Is Aluminum the New Thimerosal?
By Robert W. Sears Issue 146, January/February 2008

http://www.mothering.com/articles/growing_child/vaccines/aluminum-new-thimerosal.html

Vaccines have become the most controversial parenting topic of the decade.
When parents are considering whether or not to vaccinate their children, one
of the things that must be considered is aluminum toxicity.

Aluminum is added to a number of vaccines to help them work better.
Normally, one wouldn't consider aluminum to be a problem. It's a naturally
occurring element that is present everywhere in our environment-in food,
water, air, and soil. It's also a main ingredient in over-the-counter
antacids. And because the body doesn't absorb aluminum, it's harmless when
swallowed.

I didn't think much about aluminum when, 13 years ago, I began researching
vaccines. In fact, the early seminars on vaccine education that I offered to
parents included a brief statement that aluminum was nothing to worry about.
But as I read each product insert and saw the number of micrograms (mcg) of
aluminum contained in several vaccines, I wondered, "Has anyone determined
what a safe level of injected aluminum actually is?" I didn't have to wonder
for long, because the answer is easy to find; go to www.fda.gov, search on
"aluminum toxicity," and you'll find several documents about aluminum.

The first document I came across discusses the labeling of aluminum content
in injected dextrose solutions (the sugar solutions added to intravenous
fluids in hospitals): "Aluminum may reach toxic levels with prolonged
parenteral administration [i.e., injected into the body] if kidney function
is impaired. . . . Research indicates that patients with impaired kidney
function, including premature neonates [i.e., babies], who received
parenteral levels of aluminum at greater than 4 to 5 micrograms per kilogram
of body weight per day, accumulate aluminum at levels associated with
central nervous system and bone toxicity. Tissue loading [i.e., toxic
buildup in certain body tissues] may occur at even lower rates of
administration."1 For a tiny newborn, this toxic dose would be 10 to 20 mcg;
for an adult, it would be about 350 mcg.

The second document discusses aluminum content in IV feeding solutions, or
Total Parenteral Nutrition (TPN) solutions. The FDA requires these solutions
to contain no more than 25 mcg of aluminum per liter of solution. A typical
adult in the hospital would get around 1 liter of TPN each day, thus about
25 mcg of aluminum. The FDA document also states, "Aluminum content in
parenteral drug products could result in a toxic accumulation of aluminum in
individuals receiving TPN therapy. Research indicates that neonates and
patient populations with impaired kidney function may be at high risk of
exposure to unsafe amounts of aluminum. Studies show that aluminum may
accumulate in the bone, urine, and plasma of infants receiving TPN. Many
drug products used routinely in parenteral therapy may contain levels of
aluminum sufficiently high to cause clinical manifestations [i.e.,
symptoms]. . . Aluminum toxicity is difficult to identify in infants because
few reliable techniques are available to evaluate bone metabolism in
premature infants. . . Although aluminum toxicity is not commonly detected
clinically, it can be serious in selected patient populations, such as
neonates, and may be more common than is recognized."2

Elsewhere, I found a relevant 2004 statement by the American Society for
Parenteral and Enteral Nutrition (ASPEN), a group that monitors oral and
injectable nutritional products for safety and side effects. It reiterated
the cited FDA warnings to the letter, and recommended that doctors purchase
IV products with the lowest aluminum content possible, "and should monitor
changes in the pharmaceutical market that may affect aluminum
concentrations."3

