November 15, 2002 - From the Congressional Record
Editor's Note: Since the media, almost universally, have reported the Vaccine debate in the Senate as proof of unnecessary "pork" for a special interest group that favors Republican, we are posting Senator Bill Frist's analysis of it on the floor of the Senate. Frist is a physician. A major stumbling block in getting the Homeland Security Act through the Senate was the determination of Democrats, and at least one Republican, Sen. McCain, to defend those lawyers, and their clients, who wish to sue when medical treatment has bad results. Sen. Frist warns that vaccines that could save the lives of most people in event of a bio-terrorist smallpox or anthrax attack could be unavailable if nurses and doctors can be sued if the patient has a bad reaction.
The PRESIDING OFFICER. The distinguished Senator from Tennessee is recognized.
Mr. Bill Frist, (R-TN) Mr. President, I rise to speak in opposition to the Lieberman amendment and will spend a little bit of time over the next probably 30 minutes going to the substance of what this amendment does, talking policy, but also talking to the impact that passing the Lieberman amendment would have on our homeland security.
The bottom line is that I believe striking the provisions, which is what the Lieberman amendment does--it pulls out certain provisions from the underlying bill--will put the people of our Nation at greater risk, when we are talking about homeland security and safety and protection of individuals, of families, of children. That is a broad statement. It is a bold statement for me to make. But over the next several minutes I want to give you the substance of it.
A lot of people have said these provisions having to do with vaccines and smallpox are one-company provisions. The second argument is that in some way these provisions cut off the rights of individuals to go to court. We have heard statements by the proponents that one agent, one preservative, causes autism and thus in some way the underlying bill will hurt families with children with autism.
As a scientist, as a physician, as someone who is very familiar with the provisions that were placed in the homeland security bill, I have a certain obligation to walk my colleagues and the American people who are listening through what the Lieberman provision would do by stripping out the smallpox provisions, by stripping out the vaccine provisions.
Let me begin by saying we are a nation at risk. We are at risk from nuclear weapons and from chemical weapons; we know. But when it really comes to what could potentially happen to our homeland--remember this is homeland defense that we are talking about--I would argue that the greatest risk for a weapon of mass destruction to be microorganisms, to be anthrax, which terrorized the Nation, when we don't even think, we don't know, we don't think it was used by a State,
or the introduction of smallpox, which we know is a weapon of mass destruction, if introduced into a population that is unprepared, that has not been vaccinated. Vaccine is the front line for people at risk from anthrax. It is the front line for people at risk from smallpox. That means your children. That means your spouse. That means your grandparents. That means your family.
So we must not do anything and the LIEBERMAN amendment would do this--to increase the barrier for you to be protected.
Iraq has been mentioned. Most of my colleagues know that Iraq had one of the most robust biological weapons programs in the history of the world. It loaded anthrax, it loaded botulism toxin on missiles during the gulf war, inserted it into the warheads of these missiles. We don't know about smallpox. We didn't know that refrigerators had been found in Iraq that said ``smallpox'' across them, but we do know this robust biological weapons program is the foundation for a program of weapons of mass destruction.
The interesting thing about these microorganisms, these viruses, these bacteria, is that you don't have to have a big ship out there to send in a missile. We know that once you put smallpox in a society, it will travel through our schools, it will travel through our businesses and through our homes, and the only defense we have--the only defense, in terms of a medical treatment, is that vaccine. That is why, when we talk vaccines and when we talk smallpox, it is incumbent upon us to have those provisions in this bill.
I will begin with smallpox because it is the one that, a week from now, can be a problem. What about right now, or tomorrow morning, if we hear of three or four smallpox cases in the country? What actually happens at that standpoint? Smallpox is a disease that is one of the most deadly infectious diseases. There is a 30-percent chance, to anybody who gets it, that they are going to die. If three people are here, one of those three will die if they get smallpox.
What is the treatment? The only treatment--real treatment--is to get that vaccine on your arm within 3 days. Some people say 4 days. I personally think it is 3. Some say 5 to 10, but if your child has smallpox, not from when the manifestations start appearing but from the time of actual contact, and that entails having a vaccine out there--say 300 million doses, because we know smallpox in an unprotected population, which we are, knows no barriers. Right now, if I had smallpox lesions within my mouth, people around these four or five desks probably would already be infected. The only protection is the vaccine itself. The only treatment for smallpox--and this isn't true with all biological agents, but the only treatment is the vaccine within 3 days.
The administration has a policy, that I agree with, that basically is, if there is an outbreak, or a case, you can inoculate people in that area. That is a great policy. We don't need to mass-vaccinate everybody. What about right now?
People listening, saying we are a nation at risk--Iraq has had biological weapons programs. We know Saddam Hussein is a mass killer, a serial killer, who kills his own people and other people. He hates the United States. We know the most powerful weapon of mass destruction is smallpox, and we know there is a refrigerator sitting there that has ``smallpox'' written on it.
What if I wanted to get the vaccine now, just in case? Right now, you cannot get it. I argue that you should be able
to get it. But that is not yet the policy of the United States. I think with informed consent, knowing the side effects and knowing what the advantages could be--lifesaving--weighing the relative risk--what about if a case breaks out in the Northwest, say Oregon, tomorrow? If you wanted to get the vaccine and you live in Nashville, TN, you could not get it. We ought to change that. That is not what we are talking about today, but you see that vaccines are a front line for homeland security.
