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National Infant Immunization Week 2006

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WASHINGTON, DC

Moderator: Amy Pisani

Guest Speaker: Dr. Paul Offit
March 15, 2006
9:00 a.m. CT

Operator:
Good day and welcome to this Every Child By Two media conference call with Dr. Paul Offit to address vaccine safety concerns.  Today's call is being recorded.  At this time for opening remarks and introductions I would like to turn the call over Ms. Amy Pisani, of Every Child By Two.  Please go ahead, ma'am.  

Amy Pisani:

Good morning.  Thank you so much for joining us today.  My name is Amy Pisani and I have served as the Executive Director of Every Child By Two for the past 10 years.  Our program was founded 15 years ago by former First Lady Rosalynn Carter and former First Lady of Arkansas Betty Bumpers.  And as our goal we strive to ensure timely immunization of children by the age of two and to institutionalize immunization delivery to all children in the United States of America. 

Our co-founders have been advocating for timely immunizations for more than 30 years and have seen so many successes.  Our country now boasts the highest immunization rates ever recorded even though there are more vaccines and a more complicated immunization schedule today.  Vaccines have wiped smallpox from the face of this earth and in the past three years both measles and rubella have been declared no longer endemic in the United States.  And this means that the disease no longer circulates here in the U.S.  However, they can and they are still imported by foreign visitors. 

What's very troublesome to Every Child By Two though is that two million – 2.1 million children are still not receiving timely immunizations leaving them vulnerable to diseases like whooping cough, hepatitis, meningitis, influenza and others.  And although rates are at an all-time nationally, there are many states that fall well below the safety range and pockets of vulnerable children, particularly in inner cities.  We find that rates among African American children are 13 percentage points lower than white and Hispanic children, and due to insufficient funding from Congress, state health departments are being forced to turn away children seeking vaccines. 

Today we're here to discuss vaccine safety and legislation that's being introduced in many states to ban the use of thimerosal in vaccines.  I'm so pleased that Dr. Paul Offit is here today because he has the uncanny ability to make sense of the abundant research that's been conducted around the world to disprove allegations that the preservative thimerosal that is in some vaccines ever caused autism in children. 

Before I give the phone over to Paul I'd like to make it very clear that Every Child By Two trusts the conclusions of the scientific community that the evidence does not point to a connection to vaccines.  And one fact we all know, immunizations have saved the lives of millions of children, and not immunizing a child due to unproven accusation about vaccine safety puts his or her life in jeopardy.  Currently the only vaccine that continues to contain Thimerosal is some influenza vaccines.  But each year approximately 36,000 people in the United States die from influenza and its complications and over 114,000 people are hospitalized.  The rates of infection, though, are highest amongst children and hospitalization rates are highest among children from birth to two years of age.  During the 2004-2005 influenza season I'm sure you can remember that many people died.  In fact, over 150 children died from influenza that year and many more were hospitalized.  And studies indicate that pregnancy can increase the risk for serious medical complications from influenza.  Now, my son was hospitalized twice for influenza and I'm now the first in line each year with my children, both my five-year-old and my one-year-old, to seek the vaccine for him.  I never want him or our family to go through what we did those first two flu seasons of his life, and I really am glad and pleased that you're willing to hear what we have to tell you about vaccines and their safety and I hope you'll help your readers understand all of the information that's out there.  They have access to so much false and misleading information about the safety of life-saving vaccines. And I'm very grateful to Paul, and he's going to describe to you the scientific research behind vaccines and help you understand so that you can better help your readers to sift through all this information. 

And let me turn the phone over now to Dr. Paul Offit. 

Paul Offit:

Thanks, Amy.  For those of you who don't know me, I'm the Chief of Infectious Diseases here at Children's Hospital, Philadelphia, and the Director of something called The Vaccine Education Center, also here at Children's Hospital. And what I thought I'd talk about – and I think I can do this in about 12 or 13 minutes or so – is the question that our center most – is most commonly asked, either by phone calls or e-mail.  And that's whether or not it's safe to give the influenza vaccine, because most of the influenza vaccine out there contains this ethyl mercury containing preservative called Thimerosal.  People have read what's been written in the paper or heard it on the radio or read it magazines that Thimerosal, this mercury-containing preservative, may be harmful and may be a cause of autism.  And so what I want to do is sort of go through the scientific evidence that disproves that notion.

