    [House Hearing, 111 Congress]
    [From the U.S. Government Publishing Office]

    INSTITUTIONAL REVIEW BOARDS THAT OVERSEE EXPERIMENTAL HUMAN TESTING FOR
                                     PROFIT

    =======================================================================

                                    HEARING

                                   BEFORE THE

                  SUBCOMMITTEE ON OVERSIGHT AND INVESTIGATIONS

                                     OF THE

                        COMMITTEE ON ENERGY AND COMMERCE
                            HOUSE OF REPRESENTATIVES

                         ONE HUNDRED ELEVENTH CONGRESS

                                 FIRST SESSION

                                   __________

                                 MARCH 26, 2009

                                   __________

                               Serial No. 111-22

          Printed for the use of the Committee on Energy and Commerce

                            energycommerce.house.gov

                                    _____

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                        COMMITTEE ON ENERGY AND COMMERCE

                     HENRY A. WAXMAN, California, Chairman
    JOHN D. DINGELL, Michigan              JOE BARTON, Texas
      Chairman Emeritus                      Ranking Member
    EDWARD J. MARKEY, Massachusetts        RALPH M. HALL, Texas
    RICK BOUCHER, Virginia                 FRED UPTON, Michigan
    FRANK PALLONE, Jr., New Jersey         CLIFF STEARNS, Florida
    BART GORDON, Tennessee                 NATHAN DEAL, Georgia
    BOBBY L. RUSH, Illinois                ED WHITFIELD, Kentucky
    ANNA G. ESHOO, California              JOHN SHIMKUS, Illinois
    BART STUPAK, Michigan                  JOHN B. SHADEGG, Arizona
    ELIOT L. ENGEL, New York               ROY BLUNT, Missouri
    GENE GREEN, Texas                      STEVE BUYER, Indiana
    DIANA DeGETTE, Colorado                GEORGE RADANOVICH, California
      Vice Chairman                        JOSEPH R. PITTS, Pennsylvania
    LOIS CAPPS, California                 MARY BONO MACK, California
    MIKE DOYLE, Pennsylvania               GREG WALDEN, Oregon
    JANE HARMAN, California                LEE TERRY, Nebraska
    TOM ALLEN, Maine                       MIKE ROGERS, Michigan
    JAN SCHAKOWSKY, Illinois               SUE WILKINS MYRICK, North Carolina
    HILDA L. SOLIS, California             JOHN SULLIVAN, Oklahoma
    CHARLES A. GONZALEZ, Texas             TIM MURPHY, Pennsylvania
    JAY INSLEE, Washington                 MICHAEL C. BURGESS, Texas
    TAMMY BALDWIN, Wisconsin               MARSHA BLACKBURN, Tennessee
    MIKE ROSS, Arkansas                    PHIL GINGREY, Georgia
    ANTHONY D. WEINER, New York            STEVE SCALISE, Louisiana
    JIM MATHESON, Utah                     PARKER GRIFFITH, Alabama
    G.K. BUTTERFIELD, North Carolina       ROBERT E. LATTA, Ohio
    CHARLIE MELANCON, Louisiana
    JOHN BARROW, Georgia
    BARON P. HILL, Indiana
    DORIS O. MATSUI, California
    DONNA CHRISTENSEN, Virgin Islands
    KATHY CASTOR, Florida
    JOHN P. SARBANES, Maryland
    CHRISTOPHER MURPHY, Connecticut
    ZACHARY T. SPACE, Ohio
    JERRY McNERNEY, California
    BETTY SUTTON, Ohio
    BRUCE BRALEY, Iowa
    PETER WELCH, Vermont

                                      (ii)

