| VA'S PROSTATE
CANCER DOC SAYS HE'S NO "ROGUE"
Dr. Gary Kao, who botched prostate
cancer treatments at the Philly VA, says the mistakes he made are
not uncommon.
NOTE from
Larry Scott, VA Watchdog dot Org
... Dr. Gary Kao says he will
not be made a scapegoat for problems that belong to the VA
system at the Philly prostate cancer treatment program. Kao
also claims that
The New York Times article about him is nothing more
than false allegations. The Senate Committee on Veterans'
Affairs held a field hearing to look into this matter (links are
to prepared testimony and they are all worth reading):
Panel I
Panel II
Panel III
Below are two brief articles
about the hearing, followed by Dr. Kao's prepared testimony.
For a complete history of this debacle with backlinks,
click here.
-------------------------
Pa. doc at center of VA cancer probe admits errors
By MARYCLAIRE DALE
The Associated Press
 PHILADELPHIA
-- A radiation oncologist is fighting accusations he botched
dozens of prostate surgeries at a Veterans Administration hospital
in Philadelphia.
Dr. Gary Kao (KAY'-oh) admits he sometimes missed his target when
placing radioactive seeds or gave patients the wrong dosage. But
he says that is not uncommon.
Kao's voluntary testimony came at a congressional hearing Monday
on prostate surgery problems at the VA hospital.
Kao embraced one patient and apologized. The man says he spent
months in bed after Kao implanted seeds into his rectum instead of
his prostate.
The Nuclear Regulatory Commission says 92 veterans received
incorrect radiation doses at the hospital over a three-year
period, often because seeds were implanted in the wrong places.
-------------------------
Pa. doc in VA probe says cancer field evolving
PHILADELPHIA (AP) — An oncologist blamed for botching cancer
treatments at the Philadelphia Veterans Affairs Medical Center
says he's not the rogue physician he's been portrayed to be.
Dr. Gary Kao is testifying at a congressional hearing at the
medical center in Philadelphia. He says the prostate cancer
treatment, which involves implanting radioactive seeds, "was and
still is an evolving field."
According to a Nuclear Regulatory Commission report, 92 veterans
received incorrect radiation doses at the hospital over a
three-year period. Some patients had seeds implanted in the wrong
places.
Kao says he was instrumental in setting up the program and never
falsified results or covered up mistakes.
U.S. Sen. Arlen Specter, a cancer survivor, called Monday's
hearing.
-------------------------
STATEMENT OF GARY KAO, M.D., Ph.D.
SUBMITTED TO
THE HEARING OF THE SENATE COMMITTEE OF
VETERANS' AFFAIRS
PHILADELPHIA VA MEDICAL CENTER
PHILADELPHIA, PA
JUNE 29, 2009
Introduction
I became a doctor because of my desire to help people. I am and
always have considered myself to be a compassionate dedicated
physician who prides himself in taking care of his patients. I
have never knowingly hurt any of my patients and my record shows
that to be true - I am proud that I have not had a single
malpractice claim filed against me in fifteen years of continuous
clinical practice. In 1984 1 graduated from Johns Hopkins
University with a Bachelor of Arts in Philosophy and graduated in
1988 as a Medical Doctor from the Johns Hopkins School of
Medicine. I completed two years of Internal Medicine Residency
followed by completion of a Residency in Radiation Oncology, all
at the University of Pennsylvania School of Medicine ("Penn"). I
have been Board Certified in Radiation Oncology since 1994, and an
Attending Physician at Penn since that time. I am also a member of
American Society for Therapeutic Radiation Oncology.