I don't know what is going to happen in Iraq; none of us knows. If we come back and deal with this 6 months from now, or a year from now, or 2 years from now, we are inadequately protecting the American people. I don't want to overstate it, but that is my belief.
If smallpox hits here, right now, we are inadequately protected. The Lieberman legislation would strip out a provision, within 2 days or 3 days or 4 days, that would make us more adequately protected as a nation.
The threat of liability--this is where the other vaccine provisions are important--should not become a barrier to the protection of the American people. I will repeat that. The threat of liability should not become a barrier to the protection of the American people.
Then you go back to the question, What is this threat of liability? I will boil it down and use smallpox as an example. Smallpox can hit here tomorrow or in 30 days or in 60 days from now or in 90 days or maybe never. We all pray it never hits. We have 300 million doses of vaccine. It is not all licensed yet, but it is good vaccine and I have utmost confidence in it. It is a risky vaccine. The childhood vaccines we use, which we are inoculated with--even the anthrax vaccine that potentially has certain side effects--if you look at these, I put smallpox among the most risky because we know the side effects are that about 1 in a million people would die. If you vaccinated 300 million people, about 300 would die. Ten times that number would have serious side effects--maybe encephalitis or many others that are life threatening. As a matter of fact, probably 30, 40 times that many would have a bad rash, many of which would cause hospitalization. So it is a vaccine, in medical terms, with more potential side effects than others.
What would you say if there were an outbreak tomorrow? You would call in nurses and public health officials, and pediatricians and other doctors, and you would say, as part of the American response to bioterrorism and the use of bioterrorist agents or microorganisms as weapons of mass destruction, you need to get this vaccine to as many people as you can within 3 days. It could be maybe 100 or maybe 1,000, or 10,000; and in a city such as New York, it could be a million easily within 3 days. Okay, you have the vaccine. You have willing health care providers. I think of myself as a physician. Everybody could be mobilized to do that. You are basically saying, as American policy: You need to give that vaccine. It has side effects, but we are not going to protect you in the event there is a side effect--death or encephalitis. We are not going to protect you in any shape or form, although you are fulfilling the mandate and the policy, the emergency response of the American people.
Why would they not do that? Because of the lack of protection from skyrocketing lawsuits. I have a great fear--and I don't want to say I know for sure, but I have a fear in talking to health care providers and to the nurses who
recognize, given that vaccine is important to life saving, but at the same time is subjected to these unlimited lawsuits with punitive damages--they just might say: I cannot subject myself to giving a thousand of those doses, even looking at the statistics. That is the problem, that is why the smallpox provision has to be in there.
We have had so many people make all these statements, but nobody has been to the substance. The bill extends the Federal Tort Claims Act--the FTCA--protection to any person, such as a doctor, or a pediatrician, or a nurse, or somebody who is qualified to be giving that inoculation, lifesaving inoculation, in your arm. It provides them a protection of the Federal Tort Claims Act.
What is important there--people say if that is the case, you cannot sue. Well, that is simply not true. It basically says that the Federal Government is going to be on your side and will defend you in any lawsuit and the Federal Government will pay the damages.
It does not deny adequate, just, fair compensation if there is a side effect, but what it does do is you are going to have somebody behind you; namely, the Federal Government, to pay you damages. It does say you go to Federal court. People say Federal courts cannot do this. In truth, we all know Federal courts can do that.
It is important to point out that in Federal court, the rules that are actually used are going to be applicable to that State or according to State law.
Thus, you can still sue, but the Federal Government pays. A lot of people say you should be able to punish anybody--punish that nurse who put that vaccine in your arm--so let's have punitive damages on top of compensation. The underlying bill says you get adequate, just, fair compensation. You are defended by the Federal Government and they will pay you, but there is no punitive damages component, which makes sense because, remember, that nurse is putting that inoculation on your arm to save your life under a plan put forward by our Government, probably in response to an emergency.
Over time, I think we need much more balance in terms of the overall provisions. It was not my idea, although I support these provisions strongly, to take these specific provisions out and to put them into the bill. So over time, we need to develop a more comprehensive policy to make sure we have both a full range of vaccines developed, that we have appropriate countermeasures, and if somebody is harmed by a vaccine, there is fair compensation.
We need to come back and visit this in a more comprehensive way as we go forward. I will add, though, there is some sense of urgency to this given the threats today.
The issue of what is front line is important because the use of germs, microorganisms, and bacteria is new to the American people as weapons of mass destruction. It is causing us to say we understand nuclear weapons, gas, but what about these organisms that can wind their way through a society? What is the front line?
That is why vaccines are absolutely important because they become the front line, and that is why we address vaccines in the homeland security bill, especially since we are at risk today. One cannot turn on a television or read a newspaper without learning of this enhanced risk, this higher risk.
Let me back out of this broader issue of vaccine. Smallpox is one case. It happens to be a virus. What about the plague which wiped out a third of Europe? What about anthrax? We have an old vaccine. The vaccine has to be administered over and over, so we need newer vaccine developed for anthrax.
