Maintaining Public Confidence in Vaccines: A Case Study
Richard F. Jacobs, MDInteraction of Disease Reduction and Safety Concerns

So here's the model that we talked about, and it was a pleasure to be on an
Educational Advisory Board that put together this message to try to discuss
with pediatricians, family physicians, primary care physicians, public health
nurses, anyone that would listen on maintaining public confidence in our
vaccine program. But I think the real key is to remember we're dealing with
young physicians and young nurses working in public health. They do not have
the same perspective that many of has had that lived through the polio
epidemics, the measle epidemics, that have seen cases of neonatal tetanus or
diphtheria. But this is what we need to look at, to think about, and that's
the challenge, and our next speakers are going to build on this scenario, so
that you can interact with your parents and your younger colleagues. Because
if you look at this, this is adapted from the textbook on vaccines by Drs.
Plotkin and Orenstein who are the editors, and if you look at this
representation, certainly in the pre-vaccine area you're going to have
whatever the incidence of disease is dictated by its contagiousness, its
indemnity, and basically its cyclical swings, like many things in infectious
disease, but the incidence will be relatively high. As vaccine coverage
increases, we've already shown you this success story with all of the vaccine
preventable pathogens in this country, your disease incidence will decline.
But at some point, disease incidence is going to approach, or at least get
close enough to what people perceive, or the established adverse events
related to a vaccine. At that point, be it due to a television show, a
newspaper article, an advocacy group or now the Internet, what you see is a
blip or a change in your vaccine coverage. Your vaccine coverage rate goes
down, and that impacts disease incidence in the form of outbreaks, very
similar to what's been reported in Ireland with measles recently, with
measles in the Netherlands, and could very, very easily be measles or certain
of these other diseases within the United States. It's actually only after
you can retain or regain confidence of the public, resume your high or
effective vaccine coverage rate that you then again will see disease decline.
I don't think that there's anyone in this audience that would tell a parent
that vaccine safety is not important to you. But I think we've got a message
very clear that we can tell parents today that we take vaccine safety very
seriously. Look at the changes this year, the year 2000. We went to all live
TV, that's two more shots and it costs more money. Why did we do it? To try
to totally eliminate vaccine-associated paralytic polio. We recalled
Rotavirus vaccine. I want you to remember that we went to a DTaP schedule in
this country before we had an approved, licensed DTaP product for the fourth
and fifth dose. So I think you only have to look at the changes that occur
every year, and we need to inform you better of the issues that we have
changed that make vaccine safety very apparent to parents, that we do that it
seriously.

So let's look very briefly at just a couple of scenarios. Many of you know
this extremely well, so I'm not going to dwell on it a lot, but if you look
at the interaction of disease reduction and safety concerns, and you look at
pre-vaccine measles, in case we have a younger colleague in the audience
tonight that doesn't remember or trained during the era when there was a lot
of measles, I want you to remember that number in 1941. Complications -
here's the list, but the rate of complications following natural infection,
one to two deaths per hundred, per thousand natural infections, and about one
case of encephalitis per thousand infections.

For pertussis, here is a lesson that you all know, we learned it well, but we
seem to forget. Public concerns over the safety of the whole-cell pertussis
vaccine that became an issue in the 70s and 80s, SIDS, encephalopathy, all of
those issues related to central nervous system, temporal associations that
were "linked" to immunizations, and to the whole-cell pertussis came about
and produced several epidemics in the world.

This was the experience in Japan, 1947 to 1990. I want you to notice, up at
the top, you have your pertussis components, you have the decline in number
of cases, you have the number of deaths in the lighter blue declining
significantly, and then all of a sudden, you have this association that was
put out into their press and into their public of the association with Sudden
Infant Death Syndrome. You have a suspension or no use of the vaccine, and
what do you see? You see a relatively sudden rise in number of cases and
number of deaths.

Also significant for the experience in the United Kingdom that was previously
published. So look at the mid 70s with whole pertussis in the United Kingdom,
negative publicity, vaccination rates fall, and major outbreaks with
pertussis-related deaths occurring because of a loss of public confidence.

