Deposition of Robert C. Atkins, MD

June 25, 1980


In 1980, Dr. Robert Atkins testified in support of a man whom the U.S. Postal Inspection Service was trying to stop from marketing of an RNA product with false claims that the product would make people more youthful. Atkins said that he had administered RNA tablets to 100 to 200 patients, 20% to 30% of whom had a dramatic improvement in symptoms. However, he acknowledged that he had done no scientific study to back his "impression" and that he knew of no studies done by others. When RNA is taken by mouth, it is digested, but Atkins speculated that some enters the body intact because patients respond to it. The Administrative Law Judge disagreed with Atkins and blocked further sales of the product.


BEFORE THE UNITED STATES POSTAL SERVICE

P. S. #8/82

In the Matter of the Complaint Against:

GREAT LIFE LABORATORIES
500 Dorian Road
P. O. Box 837

at

Westfield. New Jersey 07090
|Room 400
Great Life Laboratories E 56th Street
New York, New York

Wednesday, June 25, 1980

The above-entitled matter came on for hearing, pursuant to notice, at 2:55 P.M.

BEFORE:

HONORABLE WILLIAM A. DUVALL, Administrative Law Judge

APPEARANCES:

Christopher S. Barnard, Esq.

Katz, Paller & Land
470 East Paces Ferry Road, N. E. Suite 2000
Atlanta, Georgia 30305

Kristin L. Malmberg, Esq.
Consumer Protection Division Law Department
U.S. Postal Service

PROCEEDINGS

JUDGE DUVALL: We are resuming this case today in New York at the offices of Dr. Robert C. Atkins in order to take the testimony of Dr. Atkins at the request of the Respondent. Is there any preliminary matter that we want to take up before we proceed in taking the testimony of Dr. Atkins?

MR. BARNARD: No, sir.

JUDGE DUVALL: Dr. Atkins is now on the stand. I'll ask you to stand, please. Riase your right hand.

DR. ROBERT C. ATKINS

Was called as a witness by counsel for the Respondent and, having been duly sworn by the Administrative Law Judge, was examined and testified as follows:

JUDGE DUVALL: Be seated please, sir.

DIRECT EXAMINATION

BY MR. BARNARD:

Q. Doctor, for the record, would you state your full name please?

A. Robert C. Atkins, M.D.

Q. I would like to hand you copy of this and ask you if you would just describe what it is please.

A. That is my curriculum vitae describing my educational background, society affiliations and practice history and other affiliations.

Q. Thank you. What is the type of practice that you have here in New York, Dr. Atkins?

A. Internal medicine with an emphasis on nutrition.

Q. And how long has your practice been based on nutrition?

A. One can't really put a finger on the beginning of it, but I've been working with diets since 1964 and a full scope of nutrition somewhere beginning in the 1970's.

Q. Do you have an opinion as to how many medical doctors practice nutrition or their practices are based on nutrition or emphasize nutrition?

A. A fairly small percentage. Approximately one per cent of the practicing physicians in the country.

Q. Are you familiar with ribonucleic acid?

A. Yes.

Q Could you briefly tell us what it is and what its function in the body is?"

A. Well, it's an intermediary metabolite necessary for the nutrition of the nucleus of all our cells.

Q. And how does the body get the RNA it needs for its cells?

A. Well, there are many precursors on which the various component parts can be synthesized. I really haven't you know, my particular area here has been in the clinical use of it and I have not had a chance to really prepare myself with the underlying biochemistry and so my answers are not going to be as precise as I'd like them to be.

Q. I see. We understand. Let's get your clinical use. Do you use any type of DNA either in, alone or in combination with other therapeutic modes in your practice?

A. That I do, yes.

Q. Okay. Could you describe how I it's used?

A. Well, I do not use it on every patient. It's not past of the quote "routine" end quote, but there are certain times when I do add it to my basic routine as an isolated addition for the purpose of determining whether there's going to be any improvement in the patient's well-being and there are certain clinical situations under which I have come to use it. One is a fatigue that is not responsive to other measures; another is in the cardiovascular patient—the patient with angina pectoris—the patient who has pain limiting his activity; and I may use it in a variety of other situations, mainly for the purpose of really exploring and probing as to whether it might be effective—but the two indications that I use it for are fatigue and angina pectoris.

Q. Can you tell us approximately how many patients you've used RNA on?

A. I would estimate I've used it between 100 and 200 patients.

Q. Over what period of time would this be?

A. Most of this work represents the last two years, although I began using it probably four or five years ago, but the majority of the work has been quite recent.

Q. How did you become introduced to using RNA?

A. Well, I read Dr. Frank's books; I knew Dr. Frank; I had conversations with him; I—to use the word—I picked his brains—to ask him what indications he found it useful, asked him what complications or side effects he had been getting, I asked him what dosage form he used it in, what clinical indications and I began to feel that it was worth a try in some patients of my own. .