What about Ebola? About 3 months ago, the National Institutes of Health said in their response to bioterrorism that one of its major priorities is going to be the development of a vaccine for the Ebola virus. That makes sense because we know that other states in their offensive biological weapons programs--and there are 12 offensive biological weapons programs outside the United States; people need to know that--there has been a linkage of smallpox with the Ebola virus. We know Ebola has a 90-percent mortality rate; smallpox has a 30-percent mortality rate. We should at least be thinking of a front line there which means a new vaccine. NIH said 4 months ago--and most people do not even know it--has as one of their major initiatives development of an Ebola vaccine. Why? Because intelligence tell us people have attempted to link viruses. Thus, we need to have an effective response system in terms of
the development of vaccine.
Research is good. NIH is doing research. But unless we have manufacturers in the field manufacturing vaccines, we can have the greatest research in the world and know how to do it, but unless we can produce it and produce it quickly, the know-how does not do us any good because we are not going to be able to develop the vaccine to put on your arm and protect you from the Ebola virus.
There are provisions in this bill that provide smallpox as a microcosm, but in the macro sense, there are other vaccines. Every year--and the distinguished Presiding Officer knows this--we hear about these shortages of vaccines about every 6 months. People ask: Why are there these shortages? It is multifactorial, and we have to address that.
One of the issues we know is this unlimited liability. Think back to the smallpox vaccine. It is put on your arm, and you have a bad side effect. Somebody is going to sue for that side effect. There are no protections today. In the same sense, the manufacturers, the pharmaceutical companies, which is very popular for people to beat upon aggressively these days, the manufacturing companies, the pharmaceutical companies are the only ones that can make the smallpox vaccine, the front line for that weapon of mass destruction, for the Ebola virus.
We can, through NIH, promote the research, but only a manufacturing firm, a pharmaceutical firm can make the Ebola vaccine. There used to be in the eighties 12 pharmaceutical companies making vaccines. Then it dwindled to 10, then to 8, then to 7, then to 6, then to 5, and there are now only 4 vaccine manufacturers licensed to sell vaccines in the United States, and only two of these are American companies.
Why is that the case? Why would they stand out totally exposed for making a medicine that is lifesaving, yes, but one that with one lawsuit can wipe out their whole development process, their whole manufacturing process today?
That is an issue that has to be developed, and the urgency of it is the fact we are a nation at risk from biological agents, and there are 12 states that have offensive biological weapons programs, and we are today unprotected.
On the liability issue, people have said one preservative causes autism. They mentioned this on the floor. That is just wrong. The Institute of Medicine has made it very clear that there is no established causal relationship between that preservative and autism. I will and others need to go back and look at the data, but the Institute of Medicine has basically said that to date. We need more research.
I was one of the primary authors of the autism research bill. We need to look at it again. I want to assure families in the country that those statements made on the floor of the Senate are wrong. There is nothing in the underlying bill that slows down research for autism or just compensation, if there is an association between autism and a certain preservative.
It is interesting, with these vaccines being sort of inherently risky, with the risk of liability costs driven up so high because it is easy--it is not easy, but we can have lawyers coming in and starting these lawsuits.
In the 1980s, this body started the Vaccine Injury Compensation Program. They did this through the National Children's Vaccine Injury Act. It was passed in 1986, I believe. The whole purpose of this program is to provide injured patients compensation while attempting to control litigation, based on the recognition that vaccines will always be an easy target because they have inherent side effects and everybody gets vaccines--everybody in this body has been vaccinated. Everybody listening hopefully has been vaccinated. We all depend on those vaccines.
That at the end of the day, since everybody gets it and there are certain side effects, that if you want to make a lot of money you can go out and start getting these people and start creating these lawsuits. That is why in the mid-1980s we said we have to put all of this together and look at it in a reasoned way, a way that is efficient, a way that is fair to people broadly. The vaccine injury compensation program is essentially a no-fault alternative to the traditional tort system in this whole area of vaccines. It has been a key component of stabilizing the vaccine market, of not driving even those last four companies--or the last two in this country--out of making vaccines. It has a streamlined process. It puts down a less adversarial alternative so not everybody is going to court and spending weeks, months, and in some cases years trying to have their cases actually looked at.
It encourages research and development of new and safer vaccines, and it provides the appropriate liability protection to that nurse who is putting that inoculation, that vaccine, in your arm, as well as the health care providers, the facilities, and the manufacturers.
What is in the underlying bill is a narrow set of provisions that were actually taken from a bill that I have studied for the last 3 years and that I introduced this Congress, that should eventually be passed in this comprehensive form, but the provisions have been taken out and included in the underlying bill I feel strongly about and I will continue to talk to my colleagues about them individually as they understand why those provisions were included.
I will say that the provisions that are in the bill are far narrower than what I think we actually need to do to have this balance in our liability system so we can continue to develop vaccines to protect our children, the current generation. In the event there is a bioterror attack a week from now, a month from now, a year from now, we will be adequately prepared.
The Lieberman proposal would strike these sections that are in the underlying bill. And all of them merely restate to some extent what was intended by Congress. This is a clarification, a restatement. In 1986, when it passed the bill, the underlying bill called the National Children's Vaccine Injury Act, what that act did was to create an administrative mechanism by which those children who have a serious side effect from a vaccine can receive compensation without ever having to prove in court a vaccine caused their particular injury. So you do not have to go to court. You can go to this new administrative body.
