A Deplorable U-Turn By F. Yazbak, MD, FAAP

[Guest guest]

Part 1 of 3 articles on this issue

http://www.redflagsdaily.com/yazbak/2006_apr17.php

Dr. Yazbak, a pediatrician, now devotes his time to the research of

autoimmune regressive autism and vaccine injury.

A Deplorable U-Turn

By F. Yazbak, MD, FAAP

(tlautstudy@...)

U-turns are forbidden on most busy streets because they are dangerous.

Unless you are a stuntman in a Hollywood movie, you’ll get hurt or hurt

someone else if you make a reckless U-turn.

It is now evident that the “Thimerosal is OK” lobby is hell-bent on

reversing the safe course on which the United States embarked in 1999.

Infants and unborn babies will surely be hurt.

You can bet on it.

So far, the following statements have been carefully documented in my Red

Flags columns:

* Autism affects 1 in 166 children in the United States, according to

the Centers for Disease Control and Prevention (CDC) and the American

Academy of Pediatrics (AAP).

* The CDC has spent enormous funds and effort denying that vaccines are

responsible for the increase in autism, and has sponsored and publicized a

multitude of weak local and foreign epidemiological studies to prove its

point.

* Maurice Hilleman, the world’s most famous vaccine maker, was

convinced that ethyl and methyl mercury were equally dangerous when he

wrote a memo to his boss in 1991.

* When Sweden insisted on getting thimerosal-free vaccines in 1991, the

vaccine manufacturers obliged in record time.

* When, in 1999, the CDC and AAP allowed pediatricians and parents to

delay the neonatal dose of hepatitis B vaccine because it contained

mercury, the vaccine manufacturer delivered thimerosal-free vaccine within

eight weeks.

So, why the U-turn now? Why are certain parties insisting that thimerosal

in vaccines is safe?

Why is there a battle every time a state tries to ban mercury from all

vaccines, when it is banned in just about everything else?

Why all the fuss suddenly about the unavailability of thimerosal-free

influenza vaccine for infants and pregnant women and the inability to

produce enough such vaccine?

Why is the small cost of a dose of thimerosal-free influenza vaccine

suddenly such a big deal when the CDC has been pouring millions of dollars

into the Vaccine for Children program and into its fight against a flu

pandemic that has yet to start and probably never will?

* * * *

Five years ago, the AAP Committee on Environmental Health — after

consulting with the CDC, the Environmental Protection Agency (EPA), the

National Institute of Environmental Health Sciences, the National Cancer

Institute and the AAP Section on Community Pediatrics — issued an important

and detailed report in PEDIATRICS (1) that concluded, “Mercury in all of

its forms is toxic to the fetus and children, and efforts should be made to

reduce exposure to the extent possible to pregnant women and children, as

well as the general population.” (1)

Note: Mercury in all of its forms….

We have all been impressed recently by a remarkable series on autism by Dan

Olmsted of United Press International. On April 4, 2006, the column was

titled “The Age of Autism: Mercury ban opposed.” (2) In it, Olmsted

revealed that 22 organizations, which “support safe and effective

vaccines,” contacted members of Congress to express their “opposition to

all legislative efforts at the federal and state levels to restrict access

to vaccines containing thimerosal, an ethylmercury-based preservative.”

This last sentence needs to be read a second time — just to appreciate its

significance. Representatives of those organizations actually stated that

theywere opposed to any legislation that would prohibit infants and

pregnant women from getting thimerosal in their vaccines.

These organizations are: Ambulatory Pediatric Association; American Academy

of Family Physicians; American Academy of Physician Assistants; American

College of Allergy, Asthma, and Immunology; American College of Preventive

Medicine; American Liver Foundation; American Medical Directors

Association; American Pharmacists Association; Association of Immunization

Program Managers; Council of State and Territorial Epidemiologists; Every

Child by Two; Hepatitis B Foundation; Hepatitis Foundation International;

Immunization Action Coalition; Infectious Diseases Society of America;

National Coalition on Adult Immunization; National Foundation for

Infectious Diseases; Parents of Kids with Infectious Diseases; Pediatric

Infectious Disease Society; Society for Adolescent Medicine; Society of

Teachers of Family Medicine; Vaccine Education Center at the Children's

Hospital of Philadelphia.

