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Enforcement of the U.S. Department of Veterans Affairs' Brachytherapy Program Safety Standards.

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ENFORCEMENT OF THE U.S. DEPARTMENT OF VETERANS AFFAIRS' BRACHYTHERAPY PROGRAM SAFETY STANDARDS

 



 HEARING

BEFORE  THE

SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

OF THE

COMMITTEE ON VETERANS' AFFAIRS

U.S. HOUSE OF REPRESENTATIVES

ONE HUNDRED ELEVENTH CONGRESS

FIRST SESSION


JULY 22, 2009


SERIAL No. 111-36


Printed for the use of the Committee on Veterans' Affairs

 

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COMMITTEE ON VETERANS' AFFAIRS

BOB FILNER, California, Chairman

 

CORRINE BROWN, Florida
VIC SNYDER, Arkansas
MICHAEL H. MICHAUD, Maine
STEPHANIE HERSETH SANDLIN, South Dakota
HARRY E. MITCHELL, Arizona
JOHN J. HALL, New York
DEBORAH L. HALVORSON, Illinois
THOMAS S.P. PERRIELLO, Virginia
HARRY TEAGUE, New Mexico
CIRO D. RODRIGUEZ, Texas
JOE DONNELLY, Indiana
JERRY MCNERNEY, California
ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
ANN KIRKPATRICK, Arizona
GLENN C. NYE, Virginia

STEVE BUYER,  Indiana, Ranking
CLIFF STEARNS, Florida
JERRY MORAN, Kansas
HENRY E. BROWN, JR., South Carolina
JEFF MILLER, Florida
JOHN BOOZMAN, Arkansas
BRIAN P. BILBRAY, California
DOUG LAMBORN, Colorado
GUS M. BILIRAKIS, Florida
VERN BUCHANAN, Florida
DAVID P. ROE, Tennessee

 

 

 

Malcom A. Shorter, Staff Director


SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS
HARRY E. MITCHELL, Arizona, Chairman

ZACHARY T. SPACE, Ohio
TIMOTHY J. WALZ, Minnesota
JOHN H. ADLER, New Jersey
JOHN J. HALL, New York
DAVID P. ROE, Tennessee, Ranking
CLIFF STEARNS, Florida
BRIAN P. BILBRAY, California

Pursuant to clause 2(e)(4) of Rule XI of the Rules of the House, public hearing records of the Committee on Veterans' Affairs are also published in electronic form. The printed hearing record remains the official version. Because electronic submissions are used to prepare both printed and electronic versions of the hearing record, the process of converting between various electronic formats may introduce unintentional errors or omissions. Such occurrences are inherent in the current publication process and should diminish as the process is further refined.

 

       

C O N T E N T S
July 22, 2009


Enforcement of the U.S. Department of Veterans Affairs' Brachytherapy Program Safety Standards

OPENING STATEMENTS

Chairman Harry E. Mitchell
    Prepared statement of Chairman Mitchell
Hon. David P. Roe, Ranking Republican Member
    Prepared statement of Congressman Roe
Hon. John H. Adler
Hon. John J. Hall
Hon. Chaka Fattah


WITNESSES

United States Nuclear Regulatory Commission, Steven A. Reynolds, Director, Division of Nuclear Materials Safety Region III
    Prepared statement of Mr. Reynolds
U.S. Department of Veterans Affairs, Joseph A. Williams, Jr., RN, BSN, MPM, Assistant Deputy Under Secretary for Health for Operations and Management, Veterans Health Administration
    Prepared statement of Mr. Williams


Bieda, Michael R., M.S., Clinical Chief, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania, School of Medicine, Philadelphia, PA
    Prepared statement of Mr. Bieda
Hahn, Stephen M., M.D., Henry K. Pancoast Professor and Chair, Department of Radiation Oncology, University of Pennsylvania, School of Medicine, Philadelphia, PA
    Prepared statement of Dr. Hahn
Kao, Gary D., M.D., Ph.D., Associate Professor of Radiation Oncology, Department of Radiation Oncology, University of Pennsylvania, School of Medicine, Philadelphia, PA
    Prepared statement of Dr. Kao
American Society for Radiation Oncology, W. Robert Lee, M.D., M.S., M.Ed., Professor, Department of Radiation Oncology, Duke University, School of Medicine, Durham, NC
    Prepared statement of Dr. Lee
The Joint Commission, Paul M. Schyve, M.D., Senior Vice President
    Prepared statement of Dr. Schyve


SUBMISSIONS FOR THE RECORD

Desobry, Gregory E., Ph.D., Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania, School of Medicine, Philadelphia, PA, statement
Lazarescu, George, Ph.D., Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania, School of Medicine, Philadelphia, PA, statement
Stearns, Hon. Cliff, a Representative in Congress from the State of Florida, statement


ENFORCEMENT OF THE U.S. DEPARTMENT OF VETERANS AFFAIRS' BRACHYTHERAPY PROGRAM SAFETY STANDARDS


Wednesday, July 22, 2009
U. S. House of Representatives,
Subcommittee on Oversight and Investigations,
Committee on Veterans' Affairs,
Washington, DC.

The Subcommittee met, pursuant to notice, at 10:00 a.m., in Room 334, Cannon House Office Building, Hon. Harry E. Mitchell [Chairman of the Subcommittee] presiding.

Present:  Representatives Mitchell, Walz, Adler, Hall, and Roe.

Also Present:  Representative Fattah.

OPENING STATEMENT OF CHAIRMAN MITCHELL

Mr. MITCHELL.  Good morning, and welcome to the Subcommittee on Oversight Investigations Hearing on Enforcement of U.S. Department of Veterans Affairs' (VA's) Brachytherapy Program Safety Standards.  This is July 22, 2009, and this hearing will come to order. 