Q. Are these - You mentioned Dr. Frank's books—are these the books you're referring to?

A. Yes, particularly this Nucleic Acid, Nutrition and Therapy.

Q. In what form do you use RNA . . .

JUDGE DUVALL: Excuse me. Are you going to refer to both books?

MR. BARNARD: Yes, sir.

JUDGE DUVALL: We didn't get the title of the other book.

MR. BARNARD: The other book is Dr. Frank's No Aging Diet.

JUDGE DUVALL: Thank you.

Q. In what form do your patients receive DNA? Is it in a diet mode with food that has a high content or do you give it in supplement form?

A. No, I give it in supplement form. I don't really go out of my way to recommend sardines or other so-called high-RNA foods, but rather I have found food products which are really RNA in tablet form which I would recommend as a food supplement or a nutritional supplement.

Q. Now, when you give RNA to patients, is it by itself or is it part of an overall . . .

A. Well, as I stated before, I've already started my overall program which is a diet whose main purpose is the stabilization of blood sugar, secondarily, the elimination of any specific allergy to allergenic foods to that individual, and then a comprehensive vitamin formulation and a mineral formulation based in large part on the epidemiology of the area and in large part on the mineral results of the hair analysis. Occasionally, if the presented complaint is angina pectoris, I may start DNA during the first week. More often, I will withhold that so that I have a chance to evaluate the specific impact of RNA on that patient somewhere in the midst of the course of therapy.

Q. And based on your use of RNA on these patients, do you have an opinion s to what its effects have been? Clinical observations . . .

A. Well, there are a solid core of patients—approximately between 20 and 30 percent—who seem to be quite responsive to RNA. Their clinical response had been unimpressive with all the other vitamins and minerals until the RNA was added, at which point a dramatic improvement in well-being, in so-called energy and sleep requirements, in a variety of other complaints—depression—that seemed to accompany the fatigue, would take place. And upon discontinuing the RNA, these patients, they would slip back to their old previous level of not feeling so well. So, having taken these patients on and off RNA for, often enough, I \vas able to convince myself that at least for these individuals, RNA was helpful and did have a detectable and discernible clinical role and there were many patients where it just seemed to be part of the general improvement or nothing dramatic that would make me believe that RNA was really making any major contribution.

Q. Have you noticed any other effects of RNA on other factors besides energy, fatigue, perhaps more visually noticeable factors in the body?

A. Well, very subjectively. I believe I see an improvement in their appearance and I have not really undergone the study, which I think should be done, which is before and after photography. I do believe that there is something there in that these people seem to look either healthier or younger or less lines, less crows' feet around their eyes. I do believe that I've seen this in some patients.

Q. This is based on your own observation?

A. This is so subjective that it's a difficult thing to introduce in a court of law because it's totally, this impression would be very difficult to document at best.

Q. What is the age range of patients to whom you prescribe RNA?

A. Well, I've prescribed it in every adult group including adolescence, but the emphasis has been on the older patient—the patient past the age of 50.

Q. Let me ask you this—You had mentioned that perhaps a study should be done—what would you say as the state of medical knowledge of RNA and its uses and therapeutic value?

A. It's in its infancy.

Q. Are you aware of any investigations that are ongoing now or into that, similar to that of Dr. Frank?

A. I'm not aware of anything emerging.

Q. Was Dr. Frank then, was he one of the innovators or pioneers in this area, would you consider him to be?

A. Dr. Frank was certainly the leading proponent of the concept that supplementary DNA makes a difference. I think everybody recognizes the essentiality of RNA to every cell in the body, but heretofore the feeling had been that we were going to be able to synthesize all the RNA that we need with whatever nutritional precursors we have and this is the currently prevailing thinking. It's only because there is the possibility of showing detectable differences with supplementary RNA that we might raise the question as to whether or RNA production really has rate-limiting features which can be overcome by the utilization of additional dietary RNA.

Q. Could you explain just a little bit what you mean by rate-limiting?

A. Well, the question really has to be addressed as to whether RNA is a valuable nutrient, is whether or not our ability to synthesize RNA is not limited by the rate at which we can do it. Can we make enough molecules of RNA to supply our needs at a rate at which we might use it or would supplementary RNA actually change the availability of it by providing so much more than we're getting from our manufacture of it through precursor nutrients.

Q. Do you have an opinion as to whether RNA supplementation would be or might be beneficial to people across the board rather than people who come to your office and are put on a particular carbohydrate-limiting diet?

A. I don't think the carbohydrate-limiting diet plays much role in whether or not RNA is useful. I have a group of patients who are on full carbohydrate diets and who take RNA and the same percentage of responders seems to prevail in that group as well.

Q. I have one more question. How would you characterize your impression of using RNA supplements? Are you enthusiastic about its value? Are you skeptical of it? How would you characterize, based on, your using it and talking to Dr. Frank . . .

