Wednesday, July 22, 2009

Grease wasn't the word








We'll start in the US for VA news. Brachytherapy is one treatment for prostate cancer. Walt Bogdanich (New York Times) explained the treatment last month as: "a doctor implants dozens of radioactive seeds to attack the disease." But at the VA Medical Center in Pennsylvania, Bogdanich reported, Dr. Gary D. Kao's treatment resulted in nearly all of the forty seeds ending up "in the patient's healthy bladder, not the prosate." Instead of addressing it or Dr. Kao's other problems, regulators who are supposed to oversea the VA allowed creative records to be kept and Kao was allowed to rewrite what happened, to hide his errors. The paper's investigation discovered "92 implant errors resulted from a systemwide failure in which none of the safeguards that were supposed to protect veterans from poor medical work worked". Josh Goldstein (Philadelphia Inquirer) reported last month, "It took officials more than six years to catch the mistakes, investigators said. When they were discovered last year, all brachytherapy treatments at the hospital were halted and remain so." That's some of the backstory. Today the House Veterans' Subcommittee on Oversight and Investigations, chaired by US House Rep Harry Mitchell, held a hearing entitled Enforcement of US Department of Veterans Affair Bracytherapy Safety Standards. In his opening remarks, Chair Mitchell observed:

Brachytherapy is a form of radio therapy, often used to treat prostate cancer, in which radioactive seeds are placed inside or next to a patient's malignancy. Failure to accurately place the radioactive seeds can cause serious harm. To say that it is disturbing to learn that veterans received bungled procedures and that safety protocols failed to safeguard against such mistreatment would be an understatement. As a result, we are hear today to examine system-wide safety standards for these procedures to ensure that our veterans are receiving the best and safest care available.

Mitchell explained that there were four VA brachytherapy programs which were suspended (Cincinatti, Washington and Jackson, Mississippi) and that "we know that Philadelphia was by far the worst." The hearing was composed of three panels and the first panel had the witness of greatest interest, Dr. Gary Kao who no longer works for the VA after his repeated errors. In his opening statement, he decried "some very serious false allegations that have appeared in the media about me" (in his written statement he decries the reports on himself "in recent publications, most notably the New York Times"). He sneared at the term "92 botched cases" -- insisting this was a mischaracterization and that reported incidents to the Nuclear Regulatory Commission, the VA's radiation safety program, did not mean "botched cases" or even that anything was wrong. Apparently, Dr. Kao believes, it's just a little candy heart that says "BE MY VALENTINE" on it. Kao apparently slid one over to the Ranking Member, US House Rep Phil Roe (Republican), who decried the New York Times efforts to "sensationalize" the issue. Roe apparently doesn't read, we've cited two papers above, those were not the only ones reporting on the problems.

The first panel was Kao, Dr. Steven M Hahn, Dr. Michael R. Bieda -- all of the University of Pennsylvania's School of Medicine. Kao is offended that the "botched" incidents are associated with him because he has never, ever had a medical malpractice law suit against him. Damn lucky. Most doctors plant a treatment in a liver by mistake (and botch the follow up procedure as well), they'd be sued. When his colleague, Hahn, was offering his opening remarks and got to wanting "to express my deppest regret that prostate cancer patients receiving brachytherapy at the Philadelphia Veterans Affairs Medical Center," Kao nearly dropped the pitcher he was holding to pour himself a glass of water.
For any wondering, Kao expressed no such regret in his opening statements which were all about (a) how great he was and (b) how wronged he'd been by the press. He expressed no sadness or regret for any of the veterans harmed by the 'treatment' they received (eighty of the 92 botched cases were his, according to statements made in the hearing by subcommittee members).

Chair Harry Mitchell: First can you please explain the quality of care provided at the VA compared to the quality of care at other facilities you've worked at?

Dr. Gary Kao: The-the brachytherapy procedure that we adopted at the VA was, um, identical to the system that was used at uh-uh other -- at the University of Pennsylvania and also, um, one of its satellites. Um, and in my training, in fact, um, I went to observe, uh, brachytherapy procedures performed in, um, our satellite in, um, in Trenton, New Jersey. And, uh, as a resident, I-I was trained, um, in brachytherapy by senior physicians at, uh, the University of Pennsylvania

Chair Harry Mitchell: Uh, what quality of care matrix do other facilites follow?

