and skin creams. Although an advisory committee determined that ethylmercury was unsafe in these products in 1980, a rule requiring its removal was not finalized until 1998. 9. The FDA and the CDC failed in their duty to be vigilant as new vaccines containing thimerosal were approved and added to the immunization schedule. When the Hepatitis B and Haemophilus Influenzae Type b vaccines were added to the recommended schedule of childhood immunizations, the cumulative amount of ethylmercury to which children were exposed nearly tripled. 10. The amount of ethylmercury to which children were exposed through vaccines prior to the 1999 announcement exceeded two safety thresholds established by the Federal government for a closely related substance--methylmercury. While the Federal Government has established no safety threshold for ethylmercury, experts agree that the methylmercury guidelines are a good substitute. Federal health officials have conceded that the amount of thimerosal in vaccines exceeded the EPA threshold of 0.1 micrograms per kilogram of bodyweight. In fact, the amount of mercury in one dose of DTaP or Hepatitis B vaccines (25 micrograms each) exceeded this threshold many times over. Federal health officials have not conceded that this amount of thimerosal in vaccines exceeded the FDA's more relaxed threshold of 0.4 micrograms per kilogram of body weight. In most cases, however, it clearly did. 11. The actions taken by the HHS to remove thimerosal from vaccines in 1999 were not sufficiently aggressive. As a result, thimerosal remained in some vaccines for an additional two years. 12. The CDC's failure to state a preference for thimerosal- free vaccines in 2000 and again in 2001 was an abdication of their responsibility. As a result, many children received vaccines containing thimerosal when thimerosal-free alternatives were available. 13. The Influenza vaccine appears to be the sole remaining vaccine given to children in the United States on a regular basis that contains thimerosal. Two formulations recommended for children six months of age or older continue to contain trace amounts of thimerosal. Thimerosal should be removed from these vaccines. No amount of mercury is appropriate in any childhood vaccine. 14. The CDC in general and the National Immunization Program in particular are conflicted in their duties to monitor the safety of vaccines, while also charged with the responsibility of purchasing vaccines for resale as well as promoting increased immunization rates. 15. There is inadequate research regarding ethylmercury neurotoxicity and nephrotoxicity. 16. There is inadequate research regarding the relationship between autism and the use of mercury-containing vaccines. 17. To date, studies conducted or funded by the CDC that purportedly dispute any correlation between autism and vaccine injury have been of poor design, under-powered, and fatally flawed. The CDC's rush to support and promote such research is reflective of a philosophical conflict in looking fairly at emerging theories and clinical data related to adverse reactions from vaccinations. B. Recommendations 1. Access by independent researchers to the Vaccine Safety Datalink database is needed for independent replication and validation of CDC studies regarding exposure of infants to mercury-containing vaccines and autism. The current process to allow access remains inadequate. 2. A more integrated approach to mercury research is needed. There are different routes that mercury takes into the body, and there are different rates of absorption. Mercury bioaccumulates; the Agency for Toxic Substances and Disease Registry (ATSDR) clearly states: ``This substance may harm you.'' Studies should be conducted that pool the results of independent research that has been done thus far, and a comprehensive approach should be developed to rid humans, animals, and the environment of this dangerous toxin. 3. Greater collaboration and cooperation between federal agencies responsible for safeguarding public health in regard to heavy metals is needed. 4. The President should announce a White House conference on autism to assemble the best scientific minds from across the country and mobilize a national effort to uncover the causes of the autism epidemic. 5. Congress needs to pass legislation to include in the National Vaccine Injury Compensation Program (NVICP) provisions to allow families who believe that their children's autism is vaccine-induced the opportunity to be included in the program. Two provisions are key: First, extending the statute of limitations as recommended by the Advisory Commission on Childhood Vaccines from 3 to 6 years. Second, establishing a one to two-year window for families, whose children were injured after 1988 but who do not fit within the statute of limitations, to have the opportunity to file under the NVICP. 6. Congress should enact legislation that prohibits federal funds from being used to provide products or pharmaceuticals that contain mercury, methylmercury, or ethylmercury unless no reasonable alternative is available. 7. Congress should direct the National Institutes of Health to give priority to research projects studying causal relationships between exposure to mercury, methylmercury, and ethylmercury to autism spectrum disorders, attention deficit disorders, Gulf War Syndrome, and Alzheimer's Disease. III. Thimerosal Has Been Used In Vaccines And Other Medical Products For Decades A. A brief description of mercury Mercury is a silver-colored metal, which unlike any other metal, is a liquid at room temperature. It flows so easily and rapidly that it is sometimes called quicksilver. The chemical symbol for Mercury is Hg. Mercury has many properties that have made it popular for a number of commercial uses. For example, mercury expands and contracts evenly when heated or cooled. It also remains liquid over a wide range of temperatures and does not stick to glass. These properties have prompted its use in thermometers. Mercury conducts electricity and is used in some electric switches and relays to make them operate silently and efficiently. Industrial chemical manufacturers use mercury in electrolysis cells to charge substances with electricity. Mercury vapor, used in fluorescent lamps, gives off light when electricity passes through it. Before its health effects were well understood, mercury compounds were widely used in such common products as house paints and paper. Various alloys (mixtures of metals) containing mercury have many uses. Mercury alloys are called amalgams. These would include silver amalgam, a mixture of silver and mercury that dentists use to fill cavities in teeth. Mercury comes in many different forms--organic, inorganic, elemental, and metallic. As a result of its many practical uses, mercury became widespread in the environment. However, it is now widely recognized that overexposure to all forms of mercury can harm the central nervous system (brain) and the renal system (kidneys). This has led to regulatory actions to reduce the exposure of humans to mercury on many fronts. According to the Agency for Toxic Substances and Disease Registry (ATSDR): ``The nervous system is very sensitive to all forms of mercury.'' B. Thimerosal, which