A. I'm somewhere inbetween those two extremes. I believe there's a base for RNA in medical management or the nutritional management of some patients. There's actually a risk factor which we haven't even talked about—the possibility that the uric acid level might be elevated—so that it's—I don't, cannot recommend its across-the-board usage, but I do see it as having a place in some individuals and I think more work has to be done and it has to be delineated. I think studying exercise tolerance in the angina patient would be a good place to start because I think one can document a study. I think it would be quite admissible of a double-blind study here. I think it's work that should be done.

MR. BARNARD: I have no further questions, but I would like to offer 5, 6, and 7, which are the C.V. and the two books into evidence.

JUDGE DUVALL: Very well. Exhibit 5 is received. And the other two—have you any objection to the two books?

MS. MALMBERG: My objection is the way . . .

JUDGE DUVALL: But their admissibility is not a problem with you, right?

(No response)

Well, let's identify Nucleic Acid, Nutrition and Therapy, since that was the first one mentioned, as Number 6.

MR. BARNARD: I wrote inside the front page.

JUDGE DUVALL: Did you?

MR. BARNARD: Down at the bottom.

JUDGE DUVALL: Oh. They're identified. All right. Nucleic Acid, Nutrition and Therapy is Number 7, and the book entitled Dr. Frank's No Aging Diet is Number 6, and they are received in evidence.

(The document referred to, heretofore marked for identification as Respondent's Exhibits 5, 6 and 7 were received in evidence.)

Are you ready to cross-examine now?

MS. MALMBERG: May we take a few minutes recess?

JUDGE DUVALL: Yes.

(Whereupon a short recess was taken.)

JUDGE DUVALL: Cross examine.

CROSS EXAMINATION

MS. MALMBERG:

Q. Dr, Atkins, do you have any scientific publications which are listed in the Index Medicus?

A. Well, I probably have several essays that are listed, whether they're scientific publications or just review articles . . .

Q. Would you name them?

A. Well, there's an article in Medical Counterpoint in about 1974 and another one in Medical Times, December of '79.

Q. Are either of those two journals on the Index Medicus?

A. That I don't know. I think so.

Q. Did you ever apply to take the examination of the American Board of Internal Medicine?

A. Yes.

Q. Did you take the exam?

A. Took the written exam.

Q. Did you pass the exam?

A. Passed the written exam.

Q. Why didn't you take the oral exam?

A. Well, I did take the oral exam, but I didn't pass the first time, so I just let it go because it was not necessary.

Q. So you flunked the Board of Internal Medicine?

A. Well the oral exam part.

Q. That is the exam?

A. Well, in those days, there was a written, which I passed, and an oral which I did not.

Q. When you flunked the oral, it was half the exam, wasn't it?

MR. BARNARD: Well, I object. The doctor has already testified that he did not pass the oral part of the exam.

JUDGE DUVALL: I think he's answered sufficiently.

Q. Did you pass the American Board of Nutrition?

A. I didn't take that exam.

Q. Do you have an approved Investigational New Drug Application for RNA therapy?

A. No.

Q. What Human Studies Committee has approved your human experimentation with RNA?

A. There is no evidence that this is experimentation or that this is even a drug.

Q. Does New York State Law require that human experimentation using RNA or any other therapy not approved by the FDA be preceded by approval by the Human Experimentation Committee of an approved medical institution in New York?

A. Would you repeat that question?

Q. Does New York State Law require that human experimentation using RNA or any other therapy not approved by FDA be preceded by approval by the Human Experimental—excuse me—Experimentation Committee of an approved medical institution in New York? .

A. I'm not familiar with the law as pertains to food used therapeutically. I mean, I would imagine that whatever law that is pertains to drugs, but my treatment being nutritional involves food and I'm not aware that the law places any such restriction on the use of diets.

Q. The question is whether—you stated that you use—on direct examination, you stated that you use therapeutic RNA. That brings it under the therapy law of the State of New York.

A. Well, I would wonder what the parameters of that law are and how food is therapy, whether food used as therapy is incorporated or exempted in the law and I'm not familiar with any ruling.

Q. You used the word therapy in your examination and that's what the question is. You also said that you prescribed RNA on your direct examination, did you not?

A. You mean use the word prescribe? If that's what the record so indicates, but I didn't write it, in which case it has a different meaning than writing a prescription. It's like I might prescribe jogging exercises or might prescribe eating two eggs a day. It's not the same as writing a prescription because there is no place for that prescription to be filled.

Q. In this case you prescribed a chemical substance, did you not?

A. Well, all substances are chemical.

Q. Well, you analogized it to jogging, which is not a chemical substance.

A. Well, eating a steak is.

Q. A steak is not a single chemical substance. You prescribed a single chemical substance entitled RNA, did you not?

A. Well, yes and sometimes I prescribe sodium chloride, which is also a single substance—salt.

Q. And if you prescribe sodium chloride that, in fact, can cause hypertension, can it not?

A. I would challenge whether it can cause hypertension.

Q. Do you give high sodium chloride diets to your patients with hypertension?

MR. BARNARD: Your Honor, I object. The relevance of sodium chloride I don't think is an issue.

