I have finally watched the entire House Veterans’ Affairs Committee hearing on the prostate brachytherapy program at the Philadelphia VA hospital. You can find the webcast, along with statements for the record, at the committee website. I was pleasantly surprised by the lack of grandstanding by the committee members and their restraint in avoiding getting caught up in issues regarding the larger health care reform debate. There was a direct question to Dr. Kao disputing his point that multiple seeds being placed in the patient’s bladder is a common occurrence and a known risk. While not all of the questions were asked that I would have liked to have answered, the overall direction of the hearing was positive, in my opinion.
Dr. Kao repeated his argument that he made in the previous hearing: just because the NRC states that a medical event occurred during a procedure does not mean that the patient did not receive an acceptable treatment. This is true, but only in the most superficial sense. The NRC definition of a medical event does not, in fact, refer to patient outcome. It only refers to a difference in prescribed dose and the dose the patient actually receives. However, the dose difference that triggers a medical event is chosen specifically because it is at the level at which the possibility of cure or of side effects becomes affected. A similar argument would be if a person who was driving with a blood alcohol level above the legal limit claimed that being over that limit is not the same as having an accident. The argument is true, but the limit is chosen to be at the point at which having an accident is more likely.
Dr. Kao also accused the NRC of making up the dose metrics it used to classify the procedures in question as sub-standard. He claimed that terms such as D90, the dose that 90% of the prostate receives, are nowhere in the NRC’s definition of a medical event. Again, this is superficially true. As I discussed before, the NRC does not have the authority to second guess the decision of a doctor. At least twice before the Philadelphia VA program was shut down, the NRC investigated a procedure but did not take action because Dr. Kao changed his written directive of the procedure’s goals to match what the patient actually received. To avoid this happening for all of the cases in question, the NRC developed certain dose metrics to determine if the patient was given an adequate implant. It is a little ex post facto, but the metrics were based on widespread clinical practice. If they were not met, the chance of a successful treatment were greatly reduced.
Rep. Phil Roe (R – Tenn), a practicing OB/GYN for 31 years, had the most pertinent question. Rep. Roe related a conversation he had with a radiation oncologist colleague who stated that in all the prostate brachytherapy procedures he had performed, he had never placed a seed in the patient’s bladder. He asked how Dr. Kao could reconcile his statement that seeds in the bladder are a recognized risk of the procedure. (Remember, one or two seeds may be a recognized risk, but Dr. Kao placed 40 out of 80 total seeds in the bladder during one procedure.) Dr. Kao did not have a direct answer to this, blaming poor image quality on the ultrasound for the error. When the obvious follow up was asked, why did he not stop the program then, Dr. Kao stated that to do so would have meant that some patients would not have received any care at all. However, even if the patients were unable to spend 8-9 weeks receiving external beam treatments, there are numerous clinics in the Philadelphia area who could have performed the brachytherapy procedure.
One question that was not asked was why the VA Information Technology department took over a year to install a network jack to permit post-implant dosimetry. As Dr. Silverstein feared, IT got a complete pass in this hearing. There were a few statements to the effect that these events could have happened in any hospital. This is unfortunately true; many hospitals have IT groups that are not responsive to vital patient concerns. However, this does not excuse the behavior of IT at the Philadelphia VA. As Dr. Silverstein writes, “multiple people failed here, including executives, physicians, safety officers, etc. I believe responsibility needs to be fairly assigned. However, IT needs to be included.”
I’m not sure where the debate goes from here. Probably, the NRC will come out with new guidelines and better standards for reporting of dosimetric data. I think more emphasis will be made on peer review, and accrediting organizations such as the Joint Commission and the ACR will expect to see evidence of that review. The VA will, I’m sure, take a hard look at the outside contractors brought in to provide treatment. However, in regards to the specific situation at the Philadelphia VA, I expect to see nothing more except the inevitable malpractice suits. Issues that should have been explored more thoroughly, like the failures of the IT department, will not get their fair hearing. I think that the radiation therapy community as a whole has learned a valuable lesson, though. One that should have already been apparent: triple check everything.