contains ethylmercury, has been used in medicines since the 1930's In addition to its many commercial applications, mercury has been used in a number of medical applications. One such product that came into frequent use during the twentieth century was thimerosal. Thimerosal is an organic compound made up of equal parts of thiosalicylic acid and ethylmercury. It is 49.6 percent ethylmercury by weight. Thimerosal was developed by Dr. Morris Kharasch (1895-1957; Ukraine/USA), a chemist and Eli Lilly fellow first at the University of Maryland (1922-1927) and then at the University of Chicago. He filed for a patent on June 27, 1929, for what he described as an alkyl mercuric sulfur compound (thimerosal), which he felt had potential as an antiseptic and antibacterial product. Dr. Kharasch was considered a pioneer in his field, contributing to the development of plastics and the creation of synthetic rubber. He also went on to found the Journal of Organic Chemistry. In October 1929, Eli Lilly and Company registered thimerosal under the trade name Merthiolate. Merthiolate was used to kill bacteria and prevent contamination in antiseptic ointments, creams, jellies, and sprays used by consumers and in hospitals. Thimerosal was also used in nasal sprays, eye drops, contact lens solutions, immunoglobulins, and most importantly here--vaccines. Thimerosal was patented the same year that Alexander Fleming discovered penicillin. But because it took more than a decade for penicillin to be fully developed, and large- scale production to begin, thimerosal was widely used in the interim. To the medical profession, who were without antibiotics during the 1930's and 1940's, thimerosal (marketed as Merthiolate) and other antiseptic products were gladly received. Dr. H. Vasken Aposhian, Professor of Molecular and Cellular Biology and Pharmacology, University of Arizona discussed thimerosal's history during Congressional testimony: ``In the early thirties, in fact the 1940's and up until the mid-1950's, mercurials were used in medicine . . . The medical community . . . had nothing better to use. They had nothing better to use as a preservative at that time than thimerosal. And I would venture the opinion that it has just been going on because no one has objected to it. And there's no need for it any longer. And I don't know any medical community or scientific community that would agree to the need for having thimerosal in any vaccine.'' Thimerosal became the most widely used preservative in vaccines and other medical products. Its use in antiseptic products to prevent infections was common. By the time that the FDA conducted its review of mercury in 1999, more than 50 licensed vaccines contained thimerosal. While thimerosal became widely used, there were repeated references in the scientific literature to the lack of substantial understanding of its safety. In numerous publications, researchers suggested that caution be taken in human exposure. For example, a paper published in 1934 noted, ``little is known about the mercuric compounds when inoculated into humans. It is therefore preferable to use the minimum amount of this preservative.'' Eli Lilly ceased its production of vaccines in 1974. Shortly after the FDA advisory committee determined that thimerosal in over-the-counter products was no longer ``generally recognized as safe,'' Eli Lilly and other companies chose to cease production of products such as merthiolate and mercurichrome. By the mid-1980's, Eli Lilly was completely out of the business of manufacturing or selling thimerosal-containing products. However, thimerosal continued to be used in vaccines. In the 1990's, thimerosal was manufactured by numerous companies, including Sigma- Aldrich, Inc.; EM Industries, Inc. (now EMD Chemicals Inc., the North American extension of Merck KGaA); Dow Chemical Company; Spectrum Laboratory Products, Inc. (formerly Spectrum Quality Products, Inc.); and GDL International, Inc. C. Mercury is a known neurotoxin, but methylmercury has been more carefully studied than ethylmercury After more than a century of research, it has become widely accepted in the scientific and medical communities that mercury is a neurotoxin. While debate continues over what levels of exposure to mercury are safe, it is unquestioned today that overexposure to mercury in any form can cause neurological and renal damage. There is also a growing consensus around the theory that some individuals are more susceptible to harm from mercury than others, confounding efforts to adopt a population-level threshold for safe levels of mercury in the environment. A research paper published in 2002 summarized the scientific consensus very succinctly: ``Mercury and its compounds are cumulative toxins and in small quantities are hazardous to human health.'' Because of its many commercial applications and its widespread presence in the environment, methylmercury received the lion's share of the attention in the scientific community during the twentieth century. A concise history of the early development of scientific knowledge about methylmercury is found in Dr. Thomas Clarkson's, ``The Three Modern Faces of Mercury'': ``The first methylmercury compounds were synthesized in a chemical laboratory in London in the 1860s. Two of the laboratory technicians died of methylmercury poisoning. This so shocked the chemical community that methylmercury compounds were given a wide berth for the rest of the century . . . early in the twentieth century the potent anti-fungal properties . . . were discovered, leading to applications to seed grains, especially for cereal crops . . . Despite the widespread use, few cases of poisoning were reported for the first half of the twentieth century. However, in the late 1950s and 1960s serious outbreaks of alkyl mercury poisoning (methylmercury) erupted in several developing countries . . . Also in the late 1950s, evidence emerged of environmental damage from treated grain. It was observed in Sweden that predatory birds were developing neurological disorders . . . analysis . . . indicated a sharp rise in mercury levels.'' Public health concerns about methylmercury in the edible tissue of fish suddenly erupted in 1969 when fish from Lake St. Clair bordering Michigan were found to have high levels. This and other findings . . . have maintained public health concerns over this form of mercury.'' As a result of these emerging concerns, public health officials worldwide began researching methylmercury. Today, the scientific literature is replete with evidence on toxic effects of methylmercury. In 2000, the National Academy of Sciences published Toxicological Effects of Methylmercury, which concluded: Methylmercury is highly toxic. The data indicate that the adverse effects of methylmercury exposure can be expressed in multiple organ systems throughout the lifespan. The research in humans on the neurodevelopmental effects of methylmercury is extensive. Damage to renal tubules and nephron has been observed following human exposure to inorganic and organic forms of mercury. Symptoms of renal damage have been seen only at mercury exposures that also caused neurological effects. The cardiovascular system appears to be a target for