as Q3-4HPRM and that means what? It means every three to four hours as needed. And do you know if the people who were involved in the studies of oxycontin were given oxycontin for rescue pain? Oxycontin? Yes. Or you mean oxycodone? Oxycodone, I'm sorry. I'm sorry. I don't know. It says BK brought this issue up some time ago. It is now surfacing again because of the review of our sales material. Oxy-IR, and is that oxycodone? Yes. Is being promoted as rescue to Q3-4H and that's every three to four hours, right? That's correct. He said while this may be consistent with the oxycontin package insert if it is approved as stands it will be inconsistent with the oxy-IR 5 milligram package insert which uses Q6-H, I mean take it every six hours, correct? That's what it means. He says moreover if we use the Q3-4 hours it will help to validate rock sands change in their package insert. What was the reason that you all did not want to validate rock sands change in their package insert? I would have to read this completely and try to answer your question but I'm not sure this will prompt me to remember. May I? Sure. Okay. I really don't remember this well enough to answer your question. Okay. Let me continue reading here. It says finally it creates a problem for the oxy-IR 10 milligram and 20 milligram capsules as the package insert would have two different dosing intervals depending upon the use. I.e. Q4 for rescue and Q6 for usual pain use. He says one suggestion would be to make everything consistent at Q6 hours. Rescue would then be Q6-PRN as needed as with some acute pain prescriptions. For ATC use it would just Q6 hours.  At this point we could change the frequency of dosing in the PI. What do you guys think? So what he's saying here is we've got the exact same drug. We've marketed it for two different purposes and we've got two different dosing regimens for the exact same drug, correct? It seems to suggest that, but I can't confirm it. And then Paul Goldenheim, if you turn to the next page and read the next one at the bottom, says who is Paul Goldenheim? He was head of R&D, Research and Development and Medical. He says the issue that won't go away. Robert is right. We need to discuss again. Robert, please arrange a meeting. What's the usual suspects? This is too complicated for email. Then Friedman, and what was his role? He was head of marketing and sales. The head of marketing and sales writes back and says, is it unreasonable to have a Q6H dose, I mean take it every six hours for normal dosing, and a Q34 hour for rescue? So the marketing guy's saying, can't we just take the exact same medication and say, if it's for a normal dosing, take it every six hours, but if it's for rescue, take it every three to four hours. That's what he says. And what he meant was for normal around the clock dosing, rather than rescue, which is one or two or three doses. And that's it, as needed. And then up at the top, you write back and say, second one down, I agree this is too complicated to solve through written exchange. Paul, I think that you should get us together soon. Good pickup, someone. Do you recall writing that email? No, but it looks like I wrote it. Okay. And then Robert Kaikel writes back and says unfortunately soon may be too late. Robert, question mark. As previously, so he's saying I brought this up again. As previously, I recommend we change everything to Q6 hours for immediate release oxycodone products, and he is the head of what? Robert Kaikel. He was in the medical department and he was the project, the research project head for the overall oxycodone project. Okay. So he's saying, it appears to me, perhaps to be a little frustrated in saying soon may be too late. As previously I recommend we change everything to Q6 hours. I can't say why he wrote the first sentence, whether he was frustrated or whether he was actually referring to some sort of deadline, maybe in a clinical trial, maybe on submissions to the FDA. I don't know why. But at least from the appearance of this, even in the head of marketing saying why don't we take the same product and just say take it every six hours and if it's for rescue, it's good for three or four hours. Right. This, essentially to fill in what, the blank here, what he must have meant was have two indications. For regular use of immediate release oxycodone, administer it around the clock every six hours. For rescue use, you can administer the dose every three to four. But that wouldn't be indefinite. This would be for rescue. And for breakthrough, actually for breakthrough pain. And for treatment, the head of marketing is not a physician, correct? That's correct. So he's making a suggestion. Dr. Robert Keiko, the head of the project for OxyContin, is a physician, correct? He is. And he's saying don't do what Friedman's saying. We need to make it Q6 hours for immediate release oxycodone products, correct? First of all, Friedman asks a question here. He's not asserting a proposition. He's asking, explain to me why we can't do this. And I understand why he asked the question. And the only answer could be it might be confusing to a physician. But I think the emphasis should be on might be confusing. And then you write back the next day and say, I don't know how urgent this is but I can't wait till tomorrow. Let us know immediately. I don't have a problem with this change at all. Does anyone question it? And who's Mr. Alfonso? He was head of marketing at the time. So the head of marketing comes back and he says, the way these drugs are written are Q4, 6. The rescue is for Q3-4 hours. And he explains the problem might be that if we go Q3-4 hour root, we will validate the Roxanne dosing. Again, I'm going to ask you, do you know what the problem was with validating the Roxanne dosing and why he thought it was a problem? I don't remember. I don't really think it was a problem. I can't imagine what he was thinking of. Okay, so he writes, the problem might be that if we go the Q3-4 hour root, we will validate the Roxanne dosing and possibly present a challenge to the Oxycontin studies. So if he's validating the Roxanne with the Q3-4, would it appear that perhaps the Roxanne had required, now that's an overseas company, correct? No, Roxanne was an American company. I believe at that time owned by Beringer Ingelein. Okay, did they put a dosing limit on Oxycontin to your knowledge? Oxycodone, you mean? Not an Oxycodone? No, not to my knowledge. I don't think it was an issue of limit. Do you know what Roxanne's dosing was that he's referring to? No. Okay, so he says, the problem might be that if we go the Q3-4 hour root, we will validate the Roxanne dosing and possibly present a challenge to the Oxycontin studies. On the other hand, a much more dangerous scenario can occur if we go the Q6 hour for maintenance and rescue. If we go this route, and price continues to be a major issue when we narrow the value of Oxycontin closer to the IRs, and that's immediate releases? Is that what that is? Yes, IR would be immediate releases. I'm just reading the sentence because I didn't follow what it meant. The next sentence says, in essence, if you can use an IR Q6 hours at a cheap price, then those doctors that use Oxycontin Q8 hours, there will be some, regardless of what we say or do, will not see a benefit over the immediate releases. In addition, our promotional campaign has a visual six cups representing Q4 hours. If we go Q6 hours, we might have to change the visual to four cups, and this will not have as much impact. We need to go Q6 hours for maintenance and Q3-4 hours for rescue so that we can maintain the integrity of our Oxycontin studies. Did I read that correctly? You did. Do you know whether you went Q3-4 hours for rescue and six hours for maintenance? I don't know. Sorry. Let me jump back. Why don't we go ahead and mark that as exhibit 23? This is from you, dated April 20, 2000, so Oxycontin has been on the market over four years at this point, correct? And under number five, it says Oxycontin tablets price increase is the central decision. Every 0.1% is 1M. I'm assuming that's one million? That's correct. One million to the bottom line. What would the risk of having a 4% increase instead of a, what would the risk be of having a 4% increase instead of a 3% increase? The price increase, correct? That's correct. Our average real-life price is constant, suggesting that rebates and other discounts are taking a larger share of our business. 3% annual notional increases seems to hold our per kg. Per kilogram. Price constant in an environment where many prices are going up. Was it true that every time you increased the price 0.1% you added 1M to the bottom line of Purdue Pharma? I don't remember. The answer is no to your question. I don't remember whether this is correct or not when I wrote it, but it certainly wouldn't have been correct every time. Do you have a deposition of Friedman? I'm sorry, Shapiro. We were talking earlier about Purdue Frederick versus Purdue Pharma. Did you ever determine whether the employees, the sales force that engaged in improper conduct as referenced in the felony plea agreement were employees of Purdue Frederick or employees of Purdue Pharma? I object to the form of the question. I don't think it accurately reflects the plea agreement. Could you just restate the question because I kind of lost the thrust. We've talked about Purdue Pharma and Purdue Frederick. Did you ever make a determination whether the employees who engaged in illegal activity as referenced in the felony plea agreement or improper activity as referenced in the felony plea agreement were employees of Purdue Frederick or were employees of Purdue Pharma? I'm not aware of whether such a study was done or anybody focused on that question. They may have been done, but you should be, you should think of this that the felony plea agreement came years after many remedial actions had been taken to retrain everybody to discipline sanction, correct discipline sanction or dismiss employees who had behaved improperly. And those processes which started late in 2000 or early 2001 continued right up to the plea agreement and then after the plea agreement. Sure. Have you looked at the call notes of the reps in Kentucky? I have not seen any except those that were shown to me during my preparation. There were three or four that I saw. Did you review the documents that Mr. Shapiro, the lawyer that you all hired put together for the U.S. Attorney in Virginia? I don't think so. Those don't seem familiar to me. And that was the attorney that you all hired to defend you in the case brought by the U.S. Attorney in Virginia, is that correct? Yes. You all paid him approximately $50 million to defend you on that or paid his firm approximately $50 million to defend Purdue in that case? I can't verify that. It's the first time I've heard a number attached to that. If he testified to that, would you dispute it? I would have no basis to dispute it. And do you know if anybody at Purdue made an effort to determine whether the submission and the call notes that were pulled by the lawyer hired to represent you were accurate or not? I object to the form because I don't know how anyone knows what it is you're referring to. Are you aware that he made a submission on behalf of Purdue to the U.S. Attorney's Office? I am not aware of anything that he's submitted to the U.S. Attorney's Office. You've not reviewed any of the materials he submitted to the U.S. Attorney's Office when he was defending Purdue? I did not. Were you aware of the call notes that he pulled and purported were evidence of improper behavior on behalf of Purdue salespeople? No. Did anyone at Purdue, to your knowledge, Purdue Pharma or Purdue Frederick make any attempt to ascertain what percentage of reps in Kentucky were engaging in the type of behavior that the plea agreement says was improper? I'm not aware of that. Did you ever instruct anybody to do it? To do... Could you be more precise? Did you ever instruct anybody at Purdue to undertake an investigation to find out what percentage of reps in Kentucky and which ones were engaging in conduct that was referenced as improper in the felony plea agreement? I did not. Have you reviewed Hart Shapiro's deposition in this case? I have never seen it. He was asked... Let me read this question in his answer. Mr. Sherrill, before the break we were discussing the Agreed Statement of Facts specifically paragraph 20. One of the questions that I had asked you previously about the conduct described in the Agreed Statement of Facts was did you ever figure out who the employees referenced at Purdue Frederick Company, was it Purdue Pharma LLP, or some other entity? With respect to the employees that we've been discussing and those are employees whose conduct is described in paragraph 20 in its various subparts, did you ever do a determination to determine whether those employees were employees of Purdue Frederick Company who signed the Agreed Statement of Facts or some other Purdue entity? And his answer is, without going into too much work product, once it turned this direction to satisfy ourselves and our client that there were Purdue Frederick employees who engaged in the conduct that's referenced in here and that forms the basis for the guilty plea. Question, were there any employees of Purdue Pharma LLP that are referenced here or any other Purdue entity? Answer. Well, again, and I'm just what I said before, I don't know whether at at which point in time Michael Friedman hired Udell, Paul Goldenheim, whether they were Purdue Pharma or Purdue Frederick or some of them had been one and then the other beyond them there were when we look for instance at the names that are associated with the in the first supplemental responses to whatever that was 23, I think. Did you understand that answer? Mr. Thompson, I object to the question plus could you let the witness have a copy to read because it's very hard to follow when you're reading such a lengthy Sure. Do we have another question and answer? Here, I'll tell you what, you can just read along with me if you want to do that. I'll hold it over here. No, I think he would like to see it. Well, I'd like to see it also. He really can't see that distance. Physically, it's... Here, we'll print out some copies. Yeah, why don't we go off the record and get some copies of this. We are off the record at 2.28 p.m. We are back on the record at 2.29 p.m. Sure, and to save time, I'll let you read it. Can you start with the next question, which was uh-huh, and read the answer? I'll read the answer. The uh-huh doesn't really set up the answer for me. That's page 214, line 27. The uh-huh. Page 21. Yes, I'm sorry. Page 2 214. 