You asked for a transcript of my Richard Grable interview. Here it is with pictures, sound, and other supporting material. -Andrew A. Skolnick ----------------------------------------------------------------- ----------------------------------------------------------------- Transcript of My Interview with Richard Grable and Rebecca Del Medico September 10, 1998 GRABLE: Hi. This is Richard Grable. AAS: Hi. Andrew Skolnick from JAMA Medical News. GRABLE: Yes, how are you? AAS: Fine. I want to ask you about a number of things. First, were you aware that the FDA has been investigating complaints filed against your company, in particular, allegations were made by Diane Strait. Were you aware of this? Richard Grable: Not directly. AAS: She's filed an affidavit which states she was ordered by you to fraudulently alter clinical images that were displayed at RSNA [Radiological Society of North America's 1997 annual meeting] and provided the SEC and the FDA. GRABLE: Oh, that's news to me. AAS: She said she was ordered to use a computer program to augment, to alter the photographs to make them more dramatic. She says she was ordered to scan an image from a medical text book. There was an image of a woman's breast. She says in her affidavit to the FDA that she was told to move the tumor from below, low down on the breast to higher up on the breast using Photoshop, in order to correspond with one of the CTLM images you have. GRABLE: Andrew, how are you getting your information. We're not even aware of this. AAS: Diane Strait sent me the affidavit. I also have copies of complaints that were sent to the SEC by some -- Diane Strait also sent the affidavit to the SEC -- but also from investors. So that's what I want to talk to you about, to get your side. REBECCA DEL MEDICO: Andrew, my name is Rebecca Del Medico. I am the company counsel. Actually, we [sounded like "aren't] aware of all these things. However, the company has nothing to hide. We would welcome any governmental bureau to come in here, to look at our images, to compare the images that we have, any other documentation. We invite you to come over here and see our product. You know the company is a public company. It is an open book except for proprietary information. We have a disgruntled employee who has been making allegations all over, who has been libeling and slandering the company we believe. And she's on a mission. AAS: O.K. DEL MEDICO: O.K.? Have I been reading your little things on the Internet? AAS: On the... DEL MEDICO: Silicon Investors.. AAS: Yes, you have. DEL MEDICO: O.K., and I know that Diane Strait then has probably been feeding you information for those inquiries all along. AAS: No, the vast majority of that comes from the FDA. I filed an FOIA request with the FDA and got documents. DEL MEDICO: Yeah, Andrew, but you also paraphrased it so that certain sections popped out but the other sections didn't. AAS: Well, if anything I did was misleading, point it out to me and I will correct it on that bulletin board. DEL MEDICO: O.K. We would be happy to once we get some other things done here. But Andrew, actually, why don't you come down and see the company. It's an open invitation to you. If you're going to put out a story, I think that you have an obligation to come down here, see the company, see our product. We'll show you the images that Ms. Strait allegedly had to enhance, which is nothing more than what you do is enhance images and they were clearly labeled as enhanced. And basically what happened is-- AAS: I'm sorry, I didn't see them labeled enhance at the RSNA or in the CD-ROM I have, the IDSI Future in CT Laser Mammography CD-ROM, which was distributed at RSNA, it does not say enhanced. GRABLE: Andrew, I think if you look at the file name, you're going to find an "e" there for enhanced. But that's O.K.. We're not going to get into solving these issues now. You and I have a running battle. -------------------------------------------------------------------- -------------------------------------------------------------------- [As if putting an "e" in the file name of a graphic image file would inform patients, physicians, and potential investors that the images were enhanced by a graphic artist! There are 6 graphic files on the CD-ROM, Imaging Diagnostic Systems, Inc.: The Future of CT Laser Mammography. The file names on the CD-ROM are: Cancera.tif Cancerb.tif Cancerc.tif Cysta_.tif Cystb.tif Cystc.tif NOT ONE file name has an "e" for "enhanced."] -------------------------------------------------------------------- -------------------------------------------------------------------- AAS: Now, I took a look at the image on the IDSI, it was a photograph of a woman's breast, which was displayed at the RSNA. It's also in the handout literature that was distributed at RSNA and it's on this CD-ROM. She [Diane Strait] says she scanned it from a textbook. And I took a look at the image here, enlarged it, and I saw the halfscreen [halftone] dots – the dot pattern of a [halftone] image which is consistent with an image taking from a textbook as opposed to an actual photograph. So it seems to support Diane Straits' statement to the FDA, in her affidavit, that this was scanned from a textbook and not a photograph. Do you have a photograph of this woman's breast with that tumor in this position. DEL MEDICO: Since we don't have a picture of anything that you happen to be discussing