Dr. Gary Kao: My-my understanding is that, um, the quality [long pause] control -- the quality assurance procedures are similar in that a CT is performed after the procedure and, uh, the symetry calculated, uh, from that CT.

Chair Harry Mitchell: And the last one I have, what markers are red flags when conducting the brachytherapy procedures indicated a problem?

Dr. Gary Kao: I-I now understand that, uh, [long pause] one-one of my regrets is that, um, I could have been, um, much more assertive in engaging the NRC in what it defines as a reportable medical event. Um, at -- as a result of their investigation in 2003 and 2005, we-we were, uh, under the understanding that the definition of a reportable medical event was based on the number of seeds laying outside the prostate. Um, subsequently, I-I-I, I wuh -- I was, um, I found out that that, uh, was not the case, that the NRC, um, uh, apparently is now relying on a D90 metric and that is something that, um, to my regret, I-I could have been much more, uh, much more [long pause] focused on using that metric.

It would take repeated questioning and intense pressing of the issue for Kao to express any regret at all for the patients he was supposed to be caring for. We'll note US House the questioning from US House Rep John Adler (New Jersey).

US House Rep John Adler: I guess my first question is for Dr. Kao. We've heard about, um, the closure of this program in June of 2008. We've heard about possibly 92 cases out of 116 with some concern. Some of us use the word "botched," you don't like that word. We've heard that the National Health Physics program reported to the NRC at least 35 medical events later in 2008. We heard Dr. Hahn just now acknowledge on behalf of U Penn that not every -- not in every instance did every patient get the best possible care. This program is still closed. You were running this program. You were the principle operative of this program at the VA in Philadelphia. How do you reconicle your view in your own testimony here today that patients received appropriate medical care with the VA's view that it made mistakes during this period of years, with U Penn's recognition that not every patient got the best possible care, um, with NHP and NRC saying there are medical events even in a context where we probably don't define medical event suffientilly to trigger reporting to the extent that we would want reporting? So let's assume there's some under-reporting going on. Even with under-reporting, we've got at least 35 instances from 2008, um, reported about, over a period of time, a program you ran. I'm thinking you're in a dream world right now. I'm thinking everybody else, all the other experts, are looking at this and saying, he didn't go well enough, that whether the number is 92 or less than 92, we want the number to be zero botched cases. How do you reconcile your view that every patient received appropriate medical care with the view of every other expert, of every potential supervisor, every contracting body, every regulatory body. Um, I kind of want to hear you acknowledge you did things less well than you would have wanted to have done.

Dr. Gary Kao: Sir, I, um, I don't disagree with, um, many of the other comments that-that were made. Uh, um, medicine is both an art and a science and the art of it is that, uh, even though the treatment may be effective it may be made to be even more optirmal essential, uh, theme here is [long pause] uh, what -- what is defined as a reportable medical event. An even -- a case that is a reportable medical event does not mean that the patient was harmed or did not receive effective treatment. Um, when the program was closed in 2008, we did not have any confirmed cases of tumor recurrence. Um, the NRC itself recognizes that a reportable medical event does not mean, uh, that -- does not address the ethicacy of the treatment. So-so, uh, in summary, there are -- I recognize there are many things -- several things that I could have done better, uh, but I still believe that the patients received the standard of care that was, um, in place at the time.

US House Rep John Adler: I'm just seeing it differently than you are, I guess. I understand from some news reports that it was at least a period of a year where you were not getting, um, post-implant dosimetry information to guage whether the patients had the seeds placed properly and that the seeds had stayed where you'd want them to be. Is it true that there was a year where you did not have that post-implant dosimetry information?

Dr. Gary Kao: It-it is true that [short pause] for a period of about 14 months there was a computer interface problem, uh, at the VA that, um, although the CTs that could be performed after the brachytherapy but that data could not be transmitted to the VariSeed work station used to calculate the doses. During that time, I followed the chain of command. I complained to radiation safety, to the chair of the department, uh, and, uh, other members of the program did the same but this problem was never fixed. I was then faced with the very difficult choice of either stopping the program -- but if I had done so, then the patients would not have received any care. As I mentioned earlier, many of the patients who came to us, uh, did not have re- surgery or other forms of radiation as a choice. So given the choice between delivering no care and having their cancers progress or to p -- go ahead and perform the procedure, I made that decision. I could still see from the CT that the seeds were in the prostate and I could judge that the seeds were concentrated around, uh, part of the prostate where the cancer was located. So the -- these gave me a measure of confidence that the patients were-were being appropriately treated but it is -- you're correct, sir, that is one of my regrets that I should have broken the chain of command, I should have been more assertive, I should have stopped the program at that point.