I ask unanimous consent that Mr. Fattah of Pennsylvania be invited to sit at the dais for the Subcommittee hearing today.  Hearing no objection so ordered.  Mr. Fattah, you are invited when you do come in, to come up to the dais.

I would like to thank everyone for attending today's Oversight and Investigations Subcommittee Hearing entitled, Enforcement of U.S. Department of Veterans Affairs' Brachytherapy Safety Standards.  Thank you especially to our witnesses for testifying today.

All Members of this Subcommittee take particular interest in this issue, as well as the care of our Nation's veterans; however, I would like to especially thank Congressman John Adler of New Jersey for being such a passionate advocate for this issue. 

Reports of botched prostate cancer procedures, a lack of quality and standard controls in the VA health care system, and egregious errors in the brachytherapy treatment at the Philadelphia VA Medical Center are unacceptable and wrong.

Brachytherapy is a form of radiotherapy 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 damage.  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 here today to examine the system-wide safety standards for these procedures to ensure that our veterans are receiving the best and safest care possible. 

In 2003 and 2005, the Nuclear Regulatory Commission (NRC) received reports of botched placement of radioactive seeds and inconsistent dosages at the Philadelphia VA Medical Center.  After careful review, it was determined that no NRC protocols were violated. 

In May of last year, the NRC received a notification of potential under dosing at the Philadelphia VA Center.  This led to a VA Hospital Health Physics Program inspection evaluating all the 116 brachytherapy treatments that took place since the creation of the program in 2002.

The New York Times reported last month that investigators for the Nuclear Regulatory Commission and VA officials found that 92 of the 116 men treated at the VA Medical Center in Philadelphia's brachytherapy program received incorrect doses of radiation seeds, often because they landed in nearby organs or surrounding tissue rather than the prostate.

Dr. Gary Kao, who is here today at this hearing, performed the majority of the procedures under a VA contract with the University of Pennsylvania where he was on staff.  Out of the four suspended brachytherapy programs, we know that Philadelphia was by the far the worst.

On top of this, in March of this year the NRC issued a detailed inspection report citing the Philadelphia VA Medical Center with six violations of NRC regulations.  This is downright unacceptable. 

While we are disturbed that perhaps there was a lack of proper local quality controls and management of these brachytherapy programs, our main concern is that the problem marring the program in Philadelphia could be happening at the other nine facilities still doing these procedures.  As such, we have asked the VA Office of Inspector General  (OIG) to review and assess the VA's brachytherapy programs, and although the complete NRC inspection report on the Philadelphia program, along with the other VA facilities using brachytherapy treatments, as well as the National Health Physics Program (NHPP) performance is not complete, we look forward to reading that report when it becomes available.

Though it is commendable that VA's leadership took swift action once these issues were reported, it is still troubling that it took almost 6 years for these events to actually be reported.  Even more troubling is just last month we were here discussing quality control and lack of proper procedures and oversight of endoscopy procedures being conducted by the VA, yet we are here again questioning the quality of care our veterans receive.

The VA health system relies upon a complementary system of accountability to identify quality control problems throughout the entire system and at individual levels.  Failure to ensure consistent oversight and safe treatment is unacceptable and wrong.

I am anxious to hear VA assurances not only to this Subcommittee, but to all the veterans they serve, that the issues identified once a thorough review has been conducted is not occurring at any of the remaining brachytherapy programs across the country, and that the four suspended programs may continue to deliver this important treatment to our veterans.

Lastly, I am equally interested in hearing from one of one our witnesses, Dr. Kao, regarding all allegations of erratic seed placements, as well as experts we have invited to provide their thoughts on the safety and effectiveness of the treatment.

Thank you again to all of our witnesses who are testifying today and we look forward to your testimony.

And before I recognize the Ranking Republican Member for his remarks I would like to swear in our witnesses.  I ask that all witnesses from all three panels to please stand.  Please raise your right hand.

[Witnesses sworn.]

Thank you.  I now recognize Dr. Roe for opening remarks.

[The prepared statement of Chairman Mitchell appears in Appendix.]

OPENING STATEMENT OF HON. DAVID P. ROE

Mr. ROE.  Thank you, Mr. Chairman, other Committee Members for being here today, I appreciate you holding this hearing. 

The issue we should really be addressing today is not only the instance of alleged medical malfeasance by one particular medical practitioner, but whether or not this is a symptom of an overreaching patient safety issue across the entire VA. 

Just last month, as the Chairman mentioned we held a hearing on the problems relating to cleaning and reprocessing of endoscopic equipment at the VA.  Now we are hearing testimony today to discuss problems with brachytherapy treatments at the VA Medical Center in Philadelphia.

Prostate cancer is a major problem for adults over 50 in the United States, and brachytherapy is an important tool used by oncologists to treat prostate and other cancers.  The VA treats about 575 veterans annually with low dose brachytherapy at 13 centers nationwide. 

We need to tread cautiously today.  We are here to hear testimony from the VA and other officials.  We need to keep in mind the good quality care most veterans seem to be receiving in VA medical facilities and not seek to undermine the confidence veterans have in going to the VA for their health care needs. 

That being said, I am gravely concerned that these issues continue to crop up in the news media.  VA needs to do a better job at policing itself before they let the New York Times sensationalize an issue in order to break the public's trust. 

Mr. Chairman, protection of our Nation's veterans who look at the VA for their care of a primary importance.  To hear continual reports of various health issues such as an endoscopic cleaning issue last month and now the problem with brachytherapy at select facilities is worrisome to me and others on this Committee.  We must continue to ensure that our veterans receive the best possible care available. 

