Fwd: Metzenbaum letter to Sentor Hatch regarding Aspartame approval

[Guest guest]

CancerAnswer, " mrsjoguest " <joguest@m...> wrote:

 

Letter from Senator Howard Metzenbaum on United States Senate

Stationary (Committee on the Budget) dated February 3, 1986 to Orrin

Hatch who was the Chairman of the Labor and Human Resources

Committee, Metzenbaum was a member of this committee, along with Ted

Kennedy Strom Thurmond, Lowell Weicker, Christopher Dodd, Dan Quale,

John Kerry and others.

 

Dear Orrin;

 

NutraSweet, manufactured by the G.D. Searle Company, is currently

being consumed in ever-increasing amounts by over 100 million

Americans. Last year, Americans consumed over 20 billion cans of

diet soft drinks, the vast majority of which were sweetened with 100

percent NutraSweet. The average consumer assumes that all safety

questions surrounding this sweetener had been resolved long before it

found its way onto every grocery shelf in America.

 

A recent investigation under taken by my office raises serious

questions as to whether this is, in fact, the case. These questions

can only be resolved by Congressional hearings, with full subpoena

power, being undertaken by the Senate Judiciary and labor Committees.

 

In addition, the facts uncovered by my investigation coupled with

concerns expressed in the scientific community regarding the safety

of this food additive, compel the immediate initiation of new, truly

independent safety tests on NutraSweet.

 

My concern focuses on the failure of the U.S. Attorney's Office in

Chicago to undertake a grand jury investigation of NutraSweet which

was requested by the Food and Drug Administration. The investigation

was to focus on possible criminal charges against officials in the G.

D. Searle Company " for concealing material facts and making false

statements " in reports of safety tests on NutraSweet and the drug,

Aldactone. (Doc#1)

 

NutraSweet was first approved by the FDA in 1974. However, concerns

about the credibility of Searle's tests led the Investigation Task

Force to stay that approval in December, 1975. In 1976, an FDA

investigation Task Force published a report on the testing practices

at G.D. Searle Company and concluded: " At the heart of FDA's

regulatory process is its ability to rely upon the integrity of the

basic safety data submitted by sponsors of regulated products. Our

investigation clearly demonstrated that, in the G.D. Searle Company,

we have no basis for such reliance now. " (Doc#2)

 

One of the recommendations of the FDA's 1976 Task Force Report was

that the agency should ask the U.S. Attorney in the Northern District

of Illinois to institute grand jury proceedings against G.D. Searle.

 

It is a matter of public record that in January, 1977, the FDA

formally requested that the U.S. Attorney conduct a grand jury

investigation of tests on two Searle products; NutraSweet and

Aldactone, a drug to treat hypertension. It is also known that the

U.S. Attorney declined to prosecute in December, 1978. What has not

been publicly known until now is what happened in between.

 

Following an investigation by my office, the following facts have

been established.

 

The first U.S. Attorney in charge of the case Samuel Skinner did

not convene a grand jury. A year after he was initially informed of

FDA's interest in prosecuting Searle, and two months after he

received the agency's formal request for grand jury action,

he " recused " himself from the case, citing preliminary employment

discussions with the law firm of Sidley and Austin, the firm which

was then defending Searle in the investigation. He asked his

subordinates to keep his discussions confidential " to avoid any undue

embarrassment upon the firm of Sidley and Austin. " (emphasis

supplied).Doc#10). Mr. Skinner joined Sidley and Austin four months

later.

 

Sidley and Austin requested a meeting with Mr. Skinner " prior to the

submission to the grand jury of any matters relating to this

company. " (Doc#6) When the meeting was held, Mr. Newton Minow

attended (Doc.#7) Mr. Minow is the partner at Sidley and Austin who

offered Mr. Skinner his job with the firm (Doc#8). The meeting was

held a month prior to Mr. Skinner " recusing " himself from the case.

 

In his recusal letter, Mr. Skinner stated his understanding that the

decision as to whether or not a grand jury investigation should be

conducted would await the arrival of a new U.S. Attorney. (A period

which lasted four months). (Doc.#11).

 

However, no grand jury action was taken before the appointment of a

new U.S. Attorney.

 

This four month delay in the grand jury investigation took place at a

time when nearly four and a -half years of a five year statute of

limitations on the NutraSweet tests cited by the FDA had already

expired.

 

Shortly after the appointment of the new U.S. Attorney, Mr. Thomas

Sullivan, the FDA wrote to Justice noting the delays which had

occurred in the case and urged the U. S. Attorney, to " proceed

expeditiously. " The FDA also cited additional problems they had

discovered with a key NutraSweet safety test and noted " further

criminal culpability-- the failure to report these problems to the

FDA-- may also be revealed which could require submission to the

grand jury. " (Doc#16).