MS. MALMBERG: I think what's in issue in this proceeding is his answers which he has tried to evade answering my questions and I'm trying to get back to that.

JUDGE DUVALL: Well, I'll sustain the objection. I don't think sodium chloride is germane to our inquiry.

Q. You stated that you use hair analysis for mineral status. Is hair analysis considered by Goodhart & Shils as a valid way to measure mineral status?

A. I'm not familiar with their opinion. I don't think that that's the only authoritative voice on the subject.

Q. You're a member of the AMA according to your C.V. Did not the Journal of American Medical Association several years ago publish a warning against using hair analysis to measure mineral status?

A. I'm not familiar whether they did, but my membership in no way endorses their nutritional philosophy.

Q. You stated that there may be some rate-limiting features of RNA synthesis in the body which can be overcome by oral RNA, is that correct?

A. Yes.

Q. Is oral RNA absorbed intact?

A. I don't know the extent to which it is, but I have reason to believe that some of it at least is.

Q. What's your reason to be believe that?

A. The effectiveness of RNA when given to some patients.

Q. Do you. base this on your patients in your practice, your observations?

A. That's correct.

Q. No scientific experiment?

A. That's correct. I mean, none of my own.

Q. When RNA is absorbed, is it still RNA?

A. I have no documentation of that point.

Q. What is pancreatic nuclease?

A. I'm not familiar with that.

Q. Have you heard of the pancreatic enzyme which digests RNA?

A. I'm aware of the existence of such an enzyme, yes.

Q. Do you have a Physicians Desk Reference in your office?

A. Yes.

Q. Does it not list pancreatic nuclease as a digestive enzyme for RNA?

A. I have no way of knowing that without . . .

Q. Could we look it up?

(Pause)

A. I don't know where to find it in this book.

Q. Okay, we'll just go on. Does Dr. Frank have an M.D.

A. He did, yes.

Q. How do you know that?

A. I assume that by virtue of the fact that he calls himself M.D.

Q. You don't know what university he received a degree from?

A. I do not know. I have never had occasion to look it up.

JUDGE DUVALL: Come in. Off the record.

(Discussion was held off the record.)

JUDGE DUVALL: On the record. Continue Miss Malmberg.

Q, Do you prescribe substances of unknown safety?

A. I hope not.

Q. Do you know RNA to be safe?

A. I know that there's a certain risk associated with it, particularly the risk of the person with a high uric acid and I prescribe it knowing that there is that risk . . .

Q. Have you followed . . .

A.—If you use the word prescribe.

Q. Excuse me. Have you followed, have you found any medical scientific publications which discuss the safety of RNA?

A. I'm not familiar with them.

Q. Do you prescribe substances of unknown efficacy?

A. Yes, I do that because knowing efficacy is a most difficult task. I think every doctor does that.

Q. Is it not the law that you may not prescribe substances whose safety and efficacy are unknown?

A. I would like to see the wording of that law because I challenge whether one can know the efficacy or safety of any of the substances which a doctor might prescribe. I'd like to see the wording of that statement.

Q. Were the books published by Dr. Frank subject to critical peer review?

A. Any book is subject to critical peer review.

Q. By the medical profession?

A. I'm sure it was reviewed by the medical profession.

Q. Are you familiar with the concept of peer review as used by publications such as the New England Journal of Medicine?

A. Yes.

Q. Would you describe that process?

A. Well, I'm not so familiar to give an accurate description, but you .have a board, an editorial board which would review a proposed publications before publishing.

Q. Is it sent to at least two experts in the field for testing, for review?

A. I'm not familiar with all the details.

Q. Were Dr. Frank's books subject to this kind of review which I have described?

A. No, not that kind.

Q. Have you published anything on your work in your practice with RNA?

A. No.

Q. What do you base your observations on, of the results you testified to in your use of RNA in your practice?

A. The physical exam and interview with the patients who have been taking the RNA.

Q. Have you done any double-blind testing?

A. No.

Q. Have you done any testing which would show the effects of long term use or term use of RNA?

A. No.

Q. What is your opinion about B-15?

MR. BARNARD: Your Honor, I object. B-l5 is not an ingredient in the product and therefore it's not relevant to this proceeding.

JUDGE DUVALL: What's the relevance?

MS. MALMBERG: The relevance is that I want to show Dr. Atkins' knowledge in the, or lack of knowledge in the field of nutrition.

JUDGE DUVALL: This goes to qualifications. Objection overruled.

Q. What is your opinion about B-15?

A. I think B-15 is N, N-dimethylglycine, is a useful source of methyl groups for transmethylation reactions in those patients whose diet is chronically deficient in methyl donor.