I look forward to hearing the testimony from today's witnesses.  And once again, Mr. Chairman, thank you for holding this hearing.  I yield back my time.

[The prepared statement of Congressman Roe appears in the Appendix.]

Mr. MITCHELL.  Thank you, Dr. Roe.  At this time I would like to recognize Mr. Adler.

OPENING STATEMENT OF HON. JOHN H. ADLER

Mr. ADLER.  I would like to thank Chairman Filner, Chairman Mitchell, the House Veterans Affairs' Committee, and the Subcommittee on Oversight and Investigation for holding today's hearing on the VA's brachytherapy program safety standards.  I would also like to thank our witnesses for agreeing to testify. 

The veterans who sought treatment for prostate cancer at the Philadelphia VA Hospital did not receive the quality health care their selfless service to our country earned them.  The people responsible for administering the substandard medical care in the brachytherapy program let our veterans down and sent the wrong message to young men and women thinking about joining our all volunteer armed forces.

We are here today to evaluate the suspended brachytherapy program at the Philadelphia VA Hospital who have treated prostate cancer patients from 2002 until the program was forced to close in June 2008, and also to evaluate the VA's broader brachytherapy program safety standards. 

News reports have depicted a rogue cancer unit and a rogue physician who botched nearly 80 percent of the procedures he was contracted to perform on our veterans.  These multiple failures which went undetected year after year highlight significant problems in the VA's oversight system.

Recent newspaper articles highlighted prostate cancer treatment program that operated for 6 years with a glaring lack of oversight that should have been in place to protect our veterans. 

I am outraged.  The brave men who so selflessly served our country have been subjected to such poor treatment and neglect by a hospital and a system that was created to protect them. 

I am further appalled that the routine safeguards that could have been in place to protect our veterans were either woefully inadequate or blatantly absent.  Exposing our veterans to this type of mistreatment is not only unacceptable, it violates the bond our country made with them when they agreed to fight for the safety and security of this Nation. 

We must find and analyze the specific gaps in our system so these failures never happen again in this program, in this hospital, in any program in any VA hospital. 

What occurred at the Philadelphia's VA brachytherapy program is more than just one doctor's incompetence, the Federal Government failed on many levels to protect our veterans. 

The multiple-pronged system currently in place to oversee radiation procedures across the country is not working.  It certainly was not working in Philadelphia.  That is why the VA temporarily or permanently suspended other brachytherapy programs in Cincinnati, Washington, and Jackson, Mississippi.

This hearing is an opportunity to continue our investigation into the failures that resulted in the forced closings of 4 out of 13 brachytherapy programs throughout our country.  We must avoid a recurrence of this problem at all VA medical facilities. 

This hearing is also an opportunity to begin examining the entire VA health care system.  This is a start of an ongoing process to ensure that our veterans are receiving the highest standard of medical care they deserve everywhere in the country. 

I am looking forward to getting some answers from the VA today about what steps they are taking to ensure that the problems of the brachytherapy program in Philadelphia are not repeated elsewhere in the VA health care system.  My hope is that the VA can give our veterans some confidence that the VA system is working to provide the highest level of care. 

I yield back the balance of my time.

Mr. MITCHELL.  Thank you.  Mr. Hall?

OPENING STATEMENT OF HON. JOHN J. HALL

Mr. HALL.  Thank you, Mr. Chairman, and thank you for holding this hearing.  Also, thank you Ranking Member Roe. 

I agree with the comments of Mr. Adler and yourself and the Ranking Member, all of which are complimentary.  Our veterans need to have obviously the best care available to them?and the VA I believe is in the process of trying to correct these problems where they are been identified. 

I am interested in not only answers to what went on and how it can be avoided, these cases of mistreatment or inadequate treatment, possibly harmful treatment to the patients can be avoided, but also your reaction to a New York Times article that came out recently that said that a prostate cancer diagnosis usually offers the patient the choice of five different routes, seed implantation being one of them, and that the most radical and expensive is proton acceleration, the least expensive is watchful waiting, and in between you have the removal of the prostate, radiation therapy, seed implantation, et cetera, and that no statistical difference has been shown yet in any of the studies in terms of lengthening the patient's life, especially if they are diagnosed at 65 years or older. 

So are we in the VA medical system looking at the cost benefit analysis of these various choices of treatment and telling the veteran, the patient, what the choices are and the true statistical fact?it appears to be a fact?that one is not guaranteed a longer life by having one treatment over another? 

So if I may, Mr. Chairman, I will submit a longer statement for the record, but thank you again for holding the hearing and thank our witnesses for their testimony and I yield back.

[No statement was submitted.]

Mr. MITCHELL.  Thank you.  Mr. Walz?

Mr. WALZ.  Well thank you Chairman and Ranking Member for once again holding an important hearing.  I am going to yield back my time so we can get right to our witnesses.

Mr. MITCHELL.  Thank you.  Mr. Fattah?

OPENING STATEMENT OF HON. CHAKA FATTAH

Mr. FATTAH.  Thank you, Mr. Chairman, and let me be brief.  Let me thank the Committee and the Subcommittee for holding this hearing, and I think that it is important that we hear from the witnesses.  When I first heard about this, I was obviously like others, outraged.  Nevertheless, the more you dig into it there is more nuance to it and subtleties to this procedure, and I want us to make sure that we don't do anything to discourage people from seeking treatment. 

I think it would be very helpful to hear from the experts so that we can better understand what happened and where we can go from here.  Specifically, to what degree were there difficulties in what is one of the best VA hospitals in this system, which is in Philadelphia, what was done about it, and where we can go from here.  So thank you, Mr. Chairman.

