In this deposition, Dr. Bruce Jafek discusses why he believes that Zicam can cause the loss of smell if it contacts the olfactory epithelium. This is from the case of Wyatt v. Mattrix Initiatives, Inc. and was filed in the federal district court for the Northern District of Alabama.
Q (BY MS. SHARKO) You told me this morning that your opinion is that when you're comparing animal data to human data, you have to look at the area of olfactory epithelium, correct?
A I think I pointed out that the area of olfactory epithelium is important in terms of evaluating toxicity studies.
Q And it's your opinion, I understand from prior depositions, that Zicam is toxic to the olfactory epithelium, correct?
A That is correct.
Q And one predicate of your opinion is that the dose of Zicam that's administered goes to the olfactory epithelium as opposed to elsewhere in the nose, correct?
A As a general statement, that's correct. You left out the word “all” that you used in the previous question. My opinion is based on the fact that the bolus of Zicam has a straight pathway to the olfactory epithelium and, therefore, can do its toxicity effects.
Q And in order to have toxic effects, it's your opinion, is it not, that all of the Zicam has to go up onto the olfactory epithelium, correct?
A No, I don't think that's what I said.
Q Well, how much of it has to get there to cause damage, in your opinion, to a reasonable degree of medical probability?
A If we extrapolate -- if we extrapolate from Slotnick's studies in which he showed that 8 microliters was able to produce variable effects, what we might call an effect of 50 from his curve, and if we observe that the area of the human smell tissue is just a little bit bigger than that of the mouse, then what has to get there is 10 to 12 microliters, just as an approximation, and the usual applicant dose is 140.
Dr. Goettschel believes that zinc is toxic to the olfactory epithelium?
A As a general impression of the discussions that we had, I believe that he believes that the zinc is toxic to the olfactory epithelium.
Q What did Dr. Goettschel say that led you to that conclusion.
A I don't remember any specific conversations. I don't remember -- this was my general understanding of his remarks.
Q That was my next question. Is this the female Dr. Goettschel or the male Dr. Goettschel?
A It's the male Dr. Goettschel.
Q Okay. Now, is it your opinion that Dr. Doty believes that zinc is toxic to the olfactory epithelium?
A I'm not sure that I've ever discussed that specifically with Dr. Doty. I would be speculating in terms of general discussions.
Q And is it your opinion that Dr. Bartoschuk believes that zinc is toxic to the olfactory epithelium?
A Yes.
Q What is the basis for that statement?
A General discussions over the years as well as our conversations in the hall and corridor at the ACHEMS meeting.
Q What did Dr. Bartoschuk say at the ACHEMS meeting?
A I don't remember specifically.
Q What was your discussion with Dr. Slotnick? What did you say to him and what did he say to you, as best you can recall?
A It's hard to remember the specifics. I went over the details of his poster and tried to understand the nature of his presentation and so on.
Q Were you able to understand the nature of his presentation?
A I think it was well prepared.
Q Were you able to understand the details of his research?
A Yes, generally. I was a little surprised that he left off the 8 microliter data point that he shared with Dr. Schwob.
Q Did you discuss that with him?
A I don't remember having done so, no.
Q Do you have any criticism of Dr. Slotnick's research in this in area with the Zicam and the mice?
A I think that it was relatively well done. As I say, I'm concerned about the missing data point which should have been included in the presentation, I think.
Q Well, you have the data from the 8-microliter dose from the deposition exhibits, correct?
A I do, yes.
Q Okay. And so looking at the totality of Dr. Slotnick's data, do you have any criticism of any of his research in this area?
A I think that the material that he presented was generally well done.
Q Okay. And do you disagree with any of the conclusions drawn by Dr. Slotnick from his research as it was stated in the poster and the abstract?
A I believe, as it was stated in the abstract, he mentioned that -- I think it's generally pretty well done. I would certainly question his observation that the 2 microliter injection was five times the recommended equivalent human dose. He gave no information on his poster in terms of where he had acquired that observation.
Q Do you disagree with his statement that the 2-microliter injection of Zicam into the mouse is five times the recommended human dose -- is more than five times the recommended human dose?
A Yes, I do.
Q Okay. What is the basis for your disagreement there?
A I don't understand where he had taken five times the recommended human dose. The recommended human dose, as I understand it, is 140 microliters which certainly doesn't seem to be one-fifth to me.
