- ATTORNEYS AT LAW SWANKIN & TURNER
-
- DAVID A. SWANKIN
- JAMES S. TURNER, P. C.
- BETSY E. LEHRFELD, P. C.
- CHRISTOPHER B. TURNER, P.C.
-
- SUITE 101 1400 16TH STREET, N.W. WASHINGTON, D.C. 20036
- TEL. 202 462-8800 FAX 202 265-6564
-
- September 20, 2005
-
- The Honorable Ron Curry
- New Mexico Secretary of Environment
-
- Dear Secretary Curry:
-
- I am sending the enclosed letter in hopes that it will
benefit your effort to evaluate aspartame in New Mexico. Please forward
to Barbara Claire before 5:00 pm today.
-
- Thank you for your consideration.
-
- Sincerely, James S. Turner, Esq.
-
-
- September 20, 2005
-
- To The Honorable Gay Dillingham
- Madame Chair, New Mexico Environmental Improvement Board
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- [ page 1 ]
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- Dear Ms. Dillingham and Members of the EIB:
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- I first became aware of the dangers of Aspartame in 1970.
During that year I worked closely with the United States Senate Select
Committee on Nutrition and Human Needs, to which I subsequently served
as special counsel. Dr. John Olney of Washington University in St. Louis,
whose information presented to that committee played a key role in the
elimination of Mono Sodium Glutamate (MSG) from baby food, informed me
that the aspartic acid component of aspartame created the same kind of
lesions (holes) in the brains of mice that MSG did. Dr. Olney's information
caused me to investigate aspartame further.
-
- In 1969 I was the lawyer in charge of a team of 20 law
and medical students investigating, under the direction of Ralph Nader,
food safety regulation at the US Food and Drug Administration. The Chemical
Feast: The Nader Report on Food Protection and the FDA, published in 1970,
and which I authored, reported the results of that investigation. The student
team gathered proof that led President Nixon's Secretary of Health, Education
and Welfare to effectively ban marketing the artificial sweetener Cyclamate
by removing its Generally Recognized As Safe (GRAS) designation. President
Nixon had a strong interest in food safety and quality.
-
- Dr. Olney's information about the harm caused to mice
brains by a component of aspartame -- an anti-ulcer drug turned into a
new artificial sweetener -- looked to me strikingly like the information
on cyclamate and other food chemicals that the student team had found unacted
upon in FDA files. The new, Nixon-appointed, FDA Commissioner had welcomed
the student investigation, given each team member an official FDA identification
badge and instructed FDA employees to cooperate with the study. The officials
we knew to be responsible for reviewing aspartame informed me that FDA
scientists had serious concerns about its safety.
-
- These concerns included several animal studies showing
a significant number of brain tumors in aspartame treated animals but not
in controls. Breakdown products created by the digestion of aspartame included
known cancer-causing substances. In a study of approximately 20 monkeys,
all high dose animals experienced grand mal (epileptic) seizures. Finally,
when the scientific documents were made public --the first and only time
FDA made trade-secret food additive evidence public --scientists advising
me found also that aspartame-fed animals suffered measurable eye damage
and women users experienced statistically significant weight gain.
-
- This information seemed enough to require FDA to reject
aspartame approval. However, our Nader FDA study, fueled by despairing
stories from FDA scientists, acted as a red flag against relying on FDA.
Most particularly, I learned that Dr. Olney's information on aspartame
brain [ page 2 ] lesions in mice was not part of the record.
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- In spite of Dr. Olney's having briefed Searle scientists
on the lesions and watching them find lesions in experiments they did jointly,
Searle had not -- in spite of its legal obligations -- reported the lesions
to FDA. The senior FDA food safety official arranged for me to meet Searle
representatives to discuss this problem.
-
- My meeting with Searle took place during an era when
President Nixon took an interest in food safety and the Senate Select Committee
on Nutrition was investigating food additives. The President convened a
White House Conference on Food, Nutrition and Health with a Food Safety
Panel (chaired by Pepsi's president and on which I served) mildly critical
of food additives. The President ordered a (decade long) review of all
GRAS listed food chemicals, which found ten percent of the several hundred
listed items of dubious safety and raised questions about many others.
