[Congressional Record Volume 150, Number 129 (Sunday, October 10, 2004)]
[Senate]
[Pages S11122-S11124]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                           INFLUENZA VACCINE

  Mr. FRIST. Mr. President, in a few minutes we will be closing down 
for the night. While we are waiting for some of the final paperwork to 
be provided, I wanted to take this opportunity to speak to an important 
issue that affects all children today but also our seniors--an issue 
that reflects to me a longstanding problem that we must address in this 
body yet we failed to address it adequately thus far, although we have 
attempted on several occasions. It has to do with the influenza 
vaccine.
  As we all know, this week Chiron, the company that makes the 
influenza vaccine, actually one of two companies licensed to sell the 
vaccine in the United States, announced 48 million doses could not be 
sent to the United States because of contamination problems.
  I thought I would take a few minutes and put that in perspective 
because people say, Why don't we have more manufacturers? What happened 
to the U.S. manufacturing base?
  A couple of facts: Influenza is a type of virus that kills 36,000 
Americans a year; about 100 people a day die from influenza, and about 
one-half million people die worldwide.
  This week, the influenza vaccine supply coming into the United States 
was cut in half when the manufacturer Chiron announced it would not be 
able to produce those 48 million doses for the United States--seniors 
and Americans really of all ages--because some of it may have been 
contaminated.
  As I mentioned, Chiron is only one of two companies licensed to sell 
the vaccine in the United States. As a result, as we all know, public 
service announcements and other announcements

[[Page S11123]]

of the Department of Health and Human Services asked healthy adults to 
forego getting flu shots this year. Up until that point in time, it 
encouraged everyone, in essence, to get flu shots.
  We know it is quite benign, with very few side effects, and it has a 
real therapeutic impact.
  This change in policy is required because of the fall-off in the 
number of doses that are available. Before this week's announcement, we 
had expected about 100 million doses ready for this year. Last year, it 
was 87 million doses. We were going to have 100 million doses this 
year. So it was appropriate planning but also only two companies are 
producing here. One company had its supply contaminated and we find 
ourselves in the current situation.
  General background: We have had this discussion before. I am really 
going back and repeating something we have already done on the floor 
and debated on the floor about 8 months ago. So this is not new 
information, but it is worth people thinking about because it is a real 
call to action. There are now only five major vaccine manufacturers 
worldwide that have production facilities in the United States. This is 
for all vaccines. Only two, Merck and Wyeth, are U.S. companies.
  The five large vaccine manufacturers are Aventis Pasteur, which 
produces here in the United States and over in France; Merck produces 
here in the United States; Chiron, which produces in Europe and in 
several places throughout Europe, Italy, Germany, United Kingdom; 
Wyeth/Lederle, which produces here in the United States; and 
GlaxoSmithKline with production in Belgium.
  There are some other manufacturers of much smaller scale around the 
world, but it is hard to get a real good estimate of how many there 
are, especially with developing country manufacturers. But there are 
mainly five. That is for all vaccines.
  If I focus just on the influenza vaccine, there are approximately a 
dozen manufacturers worldwide, if you put everybody together. Yet only 
two manufacturers of influenza vaccines are located in the United 
States, Aventis Pasteur and MedImmune. Aventis also has a French-based 
manufacturing plant, which I mentioned, but that vaccine is not 
licensed here in the United States.