Q I didn't catch the end of your answer there.
A It doesn't seem to be one-fifth to me.
Q Well, 140 microliters in the human nose is equivalent to how many microliters in the mouse nose, to a reasonable degree of medical probability?
MR. WENZEL: I'm going to object to the question that it lacks foundation and calls for speculation. It is an incomplete hypothetical. Are we talking about evenly
Note: Pages 560-575 missing in original document
COURT REPORTER: And pathways?
THE DEPONENT: To the bulb.
Q (BY MS. SHARKO) Did you ask Dr. Slotnick why the 8-microliter data, which you had, was not presented in his poster?
A You asked me that before, and as I mentioned, I did not ask him about that. That was from the material that Dr. Schwob shared that he had obtained from Dr. Slotnick where he represented that.
Q Okay. Have you gone back over Dr. Schwob's opinions and testimony since February?
A Yes, I have.
Q Okay. And do you have any further opinions and comments on Dr. Schwob's testimony and opinions beyond that which you gave at your February deposition?
A Now that I've had a chance to review them, I do understand the purpose of his studies a little better.
Q My question is do you have any further opinions or comments on it?
A His studies, of course, relate to the use of methylbromide, and as he points out in his article, he specifically devised those studies in order to determine that the superficial damage to the olfactory epithelium and, therefore, the regeneration. He pointed out in his article that zinc is toxic to the olfactory epithelium and that it produces deeper damage than he wanted to study in his regeneration studies.
Q Doctor, do you have any further opinions or comments on Dr. Schwob's opinions with regard to Zicam beyond those which you gave in February?
A I don't remember specifically. At the time that I saw the studies in February, I received them the night before and, therefore, went over them briefly. As I mentioned, as I look at the base of his conclusions, I'm impressed that his were methylbromide studies rather than zinc studies and, therefore, don't have applicability to Zicam. I am troubled about his reliance upon the cadaver study and the DeSanto study, as I mentioned in my deposition in February.
Q Do you have any further comments or opinions on Dr. James' opinions beyond those expressed in your February deposition?
A I think Dr. James' reliance on the Hansen study was a very reasonable approach. I think that if one does the math, the Hansen study is in fundamental agreement with Dr. Slotnick's study and shows a reasonable 50 percent level at approximately 8 microliters, as did Dr. Slotnick's study, in terms of the toxicity of zinc gluconate to Zicam.
Q Do you have an opinion, to a reasonable degree of medical probability, as to the known effective dose of Zicam in a human?
MR. WENZEL: I'm going to object to the question on the grounds that it's vague and ambiguous. It's an incomplete hypothetical. Are we assuming even distribution throughout the nose of the dose? Are we assuming more of the dose in the olfactory region? I think the question as phrased --
COURT REPORTER: I'm sorry. I didn't hear the end of your objection.
MR. WENZEL: The question as phrased has inadequate facts to allow an opinion.
MS. SHARKO: All right.
MR. WENZEL: I'm just stating it for the record.
MS. SHARKO: Okay.
MR. WENZEL: If the doctor wants to take a swing at it, go ahead.
Q (BY MS. SHARKO) Dr. Jafek, can you answer my question, please?
A I think if we were to try and speculate, and that's what we're doing, the 2-microliter dosage that Dr. Slotnick reported as a no offense -- no-effect level is probably a reasonable place to start in terms of the no-effect level.
Q Dr. James in his deposition gave testimony as to his opinion to the no-effect level of Zicam in humans. Do you have any disagreement with his testimony in that area?
A He used extensively volumetric comparisons and also weight comparisons. As I mentioned previously, I think that because of the topical activity of the zinc, that area comparisons are more pertinent. Other than that, you can use the Hansen study in a given area -- manner.
Q Do you have any further comments or opinions on the testimony of Dr. Judith Jones and her documents which were produced to you before
Note: Pages 580-607 missing in original document
Terrence Davidson, right?
MS. SHARKO: Right.
A Terrence Davidson. In general, I think it was a very reasonable deposition, and nothing leaped out to me immediately as being incorrect.
Q (BY MS. SHARKO) Now, when you were talking about comparing the area of nasal epithelium in the mouse with the area of nasal -- strike that. When you were talking this morning about comparing the area of olfactory epithelium in the mouse with olfactory epithelium in the human, you're assuming, I take it, that all of the Zicam in a dose, whatever the dose is, goes to the olfactory epithelium, correct?