The first – the first thing is just – just without going through autism in detail – but it is – it is a significant disorder that effects children and can – is associated with behavioral and language and communication deficits.  There has been a fair amount of study which I think has clearly shown that the disease is at least – or at least has a genetic basis.  Which is to say when you're trying to figure out whether or not something is associated with – or has a genetic basis probably the best way to do that is with twin studies, which is to say you look at the incidence of the disease in, say, an identical twin of someone who has the disease as compared to a fraternal twin of someone who has the disease.  And when you look at those studies what you find is that about 90 percent of an identical twin who has – where one of the twins has autism also has autism, whereas when a fraternal twin has autism the chance that that other twin would have autism is much less than 10 percent.  So that sort of takes out the environmental influenza and just looks at genetics I think and has – and there has been study after study that has shown that there's at the very least a genetic basis.

But that – I think the question from the parents’ standpoint is, OK, let's – even if – given that there's a genetic basis or genetic predisposition, is it possible for a toxic or environmental agent to cause autism.  And I think the answer to that question is yes.  There's a couple excellent studies that have looked at that.  The first was a study looking at children whose mother took a sedative called thalidomide.  This was a drug that was – that was licensed and used much more so in Europe than in the United States, where it actually was never licensed although it's still some extent used.  It was marketed as a sedative, it was said to be safe for pregnant women when clearly it wasn't.  Women who took thalidomide had a clear increased incidence of delivering babies whose hands and feet were directly attached to their bodies, this so-called phocomelia.  They also delivered babies who had stunted or mal-rotated ears. And it's interesting when you look at the way that the embryo develops, the – when the limbs, like the arms and legs, are affected that doesn't start to happen until women took thalidomide beyond 24 days gestation.  Ear abnormalities, on the other hand, occurred within sort of 15 and 20 days post-gestation. And what was interesting about thalidomide was it clearly caused an increase incidence of autism.  But the children who had autism didn't have those arm or leg abnormalities, rather they just had the ear abnormalities, suggesting that in order for thalidomide to cause autism it had to be taken by the mother before 24 days gestation, which suggested that there was a risk period or at least a window during which children were at risk for getting autism, presumably because genes are expressing developmental proteins that early in gestation.

Now, the second piece of evidence – and it's consistent with the thalidomide data – is data on congenital rubella syndrome.  Rubella's a virus; it was a virus that swept through this country for the most part causing epidemics every three to four years.  And during those epidemics – and this was before the vaccine was introduced in 1969 – before those – when those epidemics occurred, every year we would see about 20,000 babies who would have ear or eye or heart abnormalities because of rubella virus.  What's interesting – and many people didn't realize this – is that rubella virus, when it infected the mother during pregnancy and therefore consequently affected the baby, also caused autism.  But, again, just as with thalidomide, in order for babies to get autism the mother had to be infected in the first trimester, early in pregnancy.  When she was infected in the second or third trimester or certainly when babies were infected postnatally with – or after birth with rubella, there was no increased incidence in autism.  So, again, consistent with the thalidomide data there appears to be this window of vulnerability when children are at risk for a toxic or environmental or in the case of rubella a viral factor that could increase the risk of autism, again consistent with the notion that there are developmental proteins expressed early in utero, meaning when the child is in the womb, that are – that put a children at risk for autism if those genes are in any way disrupted.  And also there are studies in experimental animals like mice that suggest that some of these genes make these developmental proteins such as so-called WTN1 gene and others.  So it's all – that is all consistent.

So the next question is, OK, well, how about if the fetus is exposed to mercury, does mercury cause autism as thalidomide and rubella did. And I think the answer to that question is so far all the evidence that we have is no.  There is a – there are a number of things that can happen during pregnancy where the mother will react to her baby's blood cells, so-called blood group incompatibilities.  The ones you probably know about are the ABO incompatibilities.  But there are also other incompatibilities such are RH factor incompatibilities.  And when that happens, when the baby's RH type is different than the mother's RH type, the mother can actually make an immunologic response to her baby's red blood cells, kill those red blood cells, and cause the baby to be severely anemic and die.  And that's why there was a product developed called Rhogam – R-H-O-G-A-M – which is given to the mother during pregnancy primarily in the second and third trimester to prevent her from recognizing her baby essentially as foreign and responding to her baby as if the baby's foreign.  And Rhogam, at least previously although it doesn't anymore, but previously Rhogam contained ethyl mercury which is Thimerosal. And there is excellent – there's an excellent study that was reported recently in March 2005 in Chicago at the American College of Genetics annual meeting where they showed that mothers who received Rhogam did not deliver babies who were at any greater risk of having autism than those who didn't receive Rhogam.