Mr. MITCHELL.  Thank you.  I ask unanimous consent that all members have 5 legislative days to submit a statement for the record.  Hearing no objection so ordered.

At this time I would like to welcome Panel 1 to the witness table.  Joining us on our first panel is Dr. Gary Kao, Associate Professor in the Department of Radiation Oncology at the University of Pennsylvania.  Also joining us is Dr. Steven Hahn, Professor and Chair of the Department of Radiation Oncology, University of Pennsylvania; Michael Bieda, Clinical Chief in the Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania.  Mr. Bieda is accompanied by Dr. Greg Desobry, Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania; and Dr. George Lazarescu, Medical Physicist, Division of Medical Physics, Department of Radiation Oncology, University of Pennsylvania. 

I ask that all witnesses please stay within 5 minutes for their opening remarks.  Your complete statements will be made part of the hearing record. 

At this time I would like to recognize Dr. Kao, then Dr. Hahn, and Mr. Bieda for up to 5 minutes each. 

Dr. Kao?

STATEMENTS GARY D. KAO, M.D., PH.D., ASSOCIATE PROFESSOR OF RADIATION ONCOLOGY, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; STEPHEN M. HAHN, M.D., HENRY K. PANCOAST PROFESSOR AND CHAIR, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; MICHAEL R. BIEDA, M.S., CLINICAL CHIEF, DIVISION OF MEDICAL PHYSICS, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; ACCOMPANIED BY GREGORY E. DESOBRY , PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA; AND GEORGE LAZARESCU, PH.D., MEDICAL PHYSICIST, DIVISION OF MEDICAL PHYSICS, DEPARTMENT OF RADIATION ONCOLOGY, UNIVERSITY OF PENNSYLVANIA, SCHOOL OF MEDICINE, PHILADELPHIA, PA

STATEMENT OF GARY D. KAO, M.D., PH.D.

Dr. KAO.  Thank you, Congressman Mitchell and other Members of the Subcommittee for the opportunity to appear before you so that we may be heard on this important subject matter and correct some very serious false allegations that have appeared in the media recently about me and the Philadelphia VA brachytherapy program.

I have always worked very hard to best serve the field of radiation oncology and my patients in over 15 years of clinical practice.  My dedication to my work is reflected in my educational achievements earning a bachelors degree in philosophy and a medical doctor degree from the John Hopkins University and its School of Medicine, followed by medical internship and residency, and completion of residency in radiation oncology at the University of Pennsylvania School of Medicine.  This culminated in board certification in Radiation Oncology.  I further earned a second doctorate, a Ph.D., in researching better ways of treating cancer. 

I am especially proud that during continuous clinical practice of medicine for over 15 years I have not had a single malpractice claim filed against me.  My record and my commitment to the care of my patients make the false allegations against me and the brachytherapy program particularly devastating and misguided.

I, along with others at the VA, implemented the program for brachytherapy in 2002 to best serve the interests of veterans.  Contrary to the allegations that I was unsupervised and we were a rogue unit, we developed precise standard operating procedures and a system of oversight and monitoring of what was then a state of the art treatment for prostate cancer.  We formulated the first algorithm of any radiation oncology procedure at the VA to define the standard operating procedure.

As would be expected in any new program the brachytherapy program was not without its challenges.  However, what has become clear over the last month is that a fundamental misunderstanding of elementary principles and concepts has led some to arrive at an inappropriate and incorrect conclusion that deficient care was routinely rendered to veterans who received brachytherapy in Philadelphia.  This was not the case.

To understand why it is important to understand certain critical issues related to the NRC's definition of a reportable medical event and its applicability to our work.  Here are the facts. 

Fact 1:  A standard definition of a reportable medical event as it applies to brachytherapy was not in existence when the program started at the VA.  This definition was not referenced in my training in brachytherapy at the Northwest Hospital in Seattle, nor was it clarified by NRC personnel in their investigations in 2003 and 2005 when they were onsite in Philadelphia. 

The definition that the NRC has now chosen to retroactively apply to all cases of the Philadelphia program is predicated on a deviation from D90, the dose received by 90 percent of the prostate, but this is a definition that does not appear anywhere in the regulations published by the NRC. 

It should also be noted that there is disagreement within the medical community regarding the appropriateness of D90 as a defining metric for overall efficacy of the treatment.

Fact 2:  The definition of a reportable medical event as it applies to brachytherapy is not only unclear, but it is evolving.  The Medical Advisory Committee of the NRC has repeatedly recommended that the definition be changed from one that is dose-based to one that is activity-based, in other words, in the number of seeds.  Last summer, the NRC proposed a rule to change the definition, but the NRC is still using the old unpublished definition to judge the Philadelphia VA's brachytherapy cases.

Fact 3:  Even if a reportable medical event using the D90 based metric occurred, this does not mean the treatment failed the standard of care. 

For example, the treatment of an unusually large prostate may result in a D90 that is under-dosed or a treatment of a small prostate may result in a D90 overdose, but in both cases the treatment could still be appropriate and effective in eradicating the cancer.

Fact 4:  Whether treatment delivered has been consistent with the standard of care should not be determined by whether the treatment resulted in a reportable medical event to the NRC. 

There are many more significant factors that determine appropriate treatment such as number of seeds; location of the seeds in a prostate; location of seeds outside the prostate; concentration of seeds to the affected area of the prostate; stage, grade, extent and location of the cancer; and the clinical follow up of prostrate-specific antigen (PSA) test results.  None of these factors are addressed by the NRC.