In order to gain additional expertise in anticancer treatment, I
completed a doctoral dissertation at Penn in Molecular Biology,
which 1 successfully defended in 1998 and was awarded a Ph.D. from
Penn in Molecular Biology. While still on staff at Penn, I
completed a Postdoctoral Fellowship at the Fox Chase Cancer Center
in 2002. Shortly after completing my Fellowship, I was assigned to
the Philadelphia Veterans Affairs Medical Center ("PVAMC") and
then became a full-time staff member of the PVAMC. I was asked by
the PVAMC to start a brachytherapy program at the PVAMC and was
proud to have earned this honor. I accepted the responsibility and
worked hard with others at the PVAMC to develop a top notch
program in this evolving area of medicine. I remained a PVAMC
staff physician in Radiation Oncology continuously until the
beginning of 2008.
Given all that I have worked so hard to achieve and my commitment
to patient care, I was devastated, personally and professionally,
by the false allegations published in the New York Times on
Father's Day, branding me as a "rogue doctor" who had covered up
mistakes and operated in isolation and without supervision. Never
in my career have I ever falsified any medical records and never
have I participated in a cover-up.
On the contrary, what happened at the PVAMC in connection with the
brachytherapy program is in no way what has been depicted by the
New York Times article. The truth is that the Prostate
Brachytherapy team at the PVAMC was a collaborative
interdisciplinary effort that I led, but which was minutely
supervised every step of the way by the Radiation Oncology
Department, the Radiation Safety Office and ultimately by the
Administration of the PVAMC. Under sometimes challenging
circumstances, the Team tried to deliver quality care to veterans,
who would otherwise not have access to treatment.
That is why the malicious allegations against me and the Program
are so deeply hurtful. So too is the claim that I operated on my
own, without supervision and without guidance. The falsity of that
allegation is easily demonstrated because there was a standard
operating procedure for the administration of brachytherapy. The
procedure was codified in a Prostate Brachytherapy Algorithm that
was jointly created by Radiation Oncology, Medical Physics,
Urology, Radiation Safety and Nursing and disseminated to and
approved by all levels of the PVAMC Administration. This Algorithm
was constantly reviewed and revised as our Team gained more
expertise in delivering care to our patients. The Algorithm
established a consensus, providing structure for a procedure that
had no precedence or guiding standards at the PVAMC when I was
asked to help start this Program. Each brachytherapy patient
treated by me or any other physician at the PVAMC was cared for
according to the SOP established by Algorithm.
The following points address specific aspects in greater detail:
1. The PVAMC Prostate Brachytherapy Program was a
multidisciplinary collaboration.
The members of the Brachytherapy Team consisted of:
i. Radiation Oncology
ii. Urology
iii. Radiation Safety
iv. Medical Physics
v. Nursing/ Program Coordinator
vi. Administration
The program was supervised by Radiation Safety. I was not a member
of the Radiation Safety Committee and was not invited to attend
meetings of the Committee.
2. The PVAMC Brachytherapy Program team members received the
necessary training for Prostate Brachytherapy.
a. As a resident physician, I was taught prostate brachytherapy at
Penn by senior attending physicians.
b. I completed the same Prostate Brachytherapy course in Seattle,
WA at the Northwest Hospital that others from the PVAMC also
attended.
c. We observed the Prostate Brachytherapy Program at the Mercer
Hospital affiliate of the Department of Radiation Oncology in
Trenton, NJ, a program that also utilized the preloaded method of
brachytherapy.
d. I was proctored in the performing of my first ten Brachytherapy
cases at the PVAMC by experienced physicians.
e. Other physicians were available for immediate consultation and
additional mentoring.
f. The allegations in the NY Times of a lack of brachytherapy
training or supervision are therefore untrue.
3. I created the protocol for providing brachytherapy treatment
("Algorithm") with collective multidisciplinary input, vetted
through the PVAMC Administration.
a. The absence of standard policy regarding Brachytherapy in the
PVAMC prompted the need for written consensus when the Program was
first created in February 2002.
b. The first version was completed before the first patient was
treated in February 2002, and continuously updated through the
years of the Program.
c. The Algorithm was collaboratively written by all members of the
Brachytherapy Team, and represented our collaborative expertise
regarding the Standard Operating Procedure for providing
brachytherapy.
