Dr. Elsas Congressional Testimony

S. Hrg. 100-567
“NUTRASWEET” – HEALTH AND SAFETY CONCERNS

HEARING before the COMMITTEE ON LABOR AND HUMAN RESOURCES
UNITED STATES SENATE
ON HUNDREDTH CONGRESS
FIRST SESSION ON EXAMINING THE HEALTH AND SAFETY CONCERNS OF NUTRASWEET
(ASPARTAME)
NOVEMBER 3, 1987

STATEMENT BY DR. LOUIS J. ELSAS, II, M.D.
DIRECTOR, DIVISION OF MEDICAL GENETICS
PROFESSOR OF PEDIATRICS

(pages 360 through 369 of S. Hrg. 100-567)

Senator Metzenbaum. Dr. Elsas, since Senator Hatch saw fit to go into
the funding question, I will ask you, are your studies funded by industry?

Dr. Elsas. No, sir. I had a research grant three years ago, for three
years, from the March of Dimes, to study the effects of phenylalanine on
human brain function. When the political issue got to aspartame, the society
decided not to refund that. So all of the funding that is going on now – and
the reason it is so slow has been through my own division�s efforts,
personal funds, and university-based fund.

Senator Metzenbaum. What do you think of our present system for
funding scientific
research?

Dr. Elsas. I think the NIH is superb, I think there is a lot of
concern about how industry and the FDA interact, where industry is made
responsible for developing the data to support its own contentions. There is
not a broad enough scientific base, such as an RFA, as we can it at NIH -
research funds available – requesting input from the whole scientific
community, stating that funds are in an unbiased approach – what the
questions are which we need to ask? That is the problem here today. The
questions about phenylalanine effects on human brain function have not been
asked. So we have spent millions of dollars through our current system on
mostly irrelevant experiments without approaching those particular
questions.

Senator Metzenbaum. What about the advertising campaign that
NutraSweet puts on, and are you concerned about that?

Dr. Elsas. Yes, sir.

Senator Metzenbaum. In what way?

Dr. Elsas. I am mostly concerned that it gives the false impression
that NutraSweet is good for you, that it is nature�s best, and that it might
even be good for children to take. A lot of the ads recently have shown
children with the little ying and yang NutraSweet thing on it, making it
sound like you should go with your mommy to the grocery store and look for
that, and be sure that you buy that because it is real sweet and good.

Senator Metzenbaum. Can you tell the Committee about your own
experiences with the International Life Sciences Institute?

Dr. Elsas. Yes, sir. It was not good.

Senator Metzenbaum. Who is that group, can you tell us?

Dr. Elsas. Well, Dr. Dews is right here; he can probably give you more
personal information about it, because I have never gotten any feedback from
them. But I was asked after issuing concerns both privately and then
publicly on “Nightline” to give them a specific protocol for how I would
approach these concerns. I did this. I wrote it up completely in a
research grant format; submitted it through ILSI for their review, and
basically, got a few phone calls from Dr. Dews over a prolonged period of
time, stating that they had problems, but without ever a written peer review
of criticism.

So I basically never got funded; that is the bottom line. And the
ideas are now reappearing three years later in other places funded by
industry.

Senator Metzenbaum. ILSI is pretty much the coordinating group for
funding in the food and beverage industry, including pops, carbonated
drinks, NutraSweet itself; is that correct?

Dr. Elsas. As far as I know, that is correct, sir. I am not an expert
on ILSI; I have repressed that experience.

Senator Metzenbaum. It is my understanding that Dr. Pardridge has to
catch a plane, so I am going to pass on to him. But I appreciate your
testimony, Dr. Elsas, and I am only sorry Senator Hatch was not here to hear
you comment on the fact that – at least, the inference; it is not a fact -
that if the information

or the research is not going to be supportive of their position, that
sometimes one does not get supported by organizations such as ILSI,
NutraSweet and others.

Do you think that general conclusion of mine might be inappropriate, or
appropriate?

Dr. Elsas. Sir, I think that is very cogent and appropriate.

Senator Metzenbaum. Thank you very much. Would you agree with that,
Dr. Wurtman? Dr. Wurtman. Yes, sir.

Senator Metzenbaum. Thank you.

Dr. Pardridge, we are happy to hear from you, sir.