I also wish to address the now oft-repeated reference to 92 botched cases.  This characterization is simply wrong.  It is unfair and extremely misleading.  A case that meets the NRC definition of a reportable medical event does not mean the patient received ineffective or botched care.  The efficacy of the treatments is evidenced by the fact that there had been no confirmed cases of tumor recurrence by the time the program was terminated, with many patients doing well up to 5 years after their treatment.

Furthermore, the NRC review, which allegedly resulted in 92 reportable cases, was determined through a re-analysis of our data without our participation.  This participation would have been essential, since it is well recognized among radiation oncologists that prostate contouring is very subjective and volumes can vary substantially depending on who does the contouring.  Because of this variability, the D90 dose calculated by different reviewers can vary by as much as 60 percent.  The calculations that we performed indicated that the number of patients with D90 lower or higher than 20 percent were far fewer than 92 cases.  I do not believe that even with the use of a D90 base metric there are close to 92 reported cases.

Brachytherapy is a relatively new and evolving field.  While I recognize that certain conditions and circumstances at the Philadelphia VA could have been improved, but I remain confident based on my knowledge of the field and the nature of the patients that we treated that the patients received appropriate medical care and which was effective.

I hope that through my statements and testimony I am able to contribute to a fuller understanding of brachytherapy treatment, but also bring a degree of reassurance to our veterans regarding the treatment that was provided, and ultimately improve the care for our veterans.  Thank you.

[The prepared statement of Dr. Kao appears in Appendix.]

Mr. MITCHELL.  Thank you.  Dr. Hahn?

STATEMENT OF STEPHEN M. HAHN, M.D.

Dr. HAHN.  Yes, sir.

Mr. Chairman and Members of the Subcommittee, I am grateful for the opportunity to appear before you here today. 

I am a professor of radiation oncology at the University of Pennsylvania, and since 2005 have been chair of the University's Department of Radiation Oncology.

Before going any further I want to express my deepest regret that prostate cancer patients receiving brachytherapy at the Philadelphia VA Medical Center did not in every instance receive the best possible care.  My highest priority as a physician and as chair of the Department of Radiation Oncology is to make sure that patients do indeed receive the best possible care. 

I want to personally apologize to the patients and their families for the distress that this has caused.  I also know that the entire experience has been very difficult for the VA health care system, particularly in Philadelphia, as it has been for my department. 

Penn Medicine's relationship with the VA is long standing and we value it greatly.  It is very important to our mission as an academic medical center dedicated to patient care, teaching, and research.  We value this work and we believe that both of our organizations have learned a great deal from this painful experience.

I will focus most of my testimony today on the steps we have taken in the last year in response to this situation and the process improvements we have implemented at Penn that we believe will improve the quality of care.

The University's Department of Radiation Oncology, through a contract with the VA, provides radiation services, including brachytherapy.  Radiation oncologists working at the VA are either directly employed by the VA or Department faculty provided under the contract. 

When the Department first learned in May of 2008 of potential concerns about the prostate brachytherapy program at the VA we took immediate action.  The Department provided several faculty members and staff to the VA to assist in its quality review of all prostate brachytherapy cases. 

In June 2008, when concerns arose regarding Dr. Kao's cases in particular, Dr. Kao agreed, at my request, to suspend his clinical practice, and he has not treated any patients since that time at the VA or at our hospitals. 

Since last summer, Departmental faculty, as part of their responsibilities at the VA, have been coordinating patients' follow-up. 

In addition, since the VA and the NRC began investigations into this matter in June 2008, we have cooperated fully, and we will certainly continue to do so.

In June 2008, we also reviewed quality control and improvement measures to enhance them and to prevent a situation like this from ever happening again. 

We have adopted an additional review process that provides for patients who did not take part in the original brachytherapy procedure to assess its quality by reviewing the Computerized Axial Tomography (CT) scan and recalculating the delivered dose. 

We also have established a multi-level internal reporting system so that even a slight anomaly will be reported to our quality assurance (QA) committee.

Another notable development for us is that at Penn we recently completed the transition to a new treatment approach called "real-time dosimetry," a technology that provides for instantaneous feedback about dose to the attending physician.  We believe this approach should enhance our program.

I do not know if the VA intends to restart its permanent prostate brachytherapy program, but if and when it does, we would of course be very happy to assist the VA in any way possible.

Our Department's response has also been reviewed by Penn medicine quality reviewers and senior physicians.  Further, to assure ourselves that we have considered every safety and quality option, we will be requesting an additional review by outside experts.

Before closing, I want to briefly address NRC regulations, because the NRC, the VA, and the University all share a goal of seeing patients receive the best possible care.  My hope is that we can work with the NRC to clarify the relevant regulations which should make early detection even more likely.

Mr. Chairman and Members of the Subcommittee, I want to reiterate that I am sorry for the distress this has caused patients and their families.  Let me again stress that Penn is committed to providing the highest standard of care to our Nation's veterans and to work closely with the VA moving forward.  Thank you.

[The prepared statement of Dr. Hahn appears in Appendix.]

Mr. MITCHELL.  Thank you.  Dr. Bieda?

STATEMENT OF MICHAEL R. BIEDA, M.S.

Mr. BIEDA.  Mr. Chairman and Members of the Subcommittee, thank you for the invitation to appear here today. 

I would like to use my time to provide you with some information about my background, as well as a description of the medical physicist's role in prostate brachytherapy.  I am giving this statement on my behalf, as well as that of my two colleagues, Mr. Desobry and Lazarescu. 