Many of these organizations and their leaders are not well known.

Seeing the American Academy of Family Physicians (AAFP) listed is

surprising. According to the CDC (June 2000): “A Joint Statement issued by

AAP and the PHS in July 1999, and agreed to by the AAFP later in 1999,

established the goal of removing the vaccine preservative thimerosal as

soon as possible from vaccines routinely recommended for infants.” (3)

Seeing the Vaccine Education Center at the Children's Hospital of

Philadelphia listed was no surprise at all. Its director A. Offit, MD,

is chief of Infectious Diseases and the Henle Professor of Immunologic and

Infectious Diseases at The Children's Hospital of Philadelphia. Offit has

recently become the spokesman for the “Anti Vaccines-Cause-Autism” crowd.

Offit has been effective in his campaign: Not having been intimately

involved with the development of the MMR (measles, mumps, rubella) vaccine,

and the launch of the thimerosal-containing hepatitis B and Haemophilus

Influenzae B (HIB) vaccines, he is not at risk and therefore not personally

vulnerable.

Not at all surprising was the fact that the CDC/PHS and the AAP had no

comment.

The argument proposed in support of the petition was that “banning the

preservative in vaccines for children and pregnant women — as several

states have done and legislation in Congress proposes — would perpetuate

false and misleading information that vaccines are not safe. Parents may

see the banning of thimerosal as an admission that vaccine safety oversight

is inadequate…. There has been considerable research on this issue since

the 1999 precautionary statement of the U.S. Public Health Service and the

American Academy of Pediatrics and there is no documented scientific

evidence that ethylmercury in the form of thimerosal in the doses

administered in vaccines causes any risk to health.”

An incredible statement indeed!

U.S. Representative Dave Weldon, MD, of Florida’s 15th District, a sponsor

of the House bill banning thimerosal from vaccines, reacted by stating, " It

is warped logic to suggest that somehow public confidence is reassured by

keeping mercury in vaccines.… Buying into this logic will only further

erode public confidence in vaccines. It's time to kick the mercury habit. " (2)

All this while, the American College of Preventive Medicine was publishing

a report titled “Practicing Environmental Pediatrics” (4) and enumerating

potential dangers in the home:

At age 2 months:

Does the drinking water have high nitrate concentrations?

Is the home water-damaged?

At age 6 months:

Is there lead in the home?

Older children:

Is the home's radon concentration high?

Has mercury been handled?

Has carbon monoxide been released?

Has exposure to ultraviolet light been high?

Have pesticides been used?

The extensive report concluded: “Using these questions, providers of

healthcare to children can easily incorporate emerging knowledge about

environmental health into discussions with parents. In a busy practice, the

clinician must provide some guidance before all of the research questions

have been answered definitively. Therefore, a preventive approach is

recommended in keeping with the Hippocratic injunction to do no harm.”

So here we are, while research is still incomplete and much needed,

worrying about possible radon in the home, while insisting to Congress that

mercury in vaccines is safe.

What a tragic contradiction!

* * * *

Not only do we not know what really happened — what prompted the U-turn and

what is going on now — but it is likely that we will never know … or at

least not completely … and certainly not anytime soon.

So, what could have happened?

Parents who believe that their children were injured by vaccines cannot sue

the vaccine manufacturer. They can, however, sue the maker of thimerosal if

the suspected vaccine contained the mercury preservative. To have a chance

of prevailing, they must show by the preponderance of evidence that it was

the thimerosal — and not the vaccines themselves — that caused the

regression.