Well, what's going on today? Well, we have some people on this lectureship
that have much more expertise, insider information, have actually done the
studies that we'll be talking about, measles, mumps, rubella vaccine, and
that association. But I think that what we have seen, in at least Ireland,
and Dr. Salisbury will hopefully update us, maybe, on what it actually going
on throughout England, Scotland and Ireland, but certainly the decline in
measles immunization is of significant concern to those of us in infectious
disease because it doesn't take much to key-off a measles outbreak.

I am going to talk about the maintaining of public confidence and try to lay
out for you the problem that we have seen in the world, and certainly in the
technologically advanced world, the era of mass publication, TV, video, the
Internet, and what has played upon the issues that are truly important when
it comes to vaccine-preventable diseases. Now if you look at the
effectiveness of the vaccination programs in this country today, it's very
clear to everyone that has studied this information, that we are looking at
one of the ten greatest public achievements in the United States. We have not
seen a case of Haemophilus influenza type B meningitis at Arkansas Children's
Hospital in now 6 years. We have not had a case in the state in 6 years. If
you go back to 1985, we had almost 100 cases of H flu meningitis, we had 6
deaths, and we had 12 incredibly neurologically handicapped children. But I
want you to put yourself today into the perspective of a young physician,
modern day parents, who have never seen a case of measles, never seen a case
of mumps, never certainly seen a case of diphtheria tetanus, and we now have
house officers that cannot spell Haemophilus influenza, much less have ever
seen a case of H flu meningitis. So if you look at this incredible success
story, we really are a Prisoner of Zenda. We are now in an era where we have
incredible accomplishments as it relates to vaccine-preventable diseases, but
what that has also accomplished is to bring down the awareness of the
severity of these naturally occurring illnesses in an unvaccinated
population. So I'll show you this slide to put it into perspective.

What is presented on this slide is the maximum reported cases, the year of
that maximum reported case in the United States for diphtheria, measles,
mumps, pertussis, polio, rubella and the congenital rubella syndrome. I've
also shown you in the next column, the reported cases in 1998, and the
percent change. Now whether it is related to the antigens or current lack of
understanding of Bordetella pertussis, maybe it's the publicity of the
whole-cell pertussis vaccine, or I hate to say it, after the acellular
pertussis clinical trials, maybe it's that the whole-cell pertussis vaccine
really wasn't working very well in this country, but pertussis is typically,
at least in my opinion, the truly disappointing vaccine-preventable disease
statistic on this slide. But look at the rest of the success stories, and
certainly to go from over 200,000 cases of diphtheria, realizing the time,
but to even go up to 1968 with 152,000 cases of mumps, 57,000 cases of
rubella in 1969, and then to look at the reported cases, it truly is a
remarkable success story.

This is to graphically show you the issue of measles, and I recently had a
pediatrician at one of the lectures that I gave say I'm still not convinced
that the varicella vaccine is that important because you keep making
reference to measles, and Dr. Jacobs, measles is much more severe. Varicella
isn't measles. Well, I think if you look at the overall numbers of morbidity
and mortality, I don't think anyone would argue with you, but since it is
transmitted as a respiratory aerosol droplet, highly contagious, you didn't
want either one of those infections in your hospital because of the
contagiousness, is there any reason that we should have ever suspected that
we couldn't see this same type curve with varicella like we saw with measles?
And if you picked up some of the newspapers recently, I hope that the article
will be out, they're talking about an 80% reduction in varicella, especially
in communities studied by the CDC where immunization coverage rates with
varicella vaccine for 19- to 35-month-olds have now gotten up to the range of
60 to 70%. So this is the success story, but here's the challenge. These
little bumps don't look like much, do they, those little blips on the curve,
when you certainly go back and look at the overall number of cases of measles
back in the 50's and early 60's? But I want you to remember the number of
cases that this actually implies with one little bump, and remember, imported
measles is only an 8-hour plane ride away from many of your cities, for many
of your communities, your schools, your daycare centers, and if we don't
continue to have our current vaccination coverage rates for this contagious a
virus, that little blip is several thousand children with the potential for
several hundred deaths.