In 1996, I was awarded a master's degree in physics from the University of Tennessee, and in 1999 was graduated from the master's program in medical physics at the MD Anderson Cancer Center at the University of Texas at Houston.  Since that time, I have worked as a medical physicist at the Johns Hopkins University Oncology Center; at Christiana Care Health Systems in Newark, Delaware; and at Bryn Mawr Hospital in Bryn Mawr, Pennsylvania, in addition to the University of Pennsylvania's Department of Radiation Oncology.  I worked at Penn from 2002 to 2005, and then returned in August 2006 to take the position of Clinical Chief of Medical Physics for the Department.  I am certified by the American Board of Radiology in therapeutic radiological physics and I have had several publications in the Journal of Medical Physics.

I will describe three things that a medical physicist does to assist in prostate brachytherapy.

First, based on the physician's prescription, which specifies the amount of radioactivity implanted into the patient, a physicist prepares what is called a "preplan."  To do this the physicist will review a series of ultrasound images of the prostate that is taken by the doctor in which the physician has identified the prostate.  With this information from the doctor, the physicist will plan the places where the radioactive seeds will be implanted into and around the prostate and estimates the radioactive dose to be delivered to the prostate.  This plan is always confirmed or potentially revised by the doctor.

Second, not long after the doctor is to perform the implant, the physicist will check the activity level of a sample of seeds to be implanted and deliver those seeds to the doctor in the operating room (OR). 

The third thing a physicist does takes place after the implant.  At the Pennsylvania VA Medical Center the doctor would order a CT scan of the patient's prostate the day after the implant.  On this CT scan the physicist would identify the location of the implanted seeds, using a dedicated computer program for this purpose.  Once this was done, the doctor would locate the prostate on the CT scan and draw it in.  This would allow the computer program to generate what we call a "dose volume histogram," which is essentially a graph showing how much of the prostate received how much of the prescription dose, as well as different dose parameters.  This information is often referred to as "post-implant dosimetry."

Post-implant dosimetry is performed so that the doctor might evaluate the implant as part of his overall assessment of his ongoing treatment plan for the patient.

I recognize that the Subcommittee may have questions and I will do my best to answer them.  Again, thank you for your consideration of my testimony.

[The prepared statement of Mr. Bieda appears in Appendix.]

Mr. MITCHELL.  Thank you very much.  I have got a couple questions.  First of all I want to start with Dr. Kao.

First, can you please explain the quality of care provided at the VA compared to the quality of care at other facilities you have worked at.

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

Mr. MITCHELL.  What quality of care metrics do other facilities follow?

Dr. KAO.  My understanding is that the quality control?the quality assurance procedures are similar in that a CT is performed after the procedure and the dosimetry calculated from that CT.

Mr. MITCHELL.  And the last one I have.  What markers or red flags when conducting the brachytherapy procedures indicated a problem?

Dr. KAO.  I now understand that?one of my regrets is that I could have been much more assertive in engaging the NRC in what it defines as a reportable medical event. 

As a result of their investigation in 2003 and 2005, we were under the understanding that the definition of a reportable medical event was based on the number of seeds laying outside the prostate.  Subsequently, I found out that that was not the case, that the NRC apparently is now relying on a D90 metric, and that is something that to my regret I could have been much more focused on using that metric.

Mr. MITCHELL.  Mr. Bieda?

Mr. BIEDA.  Yes.

Mr. MITCHELL.  What do you think could have been done differently by the VA that would have prevented us having this hearing today?

Mr. BIEDA.  Differently compared to Penn, differently compared to other hospitals?

Mr. MITCHELL.  Differently so we wouldn't have had to have this hearing.

Mr. BIEDA.  Right.  My only, you know, potential thought on what could be done differently is to have a stricter peer review process by, you know, external physicians not involved directly in the cases, that probably could have, you know, helped the situation.

Mr. MITCHELL.  And this is to either three of you.  My understanding was that what caused this to become a red flag was the under dosage that the patients received.  As a result of the under dosage what has happened with these patients in terms of prostate cancer?  Has it come back?  Has it been taken care of?

Dr. HAHN.  Mr. Chairman, the VA's own internal QA system picked up the sort of index situation that led to this discovery.  And we personally, although we supplied physicians for the review of the patient's cases at the VA, this has been an internal VA investigation.  We would not personally have a lot of information with respect to that clinical outcome, sir.

Mr. MITCHELL.  One last question.  You were called in I guess as a radiation oncology to perform this procedure.  Who does that?  Is it a urologist?  There are other ways to handle prostate cancer.  How is it determined that brachytherapy was the process to use here?  Or do you know that?

Dr. HAHN.  Are you asking me, sir?

Mr. MITCHELL.  Anybody there on the panel.

Dr. KAO.  You are correct, Mr. Chairman, patients with prostate cancer have different treatments available to them.  The patient population that we served at the Philadelphia VA however was very special in that many of the patients came from very far away, from West Virginia, Ohio, upstate Pennsylvania for brachytherapy because they could not undergo surgery or external beam radiation, you know, due to the lack of these treatments back home or because of their individual personal situations.

Mr. MITCHELL.  Okay.

Dr. KAO.  External beam radiation for instance would require 8 weeks of daily Monday through Friday treatments, and I had a number of patients who for instance were farmers who could not afford the 2 months being away from their farm.  It would have been economically devastating for them.

Mr. MITCHELL.  Thank you.  Dr. Roe?

Mr. ROE.  I am going to try to put a little English translation on all this for the non-medical people in here.

What happens when you have?let us say you have a PSA that is elevated, you do a biopsy and you find a cancer, that cancer has a score called a "Gleason score," which goes from zero to ten, and they also evaluate the size of your prostate gland, it is how big it is, how many cc's of volume does it have.  So a very large volume prostate gland would not be one you would choose to treat with brachytherapy. 