  Chiron became a major player in the influenza market when it combined 
really three other companies--bought three companies that were in the 
existing influenza manufacturing business in the United Kingdom and in 
Italy and Germany.
  None of the influenza vaccines in Italy or Germany are licensed in 
the United States. The facility in Liverpool has a capacity of about 56 
million doses a year, and almost all of that--90 percent--comes to the 
United States. The other player, MedImmune, is a new player and it has 
that live vaccine nasal spray called FluMist. It was introduced last 
year--quite revolutionary at the time. The company made slightly more 
than 4 million doses last year but it only sold about 800,000. So it 
made 4 million, only sold about 500,000 to 800,000, and now they will 
say they will only have about 1 to 2 million doses in the market. The 
CDC says it is about 1.1 million doses.
  That is all really one needs to know about the manufacturing base. 
The whole point is, it is small and has gotten smaller and smaller over 
time.
  Why is that? That is really what I want to speak to because that is 
what I believe this body must act upon or otherwise it is not going to 
change.
  My point is, the manufacturing base has been weakened, devastated in 
this country in part because of lawsuits. It is the same old story--
frivolous, unnecessary lawsuits, but these frivolous lawsuits are 
tolerated into many fields.
  We talked about asbestos and medical liability on the floor. We 
talked about class action lawsuits. But once again, it is lawsuits that 
call out for tort reform because it drives companies from a 
manufacturing base--from a score down to really two in the flu vaccine.
  Our Nation's commitment to immunization: Why are vaccines so 
important? Our Nation's commitment has been one of the most effective 
public health interventions in the history of medicine. Our country has 
been proactive, it has been aggressive, and it has been the world 
leader.
  We have been able to reduce the incidence of a whole range of 
disease, whether it is measles, mumps, or polio. I spoke earlier on the 
floor today about the HIV/AIDS virus which killed 23 million people. We 
don't have a vaccine for it. That little virus, which knows no borders. 
It can't be smelled or felt. It just travels across the world. We need 
a vaccine to eradicate it.
  We did have smallpox. We eradicated smallpox which killed between 300 
million and 500 million people in the 20th century alone--that little 
smallpox virus.
  However, because we had a vaccine, we killed it. We eradicated that 
virus, which had killed between 300 million and 500 million. That is 
the power of vaccines. They can and they do protect individuals. That 
is why we recommend them to not only individuals but entire 
populations.
  Now the overall safety record and frivolous lawsuits. This is not Dr. 
Frist trying to beat up on the trial lawyers. Frivolous lawsuits are a 
huge problem. If there are all of these lawsuits, people must think 
there is a huge safety problem; otherwise why sue everybody? The 
overall safety record of vaccines has been remarkable. That is why 
today, looking at the relative benefits and disadvantages, the balance 
is huge for the benefits, largely because the vaccines have not only 
worked but have been safe, again and again and again.
  However, in spite of that safety, the escalating cost and the 
continuing threats of litigation, which drive the cost of those 
vaccines up and the manufacturers have to pay those huge premiums to be 
protected, have become major disincentives to the production and 
distribution of these products. It is obvious, if you are a 
manufacturer today in America or wherever in the world--it is just that 
our legal system is much more aggressive than any country in the 
world--if you were a manufacturer, why would you make a vaccine if you 
know you will be sued even if the product is safe? The answer is 
obvious.
  Indeed, during the past two decades, the number of manufacturers who 
make vaccines for kids, for children, has dwindled from 12 down to 4. 
Only two of the four manufacturers that make vaccines for children are 
in the United States of America. I contend and the data and the 
evidence is that a large part of that is because of the devastating 
impact of these frivolous lawsuits. In fact, only two major 
manufacturers of vaccines for children and adults are based in the 
United States, coupled with the fact that there are only five major 
companies worldwide for all vaccines.
  There are significant barriers to entry into this market. Again, I am 
addressing primarily the high cost of lawsuits. Why do I say that? If 
you look during the early and middle 1980s, litigation threatened to 
cripple our vaccine industry. Things got better for a while, but now, 
once again, there is a whole new wave of lawsuits that seek to 
circumvent a program that is called the Vaccine Injury Compensation 
Program, or VICP, a program that historically has been very successful, 
but the lawsuits go around the program, they circumvent the program, 
and with that you had the huge settlements, huge potential threats to 
our manufacturing base. The impact today is on our children's well-
being and on the well-being of all Americans, especially if we have a 
huge influenza outbreak.
  Why do I point my finger at the legal system, which is almost 
chaotic? We have the Vaccine Injury Compensation Program, which can 
work very well, but it needs to be reformed so you do not have the 
frivolous lawsuits going around it and going after the deep pockets. An 
example, and I will just give one although there is a whole list of 
examples--the overall worldwide vaccine market, every vaccine made 
everywhere in the world, is worth $6 billion. Yet just one class action 
lawsuit pending last year sought $30 billion in damages. That is one 
class action lawsuit seeking $30 billion. The overall market, every 
vaccine in the world, is only valued at $6 billion. Why would any 
manufacturer subject themselves to this potential liability? It is 
occurring right here in the United States. It is not occurring in other 
countries. So we have a weakened manufacturing base because they will 
not stay in the business due to the threat of lawsuits, leaving us in a 
situation of only two manufacturers.