In this context my meeting with Searle was cordial but nonproductive.
-
- Searle swore that its new sweetener would be approved.
I said it would not reach the market. FDA did approve aspartame in July
1974. In fact it was theonly significant food additive approved during
the 1970's. Dr. Olney and I immediately filed petitions to stay the approval
until a public hearing could be convened to review the science that we
-- and FDA scientists said prohibited FDA from approving aspartame. FDA
accepted our petitions, ordered that a Public Board of Inquiry (PBOI) be
convened to review our scientific claims and prevailed on Searle to voluntarily
refrain from marketing the chemical until the hearing on its legality concluded.
The PBOI convened in the last week of January 1980.
-
- Between 1974 and 1980 evidence against aspartame safety
piled up. A routine FDA Bureau of Drugs, inspection of Searle's Chicago
area laboratories found massive violations of sound scientific practice.
The FDA Commissioner appointed a task force to rigorously inspect Searle's
labs. It found dozens of studies on many products -- drugs, the copper
wire IUD and 11 pivotal studies on aspartame -- that violated both sound
scientific practice and food safety law. FDA officially stayed the marketing
of aspartame, got a grand jury appointed to investigate Searle's criminal
behavior, set up two committees to review Searle science and supported
legislation to require registration of research labs.
-
- By 1977 Searle was in financial chaos. At this point
it reached out to its former home town (Skokie) Congressman and Ford White
House Chief of Staff and Defense Secretary Donald Rumsfeld to work his
(political) magic to pull the company out of its free fall toward bankruptcy.
I met with Rumsfeld in 1977 to see if there was a way that the ruined studies
could be redone and studies that had not been done but should have (at
this time FDA did not require studies to rule out possible brain damage
from food additives) could be undertaken. Some of Searle's customers and
their own legal and policy advisors supported such an effort.
-
- One Searle reviewer of its aspartame submission told
me that he had never seen such a poor food additive petition. Six months
after my Rumsfeld meeting, the company responded with a robust campaign
to win aspartame approval based on the original flawed studies. Searle's
law firm approached the US attorney with arguments for aspartame. The official
let the statute of limitations run on the grand jury. He and one or two
deputies went to work for the law firm. Eventually they renamed the substance
NutraSweet -- the first branded food additive. They offered (FDA accepted)
to pay for the FDA convened pathologists committee to review the studies.
Not surprisingly, the committee whitewashed the effort, saying it could
not evaluate the study design: they would only report on whether Searle
misreported the data. They said it had not.
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- [ page 3 ]
-
- This last point underscores why we are still debating
aspartame safety today, when every study conducted by scientists not paid
for by Searle has found safety problems. One of the first FDA inspector's
concerns about the Searle laboratories was the failure to be sure that
animals intended to receive aspartame and only those animals received it.
That fact is currently unknown for most, probably all, of the studies done
in Searle's labs, the studies on which current assertions of aspartame
safety rest. This was a question that the Searle-paid-for FDA pathology
committee did not address because the question, it said, was outside its
purview.
-
- An in-house -- paid for by FDA -- FDA committee looked
at three studies that the Searle-paid committee did not. The FDA in-house
committee found that at least one of the studies could not be relied upon
because it could not be ascertained with certainty that animals received
the aspartame they were supposed to be fed. For this reason the results
were inconclusive.
-
- Five independent pathologists looking at the tumor data
in several animal studies found a statistically significant higher number
of tumors in the aspartame than in the control group. A sixth found no
statistical significance -- one tumor had moved from the treated to the
control group. The study slides disappeared from an FDA sealed file. They
turned up in the drawer of a Searle consultant.
-
- When the PBOI -- three members, one each from Searle,
the FDA and one from myself and Dr. Olney -- convened, the scientific record
against aspartame was powerful. However, because the PBOI hearing was the
responsibility of the FDA Bureau of Foods and the scathing data against
safety was in the Bureau of Drugs (Searle was a drug company), the data
from the FDA Searle Task Force investigations was not a part of the review.