Addressing Vaccine Safety Concerns
Paul A. Offit, MDRotavirus Disease and the Rotavirus Vaccine

We'll conclude with just the rotavirus vaccine. We know that in the United
States, there's about 550,000 doctor visits and 50,000 hospitalizations a
year, meaning that 1 of every 75 children born in the United States is
hospitalized with rotavirus-induced dehydration, and there's 20 to 40 deaths
from dehydration every year.

In developing countries, the disease is devastating. There is roughly 600 to
800,00 deaths per year from rotavirus-induced hydration, meaning that one
child every minute dies from rotavirus infection, or said another way, 2,000
children die a day from rotavirus infection in developing countries.
Therefore, as a single agent, rotavirus kills more infants and young children
than any other infectious disease.

So there was, like for polio, a tremendous interest, and both the public and
private sector, well, certainly the private sector, in developing a vaccine
to stop this. The Rotashield Vaccine was licensed in August of 1998, and had
it, as its backbone, a simian strain, RRV, or Rhesus Rotavirus into which, at
least for three of the strains was cloned an individual gene which coded for
one of the outer caps and surface proteins (cannot confirm underscore), so
that represented in that vaccine were the four human serotypes that cause
disease in the United States.

Pre-licensure - we knew that this vaccine had a first-dose side-effect
problem of low-grade, and to a lesser extent, high-grade fever, and then some
behavioral disturbances after dose 1. We also knew that there was, to a
lesser extent, mild or low-grade fever after dose 2, but nothing after dose
3.

We also knew pre-licensure of these data, which is actually, I think more
accurately, this would be 2 of 8,000 cases of intussusception occur in the
group that received the vaccine that was the final formulation, this
quadrivalent vaccine as compared to 1 in 4,600, which was not statistically
significantly different. Also, there was no intussusception noted after dose
1, which made people think that because this wasn't statistically
significant, because there was no dose 1-associated disease here, that this
was likely not to be a coincidence, but rather it was more likely subsequent.
However, despite this, this phenomenon was noted in the AAP statement, it was
noted in the ACIP statement, it was noted in the package insert, and the
company was required to do post marketing surveillance following the release
of this vaccine.

The vaccine, as I said, was released at the end of August in 1998. It was
temporary suspended in July of 1999 because of data that were generated by
the Vaccine Adverse Events Reporting System, and what was seen that was
worrisome to people was a few things. First of all, 13 to 15 cases reported
did occur after the first dose. Most of those occurred within a week of the
first dose, and also a significant percentage occurred in young children,
which worried people because intussusception was primarily a disease frankly
of the 5- to 9-month-old. It was an unusual disease in the 2- to 3-month-old,
so this confluence of events worried health officials enough that they
temporarily suspended the vaccine while a retrospective case control analysis
was performed by the CDC to determine whether or not it really was cause and
effect.

And in short, it was. This slide shows the relative risk of intussusception
by age after dose 1, and you can see that what was seen actually in that
VAERS data didn't really hold up in this case control series because
independent of really what age you got your first dose at, you were at fairly
high relative risk within a week of that first dose of having
intussusception. It wasn't really a phenomenon of the young infant,

and that one was at greatest risk after dose 1, lesser risk after dose 2, and
essentially no risk after dose 3. So you could immunize yourself against
intussusception by getting the Rotashield vaccine. It's a small consolation
for those who got intussusception, but that is true.

