sentiment_stocks Wednesday, 09/10/14 01:31:40 PM Re: None Post # of 18571 I just spoke to Jim Newman at MDA for about a half hour. Got his "official" take on the whole incident, as he sees it. He is very defensive in his support of Dr. Buzdar (pronounced "Boozdar") - his basic position is that when MDA was contacted by Adam, he realized that Adam had a large readership and needed to be responded to. He felt that it was a conflict of interest to have Dr. Subbiah respond as he is involved in the trial. I said that I believed Dr. Buzdar also had a conflict of interest because of his involvement with competing pharmacy companies. Jim said that Dr. Buzdar has had no affiliations with these companies since he began working at MDA. He also stated that when MDA was cited in the press release by NWBO, they should have been consulted, since that is what one does when writing a press release that involves another organization. And MDA was not consulted. I can see his point on that, but I also said NWBO said nothing negative about MDA, simply that that was where the trial was being conducted. To which he agreed as well. I then said Dr. Buzdar's comments were nothing but negative regarding NWBO and proceeded to read them off. I'm pretty sure he's familiar with it as he said he's read over a hundred times. Anyhow, his position is that MDA doesn't want people getting their hopes up on a drug until results can be put out that support or disprove whatever the trial is hoping to accomplish. The center has seen too often people hugely disappointed when a drug they were counting on fails. I said I could understand that, but I said that Dr. Buzdar has done the very thing he accuses NWBO of doing himself. That caught his attention. He said he didn't know that, wouldn't comment on it yet as he hadn't seen any documentation on that. He has asked me to send him that link. I asked him if he finds that to be the case, what would he do. He said he didn't know yet - he wants to see the link first. I also asked about the Allan Butler, the National Geo employee, clip. He immediately told me he knew all about it because Allan had approached him about doing it. He took the stance that this shows MDA is working with NWBO with the trial. I asked him to post the clip on their Facebook page with a comment and he said that he'd sent it to the social media person to do with it what they will. He's not a big follower of social media, he said. Anyhow, to help me out, could someone please access that link(s) showing Dr. Buzdar in a press release commenting on the promising results of whatever drug he was touting at the time - before it was the "appropriate time"? I'd appreciate that and will send it on to him and we'll see what results from that. sentiment_stocks Friday, 09/12/14 01:08:15 PM Re: None Post # of 18684 Email to Jim Newman below... Again, thanks to the board for all the support as well as assistance with materials (Flip!!), editing (Flip, Asta and Pyrr). I would have asked for more but I think we did pretty well as it is. I worry that it's too long - but at the same time, I really needed to support the case I was making. I also called him today and left him a voice mail that I'd sent the email so that hopefully, he'd know to look for it. Hi Jim- Thanks for taking the time to discuss the Northwest Bio issue with me the other day. It was nice to get your perspective on the situation, and for you to allow me to tell you mine. I know this is a long read (and with 500 emails a day, I’ll understand if it takes awhile to get back to me). I’ve put some things in red to help you more easily get through it. As I stated the other day, Dr. Buzdar has actually done the very thing that he stated was so “inappropriate” when done by NWBO. I therefore find it ironic that he claimed he’d “never come across a company that had done something like this before.” Here is a link to an article where Dr. Buzdar had also discussed preliminary results before the designated interim or end period while employed at MD Anderson. I will put the entire text of this article at the end of this email as you may need to sign into this forum to access it. http://www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.mxIrPR79.qkWUmKW4.dpuf Adjectives such as “optimism”, “encouraging” and “superior” are all descriptions Dr. Buzdar used when describing the preliminary results of this trial. He states, “The current trial has its origin in an M.D. Anderson study of 25 patients with metastatic disease treated with paclitaxel. The treatment led to objective responses in two-thirds of patients, including complete responses in 12%. Only one patient failed to achieve at least a minor response, Dr. Buzdar said.” and... “On the basis of these encouraging results, we decided to put paclitaxel to the test in a neoadjuvant fashion to see what the effect would be on cytoreduction and antitumor activity, Dr. Buzdar said.” Now admittedly, Dr. Buzdar cautions that the “23-month follow-up is too brief to draw definitive conclusions. With longer follow-up, we will know the true value of paclitaxel in neoadjuvant breast cancer therapy, said Dr. Buzdar, a breast medical oncologist at M.D. Anderson Cancer Center.” Despite these caveats, this article does indeed show that Dr. Buzdar is also more than willing to discuss positive results before designated timelines, and to paint them in a “rosy picture, which may not be so rosy when the entire dataset is analyzed”, as he has accused NWBO publicly of doing. And please note that in their similar pre-clinical press release on Direct, NWBO also cautioned that “the results may become greater or lesser as more data is obtained.” I had mentioned to you as well that Dr. Buzdar has also been associated with and paid by competitors of NWBO, which is fine, but I believe you stated that you weren’t aware of these associations, so I’ve listed my source for this information. This is provided from a disclosure at the bottom of an article in Clinical Oncology dtd 2009 Vol 6 no 6. that states “Aman Buzdar is on the Speakers bureau and receives grant/research support from Astrazeneca and Genentech. He also receives grant/research support from Taiho, Lilly, Roche and Pfizer, and is on the Speakers Bureau for Amgen.” I’d also like to point out that at least three other companies currently conducting trials at MDAnderson have released data in a similar manner to NWBO, at the two were at the same time as NWBO this year — and they were not publicly excoriated in any fashion like NWBO. Perhaps Dr. Buzdar should have referred to their preliminary data releases as well when he was discussing NWBO’s “inappropriate” behavior with Adam Feuerstein. Those two companies with recent releases are Sunesis and AVEO. Sunesis presented results in April of this year. Farhad Ravandi, M.D., M.D.. Anderson, said in this PR, "Emerging outcomes from this trial suggest that vosaroxin and decitabine hold meaningful promise as a potential new combination treatment option for this population. The high number of complete remissions with good tolerability are highly encouraging and make this trial a designated priority for our center." And the