d. The Algorithm describes those patients for whom brachytherapy
was most suited as well as those for whom the procedure would not
be effective. It also details the steps each patient undergoes
through the Brachytherapy process beginning with the pre-
procedure planning and following through with the actual procedure
and the post-procedure follow up.
e. The Algorithm does not include any reference to reportable
Medical Events as defined by the Nuclear Regulatory Commission
("NRC") because no such definitions existed at the start of the
program.
f. Because the PVAMC served a wide geographical patient
population, the Algorithm recognized that those patients living
far from Philadelphia may have to receive post procedure care at
their local hospitals.
g. The NRC, in its investigation, and the NY Times failed to
mention the existence and purpose of the VA Prostate Brachytherapy
Algorithm.
4. The Initial and Revised Written Directives serve different
purposes.
a. The New York Times article falsely accuses me of altering the
Written Directive.
b. The Written Directive is mandated by the NRC and VA's Office of
Radiation Safety. The forms were designed by Radiation Safety,
completed by both Medical Physics and Radiation Oncology, signed
by the physicians, and processed by Radiation Safety.
c. The Initial Written Directive (WD) specifies the number of
seeds to be ordered by Radiation Safety, i.e. the prescription for
number of seeds. It is completed by the Medical Physicist together
with the Radiation Oncologist physician, who then signs the WD.
d. A copy of the Initial WD is submitted to Radiation Safety,
which places the order of the number of seeds, and then receives
and secures the seeds. The original WD remains in the patient's
medical chart.
e. On the day of the Brachytherapy procedure, Radiation Safety
brings the seeds to the procedure room (adjacent to the OR suite),
remains in the room to supervise the procedure, and to store and
safeguard any seeds that are retrieved by Urology from the bladder
or found outside the patient.
f. Integral to the procedure is the Urologist. Immediately after
the implanting of the seeds, the Urologist, using a cystoscope,
will retrieve any seeds that have either migrated to or been
implanted in the bladder. This action by the Urologist is done in
connection with every procedure since a recognized risk of the
procedure is that seeds will come to rest in the bladder.
g. After the seeds are retrieved by the Urologist, that physician
and Radiation Safety inform the Radiation Oncologist of the number
of seeds that do not remain in the patient. Through this
collaborative process, the Team determines the actual number of
seeds that remain in the patient.
h. Under supervision by Radiation Safety, the Radiation Oncologist
completes the Revised WD that states the actual number of seeds
retained within the patient. The Revised WD is submitted to
Radiation
Safety, and a copy is again placed in the patient's medical chart.
Radiation Safety staff and Urology are present throughout the
brachytherapy procedure.
i. The WD can be revised yet again prior to the discharge of the
patient on the day following the procedure. This revision would
reflect any seeds passed by the patient in his urine while
recovering from the procedure. If there is a second revision, it
too is submitted to Radiation Safety and a copy is retained in the
patient's chart.
j. The procedure described above assures that there is an accurate
count of the disposition of all of the seeds originally ordered by
Radiation Safety for a particular procedure.
k. Given the appropriateness and the different purposes of the
Initial and Revised Written Directives, my handling of the Written
Directives was entirely appropriate and legal. I did not falsify
or erase any Written Directive at any time, contrary to the
allegations of the New York Times, nor was it likely that any
other member of the Team did so. It is for this reason that these
allegations are not only false but scurrilously so.
5. How the Brachytherapy Procedure is performed.
a. The prostate is an organ the size of a walnut and is
immediately adjacent to the bladder and rectum.
b. The procedure performed at the PVAMC was via the Preplanned,
Preloaded Method. This entailed a transrectal ultrasound sizing of
the prostate completed at least two weeks prior to the actual
implant of the seeds. This ultrasound serves as the basis for the
treatment planning which includes determining the number of seeds
and needles required to be ordered by Radiation Safety via the
Initial Written Directive.
c. Informed consent is obtained from the patient, who is counseled
that seeds can migrate away from the prostate, and that up to 5%
of patients may develop complications that include an inflammatory
condition of the rectum known as radiation proctitis.
d. The patient is taken into the procedure room and anesthesia is
induced.
e. Stabilizing needles are inserted.