And brachytherapy has really been developed since probably the 1970s, and one of my closest friends has been doing this actively since 1997, so it is not really new. 

When that diagnosis is made and you have a patient that meets the criteria they go to the operating room, they have an anesthetic, they have a rectal ultrasound placed in, and they have a device placed on the perineum. 

The calculations, and I would like to commend you on your choice of undergraduate schools too by the way, UT, the physicist has made a pretreatment plan.  These seeds then under direct ultrasound guidance are placed.  And the way?and I will let the physicist explain this a little closer in a minute?the way these calculations are made there is a thing called the "inverse square law" and I won't go through all of that, but basically on where the seeds are, you can calculate how many grays or how many reds of therapy are given to a specific spot, and then the patient has a CT scan at some point after the procedure is over and they are able to look and he would make this calculation that yes, the dosimetry is right and he would know how many grays are required to kill a cancer cell that is fairly slow growing, let us say of a Gleason score of five. 

The problem that came up with the placement of these seeds, and I was looking here, and this may come up later in the testimony, but in one particular instance here there were 45 seeds out of the 70 something that were placed that were not in the prostate gland but were in the bladder.  So what had happened was, and I reviewed some of these diagrams here, that the seed placement was not appropriate and it didn't seem to be in the prostate.  It was not in the prostate gland.  And, therefore, when that happened, when the calculation was made afterwards the dosimetry was not correct for the treatment of the disease.  Am I right on that, Dr. Hahn?

Dr. HAHN.  Yes, correct.

Mr. ROE.  And would you either Dr. Kao or Dr. Hahn, one of you, discuss on placement of the seeds, because that is absolutely critical.  And what the Chairman brought up is sometimes a radiation oncologist does that, sometimes a urologist does that in consultation with the oncologist, and sometimes they do it together.  So it is not standard.  Could you comment on placement of the seeds, and is that where the problem was?

Dr. HAHN.  So at our institution, Congressman Roe, the procedure is typically mostly done by the radiation oncologist with some participation by the urologist both in terms of identifying the base of the prostate using an ultrasound in the OR as you described, as well as perhaps the placement of some seeds.  The predominant amount of seeds?number of seeds?is performed by the radiation oncologist in the operating room.

Mr. ROE.  And to just again further clarify for those, when you place this needle in as you bring it out you drop these seeds along, but if that needle is not in the prostate gland it obviously isn't getting it treated if it is near the rectum or if it is in the bladder.  And I asked my colleague, my good friend that I have operated with hundreds, if not a thousands times, how many seeds that he dropped in the bladder over the years in the hundreds of cases that he had done, and he said now it almost never happens because of the ability?and it has happened in obstetrics ultrasound how refined the ultrasound is. 

So I guess I am asking the question, why did that happen?  Why there were so many seeds placed outside the prostate or the dosimetry seemed to be?  I think that is why when the calculations were made that the dose didn't seem to be proper.

Dr. KAO.  If I could address your question.  As Dr. Hahn mentioned, the way we do brachytherapy in Philadelphia is in conjunction with the urologist.  The urologist places the very first needle, and needle determines the depth by which all subsequent needles fall.  So if that very first needle is off, as you pointed out, then the subsequent needles may also be off. 

The placement of the seeds also depends on the image quality.  And early in the learning curve in our first few cases we did not prep the patients as thoroughly as needed, so if there is some stool in the rectum that would degrade the image quality of the ultrasound. 

The case that you are referring to, sir, I believe is one of the cases that resulted in an NRC investigation.  We implemented several measures after that first case to help ensure that this situation did not arise again.

Mr. ROE.  Thank you, Mr. Chairman, I will have further questions later.

Mr. MITCHELL.  Thank you.  Mr. Adler?

Mr. ADLER.  Thank you, Mr. Chairman.  I guess my first question is for Dr. Kao.  We have heard about the closure of this program in June of 2008.  We have 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 have heard that the National Health Physics Program reported to NRC at least 35 medical events later in 2008.  We heard Dr. Hahn just now acknowledge on behalf of UPenn that 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 principal operator of this program at the VA in Philadelphia.

How do you reconcile 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 UPenn's recognition that not every patient got the best possible care, with NHPP and NRC saying there are medical events even in a context where we probably don't define medical event sufficiently to trigger reporting to the extent probably we would want reporting? So let us assume there is some under-reporting going on.  Even with under-reporting we have got at least 35 instances from 2008 reported about over a period of time a program you ran. 

I am thinking you are in a dream world right now.  I am thinking everybody else, all the other experts are looking at this and saying it didn't go well enough, that whether the number is 92 or some 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 a view of every other expert, every potential supervisor, every contracting body, every regulatory body?  I kind of want to hear you acknowledge you did things less well than you would have wanted to have done.

Dr. KAO.  Sir, I don't disagree with many of the other comments that were made.  Medicine is both an art and a science, and the art of is it that even though the treatment may be effective it may be made to be even more optimal. 

A central theme here is what is defined as a reportable medical event.  And a case that is a reportable medical event does not mean that the patient was harmed or did not receive effective treatment. 

When the program was closed in 2008, we did not have any confirmed cases of tumor recurrence.  The NRC itself recognizes that a reportable medical event does not mean that it does not address the efficacy of the treatment. 

So in summary, I recognize there are many things?several things that I could have done better, but I still believe that the patients received the standard of care that was in place at the time.

Mr. ADLER.  I am 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 post-implant dosimetry information to gauge whether the patients had had the seeds placed properly and the seeds had stayed where you wanted them to be.  Is it true that there was a year when you did not have that sort of post-implant dosimetry information?