There are a handful of people who do not believe in vaccines. They just say all vaccines are bad. Most know that they are invaluable and have spared our children from many of the diseases that haunt us. Thus, when you have that which we all really fully understand today, that they are a protection for our children, plus this new threat of bioterror, that is why you link it to homeland security and that is why it is important in this bill. We know we must preserve that manufacturing base so with the research that is done, yes, by the pharmaceutical companies, but also maybe even more importantly by the NIH, we can actually manufacture those vaccines.
Section 171 clarifies that the components and ingredients of a vaccine listed in the vaccine's product license application and label are not contaminants or adulterants. Importantly, the advisory committee, from which all of this essentially was taken, is an advisory committee called the Advisory Commission on Childhood Vaccines. They unanimously concur with this particular provision.
The next section, section 1716, adds a definition of ``vaccine'' to the Public Health Service Act since that term was not defined at all in the initial legislation back in 1986. This section states the obvious--that the term ``vaccine'' includes all components and ingredients listed in the vaccine's product license application and product label. Again, the Advisory Commission on Childhood Vaccines recommended the appropriate modification which is a part of the underlying homeland security bill, again, which the Lieberman amendment would strip out.
Sections 1715 and 1716 restate the original intent of the law that a vaccine is all the ingredients and components in the product which are approved by the FDA. This is an important one because there have been some allegations that all this was stuck in for a single company. The fact is that there are presently more than 150 of these lawsuits against the four vaccine manufacturers, as well as pediatricians, children's hospitals, state health departments and other healthcare providers. From my comments, one can see that it is not a single company. We are talking about a huge issue that reflects back to the protection of our families and our Nation.
Section 1714 clarifies that the term ``manufacturer,'' under the VICP, includes any corporation, organization, or institution that manufactures, imports, processes or distributes any vaccine on the vaccine injury table, including any component or ingredient of such vaccine. The Advisory Commission on Childhood Vaccines, again, an independent body making specific recommendations--it is composed, by the way, of trial lawyers, medical providers, and injured parties--unanimously supported this provision. This provision restates Congressional intent to ensure that any lawsuit alleging vaccine-related injury or death follow the same process and groundrules regardless of whether it is against the final manufacturer, a physician or hospital, or a component or ingredient manufacturer and addresses those lawsuits seeking to circumvent the Vaccine Injury Compensation Program.
I also want to point out that these provisions are supported by the American Academy of Pediatrics, and I will talk more about that in a minute.
I want to run through a couple of other specific ones, again because nobody has really talked to the substance underlying what this amendment would mean.
The congressional intent very much was to encompass the manufacturers of component materials of vaccines in the definition of ``vaccine manufacturer,'' and these provisions--what they do is clarify this intent. They restate the congressional intent as part of the Vaccine Injury Compensation Act. The courts are presently correctly ruling that these amendments--what they are doing is part of that congressional intent. The courts have correctly rejected the contention that a component or ingredient of an FDA-approved vaccine can also be considered substitute an adulterant or contaminant.
Among these decisions, the court charged with adjudicating the vaccine injury compensation program recently concluded that the language and legislative history of the National Children's Vaccine Injury Act demonstrated that claims relating to components of covered vaccines are plainly subject to the act. As to the misconceptions that have been presented on the floor, No. 1, these provisions do not prevent patients from suing in court. The statement has been made that it takes away rights. It does not. It does not prevent patients from suing in court. Instead it merely requires, as is required under current law,
claimants must first go through the compensation program designed in the 1980s which has worked effectively but does need to be modified, as is being carried out in these provisions. They maintain their right to pursue a court case.
One can go through that program itself, the administrative program, in a timely way. If someone does not agree with the compensation that they put forward, they can go to court. I will say that without this clarification, litigation outside the program--and that is what is happening today--will continue and the supply of vaccines could well be jeopardized as we have these huge lawsuits.
One lawsuit today is $30 billion. That is what they are looking for in one lawsuit, $30 billion. The whole vaccine industry is only $5 billion. There are about 150 of these lawsuits out there today. Those who desire to bring litigation outside the compensation program will continue to sue the manufacturers of components of vaccines and ultimately that is going to result in the manufacturers of the products themselves simply walking away and not making vaccines and getting out of the vaccine business. Then who is going to make the vaccine for the Ebola virus, which our Federal Government, through intelligence, has identified as one of the six agents of which we are at risk, one of the six agents against which other nations have had offensive biological weapons programs.
If litigation continues against component manufacturers outside of the vaccine injury compensation program, those companies that make the components simply are going to be unnecessary to provide the vaccine or those people who make FDA-approved components and give them to the vaccine manufacturers will stop making those components. We saw that in the mid-1990s when raw material suppliers refused to sell the necessary components to the medical device manufacturers. People just stopped making materials there because of this fear of litigation. Ultimately there it took an act of Congress to protect those component manufacturers, the people making the pieces that go, for example, into a pacemaker or, in this case, it would be a component of the vaccine. It took an act of Congress to prevent a shortage back then of pacemakers and of other vital medical devices.