So because of these data, the Centers for Disease Control recommended the
withdrawal of the rotavirus vaccine recommendation. So was the Rotashield
vaccine safe? One cannot consider safety as an absolute term. One has to
consider safety by comparing the risk of the vaccine associated with the risk
of getting actual infection. In the case of rotavirus, which is ubiquitous
infection, an infection which will affect every child in this country for the
most part by 3 years of age, the choice not to get a rotavirus vaccine is
simply a choice to get rotavirus disease. So what does that choice mean?
Well, let's just go through the numbers. We should have final data by
February, but if one assumes a risk of intussusception in 1 in 12,274 vaccine
recipients, we can break it down this way. We knew that roughly a million
children got vaccinated. If you look at those who got vaccine, we know that
the rotavirus vaccine is about 80% effective or so at reducing moderate to
severe disease. So therefore one can expect that for one million children who
did get the vaccine, about 29,000 would visit their doctor with the rotavirus
illness, and 143,000 who didn't get the vaccine would visit their doctor.
Similarly, because the vaccine is essentially 100% effective at protecting
against severe rotavirus disease, we know that those who got the vaccine
wouldn't be hospitalized with rotavirus, but that about 16,000 would be
hospitalized with rotavirus that didn't get the vaccine. If you look at
intussusception, we know that we would increase the rate of intussusception
per million children by about 95 children, and we know that one child dies of
intussusception from getting the rotavirus vaccine. So one of a million
children died from rotavirus, from intussusception caused by the Rotashield
vaccine. We also know that 6 to 12 will die that didn't get the vaccine. So
there's some assumptions that were made I think that aren't correct. For
example, I think some children who will die from rotavirus disease will die
at less than 6 months of age prior to being fully immunized, and one could
also argue that now that we know of the risks of intussusception, or risk
which occurs, quite frankly soon after vaccine, you can also argue that with
that knowledge, and also knowing that when children are hospitalized or die
from intussusception, it's because of a failure to recognize that as a
problem, that we may not see any deaths from intussusception or from
Rotashield vaccine. But in either case, I think it's fair to say that roughly
5 to 10 times more children will die from the disease than would die from the
vaccine.

Addressing Vaccine Safety Concerns
Paul A. Offit, MDPoliovirus and the Polio Vaccine

So let's go through the polio vaccine story because I think there's a lot of
twists and turns in the story that makes it interesting in our attempts to
define what we mean by the word safe. Polio, in the 40s and 50s in the United
States, was highly contagious and occasionally devastating infection. In the
early 50s there were 58,000 cases of paralytic polio reported. More than half
of those cases occurred in previously healthy young children, and 90% of
adults and 100% of children living in a home with someone with polio
seroconverted.

This is a slide showing lower limb paralysis in adults with polio.

And this is a slide showing at the University of Michigan these negative
pressure ventilators or iron lungs where children who had cranial nerves
affected by poliovirus were unable to breathe on their own, and therefore
required these ventilators, and most of these children died of aspiration
pneumonia.

So there was a tremendous effort in the United States to develop a vaccine to
prevent this disease, and at the heart of this effort was this man, a man who
won the Nobel Prize for the development of that vaccine. He won it in 1954.
Anybody know his name?

John Enders. Right. With John Enders-and actually he won it with his two
graduate students, Weller and Robbins-and what he figured out was he figured
out how to grow poliovirus in non-neural cell culture, which then allowed one
to grow up that virus in cell culture, and one could then either inactivate
it as Jonas Salk did, or attenuate it via serial pathogen culture as Albert
Sabin did, and that's just purified poliovirus.

The work is done by this man on the left, Jonas Salk, and what Jonas Salk did
was he figured out how to inactivate poliovirus. He figured the conditions
under which a certain amount of formaldehyde and heat and pH allow for a
complete inactivation of that virus, so that one can retain immunogenicity,
but eliminate pathogenicity or virulence.

And so there was a huge field trial that was conducted or headed by Thomas
Francis out of the University of Michigan. It was done in 1954, and it was
sponsored by the National Foundation for Infantile Paralysis or March of
Dimes.

It was at that time, and remains today, the largest field trial in the
history of vaccines, I think to my knowledge. It was three doses of
inactivated polio vaccine given to 420,000 children. Controls included
200,000 placebo recipients and 1.2 million uninoculated children, and the
vaccine was found to be about 90% effective in preventing type 2 and 3
disease, and about 70% effective in preventing type 1 disease. It was a trial
that cost about $6 million at that time, which would work out to maybe $100
million today. But there were tremendous numbers of volunteers that
contributed to this private organization, the March of Dimes, to get this
done. I think pharmaceutical companies had trouble getting people to
volunteer their time to contribute to it. Maybe that's why it's a little more
expensive then.