I moved to have it admitted but the board ruled against me. I appealed.
The Commissioner denied my appea1. Nonetheless, even on the limited evidence
before it, the PBOI ruled unanimously that aspartame should not be allowed
to be marketed because the possibility that it caused brain tumors could
not be ruled out.
-
- The PBOI released its ruling the first week of October
1980. The FDA Commissioner appointed an in-house FDA committee to review
the PBOI findings to determine if he should let them stand or overturn
them. In the first week of November 1980, Ronald Reagan was elected President.
Republican political activist and Searle president Don Rumsfeld played
a prominent role on the Reagan transition team. That team selected, and
President Regan appointed, a relatively unknown Dr. Arthur Hull Hayes as
FDA commissioner. His primary qualification appeared to be his service
as a contract research physician at the Defense Department while Donald
Rumsfeld served as Secretary of Defense.
-
- The FDA Commissioner's review committee told the Commissioner
that the PBOI findings were supported by the data and that he should not
overturn its ruling. The Commissioner was blocked from taking any actions
until his successor took office. The new Commissioner, Dr. Hayes, overturned
the board's decision in July of 1981 and approved aspartame for dry foods.
Two years later, in July of 1983, the FDA approved NutraSweet for liquid
- diet soda -- uses and Dr. Hayes left FDA, becoming senior medical advisor
to Searle's advertising agency.
-
- In the early 1990's National Cancer Institute data showed
that there had been a ten percent rise in humans of the same kind of brain
tumor that most pathologists found in the aspartame animal studies. Dr.
Olney and I, this time accompanied by Mike Wallace of "Sixty Minutes,"
approached FDA to see if it would support doing the new brain studies we
had sought in 1977. The FDA official in charge said no, and two years later
became Vice President of Clinical Research for Searle. Over the years,
several other key decision makers for the FDA have taken [ page 4 ] jobs
with the soft drink industry association, food companies or others with
an economic interest in NutraSweet.
-
- During these past 35 years I have met with, spoken to
or corresponded with hundreds of aspartame uses who feel that the chemical
has caused them great harm -- seizures, blindness, migraines and other
problems. With over 10,000 consumer complaints filed with FDA, it is the
most complained-of food additive. In 1985 FDA asked the Centers for Disease
Control to review the first 650 complaints. The agency did, and reported
that between 25 and 30 percent of the female users could bring on the symptoms
by using NutraSweet and turn them off by stopping. So my standard advice
to all complainers has been that if they feel NutraSweet is causing them
a problem go scrupulously off it for three to six weeks and see if the
symptoms go away. Unfortunately this is not information that's readily
available to the average aspartame user.
-
- Given this entire record, I think the citizens of New
Mexico would be best served if this board banned the sale of NutraSweet
in New Mexico.
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- Your statutory powers to consider these matters are explicitly
set forth in the New Mexico Food Act (25-2-1 through 25-2-19). Poisonous
and deleterious food adulteration is the province of the Environmental
Improvement Board to delineate; your powers in that regard are very precise.
This statute provides, "A food shall be deemed to be adulterated (1)
if it contains any poisonous or deleterious substance which may render
it injurious, (2) if it contains any added poisonous or added deleterious
substance which is unsafe, and (3) if it consists in whole or in part of
....a decomposed substance, or if it is otherwise unfit." The New
Mexico Environmental Improvement Act, the act that created the Environmental
Improvement Board, in Section 74-1-2, gives you much broader powers to
promulgate rules"...in order to ensure an environment that in the
greatest possible measure will confer optimum health, safety, comfort and
economic and social well-being on its inhabitants; (and ) will protect
this generation as well as those yet unborn from health threats posed by
the environment..." Section 74-1-8A (1) created the EIB" "The
Board is responsible for environmental management and consumer protection.
In that respect the Board shall promulgate rules and standards in the following
areas: (1) food protection..."
-
- Sincerely,
-
- James S. Turner, Esq.
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