Also consistent with that is a – it's an unfortunate natural disaster that occurred in Iraq in the early 1970s where grain that was fumigated with methyl mercury, which is the environmental mercury and different – and I'll explain how in a second – to the ethyl mercury that's contained in vaccines – that's Thimerosal as ethyl mercury, environmental mercury is methyl mercury, and methyl mercury actually is much more likely to accumulate in the body because it's excreted less well than is the more harmless form of mercury contained in vaccines.  But in any case, the grain was fumigated with environmental mercury, methyl mercury, that grain was made into bread, it was distributed free of charge to farmers, and it resulted in one of the worst single-source mercury intoxications I think of man when 6,000 Iraqis were hospitalized and 450 were killed by that mercury intoxication. It was also true at that time that pregnant women ingested that bread that was fumigated with mercury and they delivered babies who had a variety of neurological problems, including mental retardation and epilepsy, but not autism. So again consistent with the Rhogam data, even massive exposure of the baby to – during a time when the child is developing, during a time when the child is most at risk of presumably, you know, developing autism if those early expressed genes are affected, those – even those babies didn't – didn't develop autism.

So then the next question is, OK, well, how about postnatally, once a child is born if they are exposed to Thimerosal is there evidence that they are more likely to develop autism.  And there are four studies that now have been published on three continents. The United States, the United Kingdom, Denmark have all looked at whether or not children who are – who are given vaccines that contain Thimerosal as compared to children who were given vaccines that contained lesser quantities of Thimerosal or children who are given vaccines that don't contain Thimerosal, is there a difference in the incidence of autism among those three groups.  And the answer was clear and consistent and reproducible – no.  So again that's consistent with what was found sort of with the in utero studies, the studies when the baby's in the womb, looking at that Iraqi disaster as well as the Rhogam study.  Further – and this was actually an excellent paper that was published by Karen Nelson and Margaret Bowman in “Pediatrics” in 2003 – what they did was they looked at the symptoms of mercury poisoning and compared them to the symptoms of autism with regard to a variety of specificities including head size, psychological problems, sensory, speech, vision, motor disorders. And what they found was there was a clear difference between mercury poisoning and autism. And I think that's one thing in the media that occasionally is stated incorrectly, that mercury poisoning and autism have similar symptoms.  Not true.  This is a wonderful study.  I'd be happy to sort of give you the details of that study if you like.

The other point is that I think people have the notion that by avoiding the ethyl mercury, you know the 25 micrograms or so of ethyl mercury that's contained in the influenza vaccine, that they therefore will be avoiding mercury in significant quantities.  Not true.  I mean, mercury is part of our earth's crust.  I mean, ever since that earth's crust was formed and we had things like, you know, the leeching of rocks by sort of continual flow of water or volcanoes or burning coal, we release mercury into the environment.  So mercury is in the water that we drink.  Mercury – methyl mercury, environmental mercury.  And because it's in the water we drink it's in the formula that we give to our babies and it's in the breast milk that we give to our babies.  It's breast milk – and there's been several studies that have looked at this – contains between 1.4 to 1.7 micrograms of methyl mercury per liter.  And this level – not surprisingly, the levels are similar in both developed and developing countries because the notion of burning coal or having volcanoes or leeching rocks is the same in developed and developing countries.  If you – if you assume that a baby is breast-fed exclusively up till six months of age, that baby will consume about 360 micrograms of methyl mercury.  That's twice the quantity of mercury that was ever contained in vaccines and obviously logarithmically greater than the 25 micrograms of ethyl mercury that's contained in the influenza vaccine. And, remember, ethyl mercury is excreted from the body much more quickly than methyl mercury.  So a typical breast-fed baby will ingest about 360 micrograms of methyl mercury as compared to a child, say, who gets the influenza vaccine who will be injected with about 25 micrograms of ethyl mercury – a form of mercury which will be excreted much more quickly.