executive vice president of Sunesis called the work “encouraging.” In the Sunesis PR, a full description is given of dosage, response rates, toxicity, etc. is provided. I can’t distinguish any substantive difference between these statements and those made by NWBO. http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=1916659&highlight= And MDA certainly expressed no concern for AVEO reporting preliminary trial data for AVEO’s Phase I study of AV-203 for advanced solid tumors (similar to the study NWBO is doing with their DCVax-Direct study for inoperable tumors). In this PR link from May 31, 2014, the drug is described as demonstrating “good tolerability and promising early signs of activity” and that “stable disease was the best response for 8” of the 22 patients. http://www.evaluategroup.com/Universal/View.aspx?type=Story&id=510778 And still another example of premature data release in an MDA trial, albeit not as recent as Sunesis and AVEO, Exelixis also released preliminary phase I data back in 2008, for XL019. In fact, their headline reads, “Exelixis Presents Encouraging Phase 1 Data”. The data provided was “unaudited”, the trial “ongoing” and at the time it was reported on, there were only nine patients enrolled at the time. The trial anticipated ultimately enrolling 100 patients. http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=1085792&highlight= Given that Dr. Buzdar has himself discussed preliminary data in the press in a manner that could certainly be considered “rosy”, and that Sunesis, AVEO and Exelixis have all provided preliminary updates on MD Anderson Phase I and I/II trials in the same time frame as NWBO, you can perhaps understand why I and others might feel that the public humiliation and chastisement of NWBO was, at the very least, unfair. If you are interested in comparing NWBO’s preliminary data releases to Sunesis, AVEO, and Exelixis, the links are listed below. http://finance.yahoo.com/news/early-positive-responses-seen-over-123000122.html http://finance.yahoo.com/news/nw-bio-announces-first-data-120000689.html You also mentioned yesterday that NWBO had mentioned MDAnderson in these same PRs, and that in doing so, they should have consulted with MDA first. I looked over the press releases in question, however, and I could not find where NWBO mentioned MDA at all in these two press releases. If you have a chance, please send me the section you were referring to. Perhaps we were both referencing different press releases. But it appears NWBO did not slight you or MDA by neglecting to discuss the PRs with you first as they did not mention MDA. In closing, I asked you the other day about moving forward from here. While I can understand MDA’s stance that releasing preliminary data might give hope, and that hope might ultimately be dashed should the trial fail, but on the other hand, people with metastic cancer have little hope and/or no other options left anyway. Is giving a little hope to these patients and their families really so inappropriate? Have you also considered that Dr. Buzdar’s comments may also have not only mitigated hope, but rather completely dashed patients' hopes? Please see the comment below from one of our own investors -- his own mother decided against trying to get her husband into the DCVax-Direct trial after looking into it. This decision was based on the negative publicity and law firms that have sprung up looking to sue NWBO on behalf of investors because of what Dr. Buzdar said (no law suits have been filed, despite over seven firms looking to start one). Here is the quote from the investor: “anotherday1225 • Sep 8, 2014 11:47 PM Pretty Sad “This week my step-father learned he has pancreatic cancer. Still figuring out the stage (biopsy was today) but sounds like stage 4 given it has spread to liver. I told my mother (a retired RN and our family expert on all things medical) about DCVax Direct and had her watch the National Geographic piece on Allen Butler in the phase 1 Direct trial. She was encouraged and said she would look into it. That was yesterday. Tonight i called and among other things asked if she had looked further into the clinical trial. She said she started to read about it, but then saw some articles that said it was a scam; management was just promoting their stock. So she stopped reading. I've been a long-term holder in NWBO and pretty much have not let the AF story line get to me as i think very long term. Ultimately the technology will decide the stock's future. But the real-life impact of AF's lies is showing up at a patient level. Not every patient has a long-term stock-holder encouraging them to look past the lies and seek out the treatment that could very well be their lifeline. Shame on you AF.” I’ve demonstrated here that NWBO’s release of DCVax Direct phase I trial preliminary data is certainly not the first time it has been done on a trial conducted by MD Anderson. Is there anything that can be done to help undo some of the damage done by Dr. Buzdar’s comments to Adam Feuerstein? If you feel I’ve demonstrated that they might have been a bit over-the-top, is there a positive note we can move forward from? Given that Allan Butler is a patient at your hospital, I’m frankly surprised that the 2 minute clip of his experience at MDA that was featured on the National Geographic’s presentation of Stand Up 2 Cancer wasn’t posted on the MDA facebook page. I know social media is not what you are involved in, but as Communications Director, surely social media is under your management? Could you see to it that the Allan Butler clip is posted by MDA onto their facebook page? And because Allan Butler’s information is now in the public domain, would you consider (with his permission), pursuing a more detailed account of his story with a national media outlet? I believe he was expecting that he would be contacted by media anyway, so perhaps you could help in the facilitation of that? It would seem an appropriate place to start from, given the treatment was received at MDAnderson. I know I’ve eaten up a lot of your time with the discussion of this, and I really want to thank you for that, and for taking the time to read this email as well. In closing, I’ve also added the text below of the article featuring Dr. Buzdar discussing preliminary data about paclitaxel below. I’ve also highlighted the “rosy picture” adjectives to show his preliminary report is analogous to those used by NWBO’s in their preliminary description of results with DCVax-Direct. Again, thank you for your time and consideration. March 01, 1999 | Breast Cancer - See more at: www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.mxIrPR79.qkWUmKW4.dpuf SAN ANTONIO -- Preliminary results from an ongoing clinical trial suggest that neoadjuvant chemotherapy of breast cancer with paclitaxel (Taxol) alone produces response rates comparable to those achieved with the three-drug FAC (fluorouracil, Adriamycin, cyclophosphamide) regimen. Speaking at a satellite symposium held in conjunction with the 21st Annual San Antonio Breast Cancer Symposium, Aman Buzdar, MD, expressed optimism for neoadjuvant use of paclitaxel, but he cautioned that the 23-month follow-up is too brief to draw definitive conclusions. “With longer follow-up, we will know the true value of paclitaxel in neoadjuvant breast cancer therapy,” said Dr. Buzdar, a breast medical oncologist at M.D. Anderson Cancer Center. The current trial has its origin in an M.D. Anderson study of 25 patients with metastatic disease treated with paclitaxel. The treatment led to objective responses in two-thirds of patients, including complete responses in 12%. Only one patient failed to achieve at least a minor response, Dr. Buzdar said. Results of this small-scale evaluation subsequently were confirmed in a similar study at Memorial Sloan-Kettering Cancer Center. Almost three-fourths of 26 patients had major responses, including complete responses in 12%. 