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December 28, 2002

HERE'S WHAT FRIST SAID on the Senate floor in encouraging people to support the vacccine language (kinda blowing the "secret" theory). It appears in the Congressional Record at S11247-02, S11279, dated November 18. I've adjusted the formatting a bit, italicizing some long block quotes to make it easier to read, but it's all here. Frist opens by discussing responses to an erroneous New York Times article on vaccine dangers:

Mr. FRIST.
Madam President, I rise to address a homeland security issue that we will be voting on tomorrow morning. Specifically, I would like to discuss the Lieberman amendment. This amendment strips out certain provisions which Senator Lieberman and other proponents of the provision believe are unrelated to the underlying homeland security bill.

More specifically, I want to address the issue of vaccines. There are three claims that have been made by the proponents of the Lieberman amendment, as they relate to the vaccine provisions. For my colleagues who were not on the floor Friday, I refer them to some of my underlying comments on the policy of the homeland security bill and the vaccine provisions which I mentioned on the floor Friday.

This afternoon, what I would like to do specifically is examine these three claims. First, the proponents of the Lieberman bill say that the underlying vaccine provisions in the bill remove individual rights to sue. Their second claim is that Thimerosal, contained in vaccines, causes autism. The third claim I would like to refute is that these vaccine provisions do not belong in the homeland security bill.

Claim No. 1: The proponents of the Lieberman amendment say the vaccine provisions remove individual rights to sue. They are saying these provisions are an example of Republicans fronting for special interests; that they take away individual rights to sue and provide legal immunity from liability for vaccine makers. *S11280

My response is that these provisions do nothing more than require injuries that are related, or allegedly related, to a vaccine to first proceed through the Vaccine Injury Compensation Program (VIC program). The VIC program was very specifically established in the mid-1980s for all injuries that are allegedly related to a vaccine.

Since the mid-1980s, all such injuries alleged to be caused by a vaccine are collected and channeled quickly and appropriately first through this Vaccine Injury Compensation Program. A no-fault, efficient alternative to our tort system; very quickly.

That requirement is law today. The provisions that are in the underlying homeland security bill simply restate and clarify what that law is and what that law does. If there is an alleged vaccine-related injury, you first go to the Vaccine Injury Compensation Program. After a period of time, whether or not the program decides in your favor, whether or not there is what you regard as adequate compensation, at the end of that program, you can simply state that you still want to go to court. Whatever that program decides, you are free to go to court. You are free to sue, and there are no caps in terms of liability.

The provisions in this bill take away no one's right to sue. The provisions in the underlying homeland security bill provide no immunity from liability.

A little perspective: There are currently about 875 cases alleging injury due to the presence of a preservative called Thimerosal that is no longer used in vaccines. Right now, these 875 cases are in front of the Vaccine Injury Compensation Program, consistent with the law since the 1980s. These cases are in no way affected by the provisions in the homeland security bill. I want to repeat that. These 875 cases that are in the Vaccine Injury Compensation Program are being dealt with in an orderly process that was outlined several months ago, and they are in no way affected by the provisions in the underlying bill.

If individuals are unsatisfied with what the Vaccine Injury Compensation Program decides, at the end of it, you can say: Forget what you have concluded from me; I am going straight to court. Anyone can do that today, and one can still do that with the provisions of this bill.

The only people who are really affected by the language in this underlying homeland security bill are the trial lawyers who are trying to circumvent the very law this body passed in the mid-1980s-a law which has worked very well since that point in time. The trial lawyers basically are trying to create a loophole in the current law.

The provisions in the underlying homeland security bill state very simply that you first go to the Vaccine Injury Compensation Program, and for good reason. After which, you can still go to court and sue with no caps or no limits.

Claim No. 2-and this one probably bothers me as much as any because it is twisting medical science. I am not sure exactly what the reasons are, but this claim is Thimerosal-containing vaccines cause autism. Additionally, proponents claim that Thimerosal as an additive in a vaccine has a causal relationship to the autism, a disease with increasing incidence. The incidence of autism is increasing. We do not know why, and that is why it is important for us to conduct the appropriate research.

There has been a lot of misrepresentation about the various vaccine provisions in the bill, but this one really irks me the most. It is grandstanding which crosses the line because it is not what science says. It is not what the medical community says. It is not what medical science in the broadest sense says. In fact, it is the exact opposite of what the Institute of Medicine has said.

Last week on the floor one of my colleagues said these provisions in the underlying homeland security bill-saying why they must be stricken-said specifically:

Liability protection for pharmaceutical companies that actually make mercury-based vaccine preservatives that actually have caused autism in children. . . .

That is scientifically wrong. Science does not validate it. Let me tell you what science says. I quote the October 2001 Institute of Medicine record. The report is called "Thimerosal-Containing Vaccines and Neurodevelopmental Disorders." That report concluded:

The hypothesis that Thimerosal exposure through the recommended childhood immunization schedule has caused neurodevelopmental disorders is not supported by clinical or experimental evidence.