The source of the daily limit of 4 to 5 mcg of aluminum per kilogram of body
weight quoted by the ASPEN statement seems to be a study that compared the
neurologic development of about 100 premature babies who were fed a standard
IV solution that contained aluminum, with the development of 100 premature
babies who were fed the same solution with almost all aluminum filtered out.
The study was prompted by a number of established facts: that injected
aluminum can build up to toxic levels in the bloodstream, bones, and brain;
that preemies have decreased kidney function and thus a higher risk of
toxicity; that an autopsy performed on one preemie whose sudden death was
otherwise unexplained revealed high aluminum concentrations in the brain;
and that aluminum toxicity can cause progressive dementia. The infants who
were given IV solutions containing aluminum showed impaired neurologic and
mental development at 18 months, compared to the babies who were fed much
lower amounts of aluminum. Those who got aluminum received an average of 500
mcg of the metal over a period of 10 days, or about 50 mcg per day. The
other group received only about 10 mcg of aluminum daily-4 to 5 mcg per
kilogram of body weight per day.4 This seems to be the source of this safety
level.

However, none of these documents or studies mentions vaccines; they look
only at IV solutions and injectable medications. Nor does the FDA require
labels on vaccines warning about the dangers of aluminum toxicity, although
such labels are required for all other injectable medications.

All of these studies and label warnings seem to apply mainly to premature
babies and kidney patients. What about larger, full-term babies with healthy
kidneys? Using the 5 mcg/kg/day criterion from the first document as a
minimum amount we know a healthy baby could handle, a 12-pound,
two-month-old baby could safely receive at least 30 mcg of aluminum per day.
A 22-pound one-year-old could receive at least 50 mcg safely. Babies with
healthy kidneys could probably handle much more than this, but we at least
know that they can handle this much. However, these documents don't tell us
what the maximum safe dose would be for a healthy baby or child, and I can't
find such information anywhere. This is probably why the ASPEN group
suggests, and the FDA requires, that all injectable solutions be limited to
25 mcg; we at least know that that level is safe.

Calculating Aluminum in Vaccines
Here are the current levels of aluminum per shot of the following vaccines,
as listed on each vaccine's packaging:

 a.. DTaP (for Diphtheria, Tetanus, and Pertussis): 170â?"625 mcg,
depending on manufacturer
 b.. Hepatitis A: 250 mcg
 c.. Hepatitis B: 250 mcg
 d.. HIB (for meningitis; PedVaxHib brand only): 225 mcg
 e.. HPV: 225 mcg
 f.. Pediarix (DTaPâ?"Hepatitis Bâ?"Polio combination): 850 mcg
 g.. Pentacel (DTaPâ?"HIBâ?"Polio combination): 1500 mcg
 h.. Pneumococcus: 125 mcg

In other words, a newborn who gets a Hepatitis B injection on day one of
life would receive 250 mcg of aluminum. This would be repeated at one month
with the next Hep B shot. When, at two months, a baby gets its first big
round of shots, the total dose of aluminum could vary from 295 mcg (if a
non-aluminum HIB and the lowest-aluminum brand of DTaP are used) to a
whopping 1225 mcg (if the Hep B vaccine is given along with the brands with
the highest aluminum contents). If the Pentacel combo vaccine is given along
with the Hep B and Pneumococcus vaccines, the total aluminum dose could be
as high as 1875 mcg. These doses are repeated at four and six months. With
most subsequent rounds of shots, a child would continue to get some aluminum
throughout the first two years. But the FDA recommends that premature
babies, and anyone with impaired kidney function, receive no more than 10 to
25 mcg of injected aluminum at any one time.

As a medical doctor, my first instinct was to worry that these aluminum
levels far exceed what may be safe for babies. My second instinct was to
assume that the issue had been properly researched, and that studies had
been done on healthy infants to determine their ability to rapidly excrete
aluminum. My third instinct was to search for these studies. So far, I have
found none. It's likely the FDA thinks that the kidneys of healthy infants
work well enough to excrete aluminum before it can circulate through the
body, accumulate in the brain, and cause toxic effects. However, I can find
no references in FDA documents that show that using aluminum in vaccines has
been tested and found to be safe.