174 Patients Randomized “On the basis of these encouraging results, we decided to put paclitaxel to the test in a neoadjuvant fashion to see what the effect would be on cytoreduction and antitumor activity,” Dr. Buzdar said. Between 1994 and the middle of 1998, investigators randomized 174 patients to paclitaxel monotherapy or to neoadjuvant treatment with conventional FAC. Paclitaxel was administered at a dose of 250 mg/m² the same dose used to treat metastatic breast cancer. Treatment was repeated every 3 weeks for four cycles, followed by surgery, an additional four cycles of FAC, and radiation therapy. Patients older than 50 years also will receive tamoxifen (Nolvadex) for 5 years. Patients in the two treatment groups had identical 79.3% overall response rates. Paclitaxel led to complete responses in 26.4% of patients vs 24.1% with FAC. FAC resulted in more patients with no evidence of residual disease (17.2% vs 5.7%), whereas more pacli-taxel-treated patients had DCIS only (8% vs 4.6%) or minimal residual disease (26.4% vs 11.5%) after neoadjuvant therapy. Dr. Buzdar also noted that paclitaxel treatment was associated with a higher rate of breast-conserving surgery, 46% vs 37% for patients receiving FAC. At a median follow-up of 23 months, patients in the paclitaxel cohort had superior disease-free survival rates at 1 year (100% vs 94%) and 2 years (94% vs 89%). Dr. Buzdar emphasized that longer follow-up is needed to provide a true indication of the impact of the two neoadjuvant regimens on survival. - See more at: http://www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.mxIrPR79.qkWUmKW4.dpuf flipper44 Wednesday, 09/10/14 01:51:11 PM Re: sentiment_stocks post# 18519 Post # of 18571 Sentiment: (By the way, I'll try to find further links where Subbiah wanted to share data on Direct last fall 2013. Also, I'll try to find the links of Budzar's conflicts. I'll also try to locate some other contrary info in response to what Newman made. Finally, did you catch the hypocrisy of Newman not wanting to raise hopes by sharing data, but then supporting a case study example from patients on National Television?) Notice the trial was ongoing still in 1999 as it took 5 years of dosing. Notice Budzar stated they could not yet know the value of this chemotherapy. He could not draw definitive conclusions. Etc. In other words, he is pumping the product before he can say what it really can do. http://www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo Quote: ________________________________________ Paclitaxel Seems Equivalent to FAC as Neoadjuvant Chemo March 01, 1999 | Breast Cancer - See more at: www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.mxIrPR79.qkWUmKW4.dpuf SAN ANTONIO? -- Preliminary results from an ongoing clinical trial suggest that neoadjuvant chemotherapy of breast cancer with paclitaxel (Taxol) alone produces response rates comparable to those achieved with the three-drug FAC (fluorouracil, Adriamycin, cyclophosphamide) regimen. Speaking at a satellite symposium held in conjunction with the 21st Annual San Antonio Breast Cancer Symposium, Aman Buzdar, MD, expressed optimism for neoadjuvant use of paclitaxel, but he cautioned that the 23-month follow-up is too brief to draw definitive conclusions. ?With longer follow-up, we will know the true value of paclitaxel in neoadjuvant breast cancer therapy,? said Dr. Buzdar, a breast medical oncologist at M.D. Anderson Cancer Center. The current trial has its origin in an M.D. Anderson study of 25 patients with metastatic disease treated with paclitaxel. The treatment led to objective responses in two-thirds of patients, including complete responses in 12%. Only one patient failed to achieve at least a minor response, Dr. Buzdar said. Results of this small-scale evaluation subsequently were confirmed in a similar study at Memorial Sloan-Kettering Cancer Center. Almost three-fourths of 26 patients had major responses, including complete responses in 12%. 174 Patients Randomized ?On the basis of these encouraging results, we decided to put paclitaxel to the test in a neoadjuvant fashion to see what the effect would be on cytoreduction and antitumor activity,? Dr. Buzdar said. Between 1994 and the middle of 1998, investigators randomized 174 patients to paclitaxel monotherapy or to neoadjuvant treatment with conventional FAC. Paclitaxel was administered at a dose of 250 mg/m²?the same dose used to treat metastatic breast cancer. Treatment was repeated every 3 weeks for four cycles, followed by surgery, an additional four cycles of FAC, and radiation therapy. Patients older than 50 years also will receive tamoxifen (Nolvadex) for 5 years. Patients in the two treatment groups had identical 79.3% overall response rates. Paclitaxel led to complete re-sponses in 26.4% of patients vs 24.1% with FAC. FAC resulted in more patients with no evidence of residual disease (17.2% vs 5.7%), whereas more pacli-taxel-treated patients had DCIS only (8% vs 4.6%) or minimal residual disease (26.4% vs 11.5%) after neoadjuvant therapy. Dr. Buzdar also noted that paclitaxel treatment was associated with a higher rate of breast-conserving surgery, 46% vs 37% for patients receiving FAC. At a median follow-up of 23 months, patients in the paclitaxel cohort had superior disease-free survival rates at 1 year (100% vs 94%) and 2 years (94% vs 89%). Dr. Buzdar emphasized that longer follow-up is needed to provide a true indication of the impact of the two neoadjuvant regimens on survival - See more at: http://www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.mxIrPR79.qkWUmKW4.dpuf hodge14 Wednesday, 09/10/14 02:01:31 PM Re: sentiment_stocks post# 18519 Post # of 18571 Sentiment- You wrote: Quote: ________________________________________ He also stated that when MDA was cited in the press release by NWBO, they should have been consulted, since that is what one does when writing a press release that involves another organization. And MDA was not consulted. I can see his point on that, but I also said NWBO said nothing negative about MDA, simply that that was where the trial was being conducted. To which he agreed as well. I then said Dr. Buzdar's comments were nothing but negative regarding NWBO and proceeded to read them off. I'm pretty sure he's familiar with it as he said he's read over a hundred times. ________________________________________ emphasis mine. I've reread a few of the Direct press releases and never see MD Anderson even mentioned. flipper44 Wednesday, 09/10/14 02:13:18 PM Re: sentiment_stocks post# 18524 Post # of 18571 Sentiment, pay very close attention to this release by Subbiah. Please note the selection I bolded below. It proves MDA wanted to share Direct data results even earlier than NWBO. How can that....umm....representative cast blame at NWBO for sharing data 7 months later? I'll get another quote from 2013 where Subbiah declares his desire to share the data. http://www.immunotherapyofcancer.org/content/pdf/2051-1426-1-S1-P238.pdf DCVax®- DIRECT: autologous activated dendritic cells for image guided intra-tumoral vaccination in patients with solid tumors - a phase I/II clinical trial in progress Vivek Subbiah2, Ravi Murthy1*, Chitra Hosing3, Indresh Kaur3, Gerald Falchook1, Marnix Bosch4 From Society for Immunotherapy of Cancer 28th Annual Meeting National Harbor, MD, USA. 8-10 November 2013 ????????????????????????????????????????????????POSTER PRESENTATION Open Access ???Dendritic cells (DC) are acknowledged to be quintessen- tial in the armamentarium to mount anti-tumor immune responses and have been utilized in varying capacities for cancer immunotherapy. Recent advancements & lessons leant from prior DC therapies have revealed that major barriers hinder the efficacy of cancer vaccination with DC, principal of which is the hostile environment of the local tumor milieu that inhibits activation and subse- quent maturation of DC. This critical step is required to process and present antigens (tumor cell) to the down- stream cascade of immune mediators. The therapeutic goals of cancer vaccination are the induction of tumor regression secondary to the production of tumor specific immune factors and local inflammatory cytokines with enhancement of long term anti-tumor surveillance to prevent recurrences. DCVax® - Direct (Northwest Biotherapeutics, Inc. Bethesda, MD) are autologous den- dritic cells activated Ex vivo with BCG and IFNg for intratumoral injection and attempts to circumvent this barrier thereby maximize the induction of anti-tumor responses. Autologous DC will be harvested from peri- pheral blood monocytes via leukapheresis. Following Ex vivo DC maturation, inoculation of the tumors will be performed 2 weeks later utilizing image guidance to ensure activated DC deposition at the peripheral aspect of the tumor thereby enhancing DC exposure to antigens from dead or dying tumor cells. Vaccination will be per- formed at least every week for 3 weeks, and subsequently at longer intervals dependent on harvested DC avail- ability. Phase I/II study with DCVax®- Direct will enable 1Interventional Radiology, MD Anderson Cancer Center, Houston, TX, USA Full list of author information is available at the end of the article evaluation of the safety, MTD, and responses in patients with solid tumors. The secondary objective addresses the feasibility, anti-tumor immune responses, PFS and OS. At the time of this poster submission, the ‘First-in-man’ patient has been consented for the study. We propose to present our initial findings at the SITC 2013 conference as more data will be available. Authors’ details 1Interventional Radiology, MD Anderson Cancer Center, Houston, TX, USA. 2Investigational Cancer Therapuetics, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, USA. 3Department of Stem Cell Therapy, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, USA. 4Northwest Biotherapeutics, Inc., Bethesda, MD, USA. Published: 7 November 2013 flipper44 Wednesday, 09/10/14 04:17:54 PM Re: flipper44 post# 18526 Post # of 18571 Something Strange happened the last time I copied this poster presentation in the related post. Here is the main portion again. I highlighted the repaired part at the end. I also underlined the emphasized points once again. ________________________________________Dendritic cells (DC) are acknowledged to be quintessential in the armamentarium to mount anti-tumor immune responses and have been utilized in varying capacities for cancer immunotherapy. Recent advancements & lessons leant from prior DC therapies have revealed that major barriers hinder the efficacy of cancer vaccination with DC, principal of which is the hostile environment of the local tumor milieu that inhibits activation and subse- quent maturation of DC. This critical step is required to process and present antigens (tumor cell) to the down- stream cascade of immune mediators. The therapeutic goals of cancer vaccination are the induction of tumor regression secondary to the production of tumor specific immune factors and local inflammatory cytokines with enhancement of long term anti-tumor surveillance to prevent recurrences. DCVax® - Direct (Northwest Biotherapeutics, Inc. Bethesda, MD) are autologous den- dritic cells activated Ex vivo with BCG and IFNg for intratumoral injection and attempts to circumvent this barrier thereby maximize the induction of anti-tumor responses. Autologous DC will be harvested from peri- pheral blood monocytes via leukapheresis. Following Ex vivo DC maturation, inoculation of the tumors will be performed 2 weeks later utilizing image guidance to ensure activated DC deposition at the peripheral aspect of the tumor thereby enhancing DC exposure to antigens from dead or dying tumor cells. Vaccination will be per- formed at least every week for 3 weeks, and subsequently at longer intervals dependent on harvested DC avail- ability. Phase I/II study with DCVax®- Direct will enable evaluation of the safety, MTD, and responses in patients with solid tumors. The secondary objective addresses the feasibility, anti-tumor immune responses, PFS and OS. At the time of this poster submission, the ‘First-in-man’ patient has been consented for the study. We propose to present our initial findings at the SITC 2013 conference as more data will be available. Authors’ details 1Interventional Radiology, MD Anderson Cancer Center, Houston, TX, USA. 2Investigational Cancer Therapuetics, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, USA. 3Department of Stem Cell Therapy, Division of Cancer Medicine, MD Anderson Cancer Center, Houston, TX, USA. 4Northwest Biotherapeutics, Inc., Bethesda, MD, USA. Published: 7 November 2013 sentiment_stocks Wednesday, 09/10/14 02:17:39 PM Re: flipper44 post# 18522 Post # of 18571 Flip, regarding the "raising hopes" on Allan's clip, he told me that Allan contacted him and wanted to do the piece, and that he warned Allan that he may get lots of emails that he'd have to deal with as a result of doing this. He said he was concerned that Allan may not want to deal with all of that during this time in his life. So given that, I'm not sure he was being hypocritical given that he didn't instigate it; and even warned against it. That doesn't mean that I agree with him about Dr. Buzdar's comments being objective - but I don't think he realized the firestorm that would result over this whole thing. I'm not sure how much posturing was going on - like, I don't read our Facebook page, or I'm not familiar with your review (that's been in first position