14, line 17. Uh-huh is the question. Answer. Of people who were referenced, but not named in some of the paragraphs, I don't believe that we made any effort in whether, at the relevant times, they were Purdue Frederick Company employees or Purdue Pharma employees. And is that testimony accurate? I can't vouch that it's accurate. It's consistent with my knowledge. So the next question says so it could have been either or one or both? Yes. The question is so it could have been one or either or both? You're not sure? The answer is correct. Now, in 2001, who did Michael Friedman work for? I don't know. You don't know if he worked for Purdue Pharma in 2001? My best guess is he worked for Purdue Frederick. But it's a guess and maybe for Purdue Pharma. But I don't really know. How about Howard Udale? Do you know who he worked for? No. What about Paul Goldenheim? I don't know that. Do you know whether you worked for Purdue Pharma or Purdue Frederick in 2001? I don't know for sure. Yeah, this one. So, going back to our Oxycontin launch team, do you want to put a number on this? Yes, let's mark that as Exhibit 25? No, 24. And I've just got a couple of paragraphs I want to ask you about. Surely. So this is dated April 4, 1995 and it says at the first paragraph, second sentence, Mike in a Rotto, Oops, first paragraph on which page? Page one. Second paragraph. Oh, second paragraph, okay. Mike in a Rotto. He's the marketing guy again, correct? Yes. Discuss the marketplace that Oxycontin will enter and how Oxycontin will expand out of the cancer pain market. Oxycontin will be launched in 10, 20, 40 milligram tablet strength, 80 and 160 milligram tablet strength and if you go on down a little bit further, he says Oxycontin will be indicated for the relief of pain with the convenience of Q12 dosing. Oxycontin's primary market positioning will be for cancer pain and the secondary market will be for non-malignant pain, musculoskeletal injury and trauma. It was reinforced that we do not want to niche Oxycontin just for cancer pain and was it for your all marketing strategy not to niche Oxycontin for cancer pain? Not to limit it, yes. Below that it says on the last paragraph in our market research office, focus groups, personal one-on-one interviews and telephone interviews were conducted with more than 500 healthcare professionals. In our focus group findings we learned that MS-contin that's the drug that you already solved, correct? I'm sorry, I didn't hear the question. That's morphine sulfate? Yes. That's the one that you had not had any reports of abuse or diversion with that you could recall, correct? None that I was aware of, yes. And it says we learned that MS-contin is the gold standard for cancer pain. Our creative concept testing showed the likelihood of Oxycontin usage by physician and nurses were 4.6 on a scale of 1 to 5 which is very favorable. Were you aware of this creative concept testing and focus groups that were being conducted? I don't recall. And then if you go to the next page, page 2, last paragraph, our meeting ended with a question and comment period. Michael Friedman emphasized the threat that AB-rated generics pose to MS-contin. We're not sure when AB-rated generics will be launched but we don't think it will be until 1996. Inevitably, the AB-rated generics will arrive and this is why it is extremely timely importance that we must establish Oxycontin. Oxycontin can cure the vulnerability of the AB-rated generic threat and that is why it is so crucial that we devote our fullest efforts now to a successful launch of Oxycontin. Were you aware that was part of the strategy? I'm sorry but what was part of the strategy? That the AB-rated generics were going to arrive and that is why it was extremely timely importance that's the way it's written that we must establish Oxycontin and it was crucial to devote the fullest efforts to a successful launch because of AB-rated generics. Objections of the form the witness can answer. Yes. I was aware of that and the reason is clear and Oxycontin was our most important product at that point and when the sales were eroded and by generics we would have if we had not replaced those sales with other product sales we would have a much smaller company that would cost many people their jobs. Oxycontin product team I've become reminded of it, yes. This mark this is exhibit is it 25? Thank you. And this is minutes of the Oxycontin product team dated the meeting was February 22nd 1996 of the top. Washington's birthday. It says, first paragraph Oxycontin product team met on Friday February 22nd 1996 and topics discussion included the following, number one is marketing's wish list for clinical studies and then it's got a list of studies number one is post operative pain to support the Abbott agreement why did you need studies on post operative pain to support the Abbott agreement? I don't recall. Pharmaco economic what was the reason for pharmacoeconomic studies being needed if you recall? I don't recall that circumstance. And then it says non malignant pain example functional improvement and then the subcategories are low back pain, osteoarthritis long term safety data. Right. Why did you think that marketing was needing on March 7th 1996 after the product had already launched long term safety data? I don't remember precisely but all studies would include or would enhance the data available to support long term safety data if the studies were long term and the studies that were referenced here low back pain and osteoarthritis would surely have been long enough to add to that database. Then can you explain why the head of the Oxycontin or the Oxycontin product team on February 22nd 1996 after the product launched said we need long term safety data. I don't think there was any question about the safety of the drug it was just an addition that it would enhance the dossier that was available. I don't know how you would do a long term safety study devoid of some condition so the long term study would be focused on following a condition let's say low back pain or osteoarthritis and at that time the studies were typically 12 weeks and with an open extension at the end they could go on for a year. That is a subcategory of non malignant pain correct? These two studies low back pain and osteoarthritis long term safety would be a general concept that would apply to any kind of study that's long enough to accumulate that data. They've included long term safety data under their marketing wish list under non malignant pain correct? They did. So it looks like they're saying we need long term safety data on prescribing Oxycontin for non malignant pain do you read that the same way or differently? I guess I read it differently than you do just that it wasn't that we needed it it was a wish list, but it was inherent in any long term study we did of any pain condition. And then we talked about the FDA's statement about comparative studies do you remember that or they said you should refrain from comparative analysis? I don't remember so if you could just go forward with the question that would be great. One of the things that the Oxycontin marketing team's wish list has under number five is comparative studies especially versus combination opioids such as hydrocodone combinations during GZIC, MS Contin, Cazdian and Ultram NSAIDs. Those are nonsteroidal anti-inflammatory drugs is that right? Ultram is an opioid drug. NSAIDs are nonsteroidal anti-inflammatory drugs. So they're not the same I don't know why they were the bullet put them together but they're different. I'm asking you is that what NSAID stands for? Yes Has it been marked? It's been marked 25. Now let's go to the launch plan and this is dated September 27, 1995 and if you'll go to page 42 of the launch plan under 5851 under public relations at the top it says the objective of the public relations campaign is to create broad awareness of the launch of Oxycontin. This awareness will be directed at the consumer and healthcare professionals through various media channels such as print, TV and radio. In an effort to create a quote media hook in quote that would coincide with the launch of Oxycontin a consumer survey conducted by companies such as the Gallup poll is being proposed. This survey would focus on the prevalence and problems of chronic pain both malignant and non malignant. The release of the results of such a survey would be publicized along with the recent FDA approval of the new controlled release Oxycodone preparation Oxycontin. This is a classic problem solution strategy to create a need for the launch of a product such as Oxycontin. Did I read that correctly? You did. Do you know if a poll was conducted by someone such as the Gallup poll? I don't know what the poll is precisely. Then the next paragraph says five eight five two. It says in an effort to continue the publicity about the launch of Oxycontin, approximately two to three months after the initial public relations campaign another campaign would be launched focusing on the expansion of Purdue Frederick's partners against pain program developed to improve pain management knowledge among health care professionals and patients caregivers. Partners against pain was a creation of Purdue Frederick, correct? That's what it says. And there were no partners, correct? No, I think there were partners in the meaning of the campaign. Physicians, nurses, other health care workers or our partners. Oh, okay, so but as far as setting it up there weren't any other partners involved in setting up partners against pain. The government wasn't involved in partners against pain. I don't know whether other health care companies were involved but the government would not have been involved in setting up this program. And it says this campaign would reiterate the prevalence and problems uncovered in the consumer survey and explain how Purdue Frederick has made a commitment to improving the level of health care for patients suffering in pain. In addition, the campaign would expand the recent launch of Purdue Frederick's newest partner against pain, OxyContin. Excuse me, I think he's just made an error in reading. He said it would explain, not would expand. I thought I said explain. Then the next paragraph says in addition to the above public relations campaigns we are exploring the possibility of Purdue Frederick sponsoring a pain management foundation in association with an organization such as Gilda's Club. Do you know if you sponsored a pain management foundation? I do not but I I I don't know if we did that. I don't think we did but that's a vague recollection. Can we agree that the main way you marketed your and promoted OxyContin was with your sales force? Yes. And those are the people that actually go out to the physicians' offices and pharmacies and to the communities and sell OxyContin, correct? They don't actually sell but they promote OxyContin. The distinction being that they don't actually take orders and arrange deliveries and collect any money. Okay. And you would consider them the most valuable resource that Purdue had to sell OxyContin, correct? It was the most valuable resource that we used. We thought it was the most efficient resource and that's why we used them. Whether other approaches or resources would have been more valuable I can't say. At some point did you figure out that the key to getting physicians to prescribe and keep prescribing OxyContin was through regular visits from the sales force? That would be typical of any pharmaceutical sales force, yes. And was there a realization that developed that certain physicians, so-called core physicians, were more likely to prescribe OxyContin? I'm not sure. I think it was the other way around. Our most significant prescribers were called core. Not that we identified a core and then they became important prescribers. And how many companies were sending sales representatives to physicians' offices to talk to them about opioids during this time? Three to five. It's a guess on my part. I don't recall any survey that counted that up. But it's a guess based upon my recollection of what was being actively promoted. And you compensated your sales force very well based predominantly on how much OxyContin they sold. Is that correct? The successful, the most successful salespeople a majority of their income was bonus. The average salesman I certainly when we launched the product the overwhelming majority of their income was their salary and the benefits that they received. And for the average salesman I think it would have been 50% of their income or 70% of their income salary and the balance and bonus. But I don't remember this in detail and of course it changed over time. The way the sales scheme was set up if they sold more OxyContin they made more money. Yes, the same as almost every other company in the industry. And then you all gave your reps an additional incentive because you de-centivized them to sell MS-Contin but you increased the incentive to sell OxyContin. Is that true? Yes. And then you had one of the highest paid sales forces in the country, is that accurate? I've heard that said for one or two years certainly wasn't the case or hasn't been the case during the history of OxyContin. Do you know if reps that promoted and sold OxyContin sometimes ended up making that was the case, I'm sure it was unusual. And then your top sellers were rewarded with trips to Bermuda or London in what was called the Toppers program, is that correct? Yes. And during the first five years of OxyContin's release Purdue more than doubled the size of its sales force, correct? That's correct. And do you know how much of this was produced by Frederick versus Purdue Pharma employees? I don't know. At some point where sales people designated, all new hires designated Purdue Pharma as opposed to Purdue Frederick? I believe that that's the case. But you're not sure what date that started? No. Do you know if it was after the creation of Purdue Pharma that that started? It would have had to have been. If Purdue Pharma didn't exist we couldn't have hired somebody. Immediately after that, once it was created all reps were hired by Purdue Pharma as opposed to Purdue Frederick? I don't know. Who would know that at Purdue? I don't know. At Purdue now? Yes. At Purdue Pharma? Yes. Well the people who were there at that time might recall it but I don't know who today would know it. And in addition to targeting providing initiatives to the sales force, you also targeted wholesalers, correct? Wholesalers were called upon by the salesman, yes. And in fact I think if you go to page 27 of the initial launch plan the last paragraph it says promotional efforts for the retail distribution of OxyContin will focus on the incredible success that Purdue Frederick has achieved and sustained with MS-Contin product line. Wholesale pharmaceutical buyers and retail pharmacists should be reminded of how MS-Contin created such a large market for the use of sustained release opioids for the treatment of pain. This in turn created profits for pharmacists helping to grow their businesses. Promotional copies should focus on the market potential for OxyContin and patient populations to be targeted, including the number of prescriptions written for Class II and Class III opioids every year. The Executive Director of National Accounts should work with drug wholesalers in developing programs to utilize the wholesaler sales representatives to ensure adequate distribution. Considerations should begin given to advertisements in drug wholesaler and computer programs. Were the sales force told to emphasize with pharmacists that they could make more money with OxyContin prescriptions? I don't think though they would have been encouraged to say that. The objective when any product is launched and certainly any medicine is launched is to be is to minimize the number of times a patient number of patients who get prescriptions from their doctor and go to the pharmacy and the pharmacist says I don't have that or even worse I never heard of that for obvious reasons. So in order to reduce that one tries to stock all three strengths in as many pharmacies as possible but to begin with there's no demand so there's a bit of tension there in order to supply the pharmacist the wholesalers have to have enough stock on hand for the ones who buy it early and a sufficient backup stock both to supply the early buyers and the later adopters and that was all that we needed to accomplish and there's not much more I can say about it except that however we did it was ethical and proper. And let me go back to my question where it says wholesale pharmaceutical buyers and retail pharmacists should be reminded of how MS cotton created such a large market for the use of sustained release opioids for the treatment of pain. This in turn created profits for pharmacists am I reading that incorrectly you're reading it correctly what you're telling what this launch plan sales force under the title sales force allocation and