Q. Is this in accord with the consensus of medical opinion?

A. I have not taken a consensus of medical opinion.

Q. Do you read the American Journal of Clinical Nutrition?

A. Yes.

Q. Did you read the article about Vitamin B-15 in that journal?

A. Yes. I found an article by Dr. Herbert to be extremely biased and extremely unlike a proper review article as appears in a usual medical journal.

Q. Is there evidence that B-15 may cause cancer?

A. I would say most unimpressive shreds of evidence along those lines.

Q. Have you read the evidence and what journals is it in?

A. I can't recount that at this point. I don't have the information at my fingertips.

Q. Are you familiar with the articles that came out last month and this month that it may cause cancer7

A. No.

Q. Do you still prescribe B-15?

A. Yes.

Q. You have published two books on diets: The Dr. Atkins SuperEnergy Diet and the Dr. Atkins Diet Revolution.
.
A. Yes.

Q. Is it the consensus of medical opinion that these are good healthful diets?

A. I have not taken such a consensus.

Q. What is the AMA's opinion on this diet?

A. The AMA' s opinion. is a negative one.

Q. What is the State of New York's opinion as to the medical association as to this diet?

A. I don't believe the State of New York has ever issued a medical opinion. (Pause) May I ask. a question on something that was asked me?

MS. MALMBERG: Off the record.

THE WITNESS: Yeah. There was some question about . . .

MR. BARNARD: Did you go off the record?

JUDGE DUVALL: No, this is on the record.

THE WITNESS: Some question about an article which appeared in the last month. or two about B-15 and I wonder if the reference was to an article about DICA rather than N,N-dimethylglycine.

MS. MALMBERG: There are two: one to each of those that you mentioned.

THE WITNESS: Well, I want to modify one answer that certainly I read the article about DICA which I do not use.

Q. Did you notice that the other article referred to the article which you read in its references?

JUDGE DUVALL: Would you give the title so . . .

A. I would like to know the title of the article that you're talking about so I can know if I read it.

Q. Okay. This is the one which I believe you have not read. It's the Proceedings of the Society for Experimental Biology and Medicine, Mutagenicity of Dimethylglycine When Mixed with Nitrate: Possible Significance in Human Use of Pangamates from the May 1980 issue.

JUDGE DUVALL: And, that's the issue of the American Journal of Clinical Nutrition, is that?

MS. MALMBERG: No, that is the other article. This one is the Proceedings of the Society for Experimental Biology and Medicine.

JUDGE DUVALL: You said it's from the May 1980 issue. Issue of what?

MS. MALMBERG: Of the proceedings. (Pause) I have no further questions.

JUDGE DUVALL: Any redirect?

MR. BARNARD: Just one question or maybe a couple of questions.

REDIRECT EXAMINATION

BY MR. BARNARD:

Q. Are you saying, the subject of safety of RNA was brought up. The particular product in question, a dosage four tablets a day would have, 180 milligrams of RNA, would you consider that level to be safe or unsafe with regard to people who might have a uric acid problem?

A. I would have a difficult time answering that question without seeing some dose-response studies. I mean, that is a low dose, but as to just how safe it would be for a person with an elevated uric acid is something which I have no way of determining.

MR. BARNARD: I don't have any further questions.

JUDGE DUVALL: Are there varying degrees of elevation of uric acid depending on the individual?

THE WITNESS: Everything is varying. I mean, every uric acid, there's no cutoff point. In clinical medicine, it's all shades of grey.

JUDGE DUVALL: Well, would it be possible for some persons that the taking of this product might be dangerous for him if they have an unusually elevated uric acid state? Would there be a state of elevation of uric acid at which this product would become dangerous or risky?

THE WITNESS: It's a very difficult question because the dose is a very low one and the word risk—it's possible a minor worsening of a" condition might take place, but .it seems from the dosage involved that any worsening would be minor indeed and that most problems from uric acid are the pain of gout which is self-limiting—once one has the pain, he would hopefully, if the package—I don't know what the package insert says, but in the presence of the gout pain, one would desist in taking an RNA preparation, so that the amount of risk would be minor in that situation.

JUDGE DUVALL: Has an RDA for RNA been established?

THE WITNESS: No. I think that the presumption is that it is non-essential.

JUDGE DUVALL: Well, under those circumstances, would it not be difficult to tell when a given individual might unduly increase his uric acid level and therefore have the gout pain that you just described?

THE WITNESS: Well, in clinical medicine one has the advantage of knowing the uric acid before he prescribes it.

JUDGE DUVALL: What about the person who does not have the advantage of consulting with a doctor, but who takes the product?

THE WITNESS: In this situation, one can envision the risk to the extent that this low dosage may add to the risk, but it's an amount which occurs in food and it presents no greater risk than certain types of food.

JUDGE DUVALL: If it is presumed that one ingests enough in his regular diet and then too that amount, 180 milligrams per day, does that increase the possibility of risk?