A I'm not assuming that all of it goes there, but based upon our studies have shown that the bolus is generally directed in that area.
Q Well, I'm not talking about direction. I'm talking about what actually gets there. Is it your assumption that the dose that is administered, whatever it is, that all of that goes to the olfactory epithelium and must go to the olfactory epithelium in order for damage to be caused?
MR. WENZEL: I'm going to object to the form of question on the grounds it's compound and disjunctive as phrased. Vague and ambiguous.
A It's a lengthy question as phrased. If you could break it into smaller pieces, I could try to --
Q (BY MS. SHARKO) You told me this morning that your opinion is that when you're comparing animal data to human data, you have to look at the area of olfactory epithelium, correct?
A I think I pointed out that the area of olfactory epithelium is important in terms of evaluating toxicity studies.
Q And it's your opinion, I understand from prior depositions, that Zicam is toxic to the olfactory epithelium, correct?
A That is correct.
Q And one predicate of your opinion is that the dose of Zicam that's administered goes to the olfactory epithelium as opposed to elsewhere in the nose, correct?
A As a general statement, that's correct. You left out the word “all” that you used in the previous question. My opinion is based on the fact that the bolus of Zicam has a straight pathway to the olfactory epithelium and, therefore, can do its toxicity effects.
Q And in order to have toxic effects, it's your opinion, is it not, that all of the Zicam has to go up onto the olfactory epithelium, correct?
A No, I don't think that's what I said.
Q Well, how much of it has to get there to cause damage, in your opinion, to a reasonable degree of medical probability?
A If we extrapolate -- if we extrapolate from Slotnick's studies in which he showed that 8 microliters was able to produce variable effects, what we might call an effect of 50 from his curve, and if we observe that the area of the human smell tissue is just a little bit bigger than that of the mouse, then what has to get there is 10 to 12 microliters, just as an approximation, and the usual applicant dose is 140.
Q Now, 8 microliters in a mouse caused only temporary damage to some of the mice, correct?
A It caused variable damage to some of the mice, yes.
Q And it caused no damage to others of the mice, correct?
A That is correct.
Q And it caused -- it did not cause permanent damage to any mouse, correct?
A That was unclear from the study that Slotnick presented.
Q So it's your testimony that you don't know whether any mouse in the Slotnick study suffered permanent damage from the use of any amount of Zicam?
A It's my testimony that permanent was not a part of the study of Slotnick.
Q Now, the purpose of doing the cadaver study and the observational study, which we marked as exhibits this morning, was to support your opinion that the administration of Zicam causes it to go directly to the olfactory epithelium, correct?
A The purpose of my -- in doing the studies was that I found it difficult to believe that the DeSanto and Dohar studies --
MR. WENZEL: Dohar.
A -- Dohar studies were correct. I agreed with Dr. Davidson that they were difficult
Note: Pages 612-635 missing in original document
Q Now, do you know Dr. Dohar at all?
A I don't.
Q Had you ever heard of him before the litigation?
A I think I had seen his name mentioned as a member of the scientific advisory board for Matrixx as we mentioned in the previous deposition.
Q Do you know Dr. Patricia Hebda?
A I don't.
Q And do you know Dr. Berrylin Ferguson?
A Yes, I do.
Q What is Dr. Ferguson's background?
A I don't know of her background specifically. I wouldn't know her if she walked through the door, but I have heard her name.
Q What is her reputation in the medical community?
A I think it's generally good, but I don't know anything specifically.
Q What in the study did Dr. Dohar do and what did Dr. Ferguson do?
A I'm not sure whose responsibility was exactly where. It's difficult to understand the study in that this was an observer-dependent study paid for by the company in which the report was that I didn't see anything.
Q Well, what is the company funding the study have to do with the results?
A It introduces the possibility of observer bias.
Q Has a pharmaceutical company or device company ever funded any studies you have done?
A Yes, I believe they have.
Q And did the fact that a company funded your study introduce bias into your study?
A I don't believe so, no.
Q Why not?
A I'm not sure I understand your question.
Q Well, you're saying that the fact that Matrixx funded the Dohar study probably introduced bias, but when companies fund your studies, bias is not introduced. I'm trying to figure that out. Why is that?
