Here's the thread of my emails to MDA - I think I posted the first letter here on ihub back when I originally sent in on June 23. So if you read that one, you can skip down to the one about CREW. I know the whole post is really long - but if you've nothing better to do, here it is.
I know some of you don't agree with this tactic but we'll just have to agree to disagree.
I’m sure at this point, you’re aware of the issues regarding the NWBO/Dr. Buzdar/MD Anderson matter.
I’m genuinely baffled as to how this interview was actually orchestrated and given to the intrepid bio-tech journalist(!) Adam Feuerstein. Was Dr. Buzdar initially contacted by Adam Feuerstein after having been given his name by one of the Big Pharma groups he (Feuerstein) so often promotes; or, did Adam really just contact the PR department of MD Anderson to inquire as to the center’s policy with regards to disseminating news about a phase I trial in progress as he claimed in his piece last Friday,
“I wanted to know if MD Anderson, as the lead hospital conducting this study, was comfortable with the way Northwest Bio was characterizing preliminary, individual patient case reports in public statements. Is this appropriate? Does MD Anderson condone Northwest Bio's actions? Is the information being disseminated by Northwest Bio about the supposed response to DCVax-Direct accurate?”
If the second scenario is more in keeping with what really actually occurred (modestly presented by our blushing reporter Adam), then may I suggest that next time a reporter calls and wants to get an official line on specific MD Anderson policy, you do something like this:
First, use google.
Next, in the google search bar, type in:
reporter name, company he/she is asking about - and change the menu bar from “web” to “news”.
If you had typed “adam feuerstein northwest biotherapeutics” before you encouraged Adam to speak with Dr. Buzdar, you would have seen something like the myriad of examples of Adam Feuerstein’s highly partisan, non-objective invective against NWBO listed below on the first page of your search.
Northwest vs Feuerstein rhubarb round 4 (NWBO) Seeking Alpha-May 29, 2014 Northwest Biotherapeutics (NWBO -0.2%) takes umbrage with TheStreet's Adam Feuerstein in response to his May 27 article asserting that the ...
Northwest Bio begins German vax trial as glioblastoma market ... FierceVaccines-Jun 12, 2014 Northwest Biotherapeutics ($NWBO) has begun enrolling patients in a ... And TheStreet's Adam Feuerstein has railed against the company, ...
Investor's Alert- UDR, (NYSE:UDR), Northwest Biotherapeutics, Inc ... Techsonian (press release)-Jun 3, 2014 Northwest Biotherapeutics, Inc (NASDAQ:NWBO), a biotechnology ... and misleading statements made by Adam Feuerstein, in an article on ...
Biotech Gainers: Inovio Pharmaceuticals Inc (NYSEMKT:INO ... eFinance Hub-Jun 4, 2014 On May 29, Northwest Biotherapeutics, Inc (NASDAQ:NWBO) refuted the statements made by Adam Feuerstein in an article on Tuesday, May ...
Biotech Stock Hate Mailbag: The Hostile React-o-Meter Meltdown ... TheStreet.com-by Adam Feuerstein-Jun 6, 2014 BY Adam Feuerstein | 06/06/14 - 10:32 AM EDT ... your comments on the various press releases of the company Northwest Biotherapeutics for quite some time.
Celldex: The Race Leader In Glioblastoma Multiforme Seeking Alpha-May 29, 2014 While Celldex and Northwest Biotherapeutics would appear to have the ..... Linda Powers continues her brouhaha with Adam Feuerstein of The ...
The Seven Deadly Sins of Biotech Investing TheStreet.com-by Adam Feuerstein-May 29, 2014 BY Adam Feuerstein | 05/29/14 - 07:00 AM EDT ... if you recognize yourself below or otherwise own Northwest Biotherapeutics (NWBO), Arena Pharmaceuticals ...
At this point, an alert PR person would have known right then and there that this journalist might have an unsavory agenda at play, and maybe, just maybe, matching up one of your perhaps not so PR-savvy physicians against this very slippery investment propagandist with an obvious agenda against Northwest Bio was not a good idea.