representative delivered promotional materials is saying hey remind them they're making a bunch of money selling our product as opposed to not selling any product. It says a cooperative direct mail advertising sales sheet offering a rebate on the initial order of oxycontin to retail pharmacist will be mailed every month during the first three months of launch. What was the rebate you all were offering to pharmacist? Some discount on their early orders to encourage them to stock the product in advance of seeing any prescriptions or one or two prescriptions and like the rest there was nothing innovative in this program this was standard programming in the pharmaceutical industry and in other industries. Well like some of your other literature talks about you all had an unprecedented marketing campaign have you ever seen another company that instituted more broad ranging marketing campaign than you all did for oxycontin? I think this was conventional unprecedented perhaps for us but not unprecedented in the industry this is conventional standard textbook this is how you do it. You all also were involved with third party organizations partners in pain they were referenced in the launch campaign and did you use partners in pain to drum up demand for oxycontin? No I think the partners in pain was principally designed to inform doctors about the proper use of our drugs our medicines and to encourage patients who may have had pain sometimes for years inadequately treated or not treated at all to present themselves to their physicians there was also Purdue funded a variety of so called pain societies the American Pain Society was that funded by Purdue Pharma? We donated money to the American Pain Society Did you also fund the American Association for Pain Management? It wouldn't surprise me I don't remember Did you also fund the Appalachian Pain Society? I don't know that I wouldn't have known it but if that's what the record shows there was a figure we looked at a while ago that said there was basically the target market for physicians was about 7,500 physicians including the cancer malignant pain and the non malignant pain across the U.S. Do you remember seeing that? No Do you think the market was more than 7,500 physicians? Much larger Pain is the most common presenting symptom for physicians in total and very few physicians would have a different experience perhaps ophthalmologists or dermatologists may but every other physician it would be the most common or the second most common presenting complaint Do you recall whether Pradoom Pharma set up a Speakers Bureau in which it allowed physicians who were recommended by salespeople to be put on the so-called Speakers Bureau? Yes, such a program existed Not everybody who was recommended was put on the Speakers Bureau They were vetted by internal experts to determine their qualifications Do you recall that there were over 3,000 physicians on the Speakers Bureau? I don't recall it, but it wouldn't surprise me Do you think somebody vetted all 3,000 physicians internally that were on the Speakers Bureau? We had quite a large organization to do that and to manage the Speakers Bureau I think everyone should have been vetted with no excuse for not validating their degrees and confirming that they were licensed to practice in the place that they were practicing and so forth I don't know precisely how they were vetted but they definitely should have all been vetted Do you think putting these 3,000 doctors on your Speakers Bureau caused them to write prescriptions for OxyContin? I don't think it would have had an effect And there were also individuals you started a program called Train the Trainers where you would fly physicians around the country to speak on behalf of Purdue, do you recall that? Actually the physicians who attended and spoke were trainers and some of them were in-house people and some were outside physicians And would these take place at resorts like in Florida and Arizona of these meetings? Certainly might have And you also But to my knowledge, I don't think anybody would go more than once and they were trained in what they could say, what they couldn't say and they were given materials to use in the presentations for a while slides and then I guess eventually PowerPoint presentations so as to create some control to see hopefully that they would not go off-label And did Purdue pay for that or did they pay their own way? At the time it was started Purdue paid for it This was again customary in the industry Who told you that was customary in the industry? I don't remember who told me but I can tell you that sometimes I go to hotels and I'd see events sponsored by Pfizer sponsored by J&J and they were precisely either they were speaking engagements in which somebody spoke and occasionally they were trained the trainer kind of ideas where the company in question other companies in that case trained physicians you can say this and this and this beware you shouldn't say that and that and that Do you know whether pharmaceutical companies and medical device companies have come under criticism for giving incentives to doctors to write prescriptions or use their medical devices? I'm aware of that The answer is they have come under criticism for that Yes Was Russell Portnoy one of the speakers that spoke on behalf of Purdue Pharma at these meetings? Oxycontin I don't know In addition to the stuff we've just talked about you also hired a number of third parties to assist in the marketing of Oxycontin such as marketing firms, correct? I don't know Do you know if Purdue retained Lion's Lavy to market Oxycontin? I've heard the name but I don't know that it was Oxycontin Do you know if public relation firms were also hired to assist in the marketing and the expansion of the market? I don't know You've got to let me finish my question That's okay We've got a video but we also have a court reporter stenographer taking it out Apologies She can't get it if we both talk at the same time So my question is do you know Can you read my question back? Do you know if public relations firms were also hired to assist in the marketing and the expansion of the market? For Oxycontin I don't know Have you heard of a company called Fleshman Hilliard? That's a vaguely familiar name but I don't know whether they were ever hired by Purdue Frederick or Purdue Pharma Do you recall at some point being notified of a problem with abuse occurring with Oxycontin and Purdue Pharma hiring a crisis management firm? Yes Do you recall when that crisis management firm was hired? All precisely Have you ever read the interview Michael Friedman gave to the crisis management firm? No And in addition to all that you also put out videos Are you familiar with the I Got My Life Back video? I've heard the title I'm not familiar with it Did you ever do any follow up to find out whether the participants in the I Got My Life Back video actually got their life back up having problems with dependency on Oxycontin? No, I did not Did Purdue also give away coupons so people could get a weeks free supply of Oxycontin? I don't know but that would be common in the industry And all of the things we've just discussed would be done these marketing efforts to sell more Oxycontin Correct? To see to it the appropriate patients had access to Oxycontin Yes Were you aware that there was a direct link between the number of sales representatives that were out promoting Oxycontin and how much Oxycontin would be prescribed? Could you just ask that again? Yeah, was there a link, a direct link between the number of sales representatives that were out promoting Oxycontin and how much Oxycontin would be prescribed? I don't think direct link would capture the concept So the answer is no Do you believe that the number of sales representatives that promoted Oxycontin would increase the more sales representatives that promoted Oxycontin the more prescriptions would be written? I don't think anybody thought of it that way We had a product that had tremendous potential and our principal means of getting it used was to convince physicians to convince physicians that he had in his practice appropriate patients to use it but the linkage there is very loose Was there also a correlation between the number of times a sales representative called on a physician to how much Oxycontin that physician would prescribe? Again, that would be a loose correlation and there would be clearly if he called not at all there'd be nothing to correlate and I am sure there was a practical limit on how many calls he could make I don't know whether there was any kind of specific relationship between calling every quarter or every month or more frequently or less frequently Why don't we mark the Oxycontin watch plan as 27 26, I'm sorry 26 This is for you This is going to be 27 Mr. Thompson, I know that exhibit 27 there is some material that's been a good deal of material that's been bracketed and I've seen that on other documents that you've marked My assumption throughout is that the brackets were not on the original and this is something that you guys added The brackets were produced that way It came to you with the brackets that have writing on them were produced that way If the email ends and it's only half an email that's also the way that they were produced What if the document was highlighted in yellow? If it was highlighted in the context that I just gave it to him I would have added that highlighting just now but in terms of attachments that are connected to the emails that's because we didn't get them from Purdue I'm trying to explain to you Tony, it's okay We're not adding Sackler exhibit 27 and this is an email from you faced for OxyContin 10 minutes dated 10 23 96 and you have a copy of it and so this would have been after the launch of OxyContin correct? Yes And it says here Michael the OxyMen12 said What was the OxyMen12? I don't know Reef that it says Results showed the following Physicians who attended the dinner programs or the weekend meetings wrote more than double the number of new prescriptions for OxyContin compared to the control group and this was sustained over the three month post-meeting evaluation period weekend meetings had the greatest impact increasing new prescriptions for OxyContin by a factor between 2.16 and 2.62 These results will be presented in more detail at a later date This is very encouraging although I must allow that a proportion of the percentage without the associated absolute numbers is inherently meaningless I don't remember of increased prescriptions commercially significant if so what would the cost per increased prescription be assuming that the absolute difference persisted when will a more complete report be available and was that your You read it correctly Did you ever get a more complete report? I don't remember And then above that Alfonso was Alfonso was head of marketing and he says interesting comments from Dr. Richard I also wonder if there was a bias in the form of representatives increasing calls to the selected physicians would we get the same ROI is that return on investment in prescriptions would we get the same return on investment in prescriptions as a result of the representatives increasing the call rate to the selected group regardless of dinners I don't have the list therefore I don't know if there was a selected preference toward this group in the part of the reps it's reasonable that these core doctors were already receiving special attention which would have generated an increase in prescriptions if this is the case the cost of the dinners would unnecessarily increase the cost per prescription to sell OxyContin I don't remember let's mark this and this says $6999 Dr. Richard Sackler subject promotion of OxyContin by Abbott and if you go down to the bottom it says in close for your information is a memorandum that Mark Alfonso that describes a substantial increase in Abbott's field force allocation toward OxyContin $120 Abbott reps previously selling Eurokinase which has been temporarily withdrawn from the market will be assigned full time to OxyContin this will be totally at Abbott's expense and should have a very positive effect on OxyContin's sales that is from Michael Friedman right what was the agreement reached with Abbott to sell OxyContin I don't recall the details of the agreement and then up at the top it says sender Dr. Richard Sackler so this would be I think your reply to that and it says that sounds very good for the brand I just hope that we can supply the surge that may follow this program and were you referring to a surge of OxyContin sales yes the expectation that these sales representatives were going to create a surge in OxyContin sales I didn't know I said let's hope and then this is a document that I wanted to bring to your attention because we were talking earlier than today where you said when I was pointing out to you the documents that from your officers that said OxyContin is believed by other physicians to be not as strong as morphing remember us having that discussion I recall and this is a phase 2 OxyContin tablets team meeting June 13, 1997 so this would be well over a year after a year and a half after OxyContin has been launched and on the marketplace correct yes about a year and a half maybe a little less and if you could go to the it says marketing and sales update first paragraph Mike Cullen discussed in detail marketing's positioning of OxyContin he explained we want to expand extensively in the non-cancer market segment because the one to start with in cancer pain and the one to stay with through proper titration and the next paragraph reads we can show that we are as effective as morphine but do not want to say OxyContin is as powerful as morphine now did I read that correctly you read the words words such as powerful may make some people think the drug is dangerous to be reserved for the more severe pain if I can interject for a moment sir while you are reading it correctly what you haven't included is the fact of the word powerful as some quotes yes we'll read it again and include that second paragraph we can show that we are effective as morphine but do not want to say OxyContin is as powerful in quote as morphine words such as quote powerful may make some people think the drug is dangerous and should be reserved for the more severe pain this could have a negative effect in the much larger non-cancer pain market Mike reminded the team that we should keep this positioning in mind as we develop future marketing programs symposia clinical study manuscripts and any other items that discuss the use of OxyContin thank you did I read that correctly are you asking me I believe you did were you aware that your marketing and sales team were being careful and did not want to say that OxyContin is as powerful as morphine I don't recall if I was aware of this and in fact it's twice as powerful as morphine correct no it's not we've gone through this quite a few times and here powerful as in quote sometimes the words stronger weaker powerful are not in quotes but here it is very clear that it was specifically the word powerful that he did not he was advising people to stay away from it had nothing to do with potency when you go in and see a doctor and you say if they say OxyContin is not as powerful as morphine what do you think the doctor thinks he was not supposed to say that and I don't think he did say that that would create confusion he was warning not to use the word powerful in any context but it clearly didn't mean potency because potency was declared as twice as potent as morphine from day one of marketing to yesterday and today in every piece of material in all the conversion charts and was recognized and understood by physicians go ahead we'll come back to that do you want to take a break now it's almost 3.30 we could speak at time and