These provisions that are in the underlying bill have been unanimously supported by the Advisory Commission on Childhood Vaccines. As I mentioned, that includes injured patients, trial lawyers, and an expert group of patients as well. They have been endorsed by the American Academy of Pediatrics.
I ask unanimous consent to have a portion of letters from the Advisory Commission on Childhood Vaccines and the American Academy of Pediatrics printed in the RECORD.
There being no objection, the material was ordered to be printed in the RECORD, as follows:
ADVISORY COMMISSION
ON CHILDHOOD, VACCINES,
Alexandria, VA, June 19, 2002.
Hon. TOMMY G. THOMPSON,
Secretary of Health and Human Services,
Washington, DC
DEAR SECRETARY THOMPSON: The Advisory Commission on Childhood Vaccines (ACCV) is authorized under Section 2119 of the Public Health Service Act to advise the Secretary of Health and Human Services (the Secretary) on the implementation of the National Vaccine Injury Compensation Program (VICP). At the June 6 meeting, the ACCV discussed in detail the need for urgent modifications of the VICP and the necessity to ensure the viability of the Vaccine Safety Datalink Project. Actions are needed to address a variety of concerns that directly impact the VICP.
BACKGROUND
As of May 2002, more than 50 individual and class action lawsuits with millions of plaintiffs alleging potential thimerosal-related injuries from childhood vaccines have been filed in state and federal courts. The plaintiffs in these lawsuits argue that their claims are not governed by the VICP because they allege that thimerosal is an ``adulterant'' to, and not a part of the vaccines. These claims have been filed against vaccine companies and, in some instances, against health care providers. Thimerosal, as you know, is approved for use by the Food and Drug Administration and is part of the vaccine formulation when licensed; hence clarification is needed to direct these claims to the VICP before tort remedies can be pursued.
Concurrently, some 500 incomplete cases have been filed as placeholders with the VICP alleging that thimerosal (mercury) has caused vaccine-related injuries. The medical records that the Act requires upon filing do not accompany many VICP petitions, including these cases. This causes problems because of the time constraints spelled out in the Act. The presiding special master must generally resolve a case within 240 days (this period excludes any period of suspension and any period during which a petition is being remanded). If the special master fails to issue a decision within such time, the petitioner may withdraw from the VICP and pursue outside litigation without affording respondent or the special master any meaningful opportunity to evaluate the VICP claim.
THE ACCV BELIEVES THIS DISTURBING NEW MEND IN CIVIL LITIGATION COULD CIRCUMVENT THE ACT
We submit the following recommendation for action:
RECOMMENDATION ON CERTIFICATION OF COMPLETENESS OF PETITIONS
The ACCV recommends that the Secretary propose legislation to amend the National Childhood Vaccine Injury Act of 1986, as amended, to require special masters to issue a certificate of completeness once a determination is made that a petition is complete in accordance with section 2111. The time period described in sections 2112(g) and 2121(b) of the Public Health Service Act would begin from the date the special master issues a certification of completeness. This would allow for a period of 240 days excluding any period of suspension of any time the petition is on remand) for the parties to consider all of the evidence and for a decision to be reached. If the special master fails to issue a decision within this time period, calculated from the date the certificate of completeness is issued, the petitioner could withdraw from the VICP and pursue outside litigation.
SENATOR FRIST'S BILL
In addition to the previous request, we also ask that you consider our recommendations regarding legislation introduced by Sen. William Frist (R-IN), ``Improved Vaccine Affordability and Availability Act'' (S. 2053). The ACCV concentrated on Title II of the bill that has provisions to ensure that all claims for a vaccine-related injury or death are first filed with the VICP. The ACCV makes the following recommendations:
RECOMMENDATIONS ON THE ``IMPROVED VACCINE AFFORDABILITY AND AVAILABILITY ACT''
The ACCV unanimously concurs with the following sections of S. 2053 which are the same as or very similar to proposals made in the ``Vaccine Injury Compensation Program Amendments of 1999'' (the 1999 Amendments), which were developed from recommendations made by the ACCV and sent to Congress as legislative proposals by the former Secretary:
Section 206, ``Clarification of When Injury is Caused by Factor Unrelated to Administration of Vaccine'';
Section 208, ``Basis for Calculating Projected Lost Earnings'';
Section 209, ``Allowing Compensation for Family Counseling Expenses and Expenses of Establishing Guardianship'';
Section 211, ``Procedure for Paying Attorneys' Fees'';
Section 212, ``Extension of Statute of Limitations'';
Section 213, Advisory Commission on Childhood Vaccines''; and
Section 218, ``Conforming Amendment to Trust Fund Provision.''
The ACCV unanimously concurs with the following sections of S. 2053:
Section 204, ``Jurisdiction to Dismiss Actions Improperly Bought'';
Section 215, ``Clarification of Definition of Manufacturer'';
Section 216, ``Clarification of Definition of Vaccine-Related Injury or Death'';
Section 217, Clarification of Definition of Vaccine''; and
Section 220, ``Pending Actions''.