If Dr. Buzdar did not previously know the power his words might have, he certainly knows now. He, along with the aid of Adam Feuerstein, managed to bring NWBO’s market cap down by 100 million dollars in a single day! Now that would hurt - a 100 million loss in one day for a company fighting cancer because they had the temerity to publish actual open label trial results conducted at your center and given to them by your center?
You might find it surprising but Adam even tweeted about his interview with Dr. Buzdar the night before he published his piece featuring Dr. Buzdar. He gloated in his tweet with that professional flair he’s so known for,
“It was a very good work day (you'll learn why tomorrow.) And now, a very good beer evening.”
He’s also looking forward to this Monday as well. On Saturday, in another immodest tweet, he stated,
"I cannot wait for Monday, when Linda Powers issues another PR refuting MD Anderson’s statement. $NWBO Fail"
The Direct trial is an MD Anderson trial. Dr. Subbiah was impressed enough with the results to submit and present the trial at ASCO. Why on earth would you sanction and actually let Adam anywhere near Dr. Buzdar? It couldn’t have been your center’s intention to seriously taint what appears to be tremendous progress that has been made thus far with this trial. Unfortunately, that “taint” is the end result.
And the tragedy is, one can’t unring that bell. Dr. Buzdar well knows the power of the media now. Through that one twist of fate, the hapless Dr. Buzdar, who could have been helped by a more dialed-in PR department, suffered a bit of a blow to his name. Of course, these following quotes of his didn’t help:
"I have read the information that the company has put in the public domain. It is extremely unusual and inappropriate,"
"MD Anderson was not involved in the decision to disclose the study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief that releasing incomplete research data is not accepted practice in our field. "
"If you flip the coin and the trial results were negative, do you think the company would be disclosing this type of information? No, the company is trying to create tremendous hype about its product, which is very concerning to me as an academic oncologist," said Buzdar.
"A patient or an investor may read these press releases and see a rosy picture, which may not be so rosy when the entire dataset is analyzed," he added. (WOW - poor Dr. Subbiah - that one’s not very nice).
"The weakness of this approach is that there have been many studies in which tumors are injected locally -- the injections could consist of anything -- and you see tumor regression because of necrosis caused by inflammation," said Buzdar. "But it is a tremendous leap to say that this is a real response, which is why what the company is saying is so inappropriate." (is Dr. Buzdar thinking of starting a clinical trial at MD Anderson where he next injects orange juice into a tumor?)
I find it interesting that your communications person did not find it unusual that a reporter wouldn’t have asked about the more positive merits of the trial first. While there are some who might consider NWBO’s early reporting of the trial’s progress to not be typical industry practice, don’t you find it far more suspect that this so-called journalist didn’t instead first inquire about how often MD Anderson has encountered a trial where tumors fully die in late stage cancer patients with inoperable tumors? Didn’t anyone at MD Anderson find it odd that the reporter was instead asking about the far less interesting angle regarding how NWBO releases the study information?
If Adam did inquire about the more noteworthy aspects of the trial, Dr. Buzdar’s responses to that line of inquiry are noticeably absent from the article. However, knowing that Adam tends to “twist the truth”, as much as possible, it could be that Dr. B’s direct quotes were not as dismissive, offensive, and misleading as Adam made them out to be.
Whatever the case might be:
1. MD Anderson set up the actual interview (or not), or,
2. Adam exaggerated Dr. Buzdar’s answers (or not), I suggest that MD Anderson take positive steps to do the right thing. Tell the truth - that’s just PR 101. Admit your error. And if Dr. Buzdar’s answers were greatly exaggerated by every Big Pharma’s favorite bloggist, Adam Feuerstein, state that. And then you gotta take the hit and apologize. It always turns out better that way. Because the problem doesn’t just go away when you decide to do the wrong thing.
A word of advice though, be prepared for Adam to come out swinging if you do the right thing. He does that to NWBO all the time. Welcome to NWBO’s world.
Then (I admit, this is kinda mean) on July 30:
Hi folks, remember me?