take a short break we are off the record at 3.27pm we are back on the record at 3.42pm okay a while ago when we were talking about salespeople making calls did I understand you to say that you did not believe the number of calls made by salesperson affected the number of prescriptions for OxyContin I didn't mean to communicate that in fact Purdue had requirements on their salespeople that they had to make a certain number of calls every day to physicians correct there was a standard of number of calls yes and before we broke we were discussing this phase 2 OxyContin tablets team meeting and to kind of put this in perspective there was this email dated 6.297 so that's June 2nd we were discussing earlier where we discussed that physicians did not think OxyContin was as strong as MSContin and that perceptin was out there and noted that it was important to be careful not to change the perception by physicians toward OxyCone when developing promotional pieces Mr. Thompson did you refer to it or the document did you identify it we've already talked about it I'm just asking a question right now but you're asking a question based on the earlier document of reading I won't read from it then do you recall us having that conversation I'm not sure it's document I've seen a lot of documents but I do recall talking about this many times yes and your comment was we're not saying that it's not as strong we're saying it's not as effective I'm sorry your comment was we're not trying to convey that it's not as powerful is that correct no what I thought I communicated perhaps I didn't do it well was that the meaning of that word strong was not that it was a weak drug weaker than morphine it was not that meaning the meaning related to the stigma of morphine and to the fear of morphine and precisely in this case I believe that efficacy of the drug and I really would like to see the document if I might if we're going to talk about it because I'd like to refresh my memory not only as to the document as to what I had meant to say if I didn't say it clearly here's the one we were talking about when we wrote what exhibit is that sir 29 it's on the bottom 29 and they've actually used two words here that are in quotes correct one is effective and one is powerful the sentence reads we can show that we are as effective as morphine but we do not want to say oxycontin is as powerful as morphine did I read that correctly that's correct the have you reviewed the oxycontin abuse and diversion and efforts to address the problem that was put out in December 2003 by the GAO no I did not review that you've never seen that document is that correct do you want to mark it as the exhibit I will but have you ever seen that document I don't recollect seeing that document if you return to page 9 I'm looking at the second paragraph last two sentences in both 2001 and 2002 oxycontin sales exceeded 1 billion 1 billion and prescriptions were over 7 million the drug became produce main product accounting for 90% of the company's total prescriptions sales by 2001 is that information correct so the best of my recollection it's correct or very close to correct and if you'll turn to page 17 under the heading Purdue focused on promoting oxycontin for treatment of non-cancer pain and if you go down to the last sentence of the second paragraph it says one of Purdue's goals was to identify primary care physicians who would expand the company's oxycontin prescribing base sales representatives were also directed to call on oncology nurses consultant pharmacist hospices hospitals and nursing homes and is that information accurate proposition yes it doesn't include oncologists I don't think in the spirit I think it's accurate and then down second sentence from the bottom Purdue has stated that by 2003 primary care physicians had grown to constitute nearly half of all oxycontin prescribers based on data from IMS health and information service providing pharmaceutical market research is that information accurate I can't vouch for the accuracy of this the next sentence says DEA's analysis of physicians prescribing oxycontin found that the scope of medical specialties was wider for oxycontin than five other controlled release scheduled to narcotic animal Jesus DEA and is that the drug enforcement agency I believe it would be DEA expressed concern that this resulted in oxycontins being promoted to physicians who were not adequately trained in pain management do you recall the DEA expressing that concern next two sentences produced promotion of oxycontin for the treatment of non-cancer pain contributed to a greater increase in prescriptions for non-cancer pain than for cancer pain from 1997 through 2002 according to IMS health data the annual number of oxycontin prescriptions for non-cancer pain increased nearly 10 fold from about 670,000 in 1997 to 6.2 million in 2002 is that information accurate I don't know I just don't have these numbers in my mind if you go to page 20 second paragraph by more than doubling its total sales representatives produced significantly increased the number of physicians to whom it was promoting oxycontin each produced sales representative had specific sales territory and is responsible for developing a list of about 105 to 140 physicians to call on who already prescribed opioids or who are candidates for prescribing opioids in 1996 the 300 plus produced sales representatives had a total physician call list of approximately 33,400 to 44,500 by 2000 nearly 700 representatives had a total call list of approximately 70,500 to 94,000 physicians each produced sales representative is expected to make 35 physician calls per week and typically calls on each physician every 3 to 4 weeks each hospital sales representatives is expected to make about 50 calls per week and typically calls on each facility every 4 weeks was that to your knowledge accurate information about how Purdue was marketing oxycontin through its sales force? without quibbling it isn't really you're asking me to vouch for the accuracy of this I just don't carry these numbers in my mind so I can't agree or disagree but this is a count of physicians and a description of the standards of calls but I don't but that really doesn't describe how we were marketing it to use your questions I'm not trying to quibble with you sir but I just don't know and if you'll go down to the middle of the next paragraph the total amount of bonuses that Purdue estimated were tied to oxycontin sales increased significantly from about 1 million in 1996 when oxycontin was first marketed to about 40 million in 2001 do you recall do you have any reason to disagree with the 40 million number for bonuses paid out to your marketing in 2001 I don't know the number so I don't have any reason to disagree and then if you go to the next page last paragraph it says according to DEA's analysis of IMS health data Purdue spent approximately 6 to 12 times more on promotional efforts during oxycontin's first 6 years on the market than it had spent on its older product MS cotton during its first 6 years or then had been spent by Janssen Pharmaceutical or one of oxycontin's drug competitors during GC did you see that yep, yes I did is that accurate I don't know I have no reason to agree with it or disagree I just don't know do you believe Purdue's marketing was overly aggressive no do you believe Purdue's marketing was appropriate I believe so it says here on page 30 oxycontin's wide availability may have increased opportunities for illicit use I'm sorry what page are you reading page 30 yes where should I look last paragraph the large amount of oxycontin available in the marketplace may have increased opportunities for abuse and diversion both DEA and Purdue have stated that an increase in a drug's availability in the marketplace may be a factor that attracts interest by those who abuse and divert drugs oxycontin if you go on down oxycontin became the top selling name brand narcotic pain reliever in 2001 is that accurate I don't know but I just don't know so let's mark that as exhibit 30 have you ever seen an article called what happened to the poster children of oxycontin no that doesn't sound familiar nobody has ever provided that to you at Purdue pharma when was it published September 8th 2012 no I wouldn't necessarily have been provided to the board but I don't I really I'm not familiar with it do you recall a time when Purdue's oxycontin was considered so successful that other companies were thinking about whether they could make their own version of oxycontin just just ask the question again so I can answer it do you recall a period of time where oxycontin was considered so successful that other companies were considering making their own version of oxycontin I can't say that they did it because it was quote so successful but I do recall that I did hear that other companies were trying to copy oxycontin yes so this is an email chain that was provided let's go ahead mark that as 31 so if you go to page 2 it's a subject press release or similar promotion author Dr. Richard Sackler 82396 just let me catch up with you 82390 the bottom of the page okay I'm with you and it says I think it is noteworthy to release information on oxycontin tablets and success in the market and the tremendous reception it received in Vancouver basically the newsworthy occasion is that this product has achieved our first year sales projection four months early and that by the end of the year we should have from 130,000 to 150,000 per salesman of sales the objectives of this release would be stimulate interest in the US community medical community of the US to recognize the tremendous success of oxycontin tablets clinically and the ratification commercially we want many more physicians than have presently used it to become aware of its availability and importance in their practice it would be hoped that this would lead to greater use by those currently prescribing and broaden our prescribing base in the US and Canada and do you know whether that press release took place and then above that it looks like there's a response to your email from Robert Reeder given the diverse and both short and midterm goals I would recommend a full flash PR firm with a one to three year contract that way this can be coordinated actively to achieve all goals rather than a one shot flash is this a departure from traditional PF and that's Purdue Frederick slash Purdue Pharma LP strategy correct and you wrote back and said I don't see this as a quote departure from policy and then it looks like and perhaps this is Friedman who says my view is different if you want to use PR to signal our market as to our development pipeline I have no problem I do not want to spend money on PR to increase sales we do not need to have an agency in our pockets I have learned my lessons and then you write back on page one and say I agree about the agency I want to signal the licensing in market for the product around the world get an audience for our patent infringement suits so that we are feared as a tiger with claws and teeth and balls and build some excitement with prescribers that oxycontin tablets is the way to go and what was your concern there about licensing and patent infringement licensing in market meant the get the attention of companies that had products that might be attractive for us to license you recall Howard Udell making a trip down to Kentucky to meet with Attorney General Greg Stumbo and other members of the of his staff I don't recall it no this is a letter dated May 17th 2005 and that would be prior to the felony plea agreement Frederick entered into correct I'm not I think I'm clear on the dates and that that would be correct please correct somebody here correct me if I'm wrong and I'll turn to page six this is appears to be a letter from Howard Udell dated May 17th 2005 to Greg Stumbo the Attorney General of Kentucky and he points out that none of the federal courts in Kentucky has found any misconduct on the part of Purdue correct I'm not sure just where you're reading I'm on page five oh page five I'm sorry I was on the wrong page and where are you reading from the third paragraph down it begins I believe that even this brief I'm reading the middle of the paragraph significantly Howard not one of these courts has found any misconduct on the part of Purdue okay please bear with me while I try to find this you see that right above the case sites I'm sorry in the paragraph that has a list of cases yes so significantly however thank you yeah Purdue answered and all of these cases and claim they had never done anything improper or wrong isn't that true I don't know are you aware prior to the I don't know whether we filed in all these cases or whatever that's what I mean when I say I don't know are you aware of Purdue ever admitting to doing anything improper prior to the plea agreement where the company played guilty to a felony of misbranding a drug with the intent to defraud or mislead just ask the question before the plea am I aware of anyone at Purdue ever admitting they did anything improper prior to entering into the plea agreement where the company pled guilty to misbranding a drug with the intent to defraud or mislead I am not aware of anybody and then if you go to page 6 the middle of the second paragraph from the bottom it says first any suit bought under the act requires proof that a defendant engaged in a practice of violation of CARES 367-170 an insurmountable obstacle since Purdue has committed no unlawful act did I read that correctly you did were you aware that Howard Udell had communicated with Greg Stumbo that Purdue had committed no unlawful act on May 17, 2005 I think he was writing for Purdue Pharma just for clarity but I was not aware of this yeah May 17, 2005 did Purdue Frederick exist I don't know do you know if the companies were merged at some point I don't believe they were let's talk about the agreed statement of facts one more quote from the letter and the agreed statement of facts yeah it's a good idea the letter is going to be exhibit 32 and the agreed statement of facts is going to be exhibit 33 hand this out by the letter you said with Udell yeah May, 2005 who was in charge of preparing and approving the sales and marketing materials at the time of Oxycontin's release I'm sorry at the time of Oxycontin's release release meaning launch launch Michael Friedman I believe and at that time at the time of the launch who was in charge of the marketing department it's the best of my recollection Mark Alfonso okay and Michael Friedman the person who ultimately was appointed CEO of Purdue he was Purdue Pharma is he one of the individuals who played guilty to the misdemeanor at the time of the plea agreement yes do you recall whether Purdue had received warning letters about its marketing of MS. Contin I don't recall you don't recall six warning letters coming in from MS. Contin no I don't recall the instances do you recall Purdue getting warning letters with respect to the way it was marketing MS. Marketing Oxycontin I don't recall do you know if Purdue consistently denied it was doing anything wrong with respect to marketing Oxycontin I'm not sure I would think that we denied doing anything wrong but that's a guess on my part I don't really know I don't recollect were you involved in approving the agreed statement of facts or the guilty plea the board voted in favor of management's recommendation that we have that we plead guilty under a plea agreement of attorney and just so there's no confusion the board voted to adopt the agreed statement of facts is that correct I don't know I don't remember is the agreed statement of facts accurate I believe it is in addition to the guilty plea of a felony for misbranding a drug we plead and that drug is Oxycontin I believe it is these three individuals Howard Udell, Michael