Dr. KAO.  It is true that for a period of about 14 months there was a computer interface problem at the VA, that although the CTs that could be performed after the brachytherapy, but that data could not be transmitted to the workstation used to calculate the doses. 

During that time I followed the chain of command.  I complained to radiation safety, to the Chief of the VA Radiology Oncology Department, and 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 did not have surgery or other forms of radiation as a choice.  So given the choice between delivering no care and having their cancers progress or to 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 the part of the prostate where the cancer was located.  So these gave me a measure of confidence that the patients were being appropriately treated.  But it is, you are 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.

Mr. ADLER.  Well what number would you say is the number of patients who didn't get adequate care?  The total you did was 116, of that number what would you say?  I have heard numbers, 57, 35, and 92.  What number would you say was the number?

Dr. 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 and probably closer to 20 cases that were reported?that were defined as medical events.  But again, a case that is defined as a medical event does not mean that the treatment was not effective, sir.

Mr. ADLER.  Dr. Hahn, let me ask you.  What lessons can UPenn take away from the situation and what sort of failures of oversight would you say were present from a UPenn perspective?

Dr. HAHN.  I think that we and our partners at the VA both would agree that there are many lessons that we have learned and will continue to learn from this very painful episode.  And let me just say even if it were just one human being who did not receive the best possible care, Congressman Adler, that would be unacceptable. 

When we became aware of the allegations in June of 2008, we did a review of quality assurance and peer review, and we determined that they certainly could be improved.  And as I mentioned in my statement, but not in great detail, we did institute a number of measures to allow for that improvement, including the oversight of each brachytherapy case that is performed by outside health care team members within the Department but who didn't perform the procedure who will review the CT as well as the dosimetry to give another level of review. 

We have also instituted a system whereby the reportable events to the Department's leadership are such a low threshold such that even a slight anomaly would be reported giving us the opportunity to capture everything. 

We have also, in partnership with the VA, instituted a Department-wide system for reporting levels of toxicity.  This uses clinical outcomes.  If we detect severe or unexpected toxicities, it triggers presentation of what we call our morbidity and mortality conference where people inside and outside of the Department review those toxicities. 

And then this other issue of real-time dosimetry, which allows us to see the needle go in and see the dose in real-time with instantaneous feedback. 

We feel that these measures are prudent certainly, and that they will and should prevent similar occurrences from occurring in the future.

Mr. ADLER.  Thank you, my time has expired.  Mr. Chairman.

Mr. MITCHELL.  Thank you, Mr. Walz?

Mr. WALZ.  Well thank you again, Mr. Chairman, and I want to thank all of our witnesses for being here, and as I always say there is no doubt that everyone in this room wants the best care for our veterans, that is an absolute given.  And I also say that it is a zero sum game, so I agree with you, Dr. Hahn.  And I think talking about this there is a human face on this.  There is Pastor Flippin and his story that was told.  We keep that in mind. 

I also want to though note, and my colleague from Pennsylvania I think started hitting on this, that your willingness to come here today and answer questions openly is truly appreciated, and it is very obvious that your sense of concern on this is very real, and I am very appreciative of that.  Because all too often we get caught up in the legal barriers that people are unwilling to try and fix this, and it is imperative that we get this right. 

So with that being said, I also want to thank Dr. Roe, he is always very helpful for me to understand the medical side of this.  My postgraduate work was in systems analysis, so that is the part that I am most concerned about, and it seems that many times we keep coming back to that of looking at these things to see if they are not just isolated incidents, but if there are things?and building on what Mr. Adler was talking about?a couple of questions I have had. 

We have recently had the questions that come up here, improperly sterilized equipment, and we are asking where best practices fall.  And something as simple as a checklist for who last cleaned the equipment, none of that was available.

So one of the red flags I think in this whole thing that came up for me was listening to people talk about the lack of peer review involved in this.  And many, and I think it was Dr. Welch who commented, in all of his medical practice he has never seen such a lack of peer review in the process that was happening. 

Can one of you comment on that of do you think that is true in the radial?the oncology here at VA as it stood in Philadelphia?  Was there a severe break down in peer review, which is meant to be there as a safeguard?  Can anyone comment on that?

Dr. HAHN.  Congressman Walz, there was peer review in place.  Brachytherapy represents about five percent of the treatments that we give, and there is peer review for both external beam as well as all the treatments that are given.  I think Congressman Walz, there is no question in our mind that when we looked back at the peer review processes, and I think it was the first process that we implemented?process change?that being dependent upon the local treatment team in and of itself to report quality issues without having a secondary look by external physicians and physicists was something that needed to be improved, sir.

Mr. WALZ.  Would it be your experience, Dr. Hahn, that this same lack of peer review in the beginning or not strong enough is happening at other VA Medical Centers?  The reason I ask this is, is the one nearest to me in Minneapolis that also practices this technique has not had?they are reporting zero medical events in this. 

And I want to be very clear on this, one of the things that gets highlighted on this is we don't know at private practices if this is happening because there is no reporting, so I think that needs to be kept in mind.  Because I am wondering across our entire health care system outside the VA it is hard to make those comparisons.  But inside the VA are there different peer review standards at different institutions as far as you know?

Dr. HAHN.  Congressman Walz, I wouldn't know the answer to that question at other VA institutions.  I can tell you that at Penn across our own institution our processes were the same for all the patients that we delivered care to both at the satellites outside facilities and at Penn, and again, this provided us with an opportunity to look at our processes because we do uniformly apply them and to make sure that they get better constantly.

Mr. WALZ.  Should this be someth