While thimerosal research boomed, the rest of vaccine/autism research came

to a halt and distinguished researchers, such as V.K. Singh of Utah State

University, whose main interest was MMR saw their funding stop. MMR has

never contained mercury.

The same thing happened in the media. The No. 1 and only subject of

discussion became “thimerosal causes autism.” Those of us who believed that

MMR was also involved were totally ignored, as though our children and

grandchildren simply did not exist.

Many suspect that in 1999, the FDA, the CDC and the AAP must have been

aware of convincing evidence indicting thimerosal to take the bold decision

to phase out mercury-containing vaccines that had been in use for decades.

Many, therefore, do not believe that the decision was taken only because

“potential risk is of concern” (5) and that the interruption of neonatal

hepatitis B vaccination was a precautionary measure. The CDC would have

never allowed such a cloud to mar its hugely successful vaccination

programs if it had not been concerned about more serious fallout.

The Institutes of Medicine (IOM) Immunization Safety Review Committee had

decided in April 2001 that the evidence was inadequate to accept or reject

a causal relationship between autism and exposure to thimerosal from

vaccines, and that the hypothesis was biologically plausible. In addition,

according to the CDC, “The Committee made the specific recommendation that

thimerosal-free DTaP, hepatitis B and Hib vaccines be used in the United

States for infants, children and pregnant women. This recommendation is

also consistent with the 1999 and 2000 goal, particularly with the actions

taken to implement the goal.” (5)

As the anti-thimerosal movement started picking up momentum, something

needed to be done to restore confidence in the national immunization programs.

Now under a cloud, the CDC turned again to the IOM and the ever-obliging

Immunization Safety Review Committee came to the rescue — as usual. In

spite of Weldon’s specific request to delay an upcoming meeting because of

pending clinical studies, Marie McCormick, MD, chair of the IOM

Immunization Safety Review Committee, convened the unfortunate meeting of

Feb. 9, 2004.

Basing their decisions mostly on epidemiological studies, some biased, some

weak, the committee members decreed that “neither the mercury-based vaccine

preservative thimerosal nor the measles-mumps-rubella (MMR) vaccine are

associated with autism … the hypotheses regarding how the MMR vaccine and

thimerosal could trigger autism lack supporting evidence and are

theoretical only … further research to find the cause of autism should be

directed toward other lines of inquiry….”

On May 11, 2005, I wrote to IOM President Harvey V. Fineberg, MD, PhD,

requesting that he withdraw the committee report and reconvene a new

meeting under another chair. (7) He never bothered to answer me.

Meanwhile, Kirby had published his now famous book, Evidence of Harm,

Mercury in Vaccines and the Autism Epidemic: A Medical Controversy, which

became a bestseller overnight. In the many interviews that followed, Kirby

candidly repeated what he had discovered through his investigations and

suggested that clinical research should continue. Interestingly, no one

from the thimerosal-does-not-cause-autism crowd wanted to challenge Kirby

in a conventional debate. The “experts” always insisted that they be

allowed to present their arguments after Kirby was done; they never

adequately countered his arguments and simply repeated that vaccines had

saved lives and that nothing should be allowed to interfere with the very

successful U.S. vaccination programs.

There were also some interesting developments in California. There were

slightly fewer new cases in recent quarters than in the same quarters in

previous years. The anti-mercury crowd started celebrating instead of

waiting for a distinct trend to occur. The

thimerosal-is-safe-in-these-amounts crowd was seriously jolted: Its best

argument — that autism had not decreased after the elimination of the

miserable preservative — was melting away, like an Ice cream cone on a

California beach.

CDC Director L. Gerberding, MD, MPH, was certainly neither going to

comment on the California figures nor confront Kirby. In a much advertised

(and quoted) long briefing on vaccines and child health on July 19, 2005,

Gerberding stated, “What we know today is based on many studies that have

looked at children in various populations around the world, including the

United States, and have involved thousands of children that the

preponderance of evidence consistently does not reveal an association

between thimerosal and autism.”