Friedman and Paul Goldenheim also led guilty to misdemeanors correct yes and Howard Udell was Purdue's executive vice president and chief legal officer he was the president and CEO of Purdue at the time of the guilty plea I believe he was and Paul Goldenheim was the former executive vice president for worldwide research and development and chief scientific officer correct I believe so by 2006 Dr. Goldenheim had already left Purdue correct did he leave voluntarily what reason did he provide you regarding why he was leaving Purdue he was leaving Purdue in order to be CEO of another company have you seen this agreed statement of facts before before today yes did you provide comments on this document no I did not were you surprised by any of the allegations in the document I didn't read the whole document so I can't say if there are allegations that would surprise me I had understood that this was a settlement document and that people in the company who investigated thoroughly said to the board that the statements in the document were true and when you say I didn't read the document as we sit here today have you ever read the entire document no at the time this was signed in May 7th and 8th of 2007 what was your position in the company I was a director of the company did you have any other role at that time not to my recollection for a period of time after I ceased to be CEO in early 2003 I was co non-executive chairman of the board but that came to an end more or less around this time but I don't remember whether it was before the play or after you ceased to be CEO in 2003 when were you first notified that the U.S. attorneys for the western district of Virginia were investigating Purdue I can't recall precisely we were as a board notified that the U.S. attorney was investigating oxy cotton abuse and diversion and that the law department in general and Howard Udell in particular were providing any documents he wished voluntarily to help his investigation that the investigation turned on Purdue was a surprise but I don't remember when that happened was it before you left as CEO I don't recall do you recall there being issues about addiction dependency tolerance buildup abuse and diversion prior to your leaving as CEO yes not all of those but abuse and diversion yes do you recall there being issues with addiction yes same time as I was informed about possible abuse and diversion and when were you first informed about possible abuse and diversion sometime in 2000 an article was published in a newspaper in Maine that very graphically described the impact of abuse and diversion of individuals who were using oxy cotton that was the first the first time I became aware of the possibility let me see do you recall receiving a letter being notified about a letter from a hospital in Pikeville or Hazard concerning problems with patients who were on oxy cotton I don't recall a letter was it directed to me I don't believe so I think it came to Purdue let's go back to the play agreement I'll try to get through this are you aware that we've requested Purdue to identify the names of documents referenced in the agreed statement of facts I'm not aware of that are you aware we've asked them to identify the individuals who are referenced in the agreed statement of facts no paragraph we can go to paragraph 13 of the agreed statement of facts paragraph 13 says that December 28th, 2004 Purdue submitted an oxy cotton NDA to the FDA the NDA included clinical trials showing that oxy cotton when dosed every 12 hours was as safe and as effective as immediate release oxy codon dosed every 12 hours every 6 hours yes that's what it says in paragraph 14 says the NDA did not claim that oxy cotton was safer or more effective than immediate release oxy codon or other pain medications and Purdue did not have and did not provide the FDA with any clinical studies demonstrating that oxy cotton was less addictive less subject to abuse and diversion or less likely to cause tolerance and withdrawal than other pain medications and is that paragraph correct that's what it says I don't know if it's correct but I wouldn't differ with it and then there are some medical officer reviews correct yeah I believe those are within the FDA and those also did not state that oxy cotton was more effective than or superior to safer had less opioid effects or cause fewer adverse events than any other marketed product correct and let me back up a minute do you know when sales people go call on physicians what type of information the physician usually asks the sales person I would not be able to comment on that you don't know whether they want to know if there's any studies there's any contraindications to the medicine any problems reported that makes sense I vote you meant in more that's a very general thing they want to understand what is the medicine for what kind of condition who are the patients what are the what is the effectiveness they might ask for comparative effectiveness if it exists and if it doesn't exist the answer is we can't give you any they might ask about safety they might ask about anything related to what they feel they should know when they were they to use the medicine one of the things they might ask is why is it better than what I'm already using why should I switch is that reasonable perfectly reasonable one of the things they might ask is you got any studies that show it's better another thing that comes up they might paragraph 16 says the medical officer review of the ISS included these statements and the blood level data and clinical use suggest the opioid effects would be of oxycontin and immediate release oxycodone would be similar and to your knowledge is that clinically correct well it's an inference and I certainly can't differ with the inference but it may not be correct under D it said withdrawal is possible in patients who have their dosage abruptly reduced or discontinued is that your understanding of the characteristic of the drug absolutely and then it said care should be taken to limit competitive promotion oxycontin has been shown to be as good current therapy but has not been shown to have a significant advantage beyond reduction in frequency of dosing and is that your understanding of the characteristic of the drug no it is my understanding that that statement is correct but the reason I said that what may not be the case was the very surprisingly large number of reports from the field that I heard second and third hand that early in the life of the product doctors spontaneously volunteered that the drug was better than we said it was and this was so frequent and so unusual that it raised in my mind and continues to raise the question maybe it is actually superior but we were never able to demonstrate using the methods that would be generally accepted that this was the case it was an impression that doctors developed on their own any studies retrospective studies of that nature that would support that statement no I said we could never prove it so if you go on here under the heading misbranding of oxycontin and when we talk about misbranding that's just really making claims and statements that aren't true about a drug that's called misbranding the drug is that correct no I wouldn't say it's that a different meaning in the regulatory world it's stating things that are not strictly in the package insert they may be true but if they're not in the package insert they're misbranding do you know if Purdue had information that physicians were concerned about the abuse potential for oxycontin? I did not have that it wouldn't surprise me that physicians would be concerned about that as with any other strong opioid or in fact any other opioid let me refer you to paragraph 20 it says here beginning on or about December 12th 1995 and continuing on or about June 30th 2001 and that is the time frame that the U.S. Attorney's office looked into the conduct at Purdue correct? I don't know certain Purdue supervisors and employees with the intent to defraud or mislead marketed and promoted oxycontin as less addictive less subject to abuse and diversion and less likely to cause tolerance and withdrawal than other pain medications as follows under A it says that you train Purdue sales representatives when I say you mean Purdue the company train Purdue sales representatives and told some healthcare providers that it was more difficult to extract the oxycodone from an oxycontin tablet for the purpose of intravenous abuse although Purdue's own study showed that a drug abuser could extract approximately 68% of the oxycodone from a single 10 milligram oxycontin tablet by crushing the tablet stirring it in water and drawing the solution through cotton into a syringe were you aware that Purdue trained sales representatives to make that misrepresentation? No is that a misrepresentation that would cause a physician to be more likely to use to write prescriptions for oxycontin or less likely to write prescriptions for oxycontin? I couldn't guess the implication is that it would be more likely but I don't know and then number B says told Purdue sales representatives they could tell healthcare providers that oxycontin potentially creates less chance for addiction than immediate release opioids were you aware that Purdue told sales representatives they could tell healthcare providers that there was less chance for addiction with oxycontin than with immediate release opioids? No I was not aware of that under C it says sponsored training that taught Purdue sales supervisors that oxycontin had fewer peak and trough blood level effects than immediate release opioids resulting in less euphoria and less potential for abuse than short acting opioids were you aware that they were teaching sales supervisors to make that misleading Absolutely not statement under D it says told healthcare providers that patients could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug I object to the form of the question in reading D you omitted the word certain which appears before healthcare providers Let me read it again under D Purdue told certain healthcare providers that patients could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug were you aware that certain healthcare providers were being told that they could stop therapy abruptly without experiencing withdrawal symptoms and that patients who took oxycontin would not develop tolerance to the drug No and that statement is false correct No it's not clear to me it's false but I am eager not to contend with it it says certain healthcare providers and it the rest of it is conditioned really in large measure on in the first case the dose that the patient is on and the second case and the duration of the patient is on but reading between the lines as I suspect those who shape this did and understood with the government I can accept it as being a reasonable expression of improper conduct that is certain healthcare providers might have been told regardless of dose or regardless of duration but had I known about this I would have alerted our attorneys were negotiating this that this ought to be a little bit more specific because it's going to be difficult to agree with it the way it's written but I won't quibble with it Well there was actually a whole lot of back and forth on this document There may have been but it wasn't with me and a lot of the things brought up the U.S. Attorney's Office said no we've reviewed the documents and we're not changing this stuff is that what happened I don't know Just to be clear in the document we're reading the agreed statement of facts Purdue refers to the Purdue Frederick Company which is the practice we've had in this deposition from the outset that you use Purdue to refer to Purdue Frederick Yes, yes because nobody at Purdue is able to say which employees were Purdue Frederick which employees were Purdue Pharma as far as I've been able to ascertain in any of the depositions I've read so far including ones taken in the past but we'll cover that later Under E here it says that Purdue certain Purdue supervisors and employees with the intent to defraud or mislead told certain health care providers that OxyContin did not cause a quote buzz in quote or euphoria calls less euphoria had less addiction potential had less abuse potential was less likely to be diverted than immediate release opioids and could not be and could be used to quote weed out addicts and drug seekers and were you aware that those statements were being made to health care providers and then the next section is misbranding of OxyContin use of graphical depictions by sales representatives and it says data from Purdue's clinical studies was used to create the following graphical demonstration of the difference in the plasma levels at steady state between patients who took OxyContin every 12 hours and patients who took immediate release OxyContin every 6 hours and it says that on October 12, 1995 Purdue requested comments from the FDA's division of drug marketing advertising communication about its proposed launched marketing materials which included the following graph and text showing OxyCodone plasma concentration provided by OxyContin on a logarithmic scale along with a statement that OxyContin's OxyCodone blood plasma levels provided fewer peaks and valleys than immediate release OxyContin OxyCodone OxyCodone, I'm sorry per graph it says on December 20, 1995 we're going, I'm sorry term page? Yes. Okay, thank you on December 20, 1995 after reviewing the proposed OxyContin launch materials DDMAC what is DDMAC? DDMAC it's the division of the FDA I don't know what the letters stand for but it is the division of the FDA that reviews promotional materials and comments on their agreement that they are reasonably reasonable and accurate and consistent with the package insert or they differ with them and recommend changes or elimination of things. To sort of cut through it what they did is they said if you wish to compare blood levels in this text we suggest that the blood levels for both dosage forms be presented in the graphic so that the reader can accurately interpret this claim they felt it was misleading the way it was, correct? No, I don't think so. I think they had a suggestion that we should add that and I don't know why it wasn't there we certainly had the data as shown above so I assume we added the data. And then it says, paragraph 24 on or about January 11th, 1996 Purdue told DDMAC that it had quote deleted the statement fewer peaks and valleys than with immediate release oxycodone and they took the statement out, correct? That's what it says I don't know why it was true but I have no knowledge of the dialogue between them or why they took it out. Did you review any of the studies that were done I mean actually get down and look at the data in the studies that were done prior to the launch? I looked at the analysis of studies but I didn't look at the data that is the individual case report forms and as we sit here today have you ever seen the data of the studies themselves? No, that would be voluminous and I don't think it would be necessary for a senior executive to do that because every study is subject to extremely rigorous validation of the database with a paper record the paper record that exists with the doctor's own records and so this approach which has been standard in the industry and I believe part of good laboratory practices or one of the other standards that the FDA has promulgated is extremely exhaustive which is one of the reasons that studies take so long because the validation of the data can take anything from a month to a year. Are you saying that your studies that you did before putting Purdue on the mark were extremely exhaustive? They were certainly appropriate for a molecule that had been in use at that point 80 years or more that was believed then to be safe and