So the notion that – and so, one, you know, there's no evidence obviously that drinking water or ingesting breast milk or ingesting infant formula increases one's risk of autism.  And so obviously one wouldn't recommend stopping breast feeding or stopping infant formula or stopping drinking water any more than one would recommend not receiving an influenza vaccine that contains Thimerosal.

So as Amy pointed in her introduction, the real question for I guess moms and dads who call our center and ask, you know – you know, I – and say to us, you know, we're scared about getting that influenza vaccine, we're scared to receive Thimerosal,” I think the question becomes where do the real risks lie and how do we educate ourselves about where the real risks lie. And I would argue, as Amy did in her introduction, that, you know, we know that every year about 75 to 150 children will die from influenza, we know that every year up to 140,000 children less than five will be admitted to the hospital – I'm sorry, will – yes, about 140,000 children less than five will be admitted to the hospital with fever or croup or bronchitis or bronchiolitis or pneumonia secondary to influenza.  And we know that the influenza vaccine is likely to induce the immune response that's going to protect those children against disease.  And so I think that what parents need to know is that a choice not to get a vaccine, including a Thimerosal containing vaccine like influenza vaccine, is not a risk-free choice, it's just a choice to take a different risk and given all the information that I've just given you I think a different and much more dangerous risk.

The last point that I want to make and then I'll turn it over to your questions is I think that things have changed over the last few years in a very dangerous way.  And that's why I'm glad that Amy asked me to be on this conference call.  In the past when, you know – autism is an awful disease.  I think it's very frustrating for parents.  I think they want desperately to find something to make it go away.  And in the past that thing were things like gluten-free diets or magnetic clay or even secretin therapy, I mean all of which are silly and aren't going to make a difference but are not harmless.  I think a few years ago we crossed an important line, because now what's happened is we're starting to give “chelation therapy,” which is to say medications whose task it is to bind heavy metals such as mercury and help them be excreted from the body more quickly.  And because mercury doesn't cause autism they're given chelation therapy which will in no sense lessen one's risk of autism.  But chelation is not benign.  And as I'm sure many of you read, there was a child – a five-year-old with autism who was brought to a doctor in suburban Pittsburgh, in Portersville, Pennsylvania, who rolled up his sleeve and the doctor, you know, injected that child with a sodium EDTA – EDTA is just a chemical that helps to bialate – helps to bind any sort of what's called a divalent cation.  So mercury is such of a cation, meaning – if you remember that from chemistry in high school it's the thing with the two pluses after it.  But, you know, mercury isn't the only thing that has those to pluses after it.  I mean, so is lead, which is why EDTA is also used for – you know, for lead chelation – but so does calcium. And calcium is something that's necessary for our heart to beat.  When this child was given this sodium EDTA, it bound to calcium, it caused his heart to stop beating, he had a heart attack and died.  He died because he received a therapy that had no chance of making him better.

The second thing – and this is I think even more heinous – is there is a drug called Leuprolide.  That's the generic name.  It's – what it is, is it's a drug which ultimately suppresses a child's capacity to make testosterone which is necessary for a child's development into puberty, a boy's development into puberty. There are a number of drugs that have trade names associated with Leuprolide, but probably the most famous is – or most well-known is one called Lupron.  So now there's this notion that because autism occurs more commonly in boys that because autism may be sort of a representation I guess of extreme boyishness that by giving this Lupron that you're going to again in some way decrease a child's risk of getting – of progressing in their autism or that one can lessen the symptoms of autism by giving Lupron.  Well, Lupron is given as a chemical castration therapy to sex offenders.

It's also given for adult men who have prostate cancer; it's given to women who have endometriosis.  And the way that now – just search any of these blogs – I mean, the way that these folks who are – who are desperate to do something for their children with autism are responding is they're getting their doctors to write a prescription for Lupron claiming that the child has precocious puberty and that therefore needs to have their testosterone lessened when the child in fact doesn't have precocious puberty. And this drug has now – and it's not a cheap drug.  It's given intramuscularly; it costs 100 – a couple hundred dollars a dose.  So it's an expensive therapy.  And doctors are completely complicit in this and I think this is where, frankly, we fail as a profession.  People – you know, doctors have been willing to say that – you know that the child has precocious puberty, which then allows the drug to be paid for by insurance.  And it's a drug that when given to 10 or 11 or 12 or 13-year-old boys is going to delay their onset of puberty, I mean change their capacity to develop.