we can't make a comment on that Andrew. AAS: Well, it's the only photograph of a woman's breast with a tumor that IMDS distributed at RSNA. There's only one. And it's a picture of a woman's breast with a tumor. Diane Strait in her affidavit said she was ordered to scan it from a textbook. GRABLE: Let me interrupt you for a second. AAS: Sure. GRABLE: What's the significance of that picture? Clinically, what's the significance of that picture. AAS: A....a.. wait, a second. I'm a little confused by the question GRABLE: You shouldn't be. Let's take a hypothetical case. Let's say the picture wasn't the exact woman, but the woman under physical examination and visual examination had a dimpling directly over the tumor. O.K.? AAS: Well, I... GRABLE: Is that a possible situation? AAS: Was the image taken from a textbook and altered or not? Is Diane Straits' statement in the affidavit true or false? GRABLE: I haven't seen her affidavit. If you want to fax it to me, I'd take a look at it. AAS: Sure. I'll fax the affidavit. Let me ask you some other questions. In the videotape display at the RSNA meeting last year, Deborah O'Brien, whom I believe was the host, the narrator. She stated that, the company has successfully imaged or scanned colorectal and neonatal. GRABLE: You'll have to show me that. You're going to have a hard time showing us that. That was never said. That was never said. AAS: All right, let me get the exact quote. GRABLE: I would love to see that. AAS: I'll get the exact quote. Just a second please. Here's the quote: In addition ... we are successfully examining other soft tissue in the body with CT laser techniques, including neonatal imaging and colorectal scanning. GRABLE: I don't recall that statement. I'll have to go back and look at it. AAS: It's on the videotape. -------------------------------------------------------------------- -------------------------------------------------------------------- Here's the exact quote from the videotape: "In addition to CTLM, we are discovering new applications for our technology. We are successfully examining other soft tissue areas in the body with CT laser techniques, including neonatal imaging and colorectal scanning." I digitized this quote into a WAV file and uploaded it to my web site. You can hear Deborah O'Brien make these claims by downloading the file from: http://www.aaskolnick.com/imds/imds.wav -------------------------------------------------------------------- -------------------------------------------------------------------- GRABLE: Well, I'll have to look at it. I don't recall that wording. AAS: That's [videotape statement] not true. You haven't gotten any permission-- GRABLE: I haven't seen what she said, O.K.? AAS: Well, let me just ask you, have you imaged any neonates or patients with colorectal cancer? GRABLE: No. AAS: O.K. Well, take a look at that videotape. I'd like you to explain to me why she said that. GRABLE: I don't recall those words. I know we planned to do that and I thought that's exactly what we said. I'll look at the video tape. AAS: Good. Let me give you my phone number. Well, I'll put it on the fax. [To date, neither Grable nor attorney Del Medico have explained why the false statement about neonatal and colorectal studies was made on IMDS' videotape shown at the Radiological Society of North America annual meeting.] GRABLE: O.K. AAS: I want to ask also about the previous companies that you – GRABLE: I have no comment to make on those companies, at all. Period. AAS: O.K. The documents I got from the FDA, which I guess you're aware of from '83 through ‘90— GRABLE: I'm aware of them. I lived through the history and I know exactly what happened and I know how you paraphrased it and how you made a real nice spin on what happened. AAS: Well, I'd like to have your side of if you want to tell me. You know, if you think I spun it in any way that is misleading or deceptive, please, I'd like to have your side. GRABLE: It's going to take more than a telephone conversation because documents tell one side of an issue. I will tell you one thing, that the statement that you claimed the FDA inspector said that I agreed with him, that's crap. Because if you know anything about medical inspections by FDA, you know first of all, you never review the affidavit. You don't even look at it, because it's only going to be a report, and you don't know if there's going to be any action taken or not. So you're going to find the industry will not even look at the affidavit. So how can I make a comment on something in the affidavit I never even saw. AAS: All I have is the statement of the investigator who filled out the report back in '88 or whenever it was [it was 1986] that you said this. Now I have your statement that you said you never said that. GRABLE: That's correct. AAS: O.K. That's all I can do, is to show both sides. -------------------------------------------------------------------- -------------------------------------------------------------------- [It think the statement that Richard Grable is objecting to was a statement in the FDA investigator's report dated June 27, 1986 (quoted in my Silicon Investor reply #1606). The investigator, Leon L. Law, of the Orlando District Office wrote this: "Mr. Grable was informed that items listed on FDA-483 may be violations of the Federal Food, Drug & Cosmetic Act. Mr. Grable stated that he agreed with my observation and