But the vaccine was then released for licensure on April 12, 1955. There were
five companies that made the vaccine in the United States at that time, and
within 2 weeks really of the release of that vaccine, this headline appeared
in the New York Times, One Firm's Vaccine Barred, Six Polio Cases are
Studied. I mean this was April in the United States. This was before we
really started to see polio, which was primarily a summer disease, but what
was seen was essentially a point source outbreak of polio associated with the
administration of this vaccine, and it was traced, at least in the early
cases, were traced to a vaccine that was made by one laboratory in Berkeley
California called Cutter Laboratories, and Cutter Laboratory vaccine was
withdrawn. The Cutter vaccine was withdrawn from the market within 24 hours
of those cases being reported, and the United States Public Health Service
then went on to investigate all of the companies that made that vaccine.

They found something that surprised them. I should take a step back and say
that when we looked at what the incidence of disease was in people who
received the polio vaccine, and compared that with the number of cases, we
would have expected in those people who received polio vaccine, we found
really for almost all of these companies, that there were a greater number of
cases in the vaccinated than in the unvaccinated group.

And when the United States Public Health Service looked at the records of
these companies to try and determine whether or not there was any hint that
there were difficulties inactivating the poliovirus for the purpose of
vaccine. They found that all companies had at least some percent of lots that
contained live virulent poliovirus, and then these lots weren't used, but we
had a relatively insensitive measure of an inactivation at that time. So it
certainly warned of a big problem, and the Poliovirus Program was shut down
in this country between May 7, 1955, and May 14, 1955.

So was the inactivated polio vaccine made in the United States in April of
1955 safe? I think that's easy. The answer is no. The vaccine actually caused
more disease than it prevented, and hence it was withdrawn from the market
for that period of time when we tried to figure out how to make a safer polio
vaccine.

In order to make a safer polio vaccine, what we did was we added an extra
filtration step. That made for, what was no doubt, a lower potency
inactivated polio vaccine, and that's the vaccine we had in this country in
the late 1950s, but the result of this whole episode was some lost faith in
the polio immunization program, and that in part resulted in lower
immunization rates. But despite a relatively low potency vaccine, if you look
at the incidence of reported cases of paralytic polio between 1955 and 1962,
there was a dramatic reduction in the incidence of polio,

such that by 1962, which was the year that the Sabin vaccine, at least the
serotypes 2 and 1 of the Sabin vaccine were licensed for use in this country,
we had gone from 28,000 to 900 cases, but there were other problems. If you
looked, first of all, the 900 cases reported there represent only about half
the states and there was also underreporting, so I think it's still fair to
say that there were thousands of cases of wild type or natural polio
infection in this country. What was also worrisome was that if you looked at
those cases, about 20% of those children had received 2, 3, 4 or even 5 doses
of the inactivated polio vaccine, and yet still had been paralyzed by wild
type polio. So what we had in this country in 1962 were relatively low
immunization rates, we had a vaccine which was certainly not, was fairly far
from 100% effective, and although this lower potency inactivated vaccine was
never subjected to the same clinical trials that the original vaccine was,
and we knew that it certainly had an effect in reducing the incidence of
disease, we knew it was far from a perfect vaccine.

So with all of that information in hand, we made the decision to go to the
Sabin or the oral polio vaccine because we know that the OPV was quite
effective when administered in three doses, we knew it had the attractive
feature of contact immunity, and that 25% of people who just were around
those who got the oral polio vaccine would in fact be vaccinated, and it
obviated concerns about the decreased potency.

Now we knew actually as early as 1957, so 5 years before the oral polio
vaccine was licensed in this country, that the oral polio vaccine was unique,
frankly, among vaccines in its capacity to revert to neurovirulent type.
There were three reasons for that. I'll just go through them quickly. One is
although the oral polio vaccine was attenuated for growth in the central
nervous system, it was not particularly attenuated for growth in the
intestinal tract, so it really still replicated well in the intestinal tract.