So I did what any pediatrician would do. I turned to the American Academy of
Pediatrics (AAP), who in 1996 published a policy statement, "Aluminum
Toxicity in Infants and Children," that made the following points:

 a.. Aluminum can cause neurologic harm.
 b.. A study from 30 years ago showed that human adults increase their
urine excretion of aluminum when exposed to higher levels of the metal,
which suggests that adults can clear out excess aluminum.
 c.. Adults taking aluminum-containing antacids don't build up high levels
of aluminum in their bodies.
 d.. Reports of infants with healthy kidneys show elevated blood levels of
aluminum from taking antacids.
 e.. People with kidney disease who build up bloodstream levels of aluminum
greater than 100 mcg per liter are at risk of toxicity.
 f.. The toxic threshold of aluminum in the bloodstream may be lower than
100 mcg per liter.
 g.. The buildup of aluminum in tissues has been seen even in patients with
healthy kidneys who receive IV solutions containing aluminum over extended
periods.5
However, nowhere in this paper was there any mention of aluminum in
vaccines.

To put this in perspective: Because the body of the average adult contains
about 5 liters of blood, receiving more than 500 mcg of aluminum in the
bloodstream all at once will be toxic if the kidneys aren't working well.
(Toxicity has also been seen in patients with healthy kidneys.) Because a
newborn's body contains about a liter (300 milliliters) of blood, more than
30 mcg of aluminum floating around in the bloodstream could be toxic if the
baby's kidneys aren't working well. The body of a toddler or preschool-age
child contains about 1 liter of blood, so more than 100 mcg in his system
could be toxic-and, as we've seen, babies can receive more than 1000 mcg of
injected aluminum all at one time. Fortunately, this amount doesn't all go
into the blood at once, but is slowly diffused into the bloodstream over a
period of time from the muscle or skin where it was injected.

But that is the main point of this article. No one has measured the levels
of aluminum absorption by the bloodstream when it is injected into the skin
and muscle of infants, or the levels of excretion from the body via
urination. All of the FDA and AAP documents that I've read state that
aluminum might be a problem, but that they haven't studied it yet, so we
should limit the amount of aluminum included in injectable solutions. But,
again, no one is talking about the levels of aluminum in vaccines.

What I think may have happened is that because aluminum used to be found in
only one vaccine-DTP, an older version of the current DTaP vaccine-no one
thought much about it. Then, in the 1980s, the PedVaxHib brand of HIB
meningitis vaccine was released, which also included aluminum; but other
brands of HIB vaccine did not, so again, no one thought much about it. In
the 1990s, the Hepatitis B vaccine began to be widely used; in the 2000s,
the Pneumococcus vaccine; and, more recently, the Hepatitis A vaccine.
Administering one aluminum-containing vaccine at a time involves only a
small amount of the metal; administering four such vaccines simultaneously
is a different story. It seems this issue has simply escaped everyone's
attention. Or has it?

Limited Studies limit thinking
Several years ago, some suspected cases of aluminum toxicity resulted in
various neurologic and degenerative problems. The Cochrane Collaboration, a
group that studies health-care issues around the world, wanted to look at a
very large study group to see if there was a real correlation between
neurologic problems and the aluminum in vaccines. They investigated all the
reported side effects of one aluminum-containing vaccine, DTP (no longer
used), and looked for any evidence that such vaccines caused more side
effects than non-aluminum vaccines. Other than more redness, swelling, and
pain at the injection site, they found no indication that an
aluminum-containing vaccine caused any more problems, and concluded that no
further research should be undertaken on this topic.6 That is a very bold
statement. Most researchers will draw conclusions from the findings of their
own research; it's unusual to say that no one else should do any more
research into the matter.

This is especially surprising because of the limitations of the Cochrane
Collaboration's study. They looked at the effects of only one standard
aluminum-containing vaccine, rather than the effects of all four being
administered at once. They didn't study aluminum metabolism itself. They
didn't test aluminum levels in children after vaccination, nor did they
explore whether or not the amount of aluminum in vaccines builds up in the
brain or bone tissues. They looked only for evidence of external symptoms of
aluminum toxicity, not internal effects. Nor did they do their own research;
instead, they reviewed all available studies conducted by other
investigators. Despite all this, the Cochrane Collaboration study
essentially closed the book on investigating aluminum toxicity from
vaccines, without really having opened it in the first place.