for 4 months or so now). But he did state that there had been a lot of hate mail going Dr. Buzdar's way and that a lot of it had racial slurs. He said it's difficult to take someone seriously with that going on. Of course, mine did not have any of that and he indicated that he was sure they didn't. As usual, I appreciate all of your help here Flip. I knew you'd have all sorts of things to throw my way. I've gotta run out to the recycle center so I'll look more carefully at all this when I get a chance later today). It'll all probably be for naught, But one can't say we didn't try. I did say the past is the past, how can we move forward on this and he seemed open to that. Evaluate Wednesday, 09/10/14 02:27:11 PM Re: sentiment_stocks post# 18519 Post # of 18571 ________________________________________ Anyhow, his position is that MDA doesn't want people getting their hopes up on a drug until results can be put out that support or disprove whatever the trial is hoping to accomplish. The center has seen too often people hugely disappointed when a drug they were counting on fails. I said I could understand that, but I said that Dr. Buzdar has done the very thing he accuses NWBO of doing himself. ________________________________________ Buzdar/MDA did not want people getting their hopes up until DCVax results were proven, but in the meantime the negative comments that Buzdar made about the trial had the opposite effect ... making people doubt that DCVax is effective, prior to trial completion. Despite encouraging early indications in various patients. Quote: ________________________________________ Anyhow, to help me out, could someone please access that link(s) showing Dr. Buzdar in a press release commenting on the promising results of whatever drug he was touting at the time - before it was the "appropriate time"? ________________________________________ Is this the link you are looking for: http://www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo I also came across http://www2.mdanderson.org/cancerwise/2014/06/giving-back-to-support-glioblastoma-research.html which makes reference to grade IV GBM treatment at MD Anderson - a clinical trial that uses a virus called Delta-24-RGD. No mention of Dr Buzdar in this article, but I still found it interesting. With standard chemotherapy and radiation treatment, Phil was given 14 months to live, but thanks to the Delta-24 RGD trial, he is now in his 33rd month of surviving this deadly disease. We believe he wouldn't be here today if it weren't for the glioblastoma research that MD Anderson is doing." flipper44 Wednesday, 09/10/14 02:30:56 PM Re: sentiment_stocks post# 18527 Post # of 18571 OK, it looks like you've changed tracks. I'll stop posting refutations. Moving forward. Yes. Look again at my last post on the 2013 Subbiah/MDA's written desire to present initial findings with more data as far back as 2013. However, here are Buzdar's conflicts since entering MDA. Newman is very misinformed. In a little while, I'll see if I can suggest something that is more in line with their desire to present early data. ________________________________________Thirdly he has massive conflicts of interests. This from a disclosure at the bottom of an article in Clinical Oncology dtd 2009 Vol 6 no 6. "Aman Buzdar is on the Speakers bureau and receives grant/research support from Astrazeneca and Genentech. He also receives grant/research support from Taiho, Lilly, Roche and Pfizer, and is on the Speakers Bureau for Amgen. flipper44 Wednesday, 09/10/14 02:49:57 PM Re: None Post # of 18571 MDA sharing results before enrollment complete in 2014. Hi again Sentiment. I really think Newman is disingenuous. Here is one of many examples on the internet where MDA joined a pharmaceutical company to share results before enrollment even stopped. (Ridiculous! MDA wanted to share NWBO phase I initial preliminary findings back in 2013, then crucified NWBO for sharing initial data while at the very same time presenting preliminary raw data with another pharmaceutical company conducting a half enrolled phase I trial). Anyway, moving forward, MDA ought to treat NWBO like they do Sunesis. (BTW: Of course no one should write MDA Anderson with racial slurs.) http://ir.sunesis.com/phoenix.zhtml?c=194116&p=irol-newsArticle&ID=1916659&highlight= Sunesis Announces Presentation of Positive Results From Ongoing MD Anderson-Sponsored Trial of Vosaroxin in AML and High-Risk MDS Data Presented at AACR 2014 Annual Meeting Company to Host Conference Call Today at 8:00 AM Pacific Time SOUTH SAN FRANCISCO, Calif., April 8, 2014 (GLOBE NEWSWIRE) -- Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) today announced the presentation of results from an ongoing Phase 1b/2 University of Texas MD Anderson Cancer Center-sponsored trial of vosaroxin in combination with decitabine in older patients with previously untreated acute myeloid leukemia (AML) and high-risk myelodysplastic syndrome (MDS). The results will be presented today at the Phase II/III Clinical Trials Poster Session of the American Association for Cancer Research Annual Meeting 2014 (AACR) in San Diego, California. The poster (Poster #7, Hall A-E, Poster Section 38) is titled "Phase I/II study of vosaroxin and decitabine in older patients with acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS)." The Phase 1b/2 trial is expected to enroll up to a combined total of approximately 70 patients. As previously announced, the Phase 2 cohort of the Phase 1b/2 was initiated in October 2013, following successful completion of a Phase 1b open-label, single-arm dose optimization phase. Patients in the ongoing trial are being followed for rate of response, leukemia-free survival, overall survival and safety. To date, the combination of vosaroxin and decitabine has been found to be effective and well tolerated in older patients with AML and high-risk MDS. Twenty four patients are evaluable for response; 9 (38%) achieved complete response (CR), 5 (21%) achieved CR with incomplete platelet recovery (CRp), and 2 (8%) achieved CR with incomplete peripheral blood count recovery (CRi), for an overall response rate of 67%. The main grade = 3 toxicity was mucositis in 6 (6/29, 21%) patients. No patients died during the initial 30-day induction period. Enrollment in the trial is ongoing. "The treatment of older patients with AML or high-risk MDS presents particular challenges, including many patients not tolerating or responding to existing therapies," said Farhad Ravandi, M.D., Professor of Medicine, Department of Leukemia, University of Texas MD Anderson Cancer Center, and a study investigator. "Emerging outcomes from this trial suggest that vosaroxin and decitabine hold meaningful promise as a potential new combination treatment option for this population. The high number of complete remissions with good tolerability are highly encouraging and make this trial a designated priority for our center." "Vosaroxin's activity against genetically heterogeneous diseases like AML and high-risk MDS is driven by its unique characteristics as a first-in-class, anti-cancer quinolone derivative – properties that appear to