She then added, “But I can't sit here today and tell you with 100 percent

certainty that there is absolutely never going to be any association of

thimerosal and autism in one or more children. Science doesn't say that and

it will be very difficult for science to ever prove a negative. What is we

can say is the predominance of evidence does not associate a link, and

we've certainly been looking hard to find such a link…. Science is an

evolving process, however, and there are more studies underway and we hope

there will be even more studies underway. One of the things I like to

emphasize is the importance of keeping an open mind.”

The format did not allow anyone to ask Director Gerberding how such

association could ever be found now that the IOM had decreed that

independent research should stop.

No one dared either to remind her that we were not talking about “one or

more children” but 1 in 166 U.S. children, the number she had mentioned

less than a minute earlier. (8)

Acting Deputy Commissioner of the U.S. Food and Drug Administration, Murray

Lumpkin, who followed Gerberding, commented on the 2005 pediatric vaccine

scene. He said in part, “Since 2001, all vaccines routinely recommended for

children six years of age and younger that are manufactured for the United

States market, as Dr. Gerberding pointed out, contain no thimerosal or only

trace amounts of thimerosal.”

Discussing the influenza vaccine recommended for children between six and

23 months of age, Lumpkin said, “... there is now a thimerosal-free version

of this. We are working with the manufacturer to increase the supply of the

thimerosal-free version and I think as capacity increases and as time goes

on, we will indeed be able, even with the influenza virus, to get us to a

position of having adequate supply without the thimerosal contamination

that we've been talking about.”

Maybe the FDA should not have been “working with the manufacturer” to

obtain all the needed thimerosal-free influenza vaccine; maybe it should

have simply said, like it did in 1999: “We want it now … if not yesterday.”

As to having adequate supply of vaccines “without the thimerosal

contamination that we have been talking about”: Was that a “Freudian slip”?

* * * *

On August 7, 2005, television anchor Tim Russert interviewed IOM President

Fineberg and Kirby about mercury in pediatric vaccines during the

second half of his popular Sunday morning program “Meet the Press.” (9)

(The first half of the program featured Cuomo, former Governor of New

York, and Kmiec, professor of constitutional law at Pepperdine

University and former Dean, Catholic University School of Law, discussing

the nomination of to the Supreme Court.)

Russert asked Fineberg to explain why the IOM committee said in 2001, “It

is medically plausible that some children's risk of a neurodevelopmental

disorder could rise in part through increased mercury exposure from

thimerosal-containing vaccines " and then reversed its stance three years

later stating, “MMR vaccine and thimerosal-containing vaccines are not

associated with autism.”

Fineberg answered patronizingly, “When you're dealing with a problem as

complex as autism, Tim, you have to look at it from many different points

of view and assemble evidence from many different vantage points.

Biological evidence in humans and in animals, toxicologic evidence, how

does the body deal with toxins, and evidence looking at the actual

experience in populations…. By 2004, the main change was that there were

completed additional studies that were actually looking in the population

at the relationship of receipt of vaccines containing thimerosal and the

development of autism…. These studies were carried out in the United

States, in Great Britain, in Denmark and Sweden. These studies covered

hundreds of thousands of individuals, children, in these populations.”

The autism audience at home gulped. The well-spoken Harvard professor had

cleverly listed the shortcomings of clinical research and anointed

international epidemiological studies as better and more convincing and

implied that the numerous epidemiological studies had shown convincingly

that a mercury-autism connection did not exist.

Brilliantly, Kirby volleyed, “Well, I think those five epidemiological

studies range from severely flawed to seriously questionable. And I also

think that you cannot rely solely on epidemiology to prove or disprove

causation. In fact, I have right here — this is from the federal court

system, but they ruled that epidemiology is not acceptable to prove there

is no causal link between an adverse event and a pharmaceutical.”

