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"...the clear cut incidence of conflict of interest that I observed in two of the three consultants appointed to the expert panel for the above referenced issue is of no concern to FASEB?"

March 13, 1993
 
 

Kenneth D. Fisher, Ph.D.
Director
Life Sciences Research Office
FASEB
9650 Rockville Pike
Bethesda, MD  20814

Life Sciences Research Office
FASEB
9650 Rockville Pike
Bethesda, MD  20814

FDA Docket No. 92N-0391
Dockets Management Branch  (HFA-305)
Food and Drug Administration
Room 1-23
12420 Parklawn Drive
Rockville, MD  20857

RE: Analysis of Adverse Reactions to Monosodium Glutamate        (MSG) FDA Docket No. 92N-0391
Dear Dr. Fisher:

I am writing in response to your letter of March 8, 1993.  Am I correct in inferring from your letter that the clear cut incidence of conflict of interest that I observed in two of the three consultants appointed to the expert panel for the above referenced issue is of no concern to FASEB?

There is not much to say in response to your letter.  You and I have discussed conflict of interest before.  At the time that FASEB was evaluating the safety of L-glutamic acid in dietary supplements (1991), I pointed out to you that some of FASEB's consultants had benefitted from funding by the very companies whose products they were evaluating.  At that time my comments were filed and forgotten.

In your letter of March 8, you spoke generally of the guidelines and rules under which FASEB operates, and in so doing, stated that the Federation has a policy of freedom from conflict of interest.  I don't understand how, then, it happened that Dr. Sampson and Dr. Maher were selected to serve as consultants for the above referenced study.  I would be interested in knowing what your guidelines are vis-a-vis conflict of interest, and how, referring only to freedom from conflict of interest, you can justify the appointments of Dr. Sampson and Dr. Maher.

I would like to note for the record that the first time you and I discussed conflict of interest was in 1991, not in 1978 as you alleged in your letter; and I have not raised the issue of conflict of interest "on several occasions since 1978" as you also alleged.  I raised the question of conflict of interest in relation to the study dated July, 1992 entitled Safety of Amino Acids Used as Dietary Supplements, and I raised it in relation to the above referenced study.  As you are well aware, both complaints were justified.  As you are also aware, you did nothing in the first case to remedy the situation, and you appear to be doing nothing now.  It would appear, in fact, that you have attempted to set the tone of your letter to suggest that I had a long history as a "complainer."  It would appear that you are attempting to discredit me.  Actually, I had not even heard of FASEB prior to 1989 when I began to probe the literature on MSG safety/toxicity in order to safeguard the health of my husband.

I wonder if you have me confused with someone else, for in your March 8 letter you also state the "Our records indicate that you requested and received many of the references in the 1978 and 1980 reports on the health aspects of MSG by the Select Committee on GRAS Substances."  I do have copies of both the 1978 and 1980 reports, but I don't remember asking FASEB for references other than the bibliography that went along with those reports.  I have copies of studies cited in both studies, but I got them from the library.

I pointed out conflict of interest to you in 1991, believing that you would do something to remedy the situation.  I was wrong.  I am now complaining about conflict of interest in persons who, by virtue of their positions with FASEB, have the power to affect the health and welfare of millions of Americans.  I am sorry that FASEB does not feel that this is important.  I am not impressed that they are but two members of what will ultimately be an eight member panel.  Not only is that irrelevant in and of itself, let me remind you that it was you who told me that they will be two of the three people who will be responsible for orchestrating the direction of the study.

Since you do not appear to feel that the issue of conflict of interest is FASEB's problem, I will move on to finding someone who feels that the health and welfare of the American people need to be safeguarded by people who have nothing to gain from preventing others from being well.

If I have misinterpreted your letter, and you are in the process of remedying the situation, I would appreciate your informing me of the same.

You may recall that in my letter of March 24, 1993, I asked that
"FASEB allow me the courtesy of providing me with copies of those [new] materials, or allow me to review and make copies of those materials so that I might review them at my leisure...[and that]...I trust that if new studies are presented to FASEB too late for me to review prior to the April 'cut off date,' FASEB will give me the courtesy of extending that date so that I might have a reasonable time to review and comment to FASEB on the new studies."
I would appreciate knowing if FASEB is able to send me a list of the items available in the LSRO open file for the above referenced study so that I might order copies from FASEB or find copies of articles in the library.  Unlike those in the food industry who have interest in this issue, I have neither staff, legal counsel, or an industry supported association at my disposal in the Washington area to review the documents on file in the LSRO open file.  Finally, I would like to know what is the latest date that any review that I might do of references and documents in the LSRO open file will receive complete review and evaluation by FASEB.

I appreciate the promptness of your March 8, 1993 reply.  I look forward to hearing from you again with answers to my questions.

Very truly yours,
 
 

Adrienne Samuels, Ph.D.
1547 Santa Sabina Court
Solana Beach, CA  92075

(619) 481-9333
 
 

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This page was last updated on June 3, 2004.


 
IF MSG ISN'T HARMFUL, WHY IS IT HIDDEN?