promised to respond to FDA in writing on each item that was listed." If I understand Richard Grable ‘s statement correctly, he denies he ever agreed with the investigator's observations that his company (Lintronics) may be in violation of the Federal Food, Drug & Cosmetic Act..] -------------------------------------------------------------------- -------------------------------------------------------------------- DEL MEDICO: Andrew, let's make sure that we do that very fairly and everything, because from your past actions and everything, I know that it seems like you have a personal vendetta against this company and Richard and please be advised that we have been reviewing your emails and everything like that. We did review what you put on about the FDA. Some of the things I think were very misleading on it and everything. AAS: Well please, I invite you, please, to correct me, anything that I stated that I misconstrued in anyway. DEL MEDICO: [unintelligible] gone to outside counsel already. But I would certainly invite you again to come down here and see what we have. I understand that you know about imaging that you are pretty in on the techniques and stuff like that. And again, I think that it would be most unfair of you based on the conversations and on what was provided to you by an ex-employee who has her own agenda, to put out any kind of a story without seeing what we actually have here. Because the possibility of you putting out a story that is incorrect and me having to go through all the problems of having you print a retraction or suing you or whatever is not going to help either one of us with our agenda. And our agenda is to get these images out there, get FDA approval. My mother died from breast cancer. I believe in this company and I believe it is really going to help women. O.K. This is not a scam corporation. This is not a company that doesn't have a facility here, that's not doing the active scanning to fulfill its requirements or anything like that. This is a company that ultimately is going to benefit millions of women across the United States and in other countries. And you need to come here and see what we actually have here. AAS: You know that many journalistic investigations are not conducted on site. They can be conducted by various forms of communication. DEL MEDICO: I understand that. But what I'm saying to you is that no matter what we sit here and say to you, you will not get the full extent of what we have here unless you actually come down and you're able to inspect and see the images and see what's here. I mean I'm really serious about this Andrew. Because right now, if you put out a one-sided biased report. AAS: I'm not going to put a one-sided, biased report out. Right now, I really don't think I would be able to convince my bosses to send me down there. DEL MEDICO: I'll tell you what. We'll buy the ticket. AAS: Oh, no. That, you know, is absolutely taboo. No way is that permitted. [It is unethical – at least in the United States -- for a journalist to accept pay, any substantial gift, or transportation expenses from a company that the journalist is planning to write about..] But, I'll just say that I would broach this question about going down to my supervisor, but I'm not optimistic, because the information that I'm trying to get is not going to be gotten from looking at the images. You greatly overestimate my knowledge of radiology. I know some things, but I'm not in any position to evaluate the potential of a new technology like this. But what I'm looking, at and have been looking at, I think I am very good at looking at, is the validity of claims made, of statements to find the truth. For instance, I can evaluate whether that image, as Diane Strait said, was lifted from a textbook and altered, or not. That I don't need to come down for. [This image and an enlargement that shows a halftone dot pattern are up on my web site: http://www.aaskolnick.com/imds/cancerc.jpg and http://www.aaskolnick.com/imds/2cancerc.jpg ] DEL MEDICO: What's the materiality of that? It was a picture of a woman there. I'm sorry. I don't know what you're talking about because I've never seen it myself personally. But is it material? AAS: I think it is. When I saw the material presented last year at RSNA, I thought that woman was a patient whose breast was imaged by your company's device. GRABLE:. Did you see the images of the lesion produced by the scanner itself? Did you see the lesion? Was it pointed out to you in the booth? AAS: a... a...I believe nobody pointed anything out to me. But I believe it's the same image that's in the brochures. GRABLE: Well let me say something to you Andrew. I'm holding a silver pointer in my pocket that I had at RSNA where I stood there and I pointed to it on the film itself to you. So I know that I pointed it out to you. AAS: O.K. I don't remember being – GRABLE: I do remember. I do remember all of these things. AAS: That very likely could be. But I know the image. GRABLE: What I'm saying to you is that the images we showed of the cancer are a cancer and those images were produced by the CTLM. Period. AAS: And they were not enhanced? And artifacts removed as Diane Strait said in her affidavit? GRABLE: Well, let me ask you a question. Are you familiar with the technique called window and centering? AAS: No. GRABLE: Well window and centering is a very common technique that's used in radiology