combine well with the anti-leukemic activity of decitabine, a hypomethylating agent, to provide a much higher rate of remission than would be expected from decitabine alone," said Adam R. Craig, M.D., Ph.D., Executive Vice President, Development and Chief Medical Officer of Sunesis. "These encouraging results support our goal of elucidating vosaroxin's full clinical benefit in different patient segments as well as in new treatment combinations. We look forward to additional progress in this study and to working closely with MD Anderson and our growing list of experienced investigators to explore vosaroxin's value within AML and MDS." The MD Anderson Cancer Center-sponsored trial is being conducted under the direction of Naval Daver, M.D., Assistant Professor, Department of Leukemia, University of Texas MD Anderson Cancer Center, and Dr. Ravandi. Dr. Ravandi is also a principal investigator of the Phase 3 VALOR trial, the company's randomized, double-blind, placebo-controlled, pivotal trial of vosaroxin plus cytarabine in patients with first relapsed or refractory AML. Results in Detail For the trial, patients were treated with vosaroxin (90 mg/m2) intravenously on days one and four in combination with decitabine (20 mg/m2) on days one to five. Vosaroxin dose was reduced to 70 mg/m2 in consolidation cycles, which were repeated in approximately four to five week intervals for a total of up to seven cycles. Dose adjustments and dose delays of one or both agents were allowed based on toxicity. Patients were eligible if they had AML or high-risk MDS (defined as having = 10% blasts in the bone marrow), were 60 years of age or older, and had adequate performance status (ECOG = 2) and organ function. Patients younger than 60 who were unsuited for standard chemotherapy were also eligible. The primary endpoint of the study is to determine the CR rate. Secondary endpoints include CR duration, disease-free survival, overall survival, safety and early mortality. To date, 29 patients (25 AML, 4 high-risk MDS) with a median age of 73 years (range, 41-78) have been enrolled; 97% were older than 60 years and 59% were older than 70 years. Of these, 24 patients were evaluable for response; 9 (38%) achieved CR, 5 (21%) achieved CRp, and 2 (8%) achieved CRi, for an overall response rate of 67%. One patient without a response after cycle one is currently undergoing re-induction. Five patients are too early for response assessment. Patients have received a median of 2 (1-6) treatment cycles with median number of cycles to response being 1 (1-4). The regimen was found to be well tolerated. The main grade = 3 toxicity was mucositis in 6 (6/29, 21%) patients. No patients died during the initial 30-day induction period. longusa Wednesday, 09/10/14 03:21:50 PM Re: flipper44 post# 18532 Post # of 18571 Wow Flip, that is very damning for MDA. It is starting to look like MDA's reason for their reaction was that they were NOT featured in the PR's, rather than because they (supposedly) were or were by inference given they are a trial site. flipper44 Wednesday, 09/10/14 03:33:33 PM Re: None Post # of 18571 Subbiah -- Second time in 6 months MDA wanting to share preliminary data on DCVax-Direct. The trials of DCVax-Direct involve 60 U.S. patients. The Phase 1 stage will focus primarily on safety, although hints of efficacy could emerge. The primary goal of the Phase II part of the study is to shrink or eliminate tumors. Dr. Vivek Subbiah, an oncologist at M.D. Anderson Cancer Center in Houston who is leading the DCVax-Direct trials, said he may present initial data at the annual meeting of the American Society of Clinical Oncology that begins May 30. Subbiah and his colleagues test scores of experimental cancer drugs, many having new mechanisms of action. "This is not a 'me-too' trial," Subbiah said. "It is one of the interesting technologies. Twenty years ago it was chemo, 10 years ago it was targeted therapies, and for this decade it will be drugs that boost the immune system." DoGood_DoWell Wednesday, 09/10/14 03:36:17 PM Re: None Post # of 18571 Regarding Dr. Newman, I echo the post which says there was never a mention of MD Anderson in NWBO press releases other than the PR that they would be submitting an abstract to ASCO that MDA was an author on. They never mentioned MDA in any press release that mentions data. MD Anderson has created the appearance of a double standard by standing by Dr. Budzar, who as mentioned, released preliminary phase I data from a breast cancer drug study. Jim Newman is just plain wrong that NWBO mentioned MD Anderson in their press releases about the Phase I data. He shouldn't be commenting and further exacerbating the mistake made by Dr. Budzar. flipper44 Wednesday, 09/10/14 04:01:56 PM Re: longusa post# 18537 Post # of 18571 To me, the primary question has always been who delayed/blocked/interfered with MDA's twice announced desire to release preliminary data on Direct? AF apparently was at least serendipitously aligned with the idea, but who else? Big Pharma? Buzdar? The Sunesis example puts Newman's defense to bed. H2R Wednesday, 09/10/14 04:25:55 PM Re: DoGood_DoWell post# 18540 Post # of 18571 Jim Newman is not a doctor at MDA. His role is director of communication. I've had the displeasure of exchanging emails with him. Here is an excerpt: "Simply put, Dr. Buzdar was asked by the MD Anderson Cancer Center's communications office to respond to questions posed by a reporter. We do consider highly read blogs to be news outlets. Those questions pertained to press releases issued by a company sponsoring a clinical trial that MD Anderson is involved in. The press releases contained data for an incomplete study. The communications office asked Dr. Buzdar to respond because the practice of releasing data in this way is not accepted practice in the field. Yet we serve as a clinical trial site for this study. Therefore, our institution felt it needed to publicly distance itself from the activity. " Newman's signature: Jim Newman Director, External Communications The University of Texas MD Anderson Cancer Center jnewman@mdanderson.org T: 713 792-0664 Smokey21 Wednesday, 09/10/14 04:32:59 PM Re: H2R post# 18547 Post # of 18574 So, it appears that Jim Newman was ambushed or coerced by Adam and he is the one who forwarded him to Dr. Budzar. BTW, Jim is a newbie at MDA, with less than a year experience with them at the time. He came from another university before. You can Google his LinkedIn profile and see that. I wonder if he know who Adam was and what is MO was. flipper44 Wednesday, 09/10/14 05:32:41 PM Re: longusa post# 18537 Post # of 18575 LongUSA, allow me to share a bit more. 1. The President of MDAnderson is Dr. Ronald Depinho. See CNBC article and SEC investigation below. 2. Mr. Depihno extoled Aveo Oncology on CNBC while President of MD Anderson. See same below. 3. Aveo Oncology is not just any cancer company, it had a phase I study, but it was not just any phase I study. "A Phase 1 Dose Escalation Study of AV-203, an ERBB3 Inhibitory Antibody, in Subjects With Advanced Solid Tumors." 