methylmercury toxicity in the same dose range as neurodevelopmental effects--at very low mercury exposures. Studies in humans on the carcinogenic effects of methylmercury are inconclusive. Methylmercury may increase human susceptibility to infectious disease and autoimmune disorders by damaging the immune system. Methylmercury may adversely affect the reproductive system. The medical literature is replete with references to the dangers to methylmercury: ``The major toxic effects of methylmercury are on the central nervous system. Its toxic action on the developing brain differs in both mechanism and outcome from its action on the mature organ . . . the action of methylmercury on adults is characterized by a latent period between exposure and onset of symptoms. The period can be several weeks or even months, depending on the dose and exposure period . . . paresthesia, numbness or a `pins and needles' sensation is the first symptom to appear at the lowest dose. This may progress to cerebella ataxia, dysarrthia, constriction of the visual fields, and loss of hearing. . . . Cardiovascular disease . . . accelerated progression of carotid arteriosclerosis.'' The research is explicit that fetal brains are more sensitive than the adult brains to the adverse effects of methylmercury, which include: Severe brain damage Delayed achievement of developmental milestones Neurological abnormalities such as brisk tendon reflexes Widespread damage to all areas of the fetal brain, as opposed to focal lesions seen in adult tissue Microcephaly Purkinje [neuron] cells failed to migrate to the cerebellum Inhibition of both cell division and migration, affecting the most basic process in brain development Additionally, elevation in both systolic and diastolic blood pressure in seven year olds correlated with prenatal exposure to methylmercury . . . indicative of later cardiovascular problems. Despite the fact that ethylmercury has been widely used in common medical treatments, ranging from vaccines to nasal sprays to ointments, comparatively little research has been done on its health effects. The few studies that have been done tend to indicate that ethylmercury is just as toxic as methylmercury. The FDA never required the pharmaceutical industry to conduct extensive safety studies on thimerosal or ethylmercury. It appears that our Federal regulatory framework (the FDA and its predecessor organizations) failed to require manufacturers to prove thimerosal was safe. They failed to require industry to conduct adequate testing to determine how thimerosal is metabolized. The FDA failed to require that industry conduct studies to determine the maximum safe exposure level of thimerosal. These basic issues should have been proven prior to the introduction of thimerosal into the marketplace, but more than 70 years after its introduction, these issues have still not been adequately addressed. The introduction of thimerosal appears to have been based on a single uncontrolled and poorly reported human study in the 1920s, possibly in combination with animal and laboratory studies. However, this sole human study was not a true safety study and produced a faulty foundation on which to build a robust vaccine program in which young children would be forced to be repeatedly injected with multiple doses of ethylmercury. During the pre-antibiotic 1920's, meningitis was a killer. Out of sheer desperation, the treating physician at a hospital dealing with dozens of patients facing a sure death from meningitis, tested thimerosal on about two-dozen patients. He injected the thimerosal intravenously, without apparent side effects. However, the treatment was not successful and all of the patients died. The leading industry scientists of that era involved in thimerosal research published a paper that made a brief reference to this study: ``Merthiolate was injected intravenously into 22 persons . . . these large doses did not produce any anaphylactoid or shock symptoms.'' In the paper, the authors acknowledge that Dr. K.C. Smithburn, the clinician who treated the meningitis patients, was not convinced of its efficacy: ``beneficial effects of the drug were not definitely proven.'' Drs. Powell and Jamieson also noted in 1930 that a ``wide range of toxicity and injury tests should be done.'' There is no evidence that Drs. Powell and Jamieson took their own advice and conducted studies to address these concerns. As a result, in 1999, 70 years after the product was first licensed, neither the FDA nor the industry had followed through on determining a safe exposure level to thimerosal or ethylmercury. Thus, when facing a policy decision on thimerosal and vaccines, the FDA had to work from an ``assumption'' that the toxicity of ingested methylmercury was the same as injected ethylmercury. One study that compared the toxicology of ethyl and methylmercury was published in 1985 in the Archives of Toxicology, written by researchers from the Toxicology Unit of the Medical Research Council of England. The researchers exposed rats to ethyl and methylmercury to ``compare total and inorganic mercury concentrations in selected tissues, including the brain, after the daily administration of methyl or ethylmercury and to relate these findings to damage in the brain and kidneys.'' This study found that both ethyl and methylmercury caused damage to the brains and the kidneys. It also found that male and female rats were affected differently: ``It has been well documented that one of the first toxic effects of methylmercury in rats is depressed weight gain or even weight loss . . . based on this criteria, ethylmercury proved to be more toxic than methylmercury . . . in both sexes . . . the concentration of total mercury (the sum of organic and inorganic mercury) and organic mercury was consistently higher in the blood of ethylmercury-treated rats . . . both alkymercurials damaged the dorsal root ganglia and 9.6 mg Hg/kg/day ethylmercury caused more damage than 8.0 mg Hg/kg/day methylmercury. Ethylmercury was more renotoxic than methylmercury . . . tubular dilation was frequently present . . . in kidneys . . . both damage and mercury deposits were more widely spread in ethylmercury-treated rats.'' While there is frequent reference to the paucity of science in understanding the harm that ethylmercury can do, there is more understanding in the scientific community than government officials have shared with the Committee. The following dialogue between Congressman Dave Weldon (R-FL) and Dr. David Baskin during the Committee's December 10, 2002 hearing sheds a great deal of light onto the true nature of ethyl versus methylmercury. Dr. Weldon: ``I have a couple of questions for Dr. Baskin about ethylmercury versus methylmercury. I have had some people say that data on methylmercury is fairly good, but we don't have good data on ethylmercury. I take it from your testimony there is actually quite a bit of data on ethylmercury and it's as toxic as methylmercury.'' Dr. Baskin: ``There is more data, more and more data on ethylmercury. The cells that I showed you dying in cell culture are dying from ethylmercury. Those are human frontal brain cells. You know, there has been a debate about . . . 