Two, because polio is a single-stranded RNA virus, it is fairly highly
immunogenic, meaning there's a base pair change per cycle of replication, so
it's not particularly faithful in its replication, unlike say double-stranded
DNA viruses. And lastly, if you look at the bottom line here, the type 3
polio was not particularly highly mutated. So not only is it not particularly
stable, it wasn't even highly mutated, and when you looked at these cases of
vaccine-associated paralysis, virtually all of them were type 3.

It's a bad confluence of three events, which is to say a virus which
replicates, which is not particularly faithful in its replication, and at
least one strain of which was not highly mutated, and the result was that the
vaccine did occasionally revert to wild type rarely, but still it really did
revert to neurovirulent-type causing vaccine-associated paralysis, which was
frankly indistinguishable from clinical wild type polio because, in essence,
it was wild type polio.

So was the oral polio vaccine safe in 1962? I think the answer to that
question is yes. Although we knew the vaccine-associated paralysis occurred,
we also knew that we had thousands of cases of polio in this country, we knew
that we had a vaccine, the OPV, which worked, and we knew that we had low
immunization rates, which was obviated at some level by a vaccine that had
contact immunity. So we chose the oral polio vaccine in 1962,

and I think in retrospect, that was the right choice because what we found
was within 17 years or so, by 1979, we had eliminated wild type polio from
this country. But what we hadn't eliminated was polio because subsequent to
1979, all the polio that was seen in this country was that which was caused
by the oral polio vaccine. We'd see about roughly six to eight cases a year.

So was the oral polio vaccine safe in 1979? I'm not sure I know the answer to
that question. I'll give you my opinion. I think it wasn't. I think that
although the inactivated polio vaccine was not a great vaccine in the absence
of having any natural infection in the United States, and knowing also that
Scandinavian countries, certain provinces in Canada, were able to essentially
eliminate epidemic and largely endemic polio in their countries using only
the inactivated polio vaccine, I think that we probably could have gone to an
inactivated polio vaccine in 1979 safely. I do think that the point I'm
trying to make here is that the equation changed. Remember our initial
hypothesis statement was that in order to define safety, one has to consider
the risks and the benefits of vaccine as compared to disease. In the absence
of disease then, I think the burden is to have a safer vaccine. So I think
that one could reasonable say that we could have gone to an inactivated
vaccine in 1979.

But what happened was as the due advances in protein chemistry and ion
exchange chromatography, we were able to make a better inactivated polio
vaccine, and we knew that this vaccine was highly immunogenic, and in studies
was also quite effective after three doses.

And so was the oral polio vaccine safe in 1995? I think the answer to that
question was clearly no because now we had an acceptable alternative that we
knew worked quite well, and hence we moved to the inactivated polio vaccine.

So this just summarizes what I said before that when one considers factors
determining safety, one needs to consider the incidence of disease or
benefits and the incidence of adverse events of the vaccine or risks, and
that much also goes into that formula, such as what are the immunization
rates in your particular country. You can argue that in Africa right now, the
oral polio vaccine is safe because there's still a fair amount of natural
infection, there is a fairly low immunization rate, and one needs to depend
on contact immunity. So although the oral polio vaccine, I think, it's not
safe in the United States, I think it is safe in Africa or Southeast Asia or
India.

Vaccine Safety: The United Kingdom Experience
David Salisbury, MB, FRCP, FRCPH, MFPHMA Planned Response to Misinformation
on a Vaccine

I'm going to end on the example about how we don't have to lose this war.
Here is a headline in one of our newspapers at the end of August this year.
On Saturday afternoon, this was a Sunday newspaper, on Saturday afternoon the
journalist contacted us, and it was perfectly clear that he neither wanted to
hear the truth, or if we told him the truth, he didn't understand the truth.
And he told his readers that there was a coverup, that a new vaccine had
killed 11 children, and that we had covered up the information. The fact that
it was publicly available to him or anybody else was irrelevant.