Do you recall my letter from June 23 when I said:
2. Adam exaggerated Dr. Buzdar’s answers (or not), I suggest that MD Anderson take positive steps to do the right thing. Tell the truth - that’s just PR 101. Admit your error. And if Dr. Buzdar’s answers were greatly exaggerated by every Big Pharma’s favorite bloggist, Adam Feuerstein, state that. And then you gotta take the hit and apologize. It always turns out better that way. Because the problem doesn’t just go away when you decide to do the wrong thing.
There are times when I do so enjoy saying I told you so.
We stand by our original comment on the matter - see bottom of this email.
A bit more detail as I see you have written several of us before.
Simply put, Dr. Buzdar was asked by the MD Anderson Cancer Center's communications office to respond to questions posed by a reporter. Like mass media, highly read blogs reach large audiences and our research demonstrated that this is a highly read blog. 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.
Dr. Buzdar answered the reporter's questions at our request on behalf of the institution and voiced concerns about the practice of sharing partial results as an expert in the field.
I am truly sorry that you have found his comments to be frustrating. However, please respect his right to comment as well-regarded expert in the field of cancer research.
PS - If you wish to communicate with MD Anderson in a meaning way, vs. mass emails, please direct all correspondence to me. - Thank you
ORIGINAL STATEMENT
The University of Texas MD Anderson Cancer Center was recently contacted by a reporter and asked to comment about patient research data from a clinical trial that was released by a biotech company before the clinical trial was completed. MD Anderson was contacted because we are one of several sites where the study is being conducted.
Dr. Aman Buzdar, MD Anderson's Vice President of Clinical Research, explained to the news outlet that the standard practice for clinical trials is that data only be released at predetermined time points defined by the research protocol or at the completion of the entire study when data are fully analyzed.
Dr. Buzdar has no associations or financial interest with this company or any other pharmaceutical company. Nor does he serve as a consultant or scientific advisor for any company.
MD Anderson was not involved in the decision to disclose the study information prior to the completion of the research. Therefore, we felt it was important to state that fact. We also felt it was important to state our belief that releasing incomplete research data is not accepted practice in our field. [/quote
To which I replied to start the meaningful conversation that resulted in nary a peep back. I didn't post it here since he seemed to want to have a "private conversation" so I thought I'd give him that opportunity.
Jim-
I understand that your organization chooses to “stand” by Dr. Buzdar. The entire premise of my previous letter and my review on Facebook is that this choice to stand by him is the wrong one. You chose to put forth Dr. Buzdar as your esteemed representative on the subject of the appropriateness of releasing data for an “incomplete study”.
You specifically state in your email to me this morning that MD Anderson and Dr. Buzdar believe that “the practice of releasing data in this way is not accepted practice in the field.” Yet in 1999, Dr. Buzdar apparently felt it was fine to publish preliminary results on a trial he was conducting on Bristol Myers Squibb’s drug Paclitzxel. See excerpts and link below.
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. 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: www.cancernetwork.com/articles/paclitaxel-seems-equivalent-fac-neoadjuvant-chemo#sthash.NSv1iQTC.dpuf
You stand by Dr. B’s statements in the Adam Feuerstein piece; however, does your center stand by Dr. Vivek Subbiah’s statement, put forth earlier on June 19 by the same Adam Feuerstein in another blog, when he asked Dr. Subbiah specifically about the propriety of releasing “anecdotal tumor shrinkage data” to which he replied that Northwest Biotherapeutics is “free to do so”? (see link below)
It would seem to me that both Dr. Buzdar, and MD Anderson (since he represents your center on this matter) feel it is inappropriate for NWBO to release data on an incomplete study; yet it is perfectly alright for Dr. Buzdar to do so — as is demonstrated in the above link regarding Paclitzxel. And, it would also appear, that while Dr. Subbiah, who is actually conducting the trial in question (and not Dr. Buzdar), seems to have no problem with NWBO’s manner of releasing data on an incomplete study, MD Anderson chooses instead to stand by Dr. Buzdar’s take on the matter, and not by Dr. Subbiah's.
I hope you can see the specious nature of this stance. Not only have you chosen the wrong person to comment on this issue, as he himself has done the very same thing he is so horrified about, but the actual doctor from MDA conducting the trial doesn’t seem to have a problem with what NWBO is doing as is demonstrated in his very answer to Adam Feuerstein.