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 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 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.'' Dr. Baskin explained that according to scientific research in humans and animals, brain tissue absorbs five times more mercury than other tissues in the body. Dr. 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 methylmercury 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 five-fold preferential uptake.'' The testimony of Dr. Baskin builds upon earlier testimony that the Committee received from recognized experts in chemistry, toxicology and pharmacology. It includes the following statement from Dr. H. Vasken Aposhian, Professor of Molecular and Cellular Biology, and Pharmacology at the University of Arizona, who provided the Committee the following information about the evidence on mercury toxicity at the July 18, 2000 hearing: ``The mercury amalgams in your mouth, the so-called silver fillings, contain 48 to 50 percent of elemental mercury. These fillings continuously emit mercury vapor, which will go to the brain and is converted to mercuric mercury . . . Certain fish contain methylmercury; again, very rapidly taken up from the GI tract, transported quickly to the brain, and converted very slowly to mercuric mercury . . . thimerosal, which again will be taken up by the brain and quickly converted to mercuric mercury--all three forms are neurotoxic. ``By neurotoxic, we mean it will damage nerves and it will damage brain tissues. ``Let me just say as a final statement that there is no need to have thimerosal in a vaccine.'' In making a presentation to the Institute of Medicine's Immunization Safety Review Committee, in July 2001, the former Director of the Environmental Toxicology Program at the National Institutes of Health, Dr. George Lucier, proffered the following conclusions: Ethylmercury is a neurotoxin. Infants may be more susceptible than adults. Ethylmercury should be considered equipotent to methylmercury as a developmental neurotoxin. This conclusion is clearly public health protective. Ethylmercury exposure from vaccines (added to dietary exposures to methylmercury) probably caused neurotoxic responses (likely subtle) in some children. While the debate over whether ethyl or methylmercury is more toxic will probably not be resolved in the near future, a consensus appears to be emerging that exposure to these different types of mercury cannot be considered in isolation. Rather, witnesses before the Committee stressed that in determining safe levels of mercury exposure, the cumulative level of exposure to all types of mercury must be considered. Dr. Jeffrey Bradstreet made the following observation at the July 19, 2002 hearing: ``More concerning to me in the Institute's treatment of mercury problems, was the almost complete absence of regard for compounding effect of thimerosal on preexisting mercury levels. The NHANES Study from the CDC had already established that perhaps one in ten children is born to mothers with elevated mercury burden.'' D. Because of its toxicity, mercury has become heavily regulated. As the dangers of mercury have become better understood, the United States and other governments around the world have taken actions to reduce the release of mercury into the environment. In 1972, the federal government halted the use of mercury compounds for many industrial uses, such the paint used on the hulls of ships and compounds used to prevent the growth of fungi in lumber, because the mercury had leached into the environment and found its way into the human food chain. In 1972, while certain agencies within the federal government recognized that mercury was a cumulative poison that damaged brain cells, the FDA's vaccine division seems to have ignored the issue until 1999. 1. The EPA is Regulating the Release of Mercury Into the Environment The Environmental Protection Agency (EPA) under the Clean Air Act regulates airborne emissions of mercury. In December 2000, the EPA announced that it would issue new regulations on the emissions of mercury from coal and oil-fired power plants. That action was taken because, ``mercury has been identified as the toxic of greatest concern among all the air toxics emitted from power plants.'' More recently, President Bush announced on February 14, 2002, that mercury emissions from power plants would be reduced 69% under his Clear Skies Initiative. Under this plan, mercury emissions would be reduced from the current level of 48 tons nationally to 15 tons by 2018. The EPA also regulates mercury emissions from municipal waste combustors, medical waste incinerators, and hazardous waste incinerators. The EPA works both domestically and internationally to reduce mercury exposures in the environment. The ``Canada- United States Strategy for the Virtual Elimination of Persistent Toxic Substances in the Great Lakes Basin'' is an example of these activities. 2. Different Limits to Exposure to Mercury Have Been Established by Different Agencies In the course of regulating mercury, different government agencies have established different minimum risk levels for daily exposure to mercury. Exposure to less than the minimum risk level is believed to be safe, while exposure that exceeds that level is believed to increase the chances of injury. All of the levels apply specifically to ingested methylmercury. The EPA established the most conservative level: 0.1 micrograms of mercury per kilogram of body weight per day. Under this standard, an 11-pound baby (roughly 5 kilograms) could be exposed to up to 0.5 micrograms of mercury per day and be considered safe. This exposure standard is a marked contrast to the 25 micrograms of mercury that was contained in several childhood vaccines until very recently. The most lenient federal minimum risk level for mercury is the FDA's, which sets its limit at 0.4 micrograms per kilogram of body weight per day. (The United Nations' World Health Organization sets a slightly higher limit of 0.47 micrograms per kilogram of bodyweight per day.) Falling in between is the U.S. Agency for Toxic Substances and Disease Registry (ATSDR) at 0.3 micrograms. In 2000, the National Academy of Sciences issued a report titled, Toxicological Effects of Methylmercury, validating the EPA's lower limit as a ``scientifically appropriate level that adequately protects the public.'' ------------------------------------------------------------------------ Methylmercury guidelines ------------------------------------------------------------------------- Guideline value for maximum daily consumption (g/kg/day) Agency (micrograms Guideline `type' per kilogram of bodyweight per day) ------------------------------------------------------------------------ EPA 0.1 Reference dose (RfD). ATSDR 0.3 Minimal risk level. FDA 0.4 Tolerable daily intake. WHO 0.47 Provisional daily tolerable intake (converted from a weekly tolerable intake). ------------------------------------------------------------------------ The Committee repeatedly heard from government officials that merely exceeding the guideline was not cause for concern. One Merck official, in teaching a Grand Rounds session to staff in November of 1999, postulated that the minimum risk level would