effective as a molecule and that had no at that time no long-term toxicities that hadn't been well developed and so a lot of that information was brought into the package insert whether we observed them in the trials or not so the standards for this kind of an approval which has its own designation are easier to meet they're called 505B2 NDA and draw upon in this case a vast public literature as I said extended back 80 plus years so for that it was very extensive in those kind of applications but when you took a controversial opioid and expanded it to nonmalignant pain at pills that contain high dosages of opiate you didn't do any addiction studies before putting it on the market, correct? I object to the form of the question first of all the compound oxycodone was mostly used in nonmalignant pain before we entered the market that was where the market the great bulk of the market existed so there was no innovation or change and are bringing it to the nonmalignant pain market the second thing was that we assumed that it was potentially addictive that it could be subject to abuse and diversion and the package insert then and through many changes has not denied that in fact has called it out explicitly in several places including right in the front of the label when we said it was a class 2 narcotic and every doctor knows that class 2 narcotics are among the most abusable products a class 2 narcotic that your own records show there was a belief among physicians that it wasn't as strong as morphine, correct? no that it wasn't as stigmatized as morphine was they knew it was if you would ask them is it more potent than morphine many physicians knew it was more potent if they use both drugs they knew that they would always start with a much lower dose of oxycodone than they would with morphine so you think physicians most physicians knew it was more potent than morphine yes they also knew what doses to use it in would you just mark this exhibit is this 34? let me refer you to the first paragraph of this document in January 26, 2001 we're now five years after oxycodone has been on the market, correct? which part of this should I read from? yes, the date is around five years from marketing and it says up here this is from Mark Alfonso the first paragraph says I think it will in the mind of the physicians hydrocodone gives them a great degree of comfort physicians rank the drugs based on the position that they have created in their mind as a result of prescription prescribing habit and promotion and promotion would be do pharma? no what do you think it means when it says promotion is the promotion of everybody in the industry from going back years and years it says for them morphine and hydro-morphone are the most potent followed by oxycodone and then hydrocodone I see it were you aware that in January 25, 2001 Mark Alfonso and what was his role at Purdue? he was head of marketing the head of marketing felt like physicians did not feel like oxycodone was as potent as morphine we've gone through this before it was that was a term of that didn't refer to relative potency it just didn't it didn't include fentanyl in this which is the most potent but is often used before hydrocodone or morphine let me ask you this I'm just saying I realize that you've changed the meaning that was intended and understood by the recipients you've changed the meaning of the word potent not the word the meaning of the word no, you've changed it when you try to use it as though it means relative potency when we first discussed the first group of documents you said no they're just talking about effectiveness not strength the second group of documents where they said it's stronger than morphine you said no they just mean strong in a general sense they don't mean potent here they use the word potent do you just not think it's as strong as morphine that's what they keep saying they don't want to clear up in the physician's mind that it's as strong as morphine this is a hierarchy here Mark Alfonso said here that if following your reasoning if your reasoning were correct physicians would see morphine as the most potent of all these drugs it was the for them morphine and then hydrocodone and in most places oxycodone and then hydrocodone the facts are that hydro morphone is 3 to 8 times more potent than morphine but that isn't how we listed it and hydrocodone and oxycodone are close to equal potent but he didn't say potent he said powerful in this case has to do with the hierarchy that they place drugs morphine was the last because it was the most stigmatized so when he says here remember that we tried to reposition oxycodone as powerful as morphine and we could not finally we decided not to mess with this perception since it was helping us in the non-cancer market did you see where he wrote that I see where he wrote it let's go back to the plea agreement how do we need to mark that document it's marked 3rd November 34 paragraph 25 of the agreed statement of facts says honor about December 1998 produce sponsored training for all its district sales managers now it wasn't some of them it's all of them correct it says all meaning a pharmacist retained by Purdue do you know who that pharmacist was no a pharmacist retained by Purdue to conduct a portion of the training used the following graphical demonstration parenthesis instead of the graphical demonstration of the actual clinical data described in paragraph 21 of this agreed statement of facts falsely stated that oxycodone had significantly fewer peak and trough blood level than immediate release opioids resulting in less euphoria and less potential for abuse than short acting opioids and they've got a graph that was used at the training for Purdue I would call that a cartoon not a graph and it says on paragraph 26 beginning in or around 1999 some of Purdue's new sales representatives those would be Purdue Pharma sales representatives in 1999 correct I can't say Purdue was defined in this document as Purdue Frederick yeah but it says new sales representatives so are we talking about Purdue Pharma or Purdue Frederick the document on its face is talking only about Purdue Frederick yeah the guy that helped put the document together the lawyer we took his deposition have you seen his deposition yeah and he says he doesn't know if they're Purdue Pharma or Purdue when he refers to this I'm telling you this document on its face defines Purdue as Purdue Frederick I don't care what anyone else said sure and I'm asking him if it's correct and he's saying you don't know correct no let's go I said I don't know who employed these new representatives okay it says some of Purdue's new sales representatives were permitted during training at Purdue's headquarters to draw their own blood level graphs to falsely represent that oxycontin unlike immediate release or short acting opioids did not swing up and down between euphoria and pain and resulted in less abuse potential and were you aware that the sales reps were doing that no and then it says during the period 1999 through June 30, 2001 Purdue reps used graphical depictions similar to the one described in paragraph 25 of this grid statement and fault agreed statement of facts and falsely stated to some healthcare providers that oxycontin had less euphoric effect and less abuse potential than short acting opioids were you aware that they had no engaged in that conduct no I'm sorry and then to go on with the conduct paragraph 28 says misbraining of oxycontin misleading use of article to claim no withdrawal or tolerance and it proceeds to discuss how Purdue well let's go ahead and read it I'll try to shorten this a little bit Purdue had an osteoarthritis study okay you don't have to rush are you familiar with that may I read it if you don't want to read it into the record can I just read it and then respond it'll save time I'll read it into the record honor about January 16, 1997 certain Purdue supervisors and employees sent to the FDA the results of a clinical study pertaining to the use of low doses of oxycontin by osteoarthritis patients it's to call it the osteoarthritis study and a final report that included in a section pertaining to respite periods the statement parenthesis no investigator reported withdrawal syndrome as an adverse experience during the respite periods in a section entitled adverse experiences by body system during respite periods the report summary of the major results listed the most frequently reported adverse experiences and respite periods insomnia, nausea, pain anxiety, depression, and diarrhea followed by the statement 28 patients 26% had symptoms recorded during one or more respite periods did I read that correctly I think so I was kind of reading ahead of you and then it says paragraph 29 honor about May 29, 1997 certain Purdue supervisors and employees stated that while they were well aware of the incorrect view held by many physicians that oxycodone was weaker than morphine they did not want to do anything quote, to make physicians think that oxycodone was stronger or equal to morphine or to quote take any steps in the form of pronomotional materials, symposia clinicals, publications, conventions or communications with the field force that would affect the unique position that oxycodone had in many physicians mind in quote and did I read that correctly you read the words correctly was that part of the agreed statement of facts it is and then it goes on to say honor about February 12, 1997 certain supervisors and employees of a United Kingdom company affiliated with Purdue provided certain Purdue supervisors and employees with an analysis of the osteoarthritis study together with another clinical study this analysis included a list of 8 patients in the osteoarthritis study and 11 patients in the other study who had symptoms recorded that may possibly have been related to opioid withdrawal including one patient in the other study who required treatment for withdrawal syndrome did you ever review that study? no the discussion section of this analysis include the following quote it's not surprising that some patients in the clinical trials developed some degree of physical dependence and consequently experienced withdrawal symptoms as a result of abrupt discontinuation of oxycodone tablets all patients who were expected to have withdrawal symptoms have been reported but this may have resulted in a falsely high incidence of the patients who participated in the osteoarthritis study in which patients entered respite periods without oxycodone tablets many symptoms suspected to be due to opioid withdrawal may simply have resulted from the return of pain after withdrawal of oxycodone tablets patient 6007 complained of nervousness patient 2004 complained of insomnia and felt restless patient 220 and 228 were restless and anxious since these are symptoms which often accompany the return of significant pain it may be wrong to label these as withdrawal symptoms nonetheless the instance of withdrawal syndromes in patients treated with oxycodone tablets is a concern and it is safer to overreport than under report this problem this analysis conclusions included this statement as expected some patients did become physically dependent on oxycodone tablets but this is not expected to be a clinical problem so as long as abrupt withdrawal of the drug is avoided were you aware that certain Purdue employees participating in the final draft of the article regarding the osteoarthritis study that was published in a medical journal on or about March 27, 2000 were you aware they participated in that publishing of that study? No. The results section of the article I'm reading from paragraph 31 the following three statements pertaining to the instance of withdrawal syndrome and withdrawal symptoms experienced by study patients quote one patient was hospitalized for withdrawal symptoms the patient who was hospitalized with withdrawal symptoms had completed the study on the previous day and had been receiving CR oxycodone 70mg symptoms resolved after three days a second patient received 60mg CR oxycodone experienced withdrawal symptoms after running out of study medication the patient had not reported withdrawal symptoms during scheduled respits from doses of 30 or 40 withdrawal symptom was not reported as an adverse event for any patient during scheduled respits adverse experiences reported by more than 10% of patients during scheduled respits were nervousness 9 patients and an insomnia 8 patients paragraph 32 says the article included a comment section summarized the the three statements and the results and further suggested that patients taking low doses could have their oxycodone treatment abruptly discontinued without experiencing withdrawal if their condition so warranted were you aware they were making that claim? No. If you go over to paragraph 34 it says on about June 2016, certain Purdue supervisors and employees sent a full text of this osteoarthritis study article do you know which supervisors and employees sent the full text of this article? No. Do you know if it was the marketing group? I don't know. It says together with a quote marketing tip to Purdue's entire sales force the marketing tip stated that a reprint of the osteoarthritis study article was available for use in achieving sales success the marketing tip also included as one of the article's 12 key points there were two reports of withdrawal symptoms after patients abruptly stopped taking CR oxycodone at doses of 60 or 70 withdrawal syndrome was not reported as an adverse event during scheduled respots indicating that CR oxycodone at doses below 60 milligrams can be discontinued without tapering the dose if the patient conditions so warrants it says on or about February 13, 2001 certain Purdue supervisors and employees received a review of the accuracy of the withdrawal data in the osteoarthritis study and stated now this is Purdue's own people reviewing this data correct? That's how I would read it and it says quote upon a review of all comments for the enrolled patients it was noted that multiple had comments which directly stated or implied that an adverse experience was due to possible withdrawal symptoms this was followed by a list of 11 study patients who reported adverse experience due to possible withdrawal symptoms during these periods 106 patients initially participated in the osteoarthritis study 32 of them withdrew because of severe I'm sorry because of adverse events not necessarily related to withdrawal and 38 patients remain in the study at 12 months next paragraph reads on or about March 28, 2001 so this is a month and a half later a Purdue employee emailed a Purdue supervisor regarding the review of the withdrawal data described in paragraph 35 of the agreed statement of facts asking do you think the withdrawal data from the osteoarthritis study is worth writing up parenthesis and abstract or would this add to the current stress that should be deferred the supervisor responded I would not write it up at this point and no abstract was prepared do you see that I see it so am I correct that Purdue was using the marketing material from this article improperly and not reporting the adverse effects and was allowing their sales force to use it I object to the form of the question let's break that into one question at a time please sure was Purdue's marketing department using this article that's what it says here and were they using it inappropriately that's what it says here and when somebody pointed out that the withdrawal data from the arthritis study was actually different than how the sales force was using it and asked should we write it up add to the current negative press and should be deferred the person supervisor said I would not write it up at this point correct? do you know if it ever got written up? do you know if any of these doctors