The argument that is being used in support of the Lieberman amendment as the reason to support stripping these provisions is based on a false premise, a totally false premise, according to medical science today. What bothers me about it, and the reason this bothers me more than any of the other three claims, is probably because it scares parents. It says vaccines are going to hurt your children, and that demagoguery is going to mean these parents are not going to let their children get these childhood vaccines. These vaccines fight diseases that have caused pandemics and epidemics, diseases that will kill children if we do not make the vaccines available. Epidemics will occur, and death will ensue.

I challenge my colleagues to go to the American Academy of Pediatrics and to the Institute of Medicine and ask that question: Does Thimerosal, according to the scientific literature, cause autism? The answer is no.

A number of the people on the floor have also held up a New York Times magazine article quoting it as further proof that the preservative Thimerosal causes autism. I do not want to spend a lot of time on it, but I do want to read what the people who are quoted in the article are saying.

I ask unanimous consent that two letters be printed in the RECORD.
There being no objection, the material was ordered to be printed in the RECORD, as follows:

___

INSTITUTE FOR VACCINE SAFETY, JOHNS HOPKINS UNIVERSITY, BLOOMBERG SCHOOL OF PUBLIC HEALTH,
November 11, 2002.
Proposed title: Misleading the public about autism and vaccines.

TO THE EDITOR: The unfortunate use of a sensationalized title in the article published November 10, 2002 in the New York Times Magazine "The not so crackpot autism theory: reports of autism seem to be on the rise. Anxious parents have targeted vaccines as the culprit. One skeptical researcher thinks it's an issue worth investigating," absolutely misrepresents my opinion on this issue. Also, the caption under the photograph of me "Neal Halsey says that vaccinologists have no choice but to take the thimerosal threat seriously" is not a statement that I ever made. There is no "threat" as thimerosal has been removed from vaccines used in children. The headline, the press release issued prior to publication, and the caption are inappropriate. I do not (and never did)believe that any vaccine causes autism.

I stated to the author on at least two occasions that the scientific evidence does not suggest any causal association between vaccines and autism and he reaffirmed that the article would reflect my opinion. Unfortunately, the title implies the opposite opinion. A "fact checker" employed by the New York Times asked me several questions and minor corrections were made, but I was never shown the text of the article and no questions were asked about the title that implies a belief that I do not hold. It was my expectation that the title would be about thimerosal and the difficult decisions that were made during the past three years that have resulted in the removal of thimerosal as a preservative from vaccines administered to infants and young children. Changes in the use of thimerosal were made by the Food and Drug Administration and the vaccine industry with urging by the American Academy of Pediatrics and the Public Health Service in a concerted effort to make vaccines as safe as possible.

The sensationalized title sets an inappropriate context for everything in the article. Readers are led to incorrectly believe that statement in the article refer to autism. I have expressed concern about subtle learning disabilities from exposure to mercury from environmental sources and possibly from thimerosal when it was used in multiple vaccines. However, this should not have been interpreted as a support for theories that vaccines cause autism, a far more severe and complex disorder. The studies of children exposed to methylmercury from maternal fish and whale consumption and the preliminary studies of children exposed to different amounts of thimerosal have not revealed any increased risk of autism.

Inappropriated reporting has contributed to public misunderstanding of vaccines and other health care issues. The use of deceptive title is one of the primary means that newspapers have misled the public. The New York Times and other newspapers need to conduct self-examinations into this role in misleading the public and modify procedures accordingly to help prevent future major misrepresentations of scientific data and opinions. Another disserve to the public comes *S11281 when scientists become reluctant to talk with the media for fear of being misquoted or misrepresented. I have already spent a great deal of time correcting the misinformation in the Sunday's NYT Magazine article. Naturally, the next reporter from the NYT who contacts me will be met with skepticism and reluctance unless changes are made to prevent recurrences of this debacles.

Apparently, editors, not authors, write most titles. To avoid misinterpretations authors should propose titles and assume responsibility for making certain that titles do not misrepresent the opinions of individuals or information presented in the article. Proposed titles and subtitles should be included in the review by "fact checkers"' when interviewing people whose opinions are included in the title. The best way to avoid these problems would be to permit individuals referred to in articles an opportunity to read a draft of the text before it is to late to correct mistakes or misunderstandings.

The New York Times and other newspapers and magazines should have policies requiring authors, editors and fact checkers to disclose personal associations with issues covered in articles they are involved in preparing and they should be relieved from their responsibility for articles where they have personal issues or conflicts of interest.

The general public and parents of children with autism have been misled by the title of this article and the news release. This is a disservice to the public and the value of my opinion has been diminished in the eyes of physicians, scientists, and informed members of the public. I encourage interested readers to review my scientific publications and to read objective reviews of this and under other vaccine safety issues conducted by the Institute of Medicine (www.iom. edu).
NEAL HALSEY, M.D.,
Director.

----

DEPARTMENT OF PEDIATRICS, DUKE UNIVERSITY SCHOOL OF MEDICINE, Durham, NC.
Subject: Thimerosal issue.