 

The Justice Department also wrote to Mr. Sullivan a month after he

assumed office complaining about the amount of time which had

transpired on the case. Letter states Justice knows of no reason

why " grand jury should not at least investigate. " (Doc#17).

 

By the time any case agianst Searle was presented to the grand jury,

NutraSweet was dropped from the investigation. This means the issue

of whether tests on NutraSweet were fraudulent, which was raised by

the 1976 task Force Report, was never put to the grand jury.

 

We have been informed by Justice there is no record of the U.S.

Attorney writing to the FDA to inform the agency that the

investigation would proceed on Aldactone alone..

 

According to a Justice Department memo, (Doc#21), Mr. William Conlon,

the Senior Assistant U.S. Attorney assigned to the Searle

case " reduced or ended " his involvement in the investigation eighteen

months after first being assigned to the case. One year later he

accepted a position with Sidley and Austin, the firm which

represented Searle in the investigation. (DOC#28).

 

Key seizure test on NutraSweet was never investigated by grand jury.

During a Searle sponsored monkey test, all the animals receiving

medium or high dosages of NutraSweet experienced Grand mal Seizures

(Doc#28). Searle never performed autopsies. The FDA said Searle

made at least four false statements and entries in the report of the

study. (Doc#1). Though the FDA later claimed it did not rely on the

study to prove safety, the seizures were never explained. Failure to

account for these seizures is of particular significance given

current concerns expressed in the scientific community on precisely

this issue. In the November 9, 1985, edition of Lancet , a

recognized authority on brain chemistry, Dr. Richard Wurtman, cited

case studies which suggest an association between NutraSweet and

Grand Mal seizures. (Doc#29).

 

Test on key breakdown component of NutraSweet, DKP, was never

investigated by grand jury. In July, 1977, the FDA wrote to Justice

telling them that FDA inspectors were reviewing a key test on DKP,

which raise issues that " could require submission to the grand

jury. " The U.S. Attorney never submitted the test to the grand

jury. " In the conducting of the study tissue masses were not

reported and uterine polyps were discovered. (Doc#30)

 

It is a matter of public record that back in 1970, the G.D. Searle

Company drew up a " strategy memo " on how to get NutraSweet approved

by the FDA. In the memo, they committed themselves to obtaining a

favorable review of NutraSweet by seeking to develop within FDA

personnel a " subconscious spirit of participation " in the Searle

studies. The memo emphasized the importance of getting the FDA in

the " habit of saying yes " , by first submitting to the FDA those

safety issues involving little or no breakdown of NutraSweet into

DKP. (Doc#31).

 

In-House FDA memos showing credibility of key tumor tests

were questioned by FDA scientists prior to Commissioner Hayes'

approval of NutraSweet. The problems with the credibility of

Searle's tests on NutraSweet continued right up to the time FDA

Commissioner Hayes overruled a public board of inquiry and approved

the food additive in 1981.

 

Two months prior to approval, the Commissioner was advised by three

of his own scientists that three key tumor tests, including the test

on DKP, were questionable and that safety had not been proven.

(Doc#26)

 

I am attaching to this letter a time-line which will highlight the

sequence of these events. I am also including an extensive list of

documents relating to the grand jury investigation. These documents

raise the question as to whether the investigation of the G.D. Searle

Company and in particular, the food additive, NutraSweet, was

properly conducted.

 

We will not be able to answer that question without Congressional

hearings, with full subpoena power.

 

As I mentioned earlier, NutraSweet is a product currently being used

by 100 million Americans. The fact that a grand jury never

investigated charges that Searle concealed " material facts " and

made " false statements " (Doc#1) on NutraSweet tests is a matter of

serious concern. One can only speculate on what a grand jury with

full investigative powers would have uncovered and how that

information in turn would have affected the credibility of those

tests in the approval process.

 

There are also the concerns being voiced by scientists over whether

key questions of safety have been adequately resolved.

 

I am including a brief synopsis of recent scientific work raising

questions about NutraSweet.

 

In conclusion, we have a grand jury which never investigated whether

criminal fraud was committed on NutraSweet tests, coupled with

continuing concerns being expressed in the scientific community

regarding this food additive's safety.

 

I urge you, Orrin, to hold oversight hearings on the health concerns

which have been raised about NutraSweet. It is the only way we can

hope to dispel the cloud hanging over the food additive presently

being consumed in massive quantities by the American people.

 

Very sincerely yours,

 

Howard M. Metzenbaum

United States Senator

 

 

 

 

 

http://aspartame.com/mpvalley/metzen2.htm

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