need to be multiplied by ten to reach a level at which harm would be expected through exposure. Dr. Roberta McKee of Merck wrote: ``A number of environmental and public health agencies have set a Minimum Risk Level (MRL) for toxic substances. An MRL for ingestion is conceptually equivalent to the Reference Dose of the US Environmental Protection Agency, the Acceptable Daily Intake of the US FDA, and the Tolerable Daily Intake of the WHO. Any exposure to the substance below the MRL is assured to be safe, while exposure to ten times the MRL is assumed to place one at risk of overdose. Exposure at or near the MRL is assumed to be safe but should trigger deliberate and careful review.'' Based on Dr. McKee's explanation, many babies were exposed to levels of mercury that ``placed one at risk of overdose,'' and were exposed to amounts well over ten times the EPA's scientifically validated reference dose. For example, at a recent Committee hearing, Chairman Dan Burton (R-IN) discussed his own family's experience with vaccine injuries: ``My grandson received vaccines for nine different diseases in one day. He may have been exposed to 62.5 micrograms of mercury in one day through his vaccines. According to his weight, the maximum safe level of mercury he should have been exposed to in one day is 1.5 micrograms, so that is 41 times the amount at which harm can be caused.'' According to the analysis of Dr. McKee, based on the methylmercury ingestion guidelines, the Chairman's grandson would have exceeded the ``ten times the MRL'' and therefore was placed ``at risk of overdose.'' In fact, with a 62.5 microgram exposure alone, the EPA, ATSDR, and FDA levels would have been exceeded by 10 times. Because the FDA chose not to recall thimerosal-containing vaccines in 1999, in addition to all of those already injured, 8,000 children a day continued to be placed ``at risk for overdose'' for at least an additional two years. It should also be noted that none of the Federal guidelines on mercury exposure have been included specific provisions for safe exposure limits for infants and children. It is widely accepted that infants and young children would be five times more sensitive to the toxic effect of mercury or other neurotoxins than adults. ``Exposures early in life are reasonably of greater health concern . . . because of greater brain organ susceptibility.'' The FDA has conceded in recent years that many children received doses of ethylmercury through their vaccinations that exceeded the EPA's minimal risk level for methylmercury. However, it is also clear that many infants received doses of ethylmercury that exceeded the FDA's higher threshold. 3. Warnings Have Been Issued About Mercury in Seafood The FDA's actions regarding the risk of medical exposures to mercury have differed greatly from their actions regarding food exposures to mercury. The agency has a long history of issuing warnings to the public to monitor their fish consumption due to concerns about mercury exposure. During the 1990's, the FDA repeatedly issued warnings advising pregnant women and young children to avoid certain fish, or to limit their consumption of these fish because of their mercury content. In September of 1994, the FDA issued an advisory entitled, ``Mercury in Fish: Cause for Concern?'' in which they stated: ``Swordfish and Shark taste great--especially grilled or broiled. But reports which state that these and other large predatory fish may contain methylmercury levels in excess of the Food and Drug Administration's 1 part per million (ppm) limit has dampened some fish lover's appetites. . .`there is no doubt that when humans are exposed to high levels of methylmercury that poisoning and problems in the nervous system can occur' . . . the types of symptoms reflect the degree of exposure . . . ``During prenatal life, humans are susceptible to the toxic effects of high methylmercury exposure because of the sensitivity of the developing nervous system . . . Methylmercury easily crosses the placenta, and the mercury concentration rises to 30 percent higher in fetal red blood cells than in those of the mother . . . none of the studies of methylmercury poisoning victims have clearly shown the level at which newborns can tolerate exposure . . . Pregnant women and women of child bearing age, who may become pregnant, however, are advised by FDA experts to limit their consumption of shark and swordfish to no more than once a month.'' Similarly, a March 2001 FDA advisory states: ``Some fish contain high levels of a form of mercury called methylmercury that can harm an unborn child's developing nervous system if eaten regularly. By being informed about methylmercury and knowing the kinds of fish that are safe to eat, you can prevent any harm to your unborn child and still enjoy the health benefits of eating seafood.. . . While it is true that the primary danger from methylmercury in fish is to the developing nervous system of the unborn child, it is prudent for nursing mothers and young children not to eat these fish as well.'' In addition to the public advisories, the FDA, in January of 2001, established an aggressive ``Education Plan on Methyl Mercury.'' In January 2001, Associate FDA Commissioner Melinda Plaiser, responding to Congressman William J. Coyne (D-PA) regarding the National Academy of Sciences' report on Methylmercury, wrote: ``[L]et me reiterate, the FDA's commitment to protecting the public's health and the environment regarding mercury.'' Furthermore, in their training materials for employees, the FDA reflects a slightly different emphasis on mercury's toxicity than what they presented to the Committee: ``People are exposed every day to a tremendous number of substances in our environment. These substances include major and trace elements that may or may not be essential for sustaining life . . . Other elements are not known to be essential but are constantly found in living tissues . . . Of these elements that have no known nutritional value, some have been found to be toxic at concentrations well below those of other nonessential elements. Lead, cadmium, and mercury are examples of elements that are toxic when present at relatively low levels.'' Other HHS entities have taken very strong mercury reduction positions. For example, the National Institutes of Health's (NIH) Division of Safety has initiated a program to make the NIH mercury-free. According to the Division's own website: ``Elemental (metallic) mercury and its compounds are toxic and exposure to excessive levels can permanently damage or fatally injure the brain and kidneys. Elemental mercury can also be absorbed through the skin and cause allergic reactions. Ingestion of inorganic mercury compounds can cause severe renal and gastrointestinal toxicity. Organic compounds of mercury such as methylmercury are considered the most toxic forms of the element. Exposures to very small amounts of these compounds can result in devastating neurological damage and death. ``For fetuses, infants, and children, the primary health effects of mercury are on neurological development. Even low levels of mercury exposure, such as result from a mother's consumption of methylmercury in dietary sources, can adversely affect the