Within this same newspaper was this headline, albeit on the back page. After
a few days when we heard that he was going to run this story again the week
later, we decided that we would turn this around and be proactive. A
newspaper a couple of days ago, this was the kiss of death. If the government
denies links, you know there has to be links.

But over the next 2 days, we decided we should stop this. This was no reason
for a good vaccine to be damned unfairly, and so we went on to a very
positive approach. We released all of the most up-to-date information on just
how effective this new vaccine had been, and we got multiples of coverage in
all of the newspapers, far, far greater coverage then was ever achieved by
the one sour article from the week before. We got enormous amounts with
television, the radio and all media coverage. So you don't have to lose this
because the news that we have is enormously good news, but we've got to
manage all of that in an effective way.

I leave you with this comment. The irony of the Information Age is that it
has given new respectability to uninformed opinion, and that was made in 1995
here in the United States, at a time before the Internet had really taken
off. Now we have got that multiplied many logs over, and we have to deal with
uninformed opinion that believes that it should be taken seriously. We have
to show that our case is a better case, so I hope I have given you some
insight into where some of these problems come from and how they can be
actively managed.

Vaccine Safety: The United Kingdom Experience
David Salisbury, MB, FRCP, FRCPH, MFPHMThe Origins of Public Concerns About
Vaccines

So next, it's published, so it must be true. So here is an article published
in the Lancet, Is Measles Vaccination a Risk Factor for Inflammatory Bowel
Disease? Well now the paper actually was awful. It compares non-comparable
groups, it uses all manner of epidemiology inexactitudes, but it gained great
credibility. So here, a few months later, is another paper if I can find it,
a case-controlled study of measles vaccine and inflammatory bowel disease.
What do we suppose that one showed? No association. When you do a properly
designed epidemiological study, you find that there is no association between
the vaccine and the disease.

But what did the leader in that edition of the Lancet say? These findings
provide no support for the hypothesis that measles vaccination in childhood
predisposes to the later development of inflammatory bowel disease, and the
real bit is the bottom bit, will this negative report be as well publicized
as the 1995 study? Well, of course not. It was inconvenient to those who were
very pleased to be able to say the vaccine caused inflammatory bowel disease,
so the negative work rarely gets reported.

So where does the public concerns come from? Well, they start in the medical
journals, as I just pointed out to you. But then what happens? They get
picked up by journalists and it starts with a fairly sensible headline,
Measles Link to Growing Bowel Disease, and then watch the headlines. The
next, we've got a scare over the measles jab, and then we've got the crying
shame of the vaccination victims. This is all from the same publication. Now
we've got an alert. Everybody has to be on alert over this vaccination.

And now we've got a ban, "Ban the three-in-one jab," urge doctors. Now that
really must make it very important because doctors are urging a ban. So where
does it come from? It comes from the medical journals. Here is a doctor
journalist who now blames the Department of Health, the fact that there
hasn't been a Ministry of Health for about 20 years is clearly inconvenient
to the headline writer.

And now the parents are right, no evidence, but the parents are right. And
just occasionally, somebody writes the reality that the scare is pure
moonshine, but those headlines are only too infrequent. So it starts in the
professional press, but it doesn't take long before it takes off in the wider
media.

So scare stories have legs. So let me just show you. This starts in the
Philippines. The government puts an anti-fertility agent into tetanus toxoid.
Somebody tested tetanus toxoid to see if it had HCG in it. Now why would you
do that? But they said it did. And the story went to Central America,
denounced by the Cardinal, the vaccine that will sterilize. I told you about
the MR story in the UK. One of the people who had Guillain-Barre was the son
of a creditor from Barbados and so the Barbados newspapers ran the story that
this child had been paralyzed by the vaccine, and it wasn't even true. Now
the MMR scare started in my country, and ran in your Congress, and it took 48
hours after it ran in Congress with no publication of the scientific data,
simply people telling stories to a gullible audience. Forty-eight hours
later, it bounced all the way back to our newspapers,

and on Sunday morning, those were the headlines on one of our newspapers; no
data, no science, no nothing. Scare stories have legs.