That was one point for our side!

A little later in the interview, Fineberg stated, “There's no question that

mercury is a neurotoxin. And if there were ways, which there are, to

protect vaccines without using mercury-containing substances, it was

prudent to remove it, not because there was evidence that it caused autism

or even definitive evidence that the amounts in those vaccines caused any

neuro problems, but because it was an added measure of precaution that was

sensible and correct. And I might add that the latest vaccines that

contained any thimerosal as a preservative, with the exception of some flu

vaccines, were completed in 2001 and outdated in 2003. So anyone watching

this program, any parent, can be confident that when they take their child

to the pediatrician to be immunized this year, they will receive vaccines

without thimerosal as a preservative.”

Still later, he added, “We have now a growing body of evidence, while

imperfect, altogether convincing and all reaching the same conclusion, even

though they vary in their methods and in their approaches. And that

conclusion was no association between the receipt of vaccines containing

thimerosal and the development of autism.”

Russert shot back, “Why was thimerosal then taken out of the vaccination?”

The repartee was superb and the home audience applauded.

But more importantly, the IOM President had stated on national television

that in 2005, parents could be reassured that their children were no longer

receiving vaccines with thimerosal.

Russert was certainly also reassured and reassuring: “And our viewers

should know that there is no thimerosal now in vaccinations, other than flu

vaccinations, and so it's safe for your children to do (inaudible). To

which, Fineberg added, “And even some flu vaccines for children are now

available without thimerosal, as well.”

By saying, “So anyone watching this program, any parent, can be confident

that when they take their child to the pediatrician to be immunized this

year, they will receive vaccines without thimerosal as a preservative”

Fineberg cleverly intimated — without saying it outright — that vaccines

without mercury were safer than those with mercury.

By adding, “And even some flu vaccines for children are now available

without thimerosal, as well,” he effectively endorsed Russert’s statement

that all pediatric vaccines and some influenza vaccines were now safe

because they did not contain mercury.

It is almost certain that this transcript of “Meet the Press” will find its

way to court.

In the next column: The Battle of the States.

* * * *

References:

1. L.R. Goldman et al. American Academy of Pediatrics. “Technical

Report: Mercury in the Environment: Implications for Pediatricians.”

PEDIATRICS. Vol. 108. No. 1. July 2001: 197-205.

Available at

http://pediatrics.aappublications.org/cgi/content/full/108/1/197

2. Dan Olmsted. “The Age of Autism: Mercury ban opposed.” The Washington

Post. April 4, 2006. Available at http://tinyurl.com/kyqq3

3. National Immunization Program, CDC. “Joint Statement Concerning

Removal of Thimerosal from Vaccines.” June 22, 2000. Available here

4. R.A. Etzel. Practicing Environmental Pediatrics, Perspectives in

Prevention from the American College of Preventive Medicine. March 29, 2006.

5. F.E. Yazbak. “Thimerosal: One Big Mistake.” Red Flags. Available at

http://www.redflagsdaily.com/yazbak/2006_apr12.php

6. Thimerosal and Vaccines: An Institute of Medicine (IOM) Report.

Immunization Safety Review: Thimerosal-Containing Vaccines and

Neurodevelopmental Disorders. April 2001. National Immunization

Program, CDC.

7. F.E. Yazbak. “Letter to Harvey V. Fineberg, MD, PhD, President,

Institute of Medicine from F. Yazbak, MD, FAAP.” Red Flags, May 16,

2005. Available at http://www.redflagsdaily.com/yazbak/2005_may16.html

8. J.L. Gerberding. Media Briefing on Vaccines and Child Health, July

19, 2005. Available at http://www.cdc.gov/od/oc/media/transcripts/t050719.htm

9. Tim Russert. Meet the Press. NBC News. Aug. 7, 2005

http://www.msnbc.msn.com/id/8714275/