to enhance the image. It's done with digital images all the time. It's the basis for being able to see detail in computed tomography on the x-ray side of the screen. So if I put an image in Photoshop and I vary the contrast, if I change the window and centering of the contrast and brightness, that's image enhancement. That's perfectly acceptable. That removes artifact. That's perfectly acceptable. O.K.? So Ms. Diane Strait doesn't have all the knowledge in the world about how images are created in radiology. She uses what she believes is true and misrepresents it and makes it sound like it was some kind of horrendous crime, when if fact it's done all the time. That's how CT works. So if you want to check the facts you ought to go out and find out about window and centering on computed tomography images [unintelligible] what that means AAS. O.K. I will GRABLE: and do. You'll find out the so called enhancement that we did is nothing more than what's routinely done. You can change the contrast and brightness to change the background. It's routinely done. That's called windowing and centering. --------------------------------------------------------------------- --------------------------------------------------------------------- [I have been reporting on radiology for almost 9 years. I never before heard of radiology images being enhanced by a graphic artist using Photoshop. Such enhancements are hardly "routine." Here's an excerpt from (Kenita) Diane Strait's Feb. 11, 1998 FDA affidavit: Cancer patient: Mr. Grabel indicated that this CTLM image was not acceptable because it looked to [sic] splotchy and had scalloped edges. He directed me to make the bright cancer area brighter and to smooth out the darker areas so they would appear to be in less contract [sic; contrast] with the grey areas. These alterations made it appear as if the CTLM breast imaging system had produced better resolved images for the cancer in this case study than what had actually been produced. Mr. Grable and I also scanned a photograph of a breast with cancer from a medical book into the computer. Because the cancer in this photograph was not in the correct location, Mr. Grabel directed me to cut and paste the cancer to a location the better matched the case history. The above altered images were posted at the IDSI [Imaging Diagnostic Systems, Inc.] booth at the RSNA [1997 Radiological Society of North America Meeting]. None were identified with the statement "images enhanced." The following publications, which I composed, also included these altered images: the CD entitled "Imaging Diagnostic Systems, Inc. The Future of CT Laser Mammography" and the brochure with the same title. These publications have been sent out to prospective investors, shareholders and potential clinical cites. Also, these altered images were used during IDSI's presentation to Nasdaq on January 29, 1998. That presentation was made by Deborah O'Brien, Investor Relations (and daughter of Mr. and Mrs. Grable) and Rebecca Del Medico, Attorney for IDSI.] -------------------------------------------------------------------- -------------------------------------------------------------------- AAS: O.K. One of my last questions for now is the IRB, the Institutional Review Board: FDA policy states that members of the IRB cannot have a conflict of interest. Yet it appears that 1 of your 5 [actually there are 8] members of your IRB is married to your software designer. GRABLE: Let me ask you a question. Do you have the IRB regulations? Did you download them from the FDA web? AAS: Yeah. I can quote them. GRABLE: Well, I have them too. I have a whole book full of them and I don't see the same allegation you have. The IRB is looking at the efficacy of the test and the safety for the patient and it's not made of one member. It's got several members that vote. They all vote. Now if it's a unanimous vote, you want me to exclude one member, fine. We can do that. That's not a problem. We didn't see it as a problem at all, a conflict of interest because she wasn't making any decision on does the machine work or not work. It was based on the scientific efficacy of the testing and what the safety of the patient would be for the testing. AAS: You've lost me. Let me get the FDA requirement here and see if you can-- GRABLE: Get it for me [unintelligible]. Tell me, who else are you investigating so thoroughly? AAS: Are you kidding? About 20 different doctors and 10 different licensing boards I've been given hell to. GRABLE: I see. Do you have a particular vendetta against me or this company? Did you lose money in the stock market? AAS: No, I never invest in the stock market. GRABLE: I have to wonder what your motivation is was to be so zealous about this. AAS: That's the way you approach I all my journalistic investigations— GRABLE: I would have to ask you why you had to hide behind an alias on a bulletin board— AAS: That is my name. I didn't give my last name. A lot of people do that. GRABLE: The problem is when you make statements and you don't identify yourself so that someone can't email you directly back and talk to you, you're hiding behind an alias. [Not true: Email could have been sent to me.] You've got that benefit of people not knowing who you are. If you're so journalistically perfect, why not just identify yourself and say email me. AAS: I didn't want give my full name until I talked with you. DEL MEDICO: Did Ms. Strait tell you how she managed to get property of the company without like removing it from the premises or—? AAS: I think it's in the, I think that's detailed in the affidavit. It's a pretty detailed affidavit. She explains to the investigators what had happened. DEL MEDICO: Did she also tell you she was a disgruntled employee? AAS: Oh, yeah. She first contacted me while she was still working for the company and told me she was disgruntled and planning to leave and wanted to file a complaint. GRABLE: Did she also inform she had an agreement to maintain confidentiality about company business and company business plans? AAS: No, I don't recall that. GRABLE: You should be aware that that exists as well. DEL MEDICO: Of course, Andrew, we're not saying that because we believe she doesn't have a right if there's a valid reason to make a complaint with any regulatory agency that she wants to. So don't take that comment incorrectly. AAS: I understand. DEL MEDICO: However, on things that she has done and removal of property from the office basically amounts to a theft of property. AAS: I believe that the stuff she took she turned over to the FDA, so I'm not sure whether you have— GRABLE: If she took it off of the company's property, it's still theft. I don't care who ended up with it. It's still theft. AAS: Yeah, but I have a feeling you're not going to have much luck with that if it was taken for the purpose of whistleblowing. GRABLE: Whistleblowing on what? I haven't heard a thing from the FDA. I talk to them practically every 2 weeks. I'm really surprised. So I'll wait to see how this falls out. AAS: O.K. I'm really sorry, but I buried this section from the FDA. GRABLE: I have it. I'll look it up. AAS: If my memory is correct, the FDA states that members of an IRB cannot have a conflict of interest in matters dealing with – I mean if you an IRB that makes many decisions about many different products and many different actions, that IRB member can have a conflict but then must remove him or herself from making a decision on that. But you have only one product. This IRB is set up to do just one thing and that is to give approval for your clinical studies on your one product. GRABLE: You have to understand as well though. We have FDA approval on the protocol as well. It's not just our IRB. AAS: I understand that. But that doesn't address the issue of the IRB regulation of the FDA. GRABLE: I think it does because if the IRB stood alone and made the decision to do scans of women and the FDA wasn't involved, that's a different matter. If the FDA looks at the same protocol and deems it to be safe and effective for its intended purpose, that of doing a clinical study, I think there's a problem here. It will fall out. Let's see where it comes. --------------------------------------------------------------------- --------------------------------------------------------------------- [Here is the section from the FDA Regulation regarding who may or may not participate on Institutional Review Board decisions. (Section 56.107 (e) of Appendix C-Part 56-Institutional Review Boards): "No IRB may have a member participate in the IRB's initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the IRB." One of IMDS' IRB members, Dr. Banchik, is married to the company's software designer. The sole purpose of the company's IRB is to review protocols for clinical trials of its CTML device. Because the FDA regulation excludes Dr. Banchik from participating in any review of IMDS' projects, why is she on the IRB? In addition, it appears that another member of the IRB may have been a consultant for the company. According to the company's April 23, 1998 PR Newswire press release, Patrick Lilam, Ph.D, assistant professor of electrical and computer engineering, Center for Research and Education in Optics and Lasers is also an IRB member. In some older IMDS material provided investors, Patrick Li Kam Wa, Ph.D, professor of physics and electrical engineering at the Center for Research in Electro-Optics and Lasers (CREOL) at the University of Central Florida, Orlando, is listed as a consultant for IMDS. On Sept. 11, 1998, I called the Center for Research and Education in Optics and Lasers and asked if they had a faculty member named Patrick Lilam. I was told no, but they do have a Patrick Lik Kam Wa on the faculty. That same day, I sent a letter to Rebecca Del Medico, IMDS' general counsel inquiring about this apparent conflict. I never received an answer.] -------------------------------------------------------------------- -------------------------------------------------------------------- AAS: O.K. I would like to continue our dialogue further, obviously. I'm not about to jump off and write an article at this point. O.K.? Let me fax you the affidavit. And I do invite you to bring to my attention anything I posted on the bulletin board that is incorrect or misleading and I will, one, get myself corrected and, two, put a correction up on the bulletin board., because it certainly wasn't my intent to put anything misleading. O.K.? GRABLE: O.K. AAS: I'll put the fax and email and phone number on the fax. I'll send that in the next half -hour or so. O.K.? DEL MEDICO: Thank you. AAS: Oh, you're going to look at the videotape where Deborah O'Brien states the thing about neonates— DEL MEDICO: Yeah, we'll look at it. AAS: O.K. Thanks. DEL MEDICO: Uh huh. AAS: Bye-bye.