                  Subcommittee on Oversight and Investigations

                        BART STUPAK, Michigan, Chairman
    BRUCE L. BRALEY, Iowa                GREG WALDEN, Oregon
      Vice Chairman                        Ranking Member
    EDWARD J. MARKEY, Massachusetts      ED WHITFIELD, Kentucky
    DIANA DeGETTE, Colorado              MIKE FERGUSON, New Jersey
    MIKE DOYLE, Pennsylvania             TIM MURPHY, Pennsylvania
    JAN SCHAKOWSKY, Illinois             MICHAEL C. BURGESS, Texas
    MIKE ROSS, Arkansas
    DONNA M. CHRISTENSEN, Virgin
        Islands
    PETER WELCH, Vermont
    GENE GREEN, Texas
    BETTY SUTTON, Ohio
    JOHN D. DINGELL, Michigan (ex officio)

                                C O N T E N T S

                                  ----------
                                                                       Page
    Hon. Bart Stupak, a Representative in Congress from the State of
      Michigan, opening statement....................................     1
        Prepared statement...........................................     4
    Hon. Greg Walden, a Representative in Congress from the State of
      Oregon, opening statement......................................     6
        Prepared statement...........................................     8
    Hon. Diana DeGette, a Representative in Congress from the State
      of Colorado, opening statement.................................    10
    Hon. Michael C. Burgess, a Representative in Congress from the
      State of Texas, opening statement..............................    11
    Hon. Donna M. Christensen, a Representative in Congress from the
      Virgin Islands, opening statement..............................    12
    Hon. Gene Green, a Representative in Congress from the State of
      Texas, opening statement.......................................    13
    Hon. Edward J. Markey, a Representative in Congress from the
      Commonwealth of Massachusetts, opening statement...............    13
    Hon. Joe Barton, a Representative in Congress from the State of
      Texas, opening statement.......................................    14
    Hon. Henry A. Waxman, a Representative in Congress from the State
      of California, prepared statement..............................   115

                                   Witnesses

    Gregory Kutz, Managing Director, Forensic Audits and Special
      Investigations, Government Accountability Office...............    17
        Prepared statement...........................................    19
    Joanne Less, Director, Good Clinical Practice Program, Food and
      Drug Administration............................................    40
        Prepared statement...........................................    43
    Jerry Menikoff, M.D., Director, Office for Human Research
      Protections, Department of Health and Human Services...........    59
        Prepared statement...........................................    61
    Daniel Dueber, Chief Executive Officer, Coast IRB, LLC...........    76
        Prepared statement...........................................    78

                               Submitted Material

    Subcommittee exhibit binder......................................   117

    INSTITUTIONAL REVIEW BOARDS THAT OVERSEE EXPERIMENTAL HUMAN TESTING FOR
                                     PROFIT

                                  ----------

                            THURSDAY, MARCH 26, 2009

                      House of Representatives,
          Subcommittee on Oversight and Investigations,
                              Committee on Energy and Commerce,
                                                        Washington, DC.
        The subcommittee met, pursuant to call, at 10:03 a.m., in
    Room 2123 of the Rayburn House Office Building, Hon. Bart
    Stupak (chairman) presiding.
        Members present: Representatives Stupak, Markey, DeGette,
    Christensen, Green, Waxman (ex officio), Walden, Burgess,
    Gingrey, Barton (ex officio), and Blunt.
        Staff present: Karen Lightfoot, Communications Director,
    Senior Policy Advisor; David Rapallo, General Counsel; Theodore
    Chuang, Chief Oversight Counsel; Dave Leviss, Deputy Chief
    Investigative Counsel; Scott Schloegel, Investigator, Oversight
    & Investigations; Stacia Cardille, Counsel; Erik Jones,
    Counsel; Ali Golden, Investigator; Jennifer Owens, Special
    Assistant; Caren Auchman, Communications Associate; Paul Jung,
    Public Health Service Detailee; Kenneth Marty, Detailee; Karen
    Christian, Counsel; Alan Slobodin, Chief Counsel; and Peter
    Kielty, Legislative Analyst.