THE WITNESS: The question is so hard to answer in many ways because it's as though you're defining a risk as something which occurs at a certain point when there is always some degree of risk with a person on the high uric acid level that this may be just the last straw, enough to cause a twinge of gouty pain, so it's . . .

JUDGE DUVALL: If one takes an excess of RNA, is the excess excreted or is it retained within it, absorbed within the body or what happens to it.

THE WITNESS: Well, it has to be metabolized. The byproducts would probably be excreted. Some would go into uric acid production and the net result might be an elevated uric acid.

JUDGE DUVALL: I don't know and I'm not sure that I can tell the period of time that would be covered by a quantity of this that is purchased through the mails, let's assume, but I would assume it would not be for one day's supply; I would assume it would be for a number of, X number of days. Would the fact that it is not, that not all of the excess is excreted have a cumulative effect and thereby produce a risk? I'm trying to . . .

THE WITNESS: Well . . .

JUDGE DUVALL:—but I don't know that I've succeeded.

THE WITNESS:—this implies that that dosage is sufficient to supply more than the daily needs and thus . . .

JUDGE DUVALL: Well, the body synthesizes supposedly the amount of RNA that the body needs—that's the present thinking as I understand it. So that if one ingests by means of taking this product, an extra 180 milligrams per day for X number of days, whatever the amount is purchased, and not all of the excess is excreted, but some of it is absorbed and goes into production of uric acid, then it could do other things rather than make, uric acid, couldn't it?

THE WITNESS: It might allow for better formation of nucleic acid, allow for a better utilization of nucleic acid itself. Let's assume that there might be a deficiency and that the individual would make not enough for his needs under a period of stress or because of the stress of an illness, for that individual, it might bring him into a therapeutic range or into a range which is optimal for that individual. I would imagine, but I have no evidence of rates of degradation of nucleic acid—I am not familiar with the real studies as to what the requirements are in various types of patients to know whether 180 milligrams would ever serve as a cumulative dose or whether it's such a low dose that the safety factor is unchallenged and only . . . it's only utility would be in helping those people with very low levels and very low rates of synthesis of their own nucleic acid. Now, this is not applied, implied that the average person has this problem. I'm talking in terms of those people who are particularly slow in producing their own nucleic acids. For these people, it might just bring them into a more useful range.

JUDGE DUVALL: You mentioned studies in your testimony and it's been mentioned by other witnesses who have appeared that, in fact, there have been no studies of this particular subject, no double-blind . . . studies of that character.

THE WITNESS: It's an unstudied area.

JUDGE DUVALL: Thank you, sir. Any further questions?

MS. MALHBERG: No .

MR. BARNARD: Just one question. A hundred and eighty milligrams per day, in this product I believe if you read the label, four tablets, four times a day, each tablet is 45 milligrams.

THE WITNESS: Uh, huh.

MR. BARNARD: Could a person get 180 milligrams or say 45 milligrams of RNA at one sitting if he ate a lot of sardines or nuts or glandular meat?

THE WITNESS: I'm sure much more than that.

MR. BARNARD: I have no further questions.

JUDGE DUVALL: Any other questions?

MS. MALMBERG: No.

JUDGE DUVALL: Thank you very much, Doctor.

THE WITNESS: Thank you.
JUDGE DUVALL: You're excused.
(The witness was excused.)

And is there anything further now? Are you going to do we have anything further to consider at this time?

MS. MALMBERG: I would like to present some rebuttal on the witness—-

JUDGE DUVALL: Now?

MS. MALMBERG:—testimony. Yeah. If we could wait a few minutes and let me . . .

JUDGE DUVALL: All right. Let's take a five-minute recess.

(Whereupon a short recess was taken.)

JUDGE DUVALL: Now, call your witness £or rebuttal testimony, Miss Malmberg.

MS. MALMBERG: I'd like to call Dr. Victor Herbert for rebuttal testimony. Whereupon,

Dr. VICTOR HERBERT

was called as a witness by counsel for Government and, having been duly sworn by the Administrative Law Judge, was examined and testified as follows:

JUDGE DUVALL: Off the record.

(Discussion was held off the record.)

JUDGE DUVALL: Proceed, Miss Malmberg.

DIRECT EXAMINATION

BY MS. MALMBERG:

Q. Would you please state your business address for the record?

A. 130 West Kingsbridge Road, Bronx V.A. Medical Center, Bronx, New York I0468.

Q. Would you briefly describe your educational and experience and your training?

A. I received my three degrees all from Columbia University here in New York City: my Bachelor's in 1948; my Medical Degree in 1952; and my legal degree in 1974.