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  No matter how big the demand, if we buy only from two people and 
there is a contamination problem, we are in trouble. In the 
announcement earlier this week, we saw what happened to Chiron and with 
that the consequences of what has happened there on Americans and on 
children abroad. That is our protection from life-threatening 
illnesses.
  Again, 36,000 people die every year of this little virus which can be 
prevented, and the vaccine helps prevent it. We have the demand, we 
have the money, but we do not have the manufacturing base because of 
this chaotic lawsuit frenzy, the frivolous lawsuits.
  We have seen shortages in childhood vaccines in recent years. We have 
experienced shortages in the influenza vaccine in recent years. After 
this week's announcement, we will clearly experience another shortage 
in the United States this year despite the tremendous planning and the 
unprecedented Federal efforts, including the wonderful work done by Dr. 
Julie Gerberding at the CDC and Secretary Tommy Thompson at HHS. We 
have to address the underlying causes. We have to address the root 
causes of the vaccine shortages in the near term. The long-term effects 
can even be more devastating if we do not.
  That is why I bring it to the Senate's attention late on a Sunday 
evening. It is our responsibility. The Senate must act. No one else has 
been able to address that underlying problem that deals with our tort 
system, but we can. We should. If we are not able to stabilize the 
world's vaccine supply and make the market stable, give it a firm 
foundation, it will not be viable. This will affect not only our 
ability to manufacture vaccines that exist today, but what about that 
HIV/AIDS virus which has killed 23 million people, has 45 million 
people infected, and will likely kill another 60 million people--and 
maybe more than that unless we act. Figure out a vaccine. People are 
not going to have an incentive to research and invest in research and 
development in a vaccine if there will not be a market because of 
frivolous lawsuits which destroy anybody entering that manufacturing 
base.
  I talked earlier today about Alzheimer's disease. Right now, could 
there be a vaccine for Alzheimer's disease? The answer is yes. Will we 
have appropriate research and development? Well, I don't know; it 
depends on whether people are given some incentive to enter that field. 
To do that, we have to have a strong manufacturing base.
  We have to have companies willing to do the research and willing to 
take the risks to develop safer vaccines that, ultimately, we know will 
protect us, will save lives, not just for adults, but for kids, against 
these biological agents, against these viruses, whether it is HIV/AIDS, 
or smallpox, where we were successful, or influenza that is of current 
concern.
  What have we done in the past? In the past, I have sponsored two 
pieces of legislation that go a long way toward moving us to 
stabilization of this market. One of those bills, the Improved Vaccine 
Affordability and Availability Act, which was S. 2053 in the 107th 
Congress and S. 754 in the 108th Congress, would restore balance to the 
litigation system for childhood vaccines by clarifying the 
congressional intent that all vaccine litigation regarding childhood 
vaccines should proceed through the Vaccine Injury Compensation 
Program.
  The program that I mentioned that is set up has worked well in the 
past. We just need to fix the program so we will not have these 
frivolous lawsuits circumventing the program.
  These bills would expand the remedies to help compensate those who 
are injured, those who suffer serious side effects from vaccines, while 
at the same time ensuring that unwarranted litigation does not further 
destabilize the supplies.
  The legislation--again, this is legislation in the 107th Congress and 
the 108th Congress which, in effect, the lawyers have beat back and 
have not let us pass; but it is going to come forward again--would also 
require the Federal Government to maintain a stockpile of prioritized 
vaccines. This will help stabilize supplies and help us prepare for 
years ahead in which vaccine production may or may not be able to keep 
pace with the need.
  These bills--again, it was S. 2053 in the last Congress and S. 754 in 
this Congress--would also expand the funding available for State and 
local efforts to boost immunization rates among children, especially 
those in underserved areas or those at a high risk to vaccine-
preventable diseases.
  Each of the major provisions included in the legislation was 
recommended by the Advisory Commission on Childhood Vaccines. That is a 
Federal expert panel composed of vaccine manufacturers, health care 
providers, and trial lawyers. The legislation also has been endorsed by 
a broad range of medical and children's health groups, including the 
American Academy of Pediatrics, Every Child By Two, and Parents of Kids 
with Infectious Diseases.
  We must return to this legislation in the next Congress. And we will 
consider other steps to address the vaccine situation in the future.
  Recently, over the course of the week--and really it plays off in the 
Presidential election again and in other discussions--people are trying 
to seize upon hot issues and turn them to their political advantage. 
Let me just say several things.
  No. 1, it is irresponsible to say that there is a quick fix. It is 
complex. It takes study. We have done that study. We are ready to 
legislate. But there is no quick fix.
  Again, there have been people--I believe it has been on the floor of 
the Senate, but I know it has been in the press--who are terribly 
misinformed. Yet when they say something, people accept it as fact. And 
a statement to suggest somehow that this is an issue that arises by 
brand drugs keeping generics off the market does not make sense. People 
can say that, and people nod their head, but it does not make sense.

  Why do I say that? Because a flu vaccine has to be unique each year. 
The generic is standardization; you just produce a lot of it. The flu 
vaccine has to be tailored. It has to be modified. And it takes several 
years to do those modifications.
  No. 2, I do want to applaud the Bush administration, the CDC, the 
Department of Health and Human Services, Dr. Julie Gerberding, who I 
mentioned, and Secretary Tommy Thompson. They had virtually as close to 
perfect as you can planning in terms of vaccines. They took immediate 
and prompt action as soon as this shortage became available.
  A third point I want to close with is, we have to create a stable 
environment through a combination. This is where there is no quick fix. 
We need to address the future stockpile, perhaps with some guaranteed 
purchase by Government, public-private partnerships for research and 
development, increased funding for safer vaccines, and perhaps--I would 
argue most importantly--legal reforms. The flu vaccine shortage we are 
seeing right now is a symptom of the broader issues of risk and low 
return of developing any vaccines.
  Lastly, healthy adults and kids not in the CDC-recommended categories 
should withhold this year so that we will have sufficient vaccines 
available for those who are at higher risk.
  Mr. President, again, I bring this to the floor because it is a 
current topic. I do not want to see it politicized. We have an 
obligation in this body to address it head-on. It is a tort reform 
issue. It is the sort of issue that we are obligated to take on, and we 
will take on very directly in the next Congress.
  Mr. President, I suggest the absence of a quorum.
  The PRESIDING OFFICER. The clerk will call the roll.
  The assistant legislative clerk proceeded to call the roll.
  Mr. FRIST. Mr. President, I ask unanimous consent that the order for 
the quorum call be rescinded.
  The PRESIDING OFFICER. Without objection, it is so ordered.

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