      OPENING STATEMENT OF HON. BART STUPAK, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF MICHIGAN

        Mr. Stupak. This meeting will come to order. Today we have
    a hearing entitled Institutional Review Boards that Oversee
    Experimental Human Testing for Profit. The chair and ranking
    member and chairman emeritus will be recognized for 5 minutes
    for opening statements. All other members of the subcommittee
    will be recognized for 3-minute opening statements. I will
    begin. Experimental medical testing on human beings has a
    troubling history. From the atrocities perpetrated by the Nazis
    in World War II to the famous Tuskegee study in the 1970s when
    subjects were denied treatment for syphilis, we have learned
    that we need strong controls in place to protect the health and
    safety of people who participate in medical experiments.
        Under current federal law, medical testing of human
    subjects that is federally funded or relates to federally
    regulated drugs or medical devices cannot proceed without the
    approval of an Institutional Review Board, a panel of doctors,
    scientists, and non-scientists charged with ensuring the health
    and safety of the people participating in the study. Our
    committee began investigating IRBs in 2007. We learned that
    Copernicus IRB allowed the study of an antibiotic Ketek to
    continue without examining reports of fraud it had received. As
    part of our continued investigation, we asked the Government
    Accountability Office, GAO, to conduct undercover testing of
    the IRB review process. We wanted to know whether IRBs are
    rubberstamping research studies, whether clinical researchers
    are IRB shopping or choosing IRBs based on how quickly and how
    inexpensively they approve studies, and whether government
    oversight of IRBs is adequate.
        Today we will hear the results of GAO's investigation, and
    they are not reassuring. GAO will explain how Coast IRB, a for-
    profit company, approved a fictitious study led by a fictitious
    doctor and submitted by a fictitious company. It called for a
    full liter of a fictitious product, in fact, the same amount in
    this bottle here, to be poured into a woman's abdomen cavity
    after surgery supposedly to help healing. GAO's fake protocol
    was based on an actual high risk study for a product that the
    FDA ultimately withdrew from the market because of deaths and
    infections among patients. Besides Coast IRB, GAO also sent its
    fictitious study to two other IRBs that they both rejected our
    proposal out of hand.
        Here are some of the things that two other IRBs said after
    reviewing the fake GAO study. The experimental design was the
    most complicated thing that I have ever seen. During a surgery,
    a major operation on a patient, a mystery guy walks in and
    dumps the solution in the body. Where is the safety for the
    patient? It appeared that people were just going to go out and
    start injecting. We realized it was a terrible risk for the
    patient. It is the worse thing I have ever seen. But Coast IRB
    approved the protocol unanimously 7 to nothing.
        The doctor with primary responsibility for reviewing the
    study told other board members that the protocol looks fine,
    and that the substance to be injected in the abdominal cavity
    was probably very safe. Nobody at Coast IRB ever reviewed any
    of the data cited in the proposal to support those claims. If
    they had, they would have discovered it did not exist. A doctor
    who reviewed the study did raise a question about if the
    study's claim was accurate and that the substance had been
    approved previously by the FDA, but no one ever followed up
    with the FDA to answer this question, and in an e-mail to the
    rest of the board members, the doctor stated it would not have
    made any difference, that he would have approved the study
    anyway and that the lack of FDA approval won't affect my
    recommendation.
        The board chair told us she relied on this recommendation
    and voted to approve the study even though she did not read the
    full protocol. Why was this review so shoddy? The evidence
    suggests that Coast was more concerned with its financial
    bottom line than protecting the lives of patients. According to
    Coast's CEO, who will testify today, Coast had a practice of
    voting on research protocols within 48 hours of the board
    receiving them. One of the testimonials that Coast sent to
    prospective customers reads thank you very much. You guys are
    the quickest IRB I ever worked with, and I have done this 7
    years. Coast even sent a coupon offering to give free IRB
    review so researchers could coast through your next study.
        After this committee wrote to Coast IRB requesting
    documents associated with their approval of this fictitious
    study, Coast officials took pride in that they were able to
    discover the study was bogus, but this was 5 months after they
    approved it. Coast CEO, Mr. Dueber, told our staff within
    seconds they were able to determine that this was not an actual
    medical device, and within 4 to 5 hours they determined that
    this was a sham. Had any of the staff done the research before
    they approved our bogus protocol 5 months ago, Coast IRB would
    not be testifying today. GAO's investigation also exposed other
    problems with the IRB system. GAO was able to create a
    fictitious IRB that it registered with the U.S. Department of
    Health and Human Services, HHS, with no questions asked.
        The president of this fake IRB was this dog, Trooper, who
    is, sadly, now deceased. Trooper didn't know anything about
    protecting human testing, but for a three-legged dog he sure
    could catch a Frisbee. GAO created a fake web site for
    Trooper's IRB called Maryland House. It received real inquiries
    from real researchers and actually had one research protocol
    submitted for review. When asked why it selected GAO's fake IRB
    and Trooper to conduct its study, a research coordinator stated
    that it was because of the low price and the quick turnaround
    time.
        GAO's findings raise serious questions, not only about
    specific IRBs involved in this investigation, but with the
    entire system for approving experimental testing on human
    beings. As a society, we have a moral obligation to ensure that
    human testing is done in the most responsible and ethical
    manner. I look forward to the testimony today, and I hope we
    can discuss ways for both government and industry to fulfill
    its obligation. That concludes my opening statement.
        [The prepared statement of Mr. Stupak follows:]