4. And this phase I trial on solid tumor cancers released results in the same month the last dose was given. Preliminary results were not supposed to be completed until October 2014 (according to clinicaltrials.gov). 5. But that was not just any month, it was May 2014. 6. There was a conference that month, but it was not just any conference, it was ASCO 2014. 7. It was not presented by just any investigator, it was presented by MD Anderson -- 5 months before preliminary results were supposed to be available. 8. Again, the creator of AVEO Oncology is Ronald Delpinho. 9. Ronald Delpinho became President of MD Anderson 8 months before his phase I multi solid tumor trial began at MD Anderson. 10. Once on November 7, 2013 and again on February 24, 2013, MD Anderson employees expressed their desire to share "initial data" on NWBO at a formal presentation. 11. Depinho was the man at the helm of MD Anderson as of September 2011 -- Current when both events did not transpire. 12. Please note that Depinho was also the man at the helm of MD Anderson when MD Anderson presented preliminary phase one data in a shared format with drug company Sunesis at ASCO 2014 -- please note that the results shared were extremely preliminary and more than half the patients were not even enrolled yet. 13. Please note that Sunesis was not chastised by MD Anderson for sharing real efficacy data this early in a trial, instead they were helped and praised by MD Anderson. 14. Please note that NWBO was trying to share preliminary results on a phase I trial treating Solid Tumor Cancers, which is the same exact condition AVEO Oncology was trying to treat in the very same phase trial. Sunesis was not trying to treat solid tumor cancers. M.D. Anderson president goes on CNBC, extols his own company Posted on June 1, 2012 | By Eric Berger During the last couple of weeks Todd Ackerman and I have been reporting on a controversial $20 million grant received by the University of Texas M.D. Anderson Cancer Center and Rice University. The story broke on May 11 when Nobel laureate Al Gilman resigned as chief scientific officer of the Cancer Prevention and Research Institute, which has 10 years to appropriate $3 billion in taxpayer funds on cancer research. DePinho Gilman’s primary concern is that M.D. Anderson’s part of the proposal, which was to be funded up to $18 million, was approved by CPRIT “without scientific review, without a score, and in record time.” In other words, the grant review process was done outside his purview and, in his view, a questionable manner. M.D. Anderson’s part of the grant has Dr. Lynda Chin as its principal Path: investigator. Chin, a well-regarded scientist, is also the wife of Dr. Ronald DePinho, who M.D. Anderson hired last year to be its new president. Chin and DePinho are also co-founders of a modestly successful biotech company, AVEO Oncology. The grant has proven problematic. M.D. Anderson has offered to resubmit it to CPRIT after questions were raised about it and the approval process, and CPRIT has agreed to re-review it. The UT System is also now probing the process. Chin’s involvement in the grant has heightened concerns among some M.D. Anderson faculty about how DePinho and Chin handle conflicts of interest. Many have contacted Todd and myself to express such concerns. Ok, so that’s a long way of saying there is, at a minimum, a perception among some faculty at M.D. Anderson that DePinho has conflicts of interest. This isn’t going to help that perception. It’s a video — shot on May 18, after the CPRIT story had broken — of DePinho appearing on CNBC with Maria Bartiromo in advance of the biggest cancer meeting of the year, the ASCO Annual Meeting, which begins today. He does so as a cancer expert, and is clearly identified as the president of M.D. Anderson. The interview starts off with DePinho explaining why he believes recent developments, including genomics, nanotechnology, gene manipulation and other research trends, are bringing cancer cures close to the clinic. It’s a historic moment, he says. The interesting part comes in the middle. Here’s a transcript of three questions (Bartiromo is in bold): Are there companies out there that you think are most promising? In the biotech sector you have to be really careful because you have to understand which companies are driven by good management and driven by the kinds of scientific advancement that I’ve mentioned, and there are a few of them out there. Historically of course Genentech was one of the prime examples of this. More recently … They were the first one to come out with a targeted treatment. Right so you can think about Herceptin and so on, those are very important advances, and in fact some of the most effective drugs have come out of the idea of using science to shepherd cancer drug development. A company that I was involved in founding, Aveo Pharmaceuticals, flipper44 Thursday, 09/11/14 11:00:15 AM Re: john1045 post# 18585 Post # of 18621 I think we should be treated like Sunesis. Sunesis was allowed to present a great deal of efficacy data at a conference before their enrollment was half completed. This was done in coordination with MD Anderson. NWBO already has full enrollment in their phase I open label trial, so it will be that much easier for MDA to support NWBO presenting their ongoing findings with MDA from here on out. Depinho's MDA did not allow NWBO to do likewise (like Sunesis). Instead MDA's Newman and Buzdar chastised/suppressed NWBO for sharing this data, hurt NWBO's share price and their potential enrollment accrual; all while helping a direct competitor, AVEO ONCOLOGY (Depinho's Company he created), share its findings on treating all solid tumor cancers in the same month it completed dosing. flipper44 Thursday, 09/11/14 04:12:16 PM Re: None Post # of 18634 Sentiment et al... In the matter I am working on, I decided to do a more extensive review of MD Anderson's phase 1 ongoing presentations where efficacy was released early... I think it is important to lay out just how singled out NWBO really is. I will get back to you all tomorrow.... For example, here is a 2008 phase 1 with only 9 patients out 100 enrolled.... http://ir.exelixis.com/phoenix.zhtml?c=120923&p=irol-newsArticle&ID=1085792&highlight= Exelixis Presents Encouraging Phase 1 Data For XL019, A Novel Selective Inhibitor of JAK2 ATLANTA, Dec. 10 /PRNewswire-FirstCall/ -- Exelixis, Inc. (Nasdaq: EXEL), today reported phase 1 data from an ongoing phase 1 trial of XL019 in patients with myelofibrosis, a myeloproliferative disorder (MPD). XL019 is an investigational small molecule that selectively inhibits the tyrosine kinase JAK2, one of four JAK family members activated in response to cytokines and hematopoietic growth factors. JAK2 is inappropriately activated in the majority of MPD patients and is deregulated in a number of solid tumors, including certain subtypes of lymphoma. Dr. Srdan Verstovsek from the M. D. Anderson Cancer Center, Houston, TX today presented data from an ongoing phase 1 study in an oral presentation session (Abstract #553) at the American Society of Hematology 49th Annual Meeting and Exposition, which is taking place in Atlanta, December 8th-11th. "We are very encouraged by