brain and nervous system. Impacts on memory, attention, language and other skills have been found in children exposed to moderate levels in the womb. ``The Campaign for a Mercury Free at the NIH seeks to eliminate, as far as possible, the use of mercury in NIH facilities; to encourage the use of safer alternatives in biomedical research; to increase general awareness of mercury hazards; and to prevent mercury pollution.'' This NIH program has initiated a ``Hatters Pledge'' program to recruit scientists to reduce the use of mercury at the NIH and to educate children on the dangers of mercury. The NIH Hatters Pledge: I will: Improve my awareness of mercury hazards and how to reduce them. Replace mercury thermometers and other mercury-containing items with non- or low-mercury alternatives if suitable alternatives are available. Dispose of mercury wastes following NIH procedures. Report spills of mercury. On the NIH campus, call the Fire Department (911) who are the NIH hazardous material (HAZMAT) emergency responder. Off campus, call the local fire department or facility's hazardous material (HAZMAT) emergency responder. Have areas that might have been contaminated by mercury surveyed and decontaminated, if necessary. 4. Over the Course of Two Decades, the FDA Slowly Removed Ethylmercury From Many Medicinal Products In 1980, the FDA began a lengthy regulatory process to remove ethylmercury products from over-the counter products like topical ointments, diaper rash creams, and contraceptives. Topical ointments are products used on the skin either for the treatment or prevention of skin infections or inflammatory processes. They are typically divided into four categories, first-aid products to be applied to small superficial wounds to prevent infection; skin wound protectant to provide a protective barrier to small wounds; antibiotic or antifungal creams to prevent or treat overt skin infection; and anti-inflammatory agents used to reduce inflammation and inhibit pruritis. In 1980, the FDA asked their Over-the-Counter (OTC) Review Panel to conduct a massive review of OTC products. The panel opted to divide the task into categories, one of which was a review of OTC products containing ethylmercury. As a result of the panel's work, in 1982, the FDA issued a proposed rule to ban thimerosal from OTC topical ointments. In addition to raising questions about the general effectiveness of thimerosal for preventing infections, the FDA found that thimerosal was too toxic for OTC use. Among the findings that they published were the following: At the cellular level, thimerosal has been found to be more toxic for human epithelial cells in vitro than mercuric chloride, mercuric nitrate, and merbromim (mercurichrome). It was found to be 35.3 times more toxic for embryonic chick heart tissue than for staphylococcus aureus. Delayed hypersensitivity in 50 percent of the guinea pigs tested, indicating that thimerosal is highly allergic and that it is reasonable to expect humans to be equally allergic. The FDA concluded that while it has been suggested that hypersensitivity may be due to the thiosalicylate portion of the molecule and not the ethylmercury, this was not confirmed. They noted a Swedish study which found in healthy subjects the following levels of hypersensitivity to thimerosal: 10% of school children; 16% of military recruits; 18% of twins, and 26% of medical students. In 1982, the FDA advisory panel concluded that thimerosal was not generally recognized as safe: ``The Panel concludes that thimerosal is not safe for OTC topical use because of its potential for cell damage if applied to broken skin and its allergy potential. It is not effective as a topical antimicrobial because its bacteriostatic action can be reversed.'' Despite this strong finding, the FDA's proposed ban on the OTC use of thimerosal was not finalized until 1998, 18 years later. At the time of the OTC review, the industry chose not to challenge the findings of the Panel regarding the toxicity of thimerosal in OTC products. It is unclear why the FDA chose to do nothing for 18 years after a ``not generally recognized as safe'' finding. Although the FDA went through that 18-year regulatory process to remove thimerosal from topical ointments, apparently no one at the FDA was prompted to review the use of thimerosal in vaccines. Action to remove thimerosal from vaccines did not begin until 1999, in response to the Congressionally mandated review. This will be discussed in more detail later in this report. At the time of the 1999 FDA review on thimerosal, it was learned that over 50 vaccines contained thimerosal. On July 9, 1999, the American Academy of Pediatrics joined the U.S. Public Health Service in issuing a joint statement recommending the removal of all thimerosal from vaccines. On its website, the FDA provides the following rationale for its policy on thimerosal: ``Over the past several years, because of an increasing awareness of the theoretical potential for neurotoxicity of even low levels of organomercurials, and because of the increased number of thimerosal-containing vaccines that have been added to the infant immunization schedule, concerns about the use of thimerosal in vaccines and other products have been raised. Indeed, because of these concerns, the Food and Drug Administration has worked with, and continues to work with, vaccine manufacturers to reduce or eliminate thimerosal from vaccines.'' In 1999, the FDA was criticized by some for not taking more forceful action to remove thimerosal from vaccinations; as a result of the FDA decision to seek a gradual removal, many children continued to receive injections of the DTaP, Hib, and Hepatitis B vaccine that contained mercury well into 2001. Mercury-containing vaccines manufactured in the United States, up to today, continue to be administered to infants and small children in the United States and abroad. E. Thimerosal is still used in some medical products While the FDA has taken steps over the last 20 years to remove ethylmercury from topical ointments and most pediatric vaccines, a number of medical products continue to contain this preservative. Some nasal and ophthalmic products containing thimerosal remain on the market. About 75 percent of the flu vaccines, recently recommended to be given to children as young as six months, contain at least trace amounts of thimerosal. Many adult vaccines contain thimerosal. Vaccines containing thimerosal continue to be manufactured in the United States and delivered through the World Health Organization (WHO) to Third World Countries. The WHO has continued to require the use of multi-dose vials and to use preservatives, including thimerosal, to address storage and transportation issues. Of additional concern to the Committee, but not discussed in detail within this report, is the continued use of thimerosal in adult vaccines. There is a growing emphasis on adult immunizations, including getting boosters to childhood immunizations. Additionally, all new military recruits, active duty, and reserve forces that are deploying overseas are routinely given a large number of vaccines, many containing ethylmercury. These vaccines are often given consecutively and all in the same day.