Q. What was your training beyond medical school?

A. I served internship and residency, passed the Board Examination of the American Board of Internal Medicine and I am certified by the American Board of Internal Medicine, having passed their exam and I am certified by the American Board of Nutrition. I have published over 400 scientific papers in peer review scientific journals, primarily in internal medicine, hematology and nutrition, particularly relating to patient care, diagnosis, treatment and biochemistry and physiology of nutrition. I am currently the President of the American Society for Clinical Nutrition, which is the arm of the United States in international nutrition matters. I am a member of the Joint Subcommittee on Human Nutrition Research of the Executive Office of the President of the United States and I am a member of the Food and Nutrition Board of the National Academy of Sciences.

Q. Would you please define what an essential nutrient is?

A. Essential nutrients are defined as those which must be taken in the diet for life and health because the body cannot make them itself.

Q. Would you define ribonucleic acid?

A. Ribonucleic acid or RNA is a chemical compound which is produced in cells, particularly outside of the nucleus of the cell in the cell plasma or cytoplasm and it consists of sticking together of purine bases, sugars and phosphate, phosphoric acid. I have done a great deal of research involving RNA and DNA and have published a number of papers in that area.
In fact, I developed a diagnostic test used in hematology and in cancer research which revolves around DNA synthesis and RNA synthesis is also involved.

Q. Is there an RDA for RNA?

A. No. We don't create—when I say, we, now I'm talking about the Food and Nutrition Board which created the RDA or Recommended Dietary Allowances and I am one of the fifteen members of that Board—we do not have an RDA for nucleic, for RNA simply because RNA is not absorbed. RNA in food is chopped up completely by pancreatic nuclease, so that it is unabsorbed. If it were absorbed, it would be dangerous because it w6uld be allergenic in part, that RNA which is not human in origin could be allergenic for humans if absorbed intact. It's chopped up in the gut and after being chopped up, the individual purines are absorbed and they then add to the burden of body uric acid to be disposed of as a waste product. RNA is made within cells; none of that which comes in diet is absorbed. The pancreatic nuclease and other pancreatic enzymes have this specific function of chopping up various undesirable' substances so that they are not absorbed, only their end products are absorbed.

Q. What relationship . . .

A. I'm sorry. I should point out that RNA as it comes in in food, like in sardines, is generally not RNA; it's ribonucleoprotein and in the intestine when the pancreatic enzymes start chopping up the big molecule, they chop off the protein first and that leaves RNA, which then gets chopped up by other enzymes. So, what's in sardines is not RNA; it's ribonucleoprotein, which is a much bigger molecule than RNA.

Q. Would you describe the process of peer review?

& Yes. Peer review is the scientific system for separating wheat from chaff—that is, for separating let's say a nutrition book for the public which may be completely fiction from a nutrition book for scientists and the process of peer review involves the writing being submitted to an editor competent in medical science who then sends it out to a minimum of two reviewers known to be competent in the specific area of the scientific paper in question, who then do their best to tear it apart, both as to theory and fact and experimental method and conclusions. Their criticisms are then synthesized by the editor and sent back to the author who is not allowed to publish until he successfully meets the criticisms of his work. . .

JUDGE DUVALL: Off the record.

(Discussion was held off the record.)

Q. What is the significance of a journal being listed in the Index Medicus?

A. On peer review journals are listed in Index Medicus, which is put out by the National Library of Medicine and that is' to help physicians find responsible writings that they can trust.

Q. Is Medical Counterpoint listed in the Index Medicus?

A. I doubt it because it is a throwaway journal. Throw-away journal means that a publisher who usually is not a medical publisher creates a journal in order to have large advertising revenue from advertising in it to physicians and the journal is then sent out free to physicians. Medical Counterpoint was such a journal; it is now defunct.

Q. Is Medical Times listed in the Index Medicus?

A. The same answer.

Q. Okay. what about the Journal of the Nutritional Academy of the Nutritional Consultants?

A. That is not to my knowledge an outfit of scientific nutritionists. I believe I know several members who I believe have criminal convictions for nutrition fraud operating in Huntington Beach, California.

Q. What relationship does interferon have with RNA?

A. The dietary RNA? None whatsoever. Dietary RNA, as I indicated, is destroyed in the intestines. There are some studies which show that in tissue culture if you add a variety of substances, you can stimulate interferon production. One such substance which you can add to a tissue culture as an intact substance is RNA in certain forms and some tissue cultures it will stimulate interferon production, in other tissue cultures, it will not; some RNA's will stimulate, others will not. RNA is not a single molecule in the sense that it's not a, pearl necklace. You can think of RNA as a necklace—that is, it's a string of substances strung together and that necklace is called RNA regardless of whether it's made out of pearls or' diamonds or glass; its component parts can be considerably different so long as it meets the basic criteria of purine bases and sugar and so on, so that the IDIA from a mouse, for example, can produce an anaphylactic reaction if injected into a human. So, RNA . . .

Q. What is an anaphylactic reaction?

A. I'm sorry. A fatal allergic reaction. And that's' one of the reasons that we have intestinal enzymes to chop up our foods so that we don't absorb food RNA which is not human except for cannibals and get allergic reactions and even possibly an anaphylactic reaction from absorbing a sardine or an animal RNA—we chop it up in our intestines.