TO THE EDITOR: As one of the two authors of the July 7, joint PHS/AAP 1999 statement that you cite in your article on "The Not-So-Crackpot Autism Theory" it is appropriate that several misconceptions in your article be rectified. The EPA guidelines on mercury levels related to methyl mercury, a very different compound from ethyl mercury which is the metabolite of thimerosal. Three other guidelines issued by federal and World Health Organization agencies were not exceeded by the vaccine levels.

Nevertheless we chose to recommend the removal of thimerosal, not because there was any evidence of its toxicity to vaccine recipients, but to enhance public confidence in vaccines. To the credit of the pharmaceutical industry, within 1 year all vaccines for children were free of thimerosal.

The only possible exception is influenza virus vaccine which is not recommended for children less than 6 months of age and for which a newly licensed product is now available free of thimerosal. Despite the absence of thimerosal from these products over the past two years, there has been no decrease, in fact an alleged increase, in the incidence of autism among our childhood population-strongly suggesting other factors involved in its etiology.

Regrettably this exemplifies another issue where the best-intentioned actions have served to benefit no one other than the liability lawyers who feed on events of this sort as sharks in bloodied waters.
Yours sincerely,
SAMUEL L. KATZ, MD,
Wilburt C. Davison Professor
and Chairman Emeritus.
____


Mr. FRIST.

Madam President, I will quote a couple paragraphs from each. The first is from Dr. Neal Halsey, who is profiled in the article in the New York Times and who is characterized as being concerned about the Thimerosal threat. Dr. Halsey heads up the Johns Hopkins University Institute for Vaccine Safety, and he wrote saying that this story

absolutely misrepresents my opinion on this issue. . . .There is no "threat" as thimerosal has been removed from vaccines used in children. The headline, the press release issued prior to publication, and the caption are inappropriate. I do not (and never did) believe that any vaccine causes autism.

He continues:

I stated to the author on at least two occasions that the scientific evidence does not suggest any causal association between vaccines and autism and he reaffirmed that the article would reflect my opinion. Unfortunately, the title implies the opposite opinion.

He concludes:

The general public and parents of children with autism have been misled by the title of this article and the news release. . . .I encourage interested readers to review my scientific publications and to read objective reviews of this and other vaccine safety issues conducted by the Institute of Medicine.

The second letter is from Dr. Samuel Katz, Professor and Chairman Emeritus at the Department of Pediatrics at the Duke University School of Medicine. Dr. Katz writes:

As one of the two authors of the July 7 joint PHS/AAP 1999 statement that you cite in your article . . . it is appropriate that several misconceptions in your article be rectified. . . .we chose to recommend the removal of Thimerosal, not because there was any evidence of its toxicity to vaccine recipients, but to enhance public confidence in vaccines. To the credit of the pharmaceutical industry, within 1 year all vaccines for children were free of Thimerosal.

Dr. Katz concludes:

Despite the absence of Thimerosal from these products over the past two years, there has been no decrease, in fact an alleged increase, in the incidence of autism among our childhood population-strongly suggesting other factors involved in its ideology. [etiology] Regrettably, this exemplifies another issue where the best-intentioned actions have served to benefit no one other than the liability lawyers who feed on events of this sort as sharks in bloodied waters.

The final statement is from Every Child by Two, the Rosalynn Carter-Betty Bumpers Campaign for Early Childhood Immunizations in a statement released today:

Most importantly, we are concerned that the Senate may be inadvertently fueling fears that vaccines cause autism. In fact, well-respected studies concluded that the evidence is inadequate. Much research is available to support these conclusions.

Madam President, the third claim-and I will be brief on the third claim-we have heard on the floor from the advocates of the Lieberman amendment, which I encourage my colleagues to oppose, is that the vaccine provisions do not belong in the homeland security bill. I would argue just to the contrary. If we do not have a stable manufacturing base for vaccines, there is absolutely no way we can prepare our communities and our Nation in the event there is a biological warfare attack on our soil.

We talk a lot about smallpox, and we all know today we are inadequately protected because today we are inadequately vaccinated against smallpox. We cannot destroy the manufacturing base for our vaccines today. We started with 12 vaccine companies in this country, companies that made vaccines. In large part because of the liability issue, the number of companies making vaccines has decreased to four vaccine manufacturers in the world. Only two vaccine manufacturers are in this country, and at the same time, the National Institutes of Health is embarking upon a new initiatives to develop a vaccine for botulinum toxin, a major initiative on their part. If we vote to strike these provisions, we are putting at risk our manufacturing base which we absolutely must have to be a prepared Nation. Vaccine development cannot be ramped up quickly because manufacturing is a highly complex process. These important provisions further stabilize the vaccine supply system, and thus, are key to our ability to establish appropriate homeland security.

Those are the three claims we have heard over the last 2 to 3 days. I encourage my colleagues to look at earlier statements on what the vaccine provisions are specifically.

I urge my colleagues to vote against the Lieberman amendment tomorrow and to move forward on this important homeland security bill.

So what we have here is Frist urging people to vote the way the Rosalynn Carter / Betty Bumpers Campaign wants them to. Some vast right-wing conspiracy.