1. The Urologist places the ultrasound probe, and inserts the
first needle
containing seeds into the prostate, and deposits the seeds
contained within the first needle. This establishes the base of
the prostate, and the deepest extent that all subsequent needles
will reach.
g. The Radiation Oncologist then inserts the remaining needles
following the lead of the Urologist and deposits the remainder of
the seeds.
h. The Urologist then performs the previously mentioned cystoscopy
to scan for and remove any blood clots or seeds from the bladder.
i. Radiation Safety uses a Geiger counter to scan the entire room
and every person leaving the room, to retrieve and store any seeds
not in the patient.
j. Anesthesia is reversed, and patient is moved to recovery.
6. The brachytherapy incident of 2003 was reported to the NRC and
resulted in a thorough investigation.
a. A patient who was implanted on February 3, 2003, had a
significant number of seeds in his bladder. All such seeds were
retrieved by the Urologist.
b. As per standard operating procedure and under the direction of
Radiation Safety, the patient had an Initial WD that specified the
numbers of seeds ordered, and then a revised WD to reflect the
actual number of seeds that were retained within the patient. A
copy of both the Initial and Revised directive was retained by
Radiation Safety, and the original put in the patient's medical
chart.
c. This event was promptly reported to the NRC, who then came to
PVAMC to conduct a full multiday investigation. The NRC ultimately
cleared the Program to resume treating patients.
d. Because the dose of radiation delivered to the prostate was
considered inadequate, a repeat brachytherapy was performed on
March 31, 2003. This was successful in increasing the radiation
dose received by the prostate. There were subsequently no unusual
or unexpected complications or toxicity reported.
e. Contrary to what was alleged by the New York Times, at no time
did I or anyone cover-up the patient's treatment by altering the
Written Directive.
7. The brachytherapy incident of 2005 was reported to the NRC and
resulted in a thorough investigation.
a. A patient was initially seen and accepted for Brachytherapy by
another Radiation Oncologist. I performed the Brachytherapy on
5/19/05. Because of poor imaging quality (due to the patient's
inability to complete the necessary bowel preparation), many seeds
were inserted into the bladder.
b. As per the standard operating procedure and under the direction
of Radiation Safety, the patient had an Initial WD that specified
the numbers of seeds ordered, and then a revised WD to reflect the
actual number of seeds that were retained within the patient. A
copy of both the Initial and Revised directive was retained by
Radiation Safety, and the original put in the patient's medical
chart.
c. During the course of the cystoscopy that is performed after
every brachytherapy, a large number of seeds was retrieved from
the bladder. This fulfilled the definition of a reportable Medical
Event as I understood that definition at that time, and the case
was promptly reported to the NRC. The NRC then came to PVAMC to
conduct a full multiday investigation, and ultimately cleared the
Program to resume treating patients.
d. On re-evaluation of the patient, the consensus among the
Prostate Brachytherapy Team was not to reimplant this patient, as
the patient's limited expected life span rendered the risks
greater than the expected benefit.
e. Contrary to what was alleged by the New York Times, the NRC
performed a thorough investigation of this case.
8. The NRC definition of a reportable Medical Event has evolved
over time and continues to be a subject of debate.
a. There was no NRC definition of a reportable Medical Event when
the Brachytherapy Program was first started at the PVAMC in 2002.
b. The physicians and physicists never received NRC training on
this issue throughout the years the Program was operational.
c. The instruction following the investigation by NRC of the 2003
prostate brachytherapy incident was that "if greater than 20% of
the seeds prescribed were retrieved from the bladder", this would
constitute a reportable Medical Event and would trigger a repeat
NRC investigation.
d. The brachytherapy incident of 2005 was clearly therefore a
reportable Medical Event and appropriately reported.
e. The Prostate Brachytherapy Team was never instructed regarding
D90 (the % of the prescribed dose that 90% of the prostate
receives) as a metric that constitutes a reportable Medical Event.