And I think it's just – it is just frightening that we participate in that.  And I think that – this is to me is malpractice, this is negligence that results in harm.  And I think that what we haven't been able to do as a medical profession is have, you know, things like ethical societies or professional societies or even licensing agencies get involved and take away the licenses of people that do this.  I just think we've crossed a very important line here.  I understand parents’ desperate desire to make their children better, but there's no evidence that this will make them better, there's abundant evidence that it will do harm.  And I think we've done very little to stop this.  And I think this is when it's – you know, when bad information goes to the level of really doing harm.

So I'll stop right there.  Thanks for your attention.  I'll take your questions.

Operator:

Thank you. The question and answer session will be conducted electronically today. If you would like to ask a question, simply press the star key followed by the digit one on your telephone keypad.  Also, if you are using a speakerphone, please make sure your mute function is turned off to allow your signal to reach our equipment.  Once again, press star one if you would like to ask a question or make a comment.  We'll pause for just one moment.

Our first question comes from Maggie Fox, with Reuters.  Please go ahead, ma'am.

Maggie Fox:

Thanks for doing this.  As you know, the autism groups have assembled quite a lot of evidence against the vaccines.  They cite a recent report that shows ethyl mercury remains in the brains of monkeys for longer than had been anticipated.  They also say that you are prejudiced and that the CDC and vaccine promoters are prejudiced and are influenced by drug companies.  Do you have anything to say to that?

Paul Offit:

Yes, so there's two questions, Maggie.  I'll take the first one first.  The study that you refer to is that Brubaker study out of the University of Washington that looked at the – whether or not ethyl mercury had the capacity to enter the central nervous system, as you said in brains, as compared to methyl mercury.  And that study did show that ethyl mercury could enter it, although it did – it was present both in blood and in the central nervous system at significantly lower levels than was methyl mercury as one would have expected.  But, again, I think – I mean, I think that – you know, there's nothing as strong, frankly, as the epidemiologic studies.  And if you look at the four studies that were published, what they found was that there was no evidence that Thimerosal at the level contained in vaccines increased one's risk of autism.  And these studies were big, I mean big enough to pick up events that were occurring, you know, as rare as one per 100,000 vaccine recipients.  I mean, this is – and that's a very sensitive study.  If you look sort of back at the swine flu epidemic in the late ‘70s, the sort of swine flu vaccine given in the late ‘70s also caused – or caused a severe event, the so-called Guillain-Barre, at one per 100,000 people easily picked up in a retrospective study.  If Thimerosal was even responsible for a very, very small number of cases of autism it should be easily picked up by these studies, and it wasn't.  And so I think it wasn't because it's not there to be picked up.

In terms of the question about whether or not those in CDC or me or people who try and educate the public about the science of vaccines or the – or the benefits of vaccines, I think the notion that we are unduly influenced by pharmaceutical companies can only be made by people who don't know us.  You know, people, you know, like me or Melinda Wharton at the CDC or others who speak up at the CDC like Steve (Patri) are all motivated by exactly the same thing.  We go into in my case into pediatrics or into medicine because we care about, in my case, in children.  And, I mean, I worked on a rotavirus vaccine and the science of rotavirus vaccine for 25 years because I want to make a vaccine that, you know, will prevent 2,000 deaths a day in this world.  And it's for the purpose – it's all consistent.  I mean, it's all because we want to do what's best for children.  I mean, the notion that somebody or any of us would sort of – would hide data or falsify data or misrepresent data that we knew was showing that Thimerosal caused harm is just ludicrous.  I mean, the rotavirus – the last rotavirus vaccine's an example.  As soon as that vaccine was shown to cause a problem it was taken off the market both by the pharmaceutical company who acted responsibly and by – and was certainly recommended to be withdrawn by the CDC.  I mean, we want vaccines to be safe and effective, but we want both.  And so I think it just – those kinds of statements can only be made by people who don't know those who are in positions of trying to make the best recommendations for children's health in this country.