that were shown this were ever told that it actually wasn't correct? I don't know do you know if anybody at Purdue made an effort to go tell these doctors that all of these marketing things that have been brought up in the facts were not correct? I don't know did you yourself ever tell anybody to go inform doctors that these marketing statements that had been used by Purdue's employees that were not accurate were in fact not accurate? I was not aware of this story the study or the marketing materials or statements and as the director of Purdue Pharma you were not made aware of any of this? I object to the form of the question you can answer I do not recall whether we were you're talking about at the time of this document being written I don't recall and at the time that this conduct went on from 96 to 2001 the time period investigated by at least this U.S. Attorney under this agreed statement of facts you were in fact the CEO of Purdue Pharma correct? during 2000 very very late 99 until early 2003 I was the CEO yes so if this conduct occurred on May 18th 2000 June 22nd 2000 February 13th 2000 and on March 18th 2001 this employee was told not to write up the withdrawal data because of negative press and that it should be deferred you would have been the CEO during this time period correct? yes from 1999 until this what was Robert Reader's role at Purdue? Senior Medical Officer next paragraph says so between June 26th 2000 and June 30th 2001 certain Purdue supervisors and employees distributed copies of the reprint of the osteoarthritis study article to all of Purdue sales representatives for use in the promotion and marketing of Oxycontin to healthcare providers including the distribution of 10,615 copies to certain Purdue sales representatives between February 13th 2001 and June 30th 2001 so it looks like on March 28th the supervisor tells the employee don't write up the withdrawal data from the osteoarthritis study it would add to the current negative press and should be deferred and between February 13th 2001 and June 30th 2001 10,615 copies of the osteoarthritis study were distributed to sales representatives correct? it says was the purpose of submitting it to the sales representatives so they could show it to the physicians that they called on? I don't know there's only 800 sales reps at Purdue's highest volume of sales reps during this period of time, correct? it's the best of my recollection that's approximately true so if you wanted to give a copy to each sales rep for their own use you'd probably only need 800 but they printed off 10,615 copies distributed, yes is it reasonable to conclude that you're showing these to the doctors? it's reasonable to conclude that some sales reps may have shown them to doctors, yes to some doctors you know if Purdue ever got any of this 10,615 copies of the osteoarthritis article I don't know if this, when this was found by sales or marketing management or medical department it would have been the practice to recover them, yes but I don't know if it was found and I don't know if it was done this all came to light in 2006 or 2007 so I don't know it could have been long past but I don't know it says during the period June 26, 2000 through June 30, 2001 certain Purdue sales representatives distributed the reprint of the osteoarthritis article to some health care providers and falsely or misleadingly stated that patients taking oxycontin at doses below 60 milligrams per day can always be discontinued abruptly without withdrawal symptoms and that patients on such doses would not develop tolerance and that's not an accurate statement is it? I don't believe so and then on with regard to misbranding of oxycontin use of reduced abuse liability claims and marketing it says oxycontin packaging sort of proved the FDA stated by the FDA stated delayed absorption as provided by oxycontin tablets is believed to reduce the abuse liability of the drug that's called the reduced abuse liability statement certain Purdue supervisors employees instructed Purdue sales representatives to use this statement to market and promote oxycontin paragraph 40 says certain Purdue sales reps while promoting and marketing oxycontin falsely told some health care providers that they reduced abuse liability statement meant that oxycontin did not cause a quote, buzz or euphoria cause less euphoria had less addiction potential had less abuse potential likely to be diverted than immediate release opioids and could be used to weed out addicts and drug seekers and it says by March 2000 various Purdue supervisors and employees in different parts of the company had received reports of oxycontin abuse and diversion occurring in different communities and that on or about November 27th 2000 certain Purdue supervisors employees introduced abuse liability statement to say that delayed absorption as provided by oxycontin tablets when used properly for the management of pain is believed to reduce the abuse liability of the drug and instructed Purdue sales reps to use the amended statement to promote and market oxycontin do you know why that statement was changed I'm not sure, no I don't and I'm not certain where it was changed in the package insert I don't know if it was in the package insert then that had to be submitted to the FDA and to get approval in advance of using it but I just don't know what this refers to well when Purdue found out that oxycontin was being abused and diverted they changed their packet insert kind of cleverly really if you read it right when used properly for the management of pain do you know what they meant by that I don't know what the people who wrote it meant by that or what the FDA understood because I was not involved in rewriting it next paragraph says from March 2000 through June 30, 2001 certain Purdue sales representatives while promoting and marketing oxycontin falsely told some healthcare providers that they reduced abuse liability statement and the amended statement meant that oxycontin did not cause a buzz or euphoria cause less euphoria, had less addiction potential had less abuse potential was less likely to be diverted than immediate release opiates and can be used to weed out addicts and drug seekers and those statements are not correct no, they're not correct introduction of misbranded oxycontin into interstate commerce and that is actually the guilty plea pardon? points out that Purdue manufactured and sold oxycontin into interstate commerce from various locations are you reading? I'm just sorry to interrupt you sir, just tell me which number I should be following the very next paragraph which is 44? yes and that's just pointing out that Purdue sold oxycontin all over the US correct? let me read it and I'll tell you if I agree yeah, that's not what it says I don't if you're reading from 44 yeah, you're right I'll withdraw the question okay did Purdue farm a cell oxycontin all over the US? during what time period? 19 96 to 2001 yes now as part of the reason Purdue was able to get away with making these misrepresentations is because Purdue was aware that physicians did not understand the complex processes of treating pain I don't think so should I answer it? sure I don't think so did Purdue's own focus groups show that doctors didn't understand whether oxycontin was stronger than morphine? I don't know what about the treatment of pain? did you feel like doctors understood or physicians understood prescribing practices that should be utilized for the treatment of pain? you'd have to put a time frame to that or ask the question with more color and more details isn't that the reason you always claiming that you needed to spend so much money educating physicians because they didn't understand pain prescribing? some physicians learned how to prescribe for pain from materials that we produced or information that sales reps gave them others knew how to treat pain and they would be more interested in trying this agent in comparison to how they were treating pain before. we entered the pain market in 1985 in the U.S. there was almost abysmal in a sense not ignorant so much as ignoring pain in patients doctors just didn't want to deal with it and left patients inadequately treated would you agree that the only way to get a large sales force to use a marketing message is to instruct them explicitly and unmistakably to do so? I don't understand the question Mr. Shapiro has testified I want you to peace testified that the only way to get a large sales force to use a marketing message is to instruct them explicitly and unmistakably to do so would you agree with that? I don't understand it once again if you're reading from a transcript please show it to me I want you to assume he's testified to that but I don't understand I don't understand I don't have a transcript in front of me I'm asking you for my own memory oh okay I don't understand I don't understand that statement so I really can't agree or disagree with it do you believe there's evidence of improper training that has occurred at Purdue based on the agreed statement of facts? I would have to review it it's my recollection as you read as we read through it was that one or two things involved improper training but I can't affirm that until I reread it did you ever do you know as we sit here today what percentage of your sales force was using statements to educate physicians about prescribing OxyContin? no I don't know whether it was 100%, 50%, 10% you don't have any idea do you know if anybody at Purdue tried to find out how many of their sales force had given physicians improper and incorrect information? I know as I said before that from 2000, sometime in 2000 as we became convinced that there was a problem many efforts were launched to train, retrain and to determine whether sales reps were following company policy and that effort goes on to this day we put in place for example a whole compliance department in 2003 or 2004 with many employees who reported independently to the board and have continued to report independently to the board to in a sense back up the sales department and marketing department own efforts to assure proper training and compliance with training but I don't know of any attempt to measure who said what and how many times when people were properly trained and they deviated from that or went beyond that they were sanctioned and many of them were dismissed we also had a whole downsizing in the field force from about 2003 or 2004 until about 2007 or 2008 in which the 800 eventually went down to something like 200 so I don't think there are too many survivors from this period because they were selectively weeded out because on average three quarters of them would have been gone but I don't I can't answer that I know of any attempt to assess blame in that sense or to count. Yeah and that's not really my question. My question is did anybody at Purdue Pharma attempt to go back and find out which reps specifically had made comments to physicians that were improper or misleading about the attributes of OxyContin. And the answer is I don't know. Would you agree that giving making the statements the improper statements that are referred to in the agreed statement of facts could compromise patient care? Some of them, yes in some patients obviously not all patients but in some patients some of the statements could compromise care I would like to say sub-optimize care. And if I understand correctly you have not reviewed any of the call notes that were pulled by Mr. Shapiro when he was doing his investigation. As far as I know I was shown a few call notes I didn't ask were these shown to Mr. Shapiro? Was there a recommendation made by somebody right about that same time that the call note system be changed? At about what time? About the same time he was doing his investigation and reviewing the call notes. I believe it was. And do the call notes not contain as much information as they used to back in 2000? That I don't know. But the biggest change was to make the first and second line supervisors audit a substantial percentage of the call notes in their span of control. If the call notes have less information in them is it more difficult to audit them? I would I couldn't possibly guess what they were before or after. They were very sketchy notes. The ones I saw they were selected and shown to me but the ones I saw were in some cases almost indeterminate. You could not know what was happening. How many did you see? Six Eight. No more. I think probably fewer than six or eight I'll say six. Who showed those to you? I was shown during the preparation for the deposition. I'd never seen them before. Were the call notes you were shown call notes from Kentucky reps? My recollection is somewhere. Did you hire anybody or ask anybody to review Mr. Shapiro's investigation for accuracy? I did not ask that his investigation be audited for accuracy. There were many people in the law department then a compliance department who may well have done so but I don't know. And would you expect if we did our own investigation we would have essentially about the same number of improper call notes that he found? That would be my expectation. That's, of course, two thousand four. You want to take a short break? Sure, that's fine. We are off the record at five twenty-six p.m. on the record at five fifty-five p.m. No, I'm going to pick up somewhere different. So let me show you an email to go to page two of this email. This is from Jim Speed. dated Tuesday November 30th let's mark this as what am I going to say? It says it's thirty-five. dated November 30th, 1999. Second period. During physician calls this issue is a topic of hot discussion between me and the physician. While many salespeople have sold controlled release opioids as having less abuse potential the current situation has placed us in an awkward situation. I feel like we have a credibility issue with our product. Many physicians now think oxycontin is obviously the street drug all the drug addicts are seeking. Issues like purposely crushing the 40 milligram and 80 milligram tabs to, quote, get high have been expressed. I have heard from physicians that pharmacists that on the streets people are finding ways to extract the oxycodone from the tablet and are using a cotton ball to filter the talk as they draw it up in a syringe for, quote, mainlining, end quote. Were you aware that that was a concern in November of 1999? No. When did you first become aware that oxycontin was being diverted or abused? In the winter best of my recollection winter of 2000 that is early in the year 2000. Who is Dr. J. David Haddix? Dr. Haddix is a both a dentist and an MD he's an expert in both analgesic pain use of analgesics and pain management in general and also I think is a recognized expert on addiction and treatment of addiction. Did he work for Purdue Pharma? He did. And what about Rena Golden and Wendell Fisher? What were their jobs? Rena Goldman I don't know and Wendell Fisher was a sales manager but I don't recall how high up he was in sales management. I think he was a regional manager at that point. And what about Jim Speed? I've recognized the name but I can't tell you what his position was. He was a field sales person I don't know whether he was a manager or not. Is it true that Wendell Fisher was a regional manager with oversight for the districts and territories located in Kentucky? I don't know. Is it true that Oxycontin does produce a buzz or euphoria just like the controlled release just like the immediate release? When used in pain patients or when abused? When used in pain patients. I don't tell you the percentages I'm sure there are some people who might say that they feel a sense of euphoria I really don't know what buzz means when people say they have a buzz. I'm not familiar. But there may be a brief period of time in which they feel some euphoria