This means that no one on the Team was advised that if the dose
received by the prostate was 20% greater or 20% less than the
optimal dose it would constitute a Medical Event and would have to
be reported to the NRC.
f. The definition of a medically reportable Medical Event that
consists of a D90 that is either 20% above or below the prescribed
dose was not in existence when the Prostate Brachytherapy Program
was first started, nor was that ever an instruction provided to
the Team.
g. While achieving a D90 that is not over and below 20% of the
prescribed radiation dose rule is an optimal standard to strive
for under NRC guidelines, it does not constitute a clinical
standard of care for brachytherapy treatment. Indeed, recent
articles published in the medical literature suggest treatment may
be appropriate even when the D90 is less than 80%. I am happy to
provide copies of those articles to the Committee should it wish
to review them.
9. I have never ordered the wrong seed strength.
a. My cases have been standardized on the 0.509 mCi seed strength.
b. The discrepancy between 0.380 mCi and 0.509 mCi seed strengths
that are mentioned in the NRC Inspection Report of March 30, 2009
involved prostate brachytherapy cases at the PVAMC that did not
involve my patients.
c. The discrepancy between the seed strengths calculated and
actually ordered was discovered by Radiation Safety and reported
to the NRC.
10. The dose to the rectum has not been defined as a reportable
Medical Event by the NRC.
a. As already stated, and as counseled in every consent form,
radiation proctitis is a known and recognized risk of
brachytherapy.
b. Given the close proximity of the rectum to the prostate,
brachytherapy cannot be performed in a way that avoids dose to the
rectum. In fact, every seed implanted in the prostate delivers
radiation dose to the rectum, since the prostate is immediately
adjacent to the rectum.
c. The dose to the rectum was not a metric that either PVAMC
Radiation Safety or the NRC requested that we measure.
11. Despite the lack of computer interface between the CT scanner
and the Variseed treatment planning workstation during 2006-2007,
I provided effective treatment to my patients.
a. At the conclusion of a procedure, a CT scan is done to
determine the location of the seeds.
b. The images of the CT scan are then transferred to a workstation
that contains the software program called Variseed and which
calculates the dose actually received.
c. In or around November 2006 a computer interface problem between
the CT scanner and the workstation containing the Variseed
software occurred that prevented the precise calculation of doses
of radiation.
d. I reported this issue on several occasions to the appropriate
persons overseeing the Program, but the problem persisted.
e. I offered to take the CT scans on disk or flash drive to Penn
to perform the Variseed calculations. However this was refused by
the PVAMC due to confidentiality/ privacy/ security concerns.
f. CT images however were still viewable and showed the location
of the seeds, all of which were concentrated in areas of the
prostate that contained cancer.
g. I had only two choices: to stop the Brachytherapy Program, or
to continue to deliver medical care which the patients needed.
Most of the patients treated for Brachytherapy did not have the
option of alternative treatments such as surgery or external beam
radiation. External beam radiation would have required the
patients to be treated on a daily basis, five days a week, for
eight weeks, Surgery also had serious drawbacks including
incontinence and impotence. Without brachytherapy, the patients'
cancers would have gone untreated.
h. I elected to continue treatment based on concern for the
patients' welfare.
i. The treatment was effective and well within the standard of
care and was effective. The proof of the effectiveness was
demonstrated in follow up visits with the patients and evaluation
of their PSA levels.