Amy Pisani:

Maggie, this is Amy as well.  I – first of all, I really – I very much respect your journalism.  And I'm sure you must know many of the folks from CDC, and I'm – Mrs. Carter and Mrs. Bumpers actually presented at the final – the final presentation at the National Immunization Conference last week.  And their message to the folks in the room was really to thank them, because these are incredibly intelligent people and they could have chosen a much more lucrative field, their professions, they could have made so much more money in their lives. But these are people that chose to go into public health.  And because – if you've ever met them, they are so passionate about children and adults, and truly – they really truly want to help people.  And they're also, if you remember, many of them have children of their own, and they're immunizing their children.  I can't imagine that they would take part in anything that would harm either the public or particularly their own children.  And so I just think it's – it's not helpful to society when people who have these allegations – and of course they have terrible things happen to their children, they need an answer.  But it doesn't help to make allegations, false allegations about the folks who really truly are out there every day trying to make a difference in the lives of people, people like Paul Offit that – he could have only been a pediatrician as well, but instead he's an advocate for vaccines and he's an advocate for children's health.  He could have just stayed in the office all day.  So I just – I feel really strongly about that.  And I know that you'll help people understand that that's just simply not true.

Operator:

We will now go to T. J. Greaney, with Southwest – Southeast Missourian.  Please go ahead.

T. J. Greaney:

Hi, Dr. Offit.  I was wondering if you could speak specifically to the research done by David and Mark Geier.  And within that study – have you read it, first of all?

Paul Offit:

Well, there's a few studies that they've published. Are you talking about ((inaudible)) ...

T. J. Greaney:  The most recent one ...

Paul Offit:  ((inaudible))

T. J. Greaney:

... in the “Journal of American Physicians.”

Paul Offit:

Right, I did, yes.

T. J. Greaney:

OK.  And within the study what you think about the vaccine adverse events reporting system that they've used for a lot of their data and how you explain the large rise in autism cases.  In a place, my home state of Missouri, we saw an 850-percent increase between ’91 and 2003.  Thank you.

Paul Offit:

So, again, two questions.  So I did read the study in the Journal, I think, of American Physicians and Surgeons by the Geiers.  That one, the one I'm talking about, was the one that showed actually a decrease in the incidence of autism in children who had – in California I think who had – over the last year or so, the notion being that since Thimerosal is largely out of vaccines that now autism is decreasing.  First of all, you can't – you really can't use VAERS data to answer that answer.  I mean, the VAERS so-called vaccine adverse events reporting system is a – is a passive reporting system that is co-directed by the CDC and the Food and Drug Administration. And anybody can report.  I mean, I think the advantage of that system is that should there be, you know, millions of children immunized, say, with a new vaccine, it's a hypothesis generating mechanism.  And that's – it worked I think with the RotaShield vaccine where it was – there suddenly was an increase in reports of intussusception and that – the so-called intestinal blockage.  Then a study was done comparing groups that did or didn't receive, you know, the vaccine to look at whether or not there was an increase in the relative risk of intussusception.  And clearly there was.  But that can only be done by doing a case-control study where you look at children and tie it to the medical records that did or didn't receive the vaccine.  You can never do that with VAERS data.  And because it's a passive reporting system it's just – it's impossible to draw those kinds of conclusions.  So I think that's why they published in something like the “Journal of American Physicians and Surgeons,” not a more reputable epidemiological journal or medical journal, because the data were just not able to support their hypothesis.

I'm sorry, there was a second question you had in there and I don't think I answered it.

T. J. Greaney:

Well, yes, just the second part of that is in a lot of states, including California, during that time period there was, you know, unequivocally a large increase.  We had in Missouri an 850-percent increase in the cases of autism.  I wonder, you know – people were talking about it being an epidemic during the ‘90s.  I wonder what you'd say to that.

Paul Offit:

Right.  I mean, also – and the same thing happened in Denmark.  I mean, in Denmark there was a dramatic increase in the reported cases of autism starting after sort of 1991, around ’93-’94-’95.  You had just a burst of increase in autism.  Interestingly, it happened in Denmark at a time when they had removed Thimerosal from all vaccines about three years earlier.  I mean, if you look at that just from a sort of gross epidemiologic standpoint you would say that Thimerosal was protecting against autism.  You take it out of all vaccines, three years later there's a burst in the incidence of autism.  So I think that's sort of one piece of evidence that vaccines had nothing to do with it.  But I think the answer to the question why is there an increase, and the answer is – my personal belief in this – and, you know, I'm not an autism epidemiologist – but my personal belief is I think we've broadened the diagnosis.  I mean, the – I had a personal experience – I'm not going to go into specifically – but, you know, a family member was diagnosed as having autistic spectrum disorder, which I think just wasn't the right diagnosis in this particular boy.  And they recommended that he – that he receive, you know, a variety of therapies that were offered by the county in which I live.  By making that diagnosis that offered that group of parents a chance to be – to get a lot of therapies that would be paid for by the county that otherwise without that diagnosis they wouldn't get.  So I do think – I think we've really broadened this diagnosis which has caused the increased rate.  That's my sense of it.  I don't – I think a sort of preliminary dense autism, I mean the kind that – that, you know, that you're more likely to see when they do the TV special and show the – you know, the really severely affected child, I'm not sure that's increased.