The ACCV does not concur with the following sections of S. 2053 and recomends:
Replacing Section 201, ``Administrative Revision of Vaccine Injury Table'', which changes the public comment period from 180 to 90 days with Section 2, ``Administrative Revision of Vaccine Injury Table'', of the 1999 Amendments which changes the public comment period from 180 to 60 days and shortens from 90 to 60 days the period that the ACCV has to review a proposed rule;
Modifying Section 202, ``Equitable Relief'', and Section 214, ``Clarification of Standards of Responsibility'' to add ``past or in front of present physical injury''. Some individuals may have sustained a vaccine-related injury in the past, but do not have a present physical injury. These individuals should not be prohibited from obtained relief in a civil action filed against a vaccine manufacturer or administrator;
Replacing Section 207, ``Increase in Award in the Case of a Vaccine-Related Death and for Pain and Suffering'' with the 2001 ACCV recommendation to increase the $250,000 benefit caps for both death and pain and suffering. These $250,000 benefit caps should be retroactively increased since 1988, and increased annually, thereafter, to account for inflation using the Consumer Price Index for All Urban Workers (CPI-U) as envisioned by Congress in the original National Childhood Vaccine Injury Act of 1986;
Replacing Section 210, ``Allowing Payment of Interim Costs'' which does not stipulate a timeframe for when the interim payment is to be made with Section 6, ``Allowing Payment of Interim Costs of the 1999 Amendments, which states that the interim payment can only be made after a determination has been made concerning whether or not the petitioner is entitled to compensation;
Modifying Section 219, ``Ongoing Review of Childhood Vaccine Data'' by deleting the phrase, ``together with recommendation for changes in the Vaccine Injury Table''; and
Replacing Section 221, ``Report'', which this language, ``The ACCV shall provide the Secretary of Health and Human Services with annual status reports on the Vaccine Injury Compensation Trust Fund (the Trust Fund), including recommendations on the allocation of funds from the Trust Fund.''
With regard to Section 203, ``Parent Petitions for Compensation'', the ACCV believes that the language in this section must be modified. The issue of compensating parents and third parties was raised when the original Act was drafted, but the focus remained on the need for an adequate compensation package that would cover the life of the injured child. Over the years, a few parent or third party petitions for compensation have been filed in state and federal courts. However, many of the class action suits contain parent petition, which prompted ACCV to revisit the issue. ACCV strongly believes that parent or third party petitions for compensation are more appropriately managed and adjudicated through the VICP rather than through outside litigation. Because of our concern for the well being of the child, the ACCV recommends that the award to the vaccine-injured child be separate from any award offered to the parent. At your request, the ACCV will develop options for such an award. In addition, this Section, as is currently drafted, raises serious constitutional concerns. The ACCV recognizes that the proposed provision, as drafted, may need to be supplemented to: (1) address potential constitutional concerns; and (2) assure that such parents or third parties claims may be properly administered by the VICP. Moreover, the ACCV believes that further consideration should be given to review of whether a third party's claim should be tied to the injured party's claim in civil actions.
Section 205, ``Application'', is a conforming charge to Section 203, and therefore, the ACCV does not concur with this Section until the language in Section 203 is sufficiently modified.
BACKGROUND ON THE VACCINE SAFETY DATALINK PROJECT
In order to enhance the understanding of rare adverse effects of vaccines, CDC developed the Vaccine Safety Datalink (VSD) project in 1990. This project is a collaborative effort, which utilizes the databases of eight large health maintenance organizations (HMOs). The database contains comprehensive medical and immunization histories of approximately 7.5 million children and adults. The VSD enables vaccine safety research studies comparing prevalence of health problems between unvaccinated and vaccinated people. Over the past decade, the VSD has been used to answer many vaccine-related questions, and has been used to support policy changes that have reduced adverse effects from vaccines.
Rep. Dan Burton, (R-IN), Chairman of the Committee on Government Reform, requested any and all records collected under the VSD and was prepared to subpoena the records if he was not given access. The CDC and HMOs, understandably, do not want to give this data to Rep. Burton because these records include confidential patient information. For now, Rep. Burton agreed to a compromise with CDC which would allow an independent researcher to replicate or conduct a modified analysis of a previous VSD study, while maintaining the confidential nature of the data, but Rep. Burton has not rescinded his threat of the subpoena. Therefore, the ACCV makes the following recommendation:
RECOMMENDATION ON THE VACCINE SAFETY DATALINK PROJECT
The Vaccine Safety Datalink Project (VSD) is a critical component of our vaccine safety infrastructure. Participation by health maintenance organizations in the VSD is predicated on confidentiality of patient identifiers. In order to assure the continued viability of the VSD, the privacy of individual patient data must be protected. Therefore, the ACCV recommends that the Secretary of Health and Human Services take all steps necessary to protect the privacy of patient data in order to ensure the continued support and viability of this important project.
In conclusion, Mr. Secretary, we believe that the VICP plays a critical role in our nation's childhood immunization program, and we urge your immediate attention to our concerns. The ACCV greatly appreciates your continued support, and looks forward to your timely reply.
Sincerely,
Elizabeth J. Noyes,
Chair, ACCV.
Mr. FRIST. In part it says:
These claims have been filed against vaccine companies and, in some instances, against health care providers. Thimerosal, as you know, is approved for use by the Food and Drug Administration and is part of the vaccine formulation when licensed; hence clarification is needed to direct these claims to the VICP before tort remedies can be pursued.