And specifically, by choosing to “stand” by Dr. Buzdar’s comments, does that mean MD Anderson believes Dr. Buzdar's statements about the trial itself?
“The weakness of this approach is that there have been many studies in which tumors are injected locally — the injections could consist of anything — and you see tumor regression because of necrosis caused by inflammation”
“But it is a tremendous leap to say that this is a real response, which is why what the company is saying so so inappropriate.”
“A patient or an investor may read these press releases and see a rosy picture, which may not be so rosy when the entire dataset is analyzed."
Instead of Dr. Buzdar just sticking to the question of whether it’s appropriate or not for NWBO to disclose early trial data, I don’t think we can argue here that Dr. Buzdar is actually putting down the efficacy of the trial itself. He most certainly is casting doubt on it.
I actually called MD Anderson the morning the article came out. I spoke to Dr. Dmitrovsky’s secretary and read the article to her. I can assure you, she was horrified. She could not believe that Dr. Buzdar had said these things.
So you know, and I know, that most of you were horrified when you read the article. I cannot imagine that you all slapped him on the back and told him what a good job he did in that interview. But you have chosen to publicly stand by him, and not NWBO, and not Dr. Subbiah. And this is something I don’t understand. I also don’t see how MD Anderson can say that Dr. Buzdar “has no association or financial interest… in any other pharmaceutical company. Nor does he serve as a consultant or scientific advisor for any company”. At it’s best, this statement is misleading. He certainly has been paid by pharmaceutical companies, as has been demonstrated. Perhaps at that moment in time, he wasn’t being paid. But the manner in which you’ve publicly stated it implies that Dr. Buzdar never has received compensation from a pharmaceutical company. How do you account for the honoraria he’s been paid then?
The appropriate response for MD Anderson, in my opinion, might have been to state that while most medical trials do not release data for an incomplete study, except at predetermined time points such as blah and blah, because Direct is an open label trial, and the agreement between MD Anderson and NWBO is that they are able to do so, they are actually “free to do so.”
Then I would have stated,
Dr. Buzdar did not represent MD Anderson when he stated that the Direct vaccine injections could cause necrosis by inflammation as a partial or complete necrosis response could never be caused by simply injecting a tumor with “anything". Whether the necrosis is minimal or complete, we will know when the dataset is analyzed. Nor do we stand by Dr. Buzdar's statement that the entire dataset may not be "so rosy" when analyzed, as until we do analyze the dataset, we can’t know whether it will be efficacious or not.
You see, by standing by him, you stood by him on everything he said. And we both know that those quotes about the trial itself that I delineated above were inappropriate. Period.
If you google my name (blank) you will immediately come across a story about a little girl named Colby Curtin. I had asked Pixar if they would bring the movie “UP” for Colby to see the day she died. The man from Pixar flew from No. California to So. California and brought the only copy of the DVD in existence at the time for Colby to see. It was literally chained to his wrist in a briefcase. Colby was my daughter’s best friend. She died when she was ten years old of a rare inoperable tumor called “Epitheliod Hemangioendothelioma”. When I first heard of Direct, I thought of how it might have saved her life. That’s why I invested in it. So when NWBO is bashed, I take it personally, as you can see.
http://www.ocregister.com/articles/pixar-128978-up-movie.html (note to ihub: this story went around the world, and was discussed on many a blog, by the way. You see, Colby died that night after the PIXAR person brought the DVD. He was head of all post production and dropped everything he was doing to bring the movie down for her the day after I asked. I know that sounds like I'm important, but I'm not. He just did it to do it.)
Now I’ve written another tome to MD Anderson - and I sent it just to you.
While I don’t know how directing all correspondence just to you (and not the others cc’d on my last email - which can hardly constitute a mass email - there were only 6!) will help us to communicate in a more “meaning [ful] way”, I’d like to see a meaningful correspondence take place, as my previous email was completely ignored. I would like my questions addressed more meaningfully than just a few copy and pasted phrases. Actually, you know exactly what I’d like to see, and that’s a press release more in keeping with what I delineated above. With the recent CREW submission to the SEC, now is a perfect time to do it.
AI