The most obvious way to study this matter would be to inject various amounts
of aluminum into children and see what happens to them internally. We know
from the FDA documents that aluminum toxicity does occur from other types of
injectable treatments; that it accumulates in the brain and bones in toxic
amounts; that this may occur more commonly than is recognized; and that
aluminum toxicity is hard to detect by looking for external symptoms. The
question remains: What happens when these amounts of aluminum are injected
via vaccines? Vaccine manufacturers may have begun to wonder about the same
thing; I found some interesting research in the product insert of the new
HPV vaccine, Gardasil. In researching the safety of Gardasil, Merck & Co.,
Inc., the vaccine's developer and manufacturer, added a step to their
testing procedure by injecting aluminum into a separate group of test
subjects used as a safety control group. They then compared the side effects
of the Gardasil vaccine with a saline placebo that contained neither
Gardasil nor aluminum, as well as with the placebo containing no Gardasil
but the same amount of aluminum as the vaccine. They found that the placebo
containing aluminum was much more painful than the saline placebo, and about
as painful as the full HPV shot. The aluminum placebo also caused much more
redness, swelling, and itching than the saline placebo, though not quite as
much as the full HPV shot.

Unfortunately, Merck looked only at the effects of aluminum at the injection
site. Nor did they state in the Gardasil product insert what role the
aluminum placebo played in all the other standard side effects, such as
fever and flu-like symptoms. Nor did they study the body's internal
metabolism of aluminum. However, their research did show how irritating
aluminum can be when injected into the muscles. It was a good first step. If
aluminum can be toxic, why not just remove it from vaccines, as is being
done with the preservative thimerosal, which contains the neurotoxin
mercury? It's not that simple. Aluminum is an adjuvant; in other words, it
helps vaccines work more effectively. When the metal is mixed with a
vaccine, the body's immune system more easily recognizes the vaccine and
creates antibodies against the disease. Thimerosal was easy to omit, because
it has nothing to do with the efficacy of the vaccine itself. But the
pharmaceutical companies would need good evidence that aluminum is harmful
before they would invest in coming up with new, aluminum-free vaccines. (The
Cochrane Collaboration report pointed out that removing aluminum from
vaccines would then require extensive trials of the reformulated vaccines.7)

What, exactly, does a toxic level of aluminum do to the brain? While no one
has studied healthy babies to see how much, if any, aluminum builds up in
the brain from the amounts of aluminum used in vaccines, the study on IV
feeding solutions in premature babies mentioned above revealed that aluminum
impaired their neurologic and mental development.8 But that was in premature
babies, not healthy, full-term infants. I found several animal studies
involving aluminum and/or aluminum-containing vaccines that did show
neurologic harm. Not only did aluminum build up in the brain and cause
damage, but some of the damage looked similar to what is seen in the brains
of Alzheimer's patients.9-1314 However, it's hard to draw conclusions about
aluminum's effects on humans from studies of animals. What we need are more
studies of human infants.

A Call for Better Research
There is good evidence that large amounts of aluminum are harmful to humans.
Because no meaningful research has specifically been done on aluminum in
vaccines, there is no existing evidence that the amount in vaccines is
harmful to infants and children. However, no one has actually studied
aluminum levels in healthy human infants after vaccination to make sure it
is safe. Should we now stop and research this matter? Or should we just go
on, continuing to hope that it is safe to use aluminum as an adjuvant in
vaccines?