Amy Pisani:

T. J., this is Amy.  I just wanted to clarify as well.  Missouri has passed one of the most restrictive anti-Thimerosal pieces of legislation thus far.  And I fear that in two years we'll find many, many more flu deaths in Missouri in children, because there simply isn't enough Thimerosal-free flu vaccine to go around.  And vaccine manufacturers are not able to give it to states that are particularly banning Thimerosal use.  They can't send more to those states.  They simply don't have that capacity.  And so I just – I hope that folks in Missouri will realize and seek the vaccine as best they can to protect their children.

T. J. Greaney:

Well, aren't there Thimerosal alternatives, alternatives that are, you know, equally cost effective or –

Amy Pisani:

Thimerosal-free vaccines?

T. J. Greaney:

Yes.

Amy Pisani:

Flu vaccine?  There isn't enough to go throughout the country, though. The manufacturers are trying to speed up production, but they can't do it any quicker than they are. And so there simply isn't enough.  Banning Thimerosal in a state doesn't help at all because these children may in fact end up getting influenza and then being hospitalized and, God forbid, dying.

Paul Offit:

It's a classic example of what we're – we're about to launch into where state by state sort of passes these restrictive laws is moving to – you know, moving away from any multi-dose vials, which will obviously make this much more expensive.  I mean, multi-dose vials make vaccines much less expensive.  But when you have a multi-dose vial you need a preservative because you continue to violate the – you know, the rubber stopper with the syringe periodically or -- and the needle periodically.  And so we'll move to single-dose vials, which will be much more expensive and therefore make this less affordable.  And all for the notion, this sort of – this – for political correctness.  I mean, Thimerosal, mercury, just is never going to sound good.  But the fact of the matter is the mercury contained in vaccines is much less – much, much less than you're exposed to during your normal day.  But it's just politically a very easy weight to lift.  And it's a shame because we're going to spend a lot of money on something that has absolutely nothing to do with vaccine safety and is only going to make vaccines more expensive.

Amy Pisani:

And preclude our ability to create vaccines for a pandemic, because we need – we need multi-dose vials in order to get vaccines out to the entire country in the event of a pandemic.

Paul Offit:

Well, I can tell you this for certain, that the government when they make pandemic flu vaccine will make it with Thimerosal, because there's not a chance in hell that they would be able to make that many single-dose vials.  So…

Amy Pisani:

Paul, if the manufacturers switch over to making single-dose vials, will they then be able to – it takes a long time to switch over to making multi-dose in the production facility, doesn't it?

Paul Offit:

Yes.

Amy Pisani:

(So maybe we can take a question).

Operator:

As a final reminder, press star one if you would like to ask a question or make a comment.  We'll pause for just one moment.

There appears to be no further questions at this time.  I would like to turn the conference back over to Ms. Amy Pisani for any additional or closing remarks.  Please go ahead, ma'am.

Amy Pisani:

I just want to thank everyone for taking the time to come to the call today.  And if you have any further questions you're more than – we would love to take your call – or e-mails at info@ecbt.org.  Any questions that you have for Dr. Offit as well we can send over to him to answer for you.  Again, that's info@ecbt.org.  We also have a very extensive website with all the information on vaccine safety available.  And our website address is www.ecbt.org.  Dr. Offit also has a wonderful website, and, Paul, I'll let you give that website address.

Paul Offit:

Sure.  It's www.vaccine.chop.edu.

Amy Pisani:

Thanks for joining us, Dr. Offit, and thank you very much, everyone, for coming today.

Paul Offit:

Thank you.

Operator:

That does conclude today's teleconference.  Thank you for your participation and have a wonderful day.

END