Dr. Pardridge. Thank you, Senator, and thank you for having me.

I am a Professor of Medicine at the University of California, a
practicing endocrinologist, and I have been doing neuroscience research on
the blood-brain barrier transport of phenylalanine and other substances
since 1970.

I believe in the discussion this morning, there are three key
scientific food policy questions that have really not been properly
illuminated.

The first question is the dosage problem. We are led to believe by the
FDA this morning that the typical consumer will have 2 to 4 milligrams per
kilogram of aspartame per day; that the 99th percentile intake is 34
milligrams per kilograms per day; and that the advisable daily intake or ADI
is 50 milligrams per kilogram per day.

Now, the layperson sitting in the audience is really in no position to
analyze these esoteric numbers. But if we put it in a different context and
recognize that 50 milligrams per kilogram per day is equal to 5 servings of
NutraSweet per 50-pound body weight, we are at great risk for
overconsumption of NutraSweet.

All one has to do in this room is look up at that chart and ask
yourself if a 50-pound or 60-pound 7 year-old is going to consumer 5 or 6
servings of that per day. If they are, then they have consumer 50
milligrams per kilogram per day, of the advisable daily intake.

Now, an 11-year study in the literature has already shown this, that
the average 7-to-12-year old, when made freely available to products like
that, consumes 5 servings per 50-pound body weight per day , and up to 77
milligrams per day.

Senator Metzenbaum. That is the average?

Dr. Pardridge. The average in children is the ADI – 5 servings per 50-
pound body weight. Ask yourself: Would an average child have 5 servings? I
think the answer is yes.

Another study by Porikos in obese subjects showed that the average
intake was 20 milligrams per kilogram per day, or 2 servings per 50-pound
body weight, and that obese adults consume up to 36 milligrams per kilogram
per day, even in the face of that high body weight.

Now, if you accept the premise of the first question, that some
individuals and in fact many children consume near the advisable daily
intake of 50 milligrams per kilogram per day, then you must ask yourself
what level of increase in blood phenylalanine will be concomitant with that
ingestion of NutraSweet. And the answer is that your blood phenylalanine
will rise three-to four-fold. That is not 10 percent or 20 percent. That
is 300 to 400 percent. And this study has been done by Drs. Stenink and
Filer, which was funded by the industry.

If you now accept that many individuals, particularly children, consume
50 milligrams per kilogram per day, or 5 servings per 50-pound body weight
per day, and that they enjoy or a four-fold increase in their blood
phenylalanine, the third question that must now be addressed is, are there
any untoward effects on the human brain, that are associated with a four-
fold increase in phenylalanine, bearing in mind that this molecule is a
known neurotoxin?

And three studies come to mind. One study shows that when blood
phenylalanine in pregnant mothers is increased five-fold, there is a 10-
point drop in the I.Q. of the baby born of that mother.

Senator Metzenbaum. Of I.Q. All right.

Dr. Pardridge. A second study shows that if you measure choice
reaction time, a test of higher cognitive function in humans, that when
their bloom phenylalanine is increased six-fold, there is a 10 percent shift
in your ability to make a key decision before a video screen.

And a more recent study by Dr. Elsas has shown that there are
quantitative changes in the human electroencephalogram when the blood
phenylalanine is raised three-fold – something that clearly will happen in
children who consume near 5 servings per 50-pound body weight.

So if I may summarize, phenylalanine, is a known neurotoxin, and the
food industry added nearly 8,000 tons of aspartame to the food supply in
1986, which amounts to approximately 8 million pounds of phenylalanine added
to our food supply in a single year.

The consumption of aspartame has increased exponentially since its
introduction in 1981. The 1986 consumption of aspartame in the United
States was equal to nearly 22 percent of the 1986 consumption of refined
sugar when one allows for a 200-fold increase in sweetener potency of
aspartame relative to sugar.

With the enormous selective infusion of phenylalanine into the food
supply, the key questions before the United States Congress and other
scientific and medical organizations are whether selective increases in the
blood phenylalanine level on the order of 200 micromolar or four- fold above
normal, are to be expected with liberal intake of aspartame, and whether
blood phenylalanine increases of this magnitude have untoward effects on the
human brain.

Thank you.

(The prepared statement of Dr. Pardridge follows:) Page 369