Mr. BURTON of Indiana

Mr. BURTON of Indiana. Mr. Speaker, I rise to express my support for the ``Child Medication Safety Act of 2003 (H.R. 1170),'' which would prohibit the required administration of psychotropic medications in order for children to attend school. Like many Members, I believe that our children are our future. We need to do our best to protect and improve the health and well-being of our Nation's children, including protecting them from medications that can potentially harm them. While I was the Chairman of the Full Committee on Government Reform, I held a hearing on September 26, 2002, to examine allegations that too many children are being medicated for Attention Deficit Disorder (ADD) and Attention Deficit/Hyperactivity Disorder (ADHD) at increasingly younger ages, and to discuss the health implications of these drugs. Our investigation found that disorders, such as ADD and ADHD, are diagnosed by a checklist of behaviors, not medical science. According to the National Institutes of Health, the behaviors, or ``symptoms'' used to diagnose these disorders are inattention, hyperactivity, and impulsivity. Based on these descriptions, almost every child in the United States would be considered afflicted, and under current law, be required to take psychotropic medication to attend school. Ritalin is perhaps the most prescribed psychotropic drug used to control children with behavioral problems. It is estimated that four to six million children are taking this drug daily in the United States, a 500 percent increase since 1990. Ritalin is classified as a Schedule II stimulant. This means that it has met three criteria: (1) it has a high potential for abuse; (2) it has a currently accepted medical use in the treatment; and (3) it is shown that abuse may lead to severe psychological or physical dependence. According to research published in the Journal of the American Medical Association, Ritalin was shown to be a more potent transport inhibitor than cocaine. In addition, the chronic use of Ritalin can lead to: aggression, agitation, disruption of food intake, weight loss, and even death. Schools should not be able to force parents to administer these psychotropic drugs to their children--not only are these disorders diagnosed without physiological testing, but they can also lead these children to further drug-use and dependence, or even the worst of all scenarios . . . death. Mr. Speaker, H.R. 1170 would protect our children from being required by schools to become subject to psychotropic medications that can lead to detrimental health effects as well as drug addiction based on unscientific diagnoses. I urge continued support from my colleagues on this important legislation.

Mr. BURTON of Indiana

Mr. BURTON of Indiana. Let me say, God bless you for what you are doing, and I think there are seniors and people all across this country who cannot buy pharmaceuticals at the proper price who are saying, go man go. Go Gutknecht go. I am one of them. But I want to find out why. My committee, the Committee on Government Reform and Oversight, was charged with the responsibility of investigating waste, fraud and abuse in government and I was chairman for 6 years. We found that there were a lot of abuses in government. I want to find out why the FDA and HHS and CDC, why these kinds of problems are existing. There is no reason for it. The purity of the products are guaranteed by the Canadian Government as well as our government. That was stated by their government officials just this past week. They are making a profit in those countries, but they are making a huge profit here, eight, nine, 10 times as much in some cases. I want to find out why the FDA appears to be protecting this industry. There has got to be something to that. The gentleman from Minnesota mentioned the GAO, a GAO investigation. I think a GAO investigation of this entire area is something that needs to be done. Not just the pharmaceutical companies and whether or not they are benefiting from government largesse from our research dollars but also I think we ought to have the GAO investigate what is going on with our health agencies and why this sort of appearance of chicanery exists. I am going to join with you in the GAO study, but I might want to expand it just a little bit further.

Mr. BURTON of Indiana. There is one last thing I would like to bring up. We passed a law in this Congress that allows people to buy imported pharmaceuticals. The gentleman recalls that. The FDA and HHS said no, because there were concerns about the safety of the imported pharmaceuticals. But the Congress of the United States, the House and Senate combined, have spoken on this issue. They want the American people to be able to buy these pharmaceuticals safely from anyplace where they can get the best price. That is a law passed by the Congress. The only thing that is stopping it, and this is something we should have started on earlier, the only thing that is stopping it is our health agencies, who are saying, wait a minute, we want to make sure they are safe. You have proven tonight, and I think conclusively, that they are safe. There has been no indication whatsoever, no cases where people have died from imported pharmaceuticals. Even if there were a problem like that, which there is not, there is a way to make absolutely sure that the products coming into the country are safe, in a sealed container where there can be no tampering. So there is no way that we cannot make sure these products are safe. Yet the FDA continues to block it. I maintain it is because of this relationship with our pharmaceutical companies. But in any event, Congress has spoken and we need to keep beating on this issue so that the current law passed by the Congress is enforced and FDA and HHS just get the hell out of the way.