US House Rep John Adler: What number would you say was the number of patients who didn't get adequate care? The total you did was 116. Of that number what would you say? I've heard numbers 57, 35 and 92. What number would you say was the number?

Dr. Gary Kao: Sir, since 2008, I have not had access to the patient records but I believe based on the calculations that our team performed before it was shut down that the cases were far fewer, uh, and, um, probably closer to, uh, 20 or uh-uh cases that were reported -- that were [short pause] defined as medical-medical events. But-but-but again, what a case that is defined as a medical event does not mean that the treatment was not effective, sir.

Throughout the hearing, Kao repeatedly shot daggers at Hahn who, sincere or not, stated what Kao refused to. Such as following the above when Hahn interjected, "And let me just say that even if it were just one human being who did not receive the best possible care, Congressman Adler, that would be unacceptable." US House Rep Timothy Walz found Hahn sincere and noted that in his remarks.

The second panel was composed of Dr. Paul Schyve of The Joint Commission, Dr. Robert Lee (American Society for Radiation Oncology) and Steven A. Reynolds (Nuclear Regulatory Commission). From that panel, we'll note NRC's Steven Reynolds on the issue of medical event. Kao wanted to repeatedly argue what the meaning was. The NRC is the one defining. Reynolds explained that the term "misadministration" had been in use prior to 2002 and was then replaced with "medical event." What does that mean? He defined it as meaning "that the radioactive material or the radiation from the material, was not delivered as directed by the physician." That definition easily translates as "botched." When something is "not delivered as directed by the physicians," it was botched.

The third panel was composed of Joseph Williams Jr. (VA), Dr. Michael Hagan (VA), E. Lynn McGuire (VA), Michael Moreland (VA), Richard Whittington (VA) and Kent Wallner (VA). We're not noting titles. Reading off the non-medical titles of one panelist, Chair Mitchell asked, "Can they put that all in a name tag? Woo." Mr. Williams would lament that the Philadelphia VA "did not deliver the intended dose".

[. . .]

Military propaganda makes it on air in the US and is disguised as news. At least two Wisconsin TV stations have aired military propaganda with one putting their own reporter over it (Jeff Alexander) to read the military's copy. Madison Wisconsin's WKOWTV offers a pure propangada look (video report) at the US run Iraqi prision Camp Cropper. It tells you that terrorists and criminals are in the prison. It forgets to tell you that no one's been tried. It forgets to tell you that at least six prisoners have died or that the Red Cross has documented abuses at the prison. But it does run it as is. Meaning the report ends with the announcer of the footage declaring, "Army Sgt. Frank Morello, Joint Area Support Group, Public Affairs." An ABC affiliate wanted to air the propaganda but they wanted to present it as a news report created within the station. What to do, what to do? Oh, I know! Let's take Morello's exact words and let's have our own Jeff Alexander read them. Let's have him step before the camera in the studio and then go to the military's footage while Jeff narrates, then we'll cut to him at the end and he'll do a wrap up and we'll let viewers think that Jeff actually reported this. As opposed to letting them know that the footage and every word spoken was from the US military. Which is how Green Bay's WBAY promotes the propagndad insisting, as they toss to Jeff, that this is "a rare behind the scenes look at their mission is our top story on Action Two News at Four." Their top story is one they didn't even film? Their top story is one they didn't even write? How pathetic is WBAY and where do they get off lying to viewers?They've put Jeff Alexander's voice over on top of Morello's and presented this as their own report. That's outrageous. That's shameful and it violates every rule of journalism. Jeff Alexander, as the on air, should be fired as should every one responsible for that segment making it on air and an on-air apology should be made to viewers.These aren't the only two stations airing this. You should look for it if you're in Wisconsin, this 'inside look' at Camp Cropper. Fox 11 at least had the good sense to state before airing the footage that it was produced by the US military, "Tuesday the military released video of the Camp Cropper, along with interviews from some Wisconsin soldiers working there." They should have noted, however, that their own Becky DeVries was reading the copy that the US military wrote with just a few variations.

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