A I mentioned within the context in which the nature of the study that they funded was I looked -- I didn't see anything. I raised the question of observer bias. The kinds of studies that I had done were antibiotic studies in which cultures were obtained and things like that which really don't have much possibility for observer bias. That's a first pass comparison in answer to your question.
Q Who would fund a study like this other than Matrixx?
A I don't know. I think it's a very unusual study. As I pointed out, most of the laryngologists when they look in your nose know that it's a straight pathway from the external opening to the olfactory epithelium area, and then to say it's not, I don't understand the observation. That's why I specifically did the study that I performed providing pictures of the results so that they're open to evaluation by independent observers.
Q Well, where in the medical literature, Dr. Jafek, does it say that it's a straight pathway from the external opening of the nose to the olfactory epithelium?
A I don't know that those exact specific words are used. I showed it with pictures, and you can see it for yourself.
Q In fact, you've published extensively on the anatomy of the nose, haven't you?
A In a variety of forms, yes.
Q In your many publications that discuss nasal anatomy, have you ever said anywhere in any of those publications other than -- have you ever said anywhere in any of those publications that it's a straight shot from the opening of the nose to the olfactory epithelium?
A It's not generally necessary to restate the obvious.
Q Dr. Jafek --
MR. WENZEL: Ms. Sharko, I suggest you move on. Our deposition here today is to inquire about the work that he did subsequent to two previous full days of depositions, and you're going back over and over on foundational issues. And we're not coming back here for another time, and we're going to finish today, and you're wasting a lot of time on foundational stuff which was not only asked at the first two deposition sessions, but was asked and inquired about ad nauseam. Please move on.
MS. SHARKO: Well, I disagree with your comments, and I think they're inappropriate.
Q (BY MS. SHARKO) Dr. Jafek, where in any of your published papers do you say that it's
Note: Pages 640-643 missing in original document
Q And then you deleted that from the next version of the document, correct?
A Yes.
Q Why did you delete that?
A I thought that that was obvious and need not be restated.
Q You thought what was obvious?
A That my findings were in conflict with the others, and as we mentioned, we might even leave out the others if this is submitted for publication.
Q Well, you wrote in March of 2005 in Exhibit 46, “The reasons for the conflicting findings have yet to be elucidated,” and I take it that means that you didn't understand why your results were different from the results in the Dohar and DeSanto studies, correct?
A I mentioned areas of concern in our previous discussions, reasons for possibilities and so on. I didn't include those in the write-up that I prepared in March.
Q What did you mean when you wrote, quote, have yet to be elucidated?
A I think, as I said, observer -- observational bias is one thing that needs to be discussed in terms of determining the conflict. Those are the kinds of things that I say have yet to be elucidated.
Q So when did you elucidate the alleged existence of a observer bias?
A I didn't say that I elucidated the observational bias. I said that's a possibility for the area of disagreement. I believe that there is a straight pathway in most patients from the nasal cilia to the olfactory region. That's anatomically the way people exist anatomically.
Q When did you first begin to believe that?
A Probably the first time that I looked into the nose as a med student, although I didn't appreciate all the nuances of the anatomy at that time. I've got more observation since and different equipment that I've used since that time.
Q So whether there is a clear, straight anatomical pathway from the opening of the nose to the olfactory epithelium is something that you have known and believed for a number of years going back well before you ever heard of Zicam?
A It seems to be obvious anatomically. I had not studied that specifically until more recently.
Q And what have you done to study it?
A Exhibit 46, 47 and 48 are some of them. I've looked into noses and observed them in the course of my clinical studies. I have looked at anatomical texts and things of that sort.
Q And have you in any of these observations -- have you observed people who did not have a straight pathway from the opening of their nose to the olfactory epithelium?
A I think probably there are some people like that with significant septal deviation or previous surgery in the area with extensive scarring or other anatomic changes that have destroyed this pathway.
Q And what percentage of people in your -- based on your research have straight pathways, and what percentage do not?
A I think that the majority do.
Q How do you define the majority?
A Greater than 50 percent.
Q How much greater than 50?
A I'm simply speculating for you as you had phrased your question in attempt to try and answer it.
MR. WENZEL: So you can't refine beyond 50, greater than 50 percent?
THE DEPONENT: I would say the majority. Greater than 50 percent have a straight pathway as I observed it.
Q (BY MS. SHARKO) How many people have you observed to come to this opinion?