Mr. BURTON of Indiana. I think I do.

Mr. BURTON of Indiana. Let me just conclude my participation in your Special Order by saying I am proud to be a member of the Gutknecht army.

Mr. BURTON of Indiana. If the gentleman will yield further, one of the things that concerns me about the prescription drug benefits the gentleman from Minnesota alluded to a moment ago is that if we pass a prescription drug bill in the Congress to provide benefits for seniors in this country and we do not do something as he suggested to make sure that they are paying a fair price for their product, then the taxpayers are going to be paying $360 for a product that you could buy in Germany for $60. Six times. I do not think the taxpayers want to be paying six times the price of a drug in Germany here in the United States. It would actually just bankrupt the United States Treasury in a few years if we did not do something about that. I am not for price controls, either; but I do believe that the marketplace ought to dictate the prices and a free market not only here in the United States but around the globe. I think the gentleman makes a very valid point. The American people should not pay six, seven, eight, 10 times the price that they do in other countries. That is what scares me about the prescription drug benefit we are going to pass in this Congress this year. I think the gentleman and I will be down here debating that when that bill comes to the floor to make sure that the taxpayers are getting their dollar's worth when we buy these pharmaceuticals for seniors.

Mr. BURTON of Indiana. What is the price comparison?

Mr. BURTON of Indiana. But why?

Mr. BURTON of Indiana. We have used the logical arguments that the FDA has used, or illogical arguments, as to why they want to stop importation of pharmaceutical products from Canada and elsewhere. The arguments they use do not hold water. I think the gentleman has made that very clear here tonight. So what is the reason? There is only one reason, and the gentleman is reluctant to say this, but I am not, and that is the pharmaceutical industry makes the biggest share, the lion's share of their profits right here on the backs of the American consumer. That is not right. They will say it is R&D, research and development, but the research and development should be shared equally around the world. But as far as them making huge profits on the back of American consumers, when they are making a profit in Europe, Canada and Mexico, but not to the degree they are here, is just unconscionable. It bothers me that the almighty dollar as far as corporate executives are concerned is more important than the health of American citizens. The facts bear this out. There are American seniors and others who are going wanting for pharmaceutical products because they cannot afford them, whereas the same products are being sold for one-sixth the price someplace else in the world, and that is critical. We ought to hold these pharmaceutical companies accountable. We cannot let them go on raping the American people, and that is a very strong word and I am using it advisedly, but they are raping the American people while the rest of the world is benefiting from these lower prices. We need to hold them accountable. The thing that bothers me is that the FDA comes before our committee with the lame excuses that they used that do not hold water, as the gentleman has made clear here tonight, these lame excuses, and we ask why? They are the regulatory agencies that are supposed to protect Americans to make sure that the products are safe but also to make sure that they get the products to which they are entitled. The FDA is blocking, they are like a lineman in a football game blocking for the pharmaceutical industry. Why are they doing that? The pharmaceutical industry is making huge profits on the back of the American people, but why is the FDA helping them? The only reason I can imagine is there is some kind of subliminal, sweetheart revolving door between the people over at FDA, HHS and CDC and over at the pharmaceutical companies. That is something that smacks of being unethical, at the very least. The FDA and HHS should be concerned about the safety of products and to make sure that the American people have access to the products that will protect their health. They have been blocking for the pharmaceutical industry, and it is something that should not be tolerated in the future. The gentleman does not need to say that, but I will.

Mr. BURTON of Indiana. So six times.

Mr. BURTON of Indiana. Mr. Speaker, because of the Enron debacle and the other corporations around the country that padded the books that made it look like they were making profits when actually they were losing money, and at the same time corporate executives were making tons, because of that, the Oxley bill that you talked about a few minutes ago set certain guidelines and standards that they had to meet. I do not know why we couldn't propose some kind of legislation that would mandate the same kind of standard be applied to the pharmaceutical industry as well as other corporations around this country. The other thing that I think we ought to take a hard look at is when Congress, you and I, when we leave here, we cannot lobby our colleagues for a year. The reason we cannot is because there is a concern that there might be collusion between an incumbent congressman and some corporation where they are going to benefit from the judgment and the vote of a congressman in exchange for him lobbying down the road. So we make sure that a congressman has to wait a year before he can lobby his fellow Members. Why cannot we do the same thing with the FDA and HHS and CDC? Why can we not stop this revolving door policy that exists by saying, if you are working for a health agency here in the United States of America, you cannot work for a pharmaceutical company where you were sitting in judgment on their products or on their policies? I know it would be very difficult to draft a bill like that, but it might send a message if we introduced one, that that kind of chicanery must not exist. I cannot think of any other reason in the world other than profits that are keeping the pharmaceutical companies from people being able to buy their products in the United States from places like Canada. I cannot think of any other reason other than the FDA is deeply involved with the pharmaceutical industry, especially after what you have said here tonight about the reasons that they use. I cannot think of any reason in the world other than profit or collusion for the FDA to stand in the way of us being able to buy those products from Canada or anywhere else. When they sat before our committee and they looked us in the eye and they said it was a safety issue, which we know is not the case, then there has got to be a reason. I cannot put my finger on it other than there is some incentive for them to support the pharmaceutical industry's position, and we have to put a stop to that.

Mr. BURTON of Indiana. Secondly, the gentleman has just pointed out that tampering with pharmaceuticals that are coming into the country is not a problem because now there is a way where you can absolutely guarantee that that package has not been tampered with, that it is the right package, that it has the right product in it, because it has a sealing device that guarantees that it is what it is supposed to be.