That is what the underlying bill does. That is what the Lieberman amendment strips out.
The American Academy of Pediatrics also wrote in support of this. I'll quote a final sentence from this letter of June 19, 2002:
The AAP has reviewed S. 2053 and has the following comments beginning first and foremost with our strong support that all claims for vaccine-related injury or death first must be filed with the VICP.
In addition, we concur with the ACCV's most recent recommendations in support of sections 204, 215, 216, 217 and 220.
I ask unanimous consent to print the letter in the RECORD.
There being no objection, the material was ordered to be printed in the Record, as follows:
AMERICAN ACADEMY OF PEDIATRICS,
Washington, DC, July 19, 2002.
Hon. Bill Frist,
U.S. Senate,
Washington, DC.
DEAR SENATOR FRIST: The American Academy of Pediatrics (AAP), and the 57,000 pediatricians we represent, greatly appreciates your leadership and support of the various immunization provisions outlined in your bill, S. 2053, the Improved Vaccine Affordability and Availability Act. This legislation addresses several issues of critical importance to the Academy.
VACCINE INJURY COMPENSATION PROGRAM
Enacted in the late 1980's, with the support and guidance of the AAP, the National Vaccine Injury Compensation Program (VICP) has helped to stabilize what was then and appears to be again a fragile vaccine market. For the past 14 years, this program has been successful in its efforts to ensure an adequate supply of childhood vaccines, promote more research and development of even safer and better vaccines and most importantly to provide for a fair and just compensation program for those that suffer vaccine-related injuries. However, over time, as reflected in your legislative proposal, some modifications are necessary to ensure that the VICP is working at it full potential.
The AAP has reviewed S. 2053 and has the following comments beginning first and foremost with our strong support that all claims for vaccine-related injury or death first must be filed with the VICP.
The Academy concurs with several sections of the bill, some of which were previously proposed in 1999 by the Advisory Committee on Vaccine Compensation (ACCV) and you have incorporated in S. 2053. These include: Sections 206, 208, 209, 211, 212, 213 and 218. In addition, we concur with the ACCV's most recent recommendations in support of sections 204, 215, 216, 217, and 220. The AAP is particularly pleased that S. 2053 includes language that allows compensation for family counseling, ongoing review of childhood vaccine data and clarifies the definition of vaccines, manufacturers, and vaccine-related injury or death.
The AAP, however, does have specific concerns about Section 203, ``Parent Petitions for Compensation,'' as currently drafted. The AAP believes that petitions for compensation by parents or third parties must be adjudicated through the VICP and not through the judicial system. Moreover, in addition to potential constitutional issues that this provision may pose, we contend that such claims by parents should be separate and apart from awards to the vaccine-injured child. Although the issue of the compensation of parents and third parties was initially raised during the drafting of the VICP in the 1980's, it was rejected to maintain the focus of the Act on providing appropriate and just compensation that covers the life of the vaccine-injured child. We believed then, as well as now, that this approach is in the best interest of the child. The AAP would suggest that consideration could be given to providing, within the scope of the VICP, a provision for the loss of consorrum that would be separate from the award to the vaccine-injured child.
The AAP agrees with your identification in Section 207, of the need for an adjustment to the award for a vaccine-related death and for pain and suffering. However, we recommend a modification to this section as written. Use of the Consumer Price Index (CPI) to account for annual inflation in providing these benefit awards had been the original intent of Congress in drafting the VICP. The AAP encourages your adoption of this approach that was also recommended in 2001 by the ACCV. In 2002 dollars, such an award would be the equivalent of an award of over $300,000.
MENINGITIS AND INFLUENZA VACCINES
The AAP supports your recommendation in Section 103 to provide information to a variety of entities concerning bacterial meningitis. We are ready to work with you to implement these efforts.
This past June, the Advisory Committee of Immunization Practices (ACIP) made the decision to expand the Vaccine for Children (VFC) program coverage of the influenza vaccine to all healthy children aged 6 to 23 months. This will take effect March 1, 2003. As physicians, we are both aware that this age group has a high likelihood of hospitalization if they get the flu, therefore the availability of an adequate supply of the influenza vaccine is critical. In addition, this expanded recommendation means that adequate funding--both public and private--is essential. The estimated first-year costs of influenza vaccination of children, according to the Centers for Disease Control and Prevention, are $11.5 million in the VFC program, $2.6 million in Section 317 funds, and $1.42 million in state funds. This assumes vaccination of 20% of children aged 6 to 23 months (most requiring two doses), 15% of high-risk children aged 2 to 18 years, and 5% of children living with high-risk household contacts. These costs dramatically increase as we assume higher vaccination coverage rates for these populations of children. We applaud your support of increasing the supply of the influenza vaccine (Section 101) and encourage your proactive support to ensure sufficient public and private funding to meet the need and demand of the pediatric population. We should expect nothing less than, at a minimum, coverage by the Medicaid program for our youngest citizens as is received under Medicare for our senior citizens.