Vaccine policy makers and advocates may read this article, review my
perspective, and initiate research studies to explore the risks of aluminum.
I would hope that those researchers do not conduct a retrospective review of
all the old vaccine safety studies and journal articles to look for the side
effects of aluminum. As the FDA, AAP, and others have stated, aluminum
toxicity can't be detected by external observation alone. It would be a
waste of time, and a grave disservice to the health of America's children,
to have several such reports show up in the medical literature. The only way
the issue of aluminum safety can be put to rest is to conduct real-time
studies on thousands of infants and measure aluminum levels after
vaccination.

In such a study, the researchers should look not only at blood levels. They
should also find out whether or not aluminum accumulates in the body, where
it accumulates, how the body eliminates it, and at what rate. Once I see
such research, and have determined to my satisfaction that aluminum has been
proven safe, I will post an update on www.thevaccinebook.com, and revise
future editions of the book accordingly. If such research finds that
aluminum may not be safe, then I would expect a new vaccine schedule to be
adopted in which the administering of vaccines is spread out to minimize the
amount of aluminum a child receives at any given time. I would also expect
vaccine manufacturers to begin finding ways to reduce or remove aluminum
from vaccines without compromising their effectiveness. We need to know the
answers to many questions: Why does one brand of HIB vaccine require
aluminum to make it work while another brand does not? Why does one brand of
DTaP vaccine contain four times as much aluminum as another? Why does one
brand of combination vaccine contain three times as much aluminum as the sum
of its parts?

Learning from the Past
I worry that aluminum may end up being another thimerosal. I am relieved
that, as of 2002, the mercury-containing preservative had been removed from
most vaccines. But according to an article in the Los Angeles Times, Merck &
Co., the makers of several vaccines, knew in 1991 that the cumulative amount
of mercury in vaccines given to infants by six months of age was about 87
times the level then thought to be safe.14 The article includes a copy of an
internal memo, written by one of Merck's research doctors and sent to the
president of Merck's vaccine division, clearly stating the doctor's worry
about mercury overload. What was done with that information back in 1991?
We'll never know. What we do know is that vaccine manufacturers knew that we
were overdosing babies, but that the mercury wasn't removed from vaccines
until 10 years later. This was because few paid attention to the potential
problems with mercury. When we did find out, we hoped it wasn't harmful, we
did extensive research to try to show that it wasn't, and we slowly removed
it from most vaccines.

The issue of mercury toxicity from vaccines is moot for infants receiving
vaccines today, as long as doctors and parents choose a flu shot without
mercury, know which brands of vaccines still contain barely detectable
traces of mercury, and are aware that some plain Tetanus and
Diphtheria-Tetanus vaccines still contain mercury (though these last
vaccines are not parts of the routine vaccine schedule). [For a current list
of vaccines and their thimerosal contents, go to www.vaccine
safety.edu/thi-table.htm.-Ed.]

What isn't moot is the question of aluminum toxicity. As doctors, we can
choose certain vaccine brands that contain less or no aluminum. We can be
careful about giving only one aluminum-containing vaccine at a time. And we
can talk about it instead of sweeping the issue under the rug. I pray that
my fears about aluminum are unfounded, and that objective studies performed
by completely independent groups with no ties to vaccine manufacturers or
political organizations show that it is safe. If not, I would hope that
manufacturers would start to reduce or eliminate the aluminum content of
their vaccines as soon as possible. I know this won't be an easy task, but
our children are worth it.

Excerpted from The Vaccine Book © 2007 by Robert Sears, MD. Reprinted by
permission of Little, Brown and Company. New York, NY. All rights reserved.
For more information, see www.thevaccinebook.com. For the notes to this
article, see www.mothering.com/ 
articles/growing_child/vaccines/aluminum-new-thimerosal-notes.html.

The question is, how much is too much?  It is almost
certain that aluminum is necessary, but it is next
to impossible to produce an aluminum-deficient diet.

Please compare the amount in the vaccines with the
amount in breast milk or formula before making any
accusations.  I do not know those figures.