A Thousands and thousands and thousands in my 30 years of experience as an otolaryngologist.
Q You say in your second version of the cadaver report you add the Wormald and Miller and the Homer papers, correct?
A That is correct.
Q When did you first read these three papers?
A I had read the -- the Wormald paper is relatively recent, I think. The Homer paper was one that I became aware of probably a week or two ago in my ongoing research in this area. The Miller one was probably one of the earliest ones that I had seen.
Q But these are all papers that you found in the course of your work on the litigation?
A They were found in the course of my work on continuing investigation of zinc gluconate toxicity.
Q Well, are you working on zinc gluconate toxicity for any purpose other than litigation?
A I think it's an ongoing academic study in the course of my academic activities at the university. It happens to be involved in litigation at this time. If it weren't involved in litigation, I think that we would be continuing to study it.
Q Now, what is the basis for your statement that the results of your experiment are, quote, quite consistent with what was seen in the Wormald study?
A In the Wormald study, he used several different kinds of nasal irrigation, sprays and atomized sprays as well as direct irrigation. What he found was that with the direct irrigation, which probably most closely replicates the Zicam delivery system, that the highest concentration of materials was high in the nose. That's why I say it was consistent.
Q Do people with nasal polyps have a straight pathway from the opening to the olfactory epithelium?
A I think probably those with relatively larger nasal polyps do not, and that's why they have difficulty smelling.
Q Do people with chronic rhinosinusitis have a straight pathway from the opening of the nose to the olfactory epithelium?
A Generally they probably do. And, of course, you've said nothing about the situation of the septum and other kinds of things like that. So I think, as a general statement, the answer is probably yes.
Q Now, in the Wormald paper, they were irrigating the nose with saline solution, correct?
A That is correct.
Q Now, how does irrigating the nose with saline solution differ from the instructions for application of zinc gluconate gel?
A Generally, as I mentioned, they use several different kinds of apparatuses. That's probably more true in the Miller study, but the irrigation, the straight stream of liquid replicates somewhat the straight stream as it comes out of the Zicam applicator. That's why I indicated this it was consistent. I didn't say it was identical.
Q How does saline solution behave in the nose compared to zinc gluconate gel?
A The comparison I was attempting to draw is the both are relatively straight streams, and in that respect end up in a similar area.
Q What is the difference in viscosity between saline solution and zinc gluconate gel?
A Zinc gluconate gel is specifically formulated to be more viscous. So it is more viscous than the saline.
Q What does that mean in terms of its movement through the nose, if anything?
A If it's propelled, then it goes -- both go in a straight line. On the other hand, one would expect that the saline would be cleared more quickly because of its lesser viscosity with mucociliary action.
Q Now, they use three different irrigation techniques in the Wormald paper, correct?
A That's correct.
Q One was a metered nasal spray?
A Yes.
Q And how does that metered nasal spray differ from the Zicam applicator?
A That generally would be quite different because it isn't a straight stream. It's more of a spray stream.
Q The second technique used in the Wormald paper was nebulization with RinoFlow. What is nebulization with RinoFlow?
A Nebulization means that you are trying to distribute the fluid particles in as small a particle as you can so they can flow throughout the nose.
Q How does a RinoFlow device work?
A I'm sorry. I believe that's the nebulizer system, but I don't know much more about it.
Q So you're, therefore, not in a position to compare the RinoFlow apparatus to the Zicam container, is that fair to say?
A Only in the stream that they deliver. I don't know about the specific nature of the apparatus.
Q You've never seen a RinoFlow applicator, correct?
A No, I haven't. And Wormald is in
Note: Pages 652-683 missing in original document
materials are getting scattered here. 1.6 percent he used for zinc gluconate which is roughly 33 percent millimolar, and then he used 5 percent zinc sulfate, which is roughly 1 -- I think it's about 173 millimolars, something like that. It's a little bit more concentrated. Why he used those two, I'm not exactly sure, but that's what he speculated.
Q What adjustment did you make for Ph in your experiments?
A As I noted in the report there, I did an adjust for Ph. The Ph of zinc cells is generally about roughly within physiologic range, six to seven. I didn't measure Ph in all of them.
Q Now, what is the difference between study 49 and study 50?