the results from this ongoing trial that show rapid decrease in spleen size and relief of disease-related symptoms at low doses of XL019. XL019 is a highly selective inhibitor of JAK2 that may have the potential to provide important benefit for patients with myeloproliferative disorders and other diseases driven by JAK2," said Michael Morrissey, Ph.D., president of research and development at Exelixis. "We believe that JAK2 is a critical target in myeloproliferative disorders, and effective inhibition of JAK2 may directly translate into clinical benefit. The strong linkage of JAK2 to MPDs provides a potentially quick route to market, with potential for additional opportunities in larger commercial indications. We are planning to initiate pivotal trials of XL019 in myelofibrosis patients in 2008." Trial Design The phase 1 dose escalation study of XL019 is ongoing in subjects with primary myelofibrosis (MF) and post-polycythemia vera/essential thrombocythemia MF. To date nine patients have been enrolled. The primary objective of this study is to determine the safety and tolerability of XL019 when administered orally once daily for 21 days in 28-day cycles. Secondary objectives include evaluation of the pharmacokinetics and pharmacodynamics of XL019, and to evaluate response using the International Working Group for MF consensus response criteria. Results To-Date Data (unaudited) from cohort 1 (100mg), cohort 2 (200mg) and cohort 3 (300mg) were presented today and the key findings by investigators include: -- Preliminary clinical activity observed in most subjects, including: - Reduction in spleen size of 33 to 100% in five of six patients evaluated - Reduction in erythropoietin-independent colony formation of up to 39% and up to 100% in two patients evaluated -- Relief of constitutional symptoms, including pruritus, fatigue, back pain and abdominal fullness -- Reduction in the number of cells with the JAK2 V617F mutation (allele burden) -- Correlation between XL019 exposure and decreases in phosphorylation of STAT, a marker for JAK activity. -- XL019 was generally well tolerated. - Adverse events included Grade 1 nausea, headaches, equilibrium imbalance, dizziness, chest discomfort, visual disturbances, fatigue and hypertension. - Grade 2 AEs of lightheadedness and decreased sensation in soles and one serious adverse event of confusion in a patient with baseline history of dementia were also observed. -- No evidence of myelosuppression The maximum tolerated dose has not been reached. The phase 1 dose escalating clinical trial continues rrflyboy Friday, 09/12/14 02:29:15 PM Re: sentiment_stocks post# 18667 Post # of 18685 Nicely done, your research and writing skills are a real asset to the rest of us. In a prior life I obtained a paralegal degree and did a lot of legal research. If push came to shove with MD Anderson, they would have some difficulty defending their actions particularly given their Code of Ethics (on their website) which I copied and pasted below. Principle 7 would likely be the bane of their legal defense given Dr. Buzdar's apparent conflict of interest and disingenuous statements. I also wonder what conflict, if any, their current CEO may have with regard to NWBO's clinical successes given his prior apparent questionable ethics with the Bio company he headed prior to leaving for MD Anderson. Perhaps his employment contract has a separate conflict of interest provision, but the Code of Ethics on MD Anderson's website may not be specific enough to forbid his short selling NWBO stock. Maybe I'm seeing the "black helicopters" circling, but there seems to be more unsettling reasons surfacing to doubt the veracity of MD Anderson. MD Anderson Code of Ethics: Code of Ethics Preamble Our institution is a specialized center devoted to the care of people with cancer and to the prevention and eradication of malignant disease. We strive to combine the activities of patient care, prevention, education, and research to benefit not only patients currently receiving care but also future generations. In this diversity, there is often tension; therefore, we hold before us this Code of basic moral principles to guide our service and to bond patients and staff together in the difficult task of contending with cancer. Principle 1 Reverence for the people for whom we are privileged to care is our primary concern. Such respect affirms the value and dignity of life. Principle 2 Curing disease, reducing suffering, and achieving an acceptable quality of life, as defined by the patient with the help of healthcare professionals, are the central goals of our institution. The presence of cancer may justify, but not demand, heroic measures. Principle 3 The diagnosis of cancer is not just an identification of a disease but may also carry with it serious emotional, social, and financial burdens for patients and those close to them, including the burden of making and living with difficult choices. It is our responsibility to offer support and assistance by providing patients and their families with the information they need to make decisions. Principle 4 Patients' information is confidential and may not be disclosed to third parties without patient consent. All information must be recorded accurately and communicated responsibly. Access confers an obligation to protect patient privacy and personal interests. Principle 5 Prevention is an essential part of our mission. Through public education, clinical preventive service, and research, we strive to reduce the incidence of cancer and serve people who may never be our patients. People who come to us for preventive services are to be cared for with sensitivity to issues of stigmatization, confidentiality, and the avoidance of harm. Principle 6 Education is both an investment in a better future and a tribute to past generations of patients and scholars. Our educational mission embraces those who come to us to learn -- our patients, the public, and our colleagues. We commit ourselves to further progress against cancer by sharing the knowledge, skills, and ethical values that are the foundation of this institution. Principle 7 Basic and clinical research are central to our mission. They are fundamental to the prevention, diagnosis, treatment, and ultimately to the eradication of cancer. Research requires activities that are anticipated to improve patient care and participants who are adequately informed about risks and benefits. It must reflect the highest standards of research integrity including accurately collected, precisely analyzed, and honestly reported data. Principle 8 All who serve in this institution have specific tasks and roles, yet all are equal in their capacity to befriend patients. Individually, each of us bears a moral obligation to our patients. Principle 9 We affirm the need to demonstrate mutual respect and to acknowledge interdependence as co-workers responsible for the welfare of patients. Principle 10 Cancer therapy, prevention, education, and research are costly endeavors demanding conscientious stewardship; however, financial considerations should not dictate the quality of care offered to each patient.