Q. Is there any scientific evidence that RNA will cause wrinkles to disappear?

A. None whatsoever.

Q. Is there any scientific evidence that RNA will make some individuals look ten to fifteen years younger?

A. No.

Q. That RNA will reduce breathlessness and fatigue?

A. You're talking about dietary RNA?

Q. Yeah. Taken, ingested . . .

A. No such evidence exists.

Q. Is there any evidence that RNA will heal acne, age spots and other skin ailments?

A. Again, you're talking about oral RNA?

Q. Right. Oral RNA.

A. No. Absolutely no evidence. It would be worthless for any such claim because it ceases to be RNA once it hits the intestine and the pancreas enzymes chop it up.

Q. So that—okay—let me go through the other—is there any evidence that RNA will promote good health, dietary RNA will promote good health and a general sense of well-being?

A. No.

Q. Or that it will prevent aging and disease?

A. No such scientific evidence exists.

Q. Okay.

MS. MALHBERG: I have no further questions.

CROSS EXAMINATION

BY MR. BARNARD: How do you define scientific evidence?

A. I mean a demonstration that it occurs published in a peer reviewed scientific journal based on data which is sufficiently valid to allow the possibility of such an interpretation as opposed to allegations of fact in books for the laymen which are just anecdotes and scientifically worthless. An allegation of fact, as you as, an attorney know, is worthless until tested.

Q. You were in this room when Dr. Atkins testified that he has obtained positive results with oral RNA therapy. You don't consider that scientific evidence?

A. I consider that worthless anecdote and, in fact, I would qualify it as nonsense because under cross examination Dr. Atkins admitted that he did not do any double-blind controlled studies and therefore one concludes that he has no way of being able to separate cause and effect from coincidence. It is well-recognized in medicine that 80 per cent of symptoms patients present with improve regardless of therapy. Dr. Atkins just suggested that he was incapable of telling coincidence from cause and effect. And I'm astonished that he would make a claim without doing double blind controlled study since he went to a decent medical school where I'm sure he was taught, because I teach in that medical school each year, I'm sure he was taught that to make therapeutic claims without a double-blind controlled study is irresponsible.

Q. You said that you have published a number of papers on RNA and DNA.

A. That's correct.

Q. How many and what are their titles?

A. Well, the last such paper was this January in the Journal Clinical Chemistry and this January in the British Journal of Hematology. The paper this January in Clinical Chemistry was a description of a new diagnostic test for studying DNA synthesis in human lymphocytes. from the peripheral blood, and the paper in the British Journal of Hematology was on our studies demonstrating the relative productions of DNA by the two pathways the human body uses to make it: 1, the de novo pathway and the other the salvage pathway—and each of those papers recites prior publications of ours which would carry you back through the years to our earlier work.

Q. What do you mean by our?

A. My laboratory - myself and my collaborator or collaborators. Some of the papers are work that I did alone; the majority I've done with research fellows, other physicians, Ph.D.'s in biochemistry, et cetera.

Q. You also mentioned tissue culture studies with regard to interferon.

A. Yes.

Q. Who were those studies done by? And are they recorded somewhere?

A. Well, they've been done in Sweden and the United States. A number of studies, of course, the major, one of the major interferon worker groups is the group at Sloan-Kettering here in New York City. They've done some of that work.

Q. Are these studies published?

A. Pardon?

Q. Are they published?

A. I'm not sure if the RNA work is published. I'm familiar with the work on various substance stimulating interferon production because I am involved in cancer research myself. I'm familiar with a lot of work that isn't published.

Q. Okay. Well, if it's not published, it doesn't meet your standard of scientific evidence, does it?

A. I didn't claim that it met my standard of scientific evidence. I claimed that there was no evidence that oral RNA had any value for interferon and then I went. onto say there is some evidence for adding intact RNA to tissue cultures, but I didn't say that evidence was valid.

Q. Are you in a private practice seeing patients?

A. I see patients. I act as Senior Consultant on a 40-bed ward in Internal Medicine at Bronx V.A. Medical Center. I do not practice privately although I will occasionally see a private patient who is a diagnostic enigma at the request of another physician to help him solve the problem. I should mention that I am in addition to running the Hematology and Nutrition Laboratory at the Bronx V. A. Medical Center, I'm also Professor of Medicine at the State University of New York, Downstate Medical Center in Brooklyn and Professor of Clinical Pathology at the Columbia University College of Physicians and Surgeons.

MR. BARNARD: I don't have any further questions at this time, but I would like to have time to continue to cross-examine at a later time and also I would ask Your Honor, our initial exchange of documents and application for production of documents would be considered a continuing one so that I could have access to those papers he has.

JUDGE DUVALL: Yes.

This page was posted on July 19, 2004.