IMMUNIZATION RATES
The AAP appreciates the recognition of increasing immunization rates and data collection especially for adolescents as well as adults included in Section 102 of S. 2053. However, as pediatricians dedicated to the health, safety and well being of infants, children, adolescents and young adults we would be remiss if we also did not encourage the inclusion of all infants and children in the collection of data and in efforts to increase immunization rates. We have made remarkable progress. Presently, the rates of immunizations for children may well be at an all time high. But we still have significant disparities and pockets of need among rates of immunization for racial and ethnic groups. This is further exacerbated by the potential impact that vaccine shortages may have on the rates of immunizations. We cannot allow complacency or less vigilance of rates for infants and children at this critical time.
VACCINE SUPPLY
Although pediatricians over the years have encountered brief childhood vaccine shortages nothing compares to the most recent situation because of both the number of different vaccines involved and the scarcity of the available supply. For most of the first half of this year, the shortage of vaccines included eight of the 11 diseases preventable through routine vaccination of children. In many instances these shortages and delays by necessity resulted in temporary changes to immunization entry requirements for day care and school. Until just recently the longest-standing significant shortage was with the Td vaccine that began about a year ago and affected the ability to give teens the booster Td they need. Currently, the most serious shortage continues to be with the new 7-valent pneumococcal conjugate vaccine (PCV7, Prevnar). The AAP supports and appreciates the recognition in Section 104 of the need to maintain a sufficient vaccine supply. Moreover, we also support the discretionary authority of the Secretary of Health and Human Services to develop a national vaccine stockpile for a minimum of six months and as long as 12 months. This stockpile should include all of the routine recommended childhood vaccines and certain other vaccines that may be critical to the public's health such as Hepatitis A and meningococcal.
Thank you for your commitment to an immunization strategy that promotes the safety, efficacy as well as the adequacy of the supply of vaccines for the nation. We look forward to working with you as this legislation moves forward.
Sincerely,
Louis Z. Cooper,
President.
Mr. FRIST. I will read from a statement by Dr. Timothy Doran, testifying on behalf of AAP, to the Health, Education, Labor and Pensions Committee earlier this year on behalf of the American Academy of Pediatrics, relating to these provisions. He testified it was crucial:
to preserve and strengthen the liability protections for consumers, manufacturers and physicians through the Vaccine Injury Compensation Program. The VICP has been an integral part of maintaining the vaccine market. Enacted in the last 1980's with the support and guidance of the American Academy of Pediatrics the VICP has helped to stabilize what was then and appears again to be a fragile vaccine market. We reiterate our strong support that all claims for vaccine-related injury or death must be filed first with the VICP. We appreciate the intent of the legislative proposal put forth by Sen. Frist and others to craft appropriate modifications as necessary to ensure that the VICP is working to its full potential.
Those are the provisions in the underlying bill. That is exactly what is in the homeland security legislation that would be stripped out by the Lieberman amendment.
The effect of these provisions in this bill is important because of the new era of bioterrorism, not knowing the direction the world is moving, recognizing we are unprotected today from smallpox. We now have a tremendous initiative by the administration, the private sector, and the public sector. We have better coordination and better public health infrastructure, better communication, better coordination. But at the end of the day, if smallpox is in your community and you know it, you know where to go, that is good, but unless you have a health care provider to put it on your arm, you are not protected. We do not know when it will hit again.
The fact the Advisory Commission on Childhood Vaccines endorses these provisions is important. The fact that the American Academy of Pediatrics endorses these provisions is also important. This shows they are not just pulled out or from a single company or they have not been thought through by both trial lawyers and patients and families and providers. We have heard the claims that these are not relevant to the underlying bill. But at the end of the day, in this world where we are at risk from bioterrorism, germs, viruses, I guarantee, based on everything I know and everything I have read, it is critical we increase our protection for these agents. That is what the underlying bill does.
The liability protections are important for health care providers. I argue, also, for the facilities where they are administered and the manufacturers. If we allow out-of-control lawsuits to drive people out of the business of making these vaccines, no matter how good our research is, we will not be able to make vaccines which are critically important. We started with 12 companies and we are now down to 4 companies in the United States who make the vaccines. We have no guarantee they will stay in the business. They are unlikely to stay in the business if the huge lawsuits hit them in a way that simply is not favorably judged.
The provisions in the underlying bill only restate the original intent of Congress. They restate current law that individuals claiming injury for covered vaccines must first file for compensation under the vaccine injury compensation program, the VICP. These sections state what really should be obvious. A vaccine itself is the sum total of all of its parts as determined by our Food and Drug Administration, and that the manufacturers of vaccines include those who contribute to each of these various components. We have the vaccine, the components, the manufacturers who make the vaccine, and also the people who make the components.
Nothing in this language takes away one's right to sue. These provisions simply clarify and restate current law which requires all claims of injury related to a vaccine covered by the compensation program must first go through the compensation program before a lawsuit can be filed. There is much more that needs to be done, I believe in a more comprehensive way, but these provisions take the first step in a timely way, when time certainly matters.
In the long run, it is critical to expand the vaccine market for a whole range of microorganisms we are not protected from. We need to provide greater access to their vaccines. We need to be able to look the parents in the eye and say, when you take your child to the doctor or the public health center, those children, as well as all Americans, are not going to be in some way turned away by a barrier that we failed to address in the Senate. That is why a vaccine provision is necessary, is necessary now, is necessary in this homeland security bill.
I yield the floor.