A Study 49 was a millimolar dilution series using only zinc sulfate and zinc gluconate, both of which had an equal number of zinc ions available in the solution as prepared. On 50, what I did was prepare I percent solutions of the zinc sulfate, the zinc gluconate, zinc salicylate, zinc chloride, and potassium hydroxide just for purposes of putting in a very strong base, which Schultz had not included in his group. It showed clearly that all of the zinc salts precipitated albumin under experimental conditions and potassium hydroxide, of course, did not.
Q How about everything with gluconate? You used sodium gluconate and axium D gluconate, and zinc gluconate. How did those compare?
A You notice that that's -- there's an asterisk there, and those are pending experiments which I tend to do later on. I didn't report those results, nor did I use them in my opinion. However, my experimental technique allows direct comparison to the very extensive salt experiments that Schultz had conducted that were previously reported.
Q Why didn't you compare sodium gluconate to potassium gluconate and zinc gluconate?
A Science is always an evolving process, and I didn't have those in the lab. I have ordered those, and I intend to do those experiments at some later time when the chemicals arrive, but I'll be happy to report those results to you, if you wish.
Q And you didn't -- you also then didn't do zinc sulfate compared to sodium sulfate compared to calcium sulfate dihydrate?
A That's correct. Those are pending. I have done the zinc sulfate and the zinc gluconate and the zinc chloride, but I intend to compare those side by side to the other set of salts under similar circumstances.
Q So what is the role of the sulfate?
A I don't think that the sulfate plays a role at all, and certainly in Cancalon's studies, it was shown not to play a factor of the sodium salt. So I don't think that the anion is important. It's the zinc cation that is consistently the one, and that is shown in some of the other studies by Cancalon with iron and mercury and things of that sort and consistent with the literature in terms of selenium, cadmium, silver and so on.
Q How does the zinc sulfate which you used in your experiments compare to the zinc sulfate which was used in the polio experiments?
A I think the zinc sulfate is the same.
Q And how does the volume compare?
A That's a broad general question. These were chemical experiments, and I used 2 cc rather than 1 cc, but the purpose of the experiment was very different. The concentration was very similar in terms of the 1 percent by weight, and the molar was very similar in terms of comparing to some of Schultz's molar strength. It was very appropriate in terms of comparing some of Schultz's experiments.
Q All right. Well, let's -- you keep referring to Schultz. Let's go back to his paper and talk about that.
A Okay.
Q Do you have a copy here?
A I didn't bring it with me, no.
Q Okay.
A It's the 1942 paper.
Q Right. It's previously marked as Jafek Exhibit 9.
A Probably so.
Q I just have one copy.
A That's okay. I also had made reference, of course, to his 1938 paper as well. And there are a number of others that we made reference to, but anyway --
Q Well, no, wait a minute. In Exhibit 49 and 50, which are the subject of today's
Note: Pages 688-691 missing in original document
might be a deterioration in time. As I mentioned, I specifically mentioned a magnitude of change rather than change. She might have deteriorated with fibrosis. She might have remained exactly the same or she might have improved. There is no evidence that she has improved over time.
Q (BY MS. SHARKO) All right. Let's take a look at the Schultz 1942 paper, please.
A Okay.
Q If you could turn to page 10 --
A Okay.
Q -- The method section, it's the fourth page there.
A Yes.
Q Here he talks about the method he used in applying the solutions in his experiments that are discussed in this paper, correct?
A That is correct.
Q Are any of these methods the same as the method by which Zicam is delivered to the human nose?
A I don't think so, no.
Q Now, if you could turn to page 19?
A 19.
Q And I draw your attention to Table 2.
A Yes.
Q In the top part of the table he has the results for 7 percent compounds, correct?
A That's correct.
Q He has a relatively small number of test animals, correct?
A I don't think so.
Q Well, he does four animals with zinc sulfate. He does three with zinc bromide, et cetera. He has either three, four or five animals?
A I see. That was the part you're looking at. I was looking at the protein precipitating power.
Q Can you draw valid conclusions from a test that has just done on three or four monkeys?
A At least you should be able to draw a trend, and he draws the trend that the effect of Ph is not related to precipitating power.
Q Is that a valid conclusion to draw from that number of animals, in your opinion, to a reasonable degree of medical probability?
A I think he said that you can't draw a conclusion relative to the effect of Ph on precipitating power, but it appeared that that was not important. I think that rather than to focus on the two to five animals in each group, one has to look at the whole group of animals and sum the total, and it appears from those that with the zinc, there was less infection than with the other salts, and that was the conclusion that Schultz was trying to make here.