or sensation. Whether you feel a buzz or euphoria does that have to do with how quickly the drug works? That's an element but it has to do also with the dose and also with the patient's familiarity. If they've been on the same dose for a while I would think it's far less likely and then there's individual patient variation finally. And with respect to peaks and valleys to the peaks and valleys that are referred to in all the marketing materials or a number of the marketing materials does that have to do with whether somebody experiences a euphoria from taking oxycontin? If they have any psychological experience like euphoria it's most likely to be at the peak blood level. So the fewer the peaks the fewer the periods of euphoria. But I'm just generalizing I'm not telling you that we've ever measured that. When did you first become aware that Purdue had marketed and promoted oxycontin as having less abuse potential? Not until the investigations were done. And I can't tell you which investigation or when but I certainly didn't know that people were saying that until I was told by management that they had done investigation and found that some people had said that. Let me ask you about patients who have not had a prior incidence of addiction or abuse but just someone who's put on oxycontin and has never had an opioid in the past. Do you know if they're put on a 20 milligram dose of oxycontin twice a day how long they would have to take it before developing dependency? I can give you a guess but I don't know. There's enormous individual variation here. So you can't say with any one person or predict that this person will develop dependency or that person won't at 40 milligrams a day. I assume that's the presumptive daily dose you're asking me about. Do you know if Purdue ever conducted any studies to determine how long a non-malignant pain patient who's never had an opioid before would have to be on the drug before they develop dependency or addiction? I'm not aware of those studies being conducted. Is it fair to say that if Purdue wanted to do a study to make that determination that could be done? Dependency that is physiologic dependence I think would be an achievable study that could be done. Addiction remains to be seen. A lot of people would say it's almost impossible to do that. But Purdue and other industry partners are on the cusp of trying to do that with a number of studies. Could you do a retrospective study or could you have done a retrospective study if you had wanted to look at patients? I would have to think about whether I could figure out a retrospective study. It would be an interesting question but I don't know the answer to it. What was Robert Reader's role? Robert was a senior medical scientist in the medical department. I want you to assume he's testified that Purdue lacked any evidence that Oxycontin had a lower abuse potential. If that's true, would you have testified to that? Would you agree with that statement or disagree? If you could just repeat the statement so that I can concentrate on it. He testified Purdue lacked any evidence that Oxycontin had a lower abuse potential. I object to the question. It's a very odd hypothetical question. I don't know of any study that was done but I don't know of any study that was done. I can't tell you for sure. You're referring to Purdue Frederick and you're referring to the time frame up to the 2007 or 2010? Yes. I just want to do it. I don't know. My answer is the same but I just want to be sure that my answer conforms. Has Purdue Pharma done a study since then? On abusability of many formulations and that we did them in the course of trying to develop and then select amongst several formulations. These were studies that were pioneered by Purdue with outside investigators and they attempted to and I think quite would be considered today state of the art to discern how easily practiced drug abusers might be able to defeat the delivery system and abuse it. Have you ever seen the deposition of Curtis Wright in the Poston case? In the Poston P-O-S-T-O-N? No, I've not. Did you ever discuss with Curtis Wright whether studies could have been done on the abuse potential of OxyContin prior to the release of OxyContin? No. If he testified those studies were possible and could have been performed prior to the release of OxyContin would it surprise you? I would have to know more before I've registered surprise or not. I would have to know what he meant what kind of studies and perhaps he said we could have attempted to do it that would surprise me less than if he said absolutely it could have been done so I just have to know what he's talking about. This email this is an email here for the Richard Sackler on 82797 to Craig A. McManema in Utah that's a doctor, is that right? No, he's not instantly familiar to me. If you will go to the why don't we mark this 36? If you'll go to the bottom of the second paragraph you write to him I am drawing your attention to our newest product OxyContin tablets controlled release Oxycodone HCI and have included some literature most important to your practice time of onset of OxyContin is as rapid as immediate release Oxycodone but duration is a full 12 hours and the patient reaches full blood levels in just two doses one day was it your belief that the time of onset of OxyContin was as rapid as immediate release Oxycodone? That was what our data showed more or less almost as immediate I believe in the study that I was referencing but didn't reference in the note I think it was 41 minutes for immediate release and 45 minutes or something like that for OxyContin now I recognize who he is he was a doctor who a friend in Utah was using and he must it looks like he may have asked through his friend for me to send him some Betadine he was a DPM doctor of podiatric medicine and they do a lot of surgery and Betadine is a necessary part of any surgical procedure at least it's an antiseptic an antiseptic is a necessary part I'll give you a copy of this and this is if we can mark this as 37 this is an email dated May 15, 1996 looks like it was received by P. Goldenheim MD but he does work for Purdue Pharma, correct? Yes, he was and it looks like you were also included by facts Dr. Richard Sackler and if you go to the third page it says Professor Dair did not see any major problems regarding registration of OxyContin in Switzerland some specific points need to be clarified the monitored release approval as for DHC may be a possibility in parentheses he considers the following subjects as important and would need further investigations the first paragraph says information about the abuse addiction potential versus other opioids because of the rapid onset of action of OxyContin do you read that correctly? You did do you know OxyContin in Switzerland? I believe we did and did you provide him with the information about the abuse addiction potential versus other opioids because of the rapid onset of action of OxyContin that he requested? I'm not clear that he was actually requesting it just saying that it was his opinion it was necessary for registration but I don't know anything was produced I doubt anything was produced here that was not produced for the FDA or the other European agencies who approved OxyContin if anything was produced that was different that his additional studies they would have also gone to the FDA do you know why he was concerned about the rapid onset of action of OxyContin with respect to abuse and addiction? I don't know with respect to the claims about peaks and valleys did you ever review the information to see what peaks and valleys were present in the plasma blood levels with respect to OxyContin? in the five month did you say? no did you ever review that? with respect to peaks and valleys the claim that there are peaks and valleys are different did you ever review the literature regarding that? I was familiar with some studies that demonstrated that it was to some extent an obvious characteristic since the drug was taken twice a day you'd have two peaks whereas the immediate release was taken four to six times a day and so you'd have four to six peaks do you know if the level of peaks and troughs are similar or different? my recollection is that they are about the same but that's a fuzzy recollection and I would need to see the data myself and be sure but I think you my recollection is they were close do you know whether the controlled release because it maintained a higher level and didn't have as much trough during the day would be more likely to cause addiction or less likely to cause addiction? my impression is that the average blood level was the same and I'm not certain so your question is given that the average blood level is the same if I'm correct and that's a recollection I haven't seen that data for a very long time the only difference in the blood level the remarkable difference would be half as many or a third as many peaks and valleys and to the extent that somebody was seeking the drug or enjoying that element of the drug the peak effect I would think that the drug would be less attractive but it's a conjecture it's not knowledge because I don't think we ever did a study that I'm aware of if somebody has a controlled release and maintains a higher level during the day with respect to valleys they don't have as many valleys is that more likely to make them become addicted or less likely do you know? I don't think the valleys were about the same too so I don't think that the valleys or the height of the peak would have been any difference the principal difference I think would have been and you saying addicted would have been fewer peaks and all of this presumes that they were using the drugs as they were made and presented and if they use it as made and presented they would also be taking drugs for breakthrough pain potentially correct? will be have gotten two prescriptions from the physician right the study show that it lasts from 8 to 12 hours and if it lasts 8 or 9 hours in a patient and doesn't last till 12 he may need an additional prescription rescue prescription for that also correct? possibly I would have told the physician use the rescue compute the daily dose and try giving that dose as oxycontin twice a day that is half of that dose twice a day do you know was there any study done to determine whether patients who were given a controlled release oxycodone and then had to take another one because it didn't last 12 hours were more likely to develop addiction or less likely to develop addiction? I know of no such study and I don't recollect that anybody ever suggested such a study or such a hypothesis I would have asked them why do you think that they are more prone or less prone to addiction I wouldn't think it would make a difference again not based on a study based on a conjecture so I really would have to understand what is the reasoning why taking the drug three times a day would be more likely to cause addiction or less likely can we go up the record one second sure we are off the record at 6.20 p.m. we are back on the record at 6.33 p.m. what I like to do is have you sift through these documents and with the exception of the GAO report are all of these documents that are kept in the ordinary course of business at Purdue? no they would not all have been kept to my knowledge in the ordinary course of business we would have had some sort of destruction policy but we have been engaged in litigation for so long and so many different matters that basically at least my documents I don't think anything has been thrown away are these all documents that were generated in the ordinary course of business at Purdue? or at Purdue Frederick or in other companies or some of the overseas companies yes Purdue Pharma and Mundy Pharma Purdue Pharma, Mundy Pharma Purdue Frederick whatever then are all of these business records? I don't know that you know I'm not a lawyer I'm not sure it is can you answer the question? okay are they business records? I really don't understand what that term means it's not a term I've ever used they are what they are I mean I asked you about the Oxycontin 20 milligrams prescription to your knowledge was anything done to determine how many people put on 40 milligram 80 milligram or 160 milligram prescriptions would become addicted or dependent if they took it for a certain period of time no sitting here today after all you've come to learn as a witness do you believe Purdue's conduct in marketing and promoting Oxycontin in Kentucky caused any of the prescription drug addiction problems now plaguing the commonwealth? I don't believe so sitting here today after all you've come to learn as a witness do you believe that Purdue's conduct in Kentucky has led to an excessive or unnecessary of opioids being located throughout the commonwealth of Kentucky? I don't believe so do you believe that any of Purdue's conduct has led to an increase in people being addicted in the commonwealth of Kentucky? no do you agree that education information presented by a drug company to physicians needs to be fair and balanced? yes and do you agree if a company learns that a physician does not understand a drug that is being sold by the company that they have a responsibility to educate them properly about the drug? yes do you think Purdue has an obligation to provide physicians with truthful information? yes do you believe Purdue provided any of the physicians in Kentucky with information that was not truthful? no I don't believe that do you believe any of the sales reps engaged in the conduct that is any of the sales reps in Kentucky engaged in the conduct that is described in the felony plea agreement? that's my belief I don't have any facts to inform the otherwise and you never checked did you? I don't know how I would have checked that you have looked at the call notes from your sales people in Kentucky to see what they were telling physicians and whether it was the same information referenced in the felony plea agreement? I could have looked at the call notes but I believe that all the call notes were reviewed at least once and probably multiple times by many people and why do you have that belief? because I know of the number of investigations and the extensive training and retraining that was done I believe it would have surfaced any evidence of wrongdoing and inactionable but as I said I've only seen a few call notes and the ones I've seen are so cryptic and imprecise and unclear in their references often you don't even know who's saying what these were memory joggers that I've seen they were written by a person who had a conversation who wanted to recall that conversation two, four, six weeks later and when the call notes say I told the doctor about less abuse or I told the doctor the drug had less euphoria or emphasize that that would be improper, correct? if such call notes existed and they were that explicit yes I didn't see any like that did it ever occur to you to check and see whether the the people you hired and paid $50 million for to do a presentation and defend Purdue in the US Attorney's office in the western district of Virginia gave accurate and truthful information to the US attorneys regarding the call notes I object to the floor for the question you can answer it wouldn't occur to me that any attorney that we hired would give false information to any other attorney and much less so to the US attorney and his deputies when doing a call note search did you ever find out how they went about it? I'm sorry? when the people you hired did their call notes search did you ever find out how they went about it? at the time it was described in fairly explicitly but that was years and years ago almost 15 years ago I think any further questions along this line will really impinge on the attorney's line probably so I object was a breakdown of the results