12. There were a number of systematic failures at the PVAMC that
affected the Brachytherapy Program.
a. Prior to the development of the PVAMC Prostate Brachytherapy
Program, there were no guidelines or policies for the design and
operation of a VA brachytherapy program. Consequently, the
Brachytherapy Team had to design its own set of procedures and
policies, which led to the creation of the Prostate Brachytherapy
Algorithm.
b. When the Brachytherapy Program was first started, there was no
standard definition of what is a reportable Medical Event.
c. There was no system to train key members of the Brachytherapy
Program on what later became a definition of a reportable Medical
Event.
d. There was no full time medical physicist dedicated to the
brachytherapy program. This impacted on the ability to timely
calculate the dose received by the patients.
e. The lack of a computer interface between the CT scanner and the
Variseed dose calculation workstation prevented the precise
calculation of the doses of radiation received by the patient.
f. There was no mechanism by which concerns regarding key steps of
the procedure could bypass the chain of command to solve problems,
such as the computer interface problem.
g. Understandable concerns about patient confidentiality prevented
the alternative transport of data from the CT scanner via memory
storage media and devices.
13. To address some of these concerns, the Brachytherapy Program
was in the process of moving from Preloaded to Real-time Treatment
Systems.
a. The members of the Brachytherapy Program recognized the
drawbacks of the Preloaded Brachytherapy System, such as the
inability to customize the placement of the seeds to match the
patient's actual anatomy.
b. Consequently, members of the Team were in the process of
receiving training in the Real-time Treatment System, which does
account for changes in the patient's anatomy and which includes
continuous fluoroscopic verification of the location of the
deposited seeds.
c. Real-time treatment would allow for the seeds to be customized
to the prostate on the day of the procedure.
d. The Brachytherapy Program was halted before the change in
Treatment approach could be implemented.
14. During a meeting of the Advisory Committee on the Medical Uses
of Isotopes of the NRC, held in Rockville, Md. on May 7, 2009, it
was falsely alleged that a key physician of the Brachytherapy
Program had made certain statements and actions ("Committee
Meeting Transcript"). Inflammatory statements and actions were
falsely attributed to this member of the Prostate Brachytherapy
Program, including:
i. "The physician that did this particular implant, once again, he
felt that the 24 Gray was clinically acceptable." Committee
Meeting Transcript at page 192.
ii. "And if he felt that 24 Gray was satisfactory, that is the way
it was." Committee Meeting Transcript at page 192.
iii. "Well, one of the things that we noticed was that the
physician that was primarily involved in the brachytherapy
program, he consistently did this. They didn't use fluoroscopy
during seed placement. He refused to use fluoroscopy, said he
didn't need it." Committee Meeting Transcript at page 204.
iv. "-- yes, 2002, and -- but from the time the physician had
received training to the time they started the implant program,
there was some delay. And there was no -- there was no effort on
the part of the physician to maybe proctor or observe or be
involved with some implants before they decided to go and proceed
and treat their first patient.... that was a decision that was
made by the Authorized User". Committee Meeting Transcript at page
221.
v. "No. According to him, it was clinically acceptable. As a
matter of fact, his exact words are, "43 Gray is better than zero
Gray."" Committee Meeting Transcript at page 241.
vi. "But it is mindboggling to me that a physician could say that
a dose of 40 Gray, 24 Gray, is acceptable, and then look at these
implants and not realize that this is gross incompetence."
Committee Meeting Transcript at page 243.
a. These inflammatory actions and statements that are being
attributed to a key physician are being attributed to me, but are
not accurate. I neither said these statements nor took the actions
described.
b. These false attributions are appropriately alarming and
inflamed the subsequent discussions of the Committee.
Conclusion
I have come to the hearing today to answer questions and to submit
this written statement in order to correct the record and salvage
my reputation. I hope that, through the hearing process, the
investigations and through media reports, the truth will emerge. I
am not the physician who has been portrayed in the media. 1 am not
willing to be the scapegoat for the complex, systematic problems
that affected the Brachytherapy Program at the PVAMC. I hope that
the information I have provided today will help the Committee
understand my role and responsibilities in developing and
directing the Brachytherapy' Program. More importantly, it is also
my hope that this information will help improve future medical
care for veterans.
-------------------------
TOPICS:
veterans, veterans' benefits, VA, Department of Veterans' Affairs,
prostate cancer, Dr. Gary Kao, Philadelphia |