Q What is the significance of protein precipitation? What does that tell you?
A It simply indicates that there is a chemical reaction going on. Schultz described that as a protein -- or a zinc proteinate, a precipitate form. Some sort of reaction happened between the zinc ion and the protein in albumin that caused it to precipitate, some sort of biochemical change took place.
Q Now, how does precipitation of albumin in a test tube differ from precipitation in a human system?
A Well, that's a broad general question. Obviously the test tube is different from a human, but the point of the experiment was that the precipitate does occur meaning that there has been a chemical reaction between the zinc ion and the albumin, or the protein, and this is what he was looking for to try and seal the transneuronal transport of the virus. That was the purpose of this experiment.
Q Now, turn to page 46, if you could, please.
A Thank you.
Q On the left-hand side, he talks about an incidence of 1 percent of anosmia coming out of the Tisdall test?
A He refers to the incidence of lasting anosmia of an incidence of about 1 percent, yes.
Q Okay. How does that differ from the incidence of anosmia you would expect to see in the general population from any source?
A That's a broad general question that that can't be answered from this data. This data deals with an acute toxic exposure. The broad general population would include anosmia in the case of people who never were able to smell. Hypogonadism will do that and so on and so on. So that question is difficult to answer. This is an acute toxic experiment.
Q But you don't know how many of those people of the I percent could smell had perfect smell before they had the treatment, do you?
A The I percent of people were the people that said, “I lost my sense of smell.” Therefore, one must infer historically that most of those people were unproffered correct observers who had lost their sense of smell with the zinc sulfate exposure because that was the purpose of the experiment. He went on to say that 15 to 24 percent have temporary anosmia, and he was very alarmed in his report in 1938 in the Journal of American Medical Association where he said, “Gosh, we're seeing some people that have prolonged loss of smell.” He even used the word “permanent,” and he went on and made a justification here on that same page 46, that a small risk of inducing a permanent anosmia is not a serious contraindication. So he's concerned about permanent anosmia.
Q Which he found the incidence of which to be about I percent, correct?
A About I percent in his group, correct.
Q Turn to page 48 if you could, please.
A Okay.
Q The first footnote with an asterisk on the right side states, “While a I percent Pontocaine fluid solution marked as spinal anesthesia is apparently without damaging effect on the olfactory mucosa of monkeys a similar concentration of ordinary Pontocaine solution marked self-sterilizing has been found to inflict well-defined damage.”
Do you have any reason to disagree with that statement?
A That's the statement that Mr. Schultz made.
Q You have no reason to disagree with that, correct?
A No.
Q Okay.
A Self-sterilizing, of course, is different in that there is obviously some sort of preservative in there. What that is, he doesn't indicate.
Q Well, what type of Pontocaine did they use across Canada and Nicaragua in the polio experiments?
A I'm not sure. They didn't use it in all the experiments, however, nor has that been used in animal experiments that have been conducted subsequently.
Q All right. Now, you said you have color photographs because, quite frankly, as you can see from the copies attached to the exhibits, the faxed photocopy is potentially worthless.
A I wouldn't say they're essentially worthless, but they're suboptimal. The point is, the white and the dark, and I think that those are pretty well done, but certainly the colored ones are better.
MR. WENZEL: Which ones do you want to see first?
Q (BY MS. SHARKO) Well, why don't you give me all your color copies --
A Yes.
Q -- All the color copies that you brought today.
A Okay.
Q We'll mark as Exhibit Jafek 54 -- this is a color version of the photograph of your individual patient you looked at?
A That's correct.
(Exhibit 54 was marked.)
Q (BY MS. SHARKO) And the schematic on the left side of Exhibit Jafek 54 is something from a textbook?
A That is correct.
Q What is this picture here?
A It's a larger blowup of the one in 54. That may be redundant.
Q I'll staple that to 54. What is this one?
A That's similar. One is a more distant view and one is the close-up view in terms of the approach past the middle turbinate to reach the olfactory epithelium.
Q All right. So Jafek 54 will be three pages, and those are a color version of the photocopies attached to the report, which is what number? Jafek 48?
A Jafek 48, yes.
Q Okay. So 54 and 48 go together.
A Okay.
Q The next six pages we'll mark as Jafek 55 collectively.