        Mr. Stupak. I next go to the ranking member, my friend, Mr.
    Walden, for his opening statement, please.

      OPENING STATEMENT OF HON. GREG WALDEN, A REPRESENTATIVE IN
                   CONGRESS FROM THE STATE OF OREGON

        Mr. Walden. Thank you, Mr. Chairman, for convening this
    hearing. It is another example of the kind of investigative
    work that is possible when we work together in a bipartisan
    manner as we most always do. The subject of this hearing, the
    oversight of human subjects in clinical trials by Institutional
    Review Boards or IRBs, grew out of a drug safety investigation
    in the last Congress. Working together we identified what we
    thought might be problems in IRB oversight of clinical trials.
    We made a joint request to the Government Accountability
    Office, the GAO, to take a closer look into what was going on.
    Now we are here today to learn about the results of that
    investigation.
        As we meet today, literally millions of Americans are
    engaged in clinical trials taking place in more than 350,000
    locations across America. Right now people who have volunteered
    for these trials are walking into a doctor's office or a
    hospital or some other setting, and they are taking
    experimental medicines or allowing new devices to be used on
    their bodies so that scientists and doctors can determine
    whether and how a new treatment will work. Without their
    willingness to volunteer for a trial, all of us would not
    benefit from the new drugs or devices to treat illness and
    disease. But they volunteer believing that an independent
    government-sanctioned process is reviewing the protocols and
    products to maximize their safety.
        And I have to tell you that after reading the report of the
    GAO that explains how easy it was for the undercover
    investigators to fake their backgrounds and get approval for
    human trials and create their own fake IRB something is
    horribly wrong. Mr. Dueber, I have read your testimony for
    today, and I find it to be the most pathetic example of trying
    to spin your way out of taking responsibility for a serious
    approval error I have ever seen. The fact that your board
    unanimously approved this fake company to turn fake tests using
    a witches' brew recipe for a gel that doesn't exist, I find to
    be outrageous. Two other IRBs rightfully rejected the
    application saying the plan was awful, a piece of junk, and the
    riskiest thing I have ever seen on this board.
        So why did your company unanimously approve it? And would
    you want your family members to participate in a trial using
    this gel? No, rather than discuss how your board reached
    unanimous approval and said the gel is probably very safe and
    that a risk assessment is not required, you chose to attack the
    investigators and even called this oversight effort tyranny.
    Well, sir, your approach is misguided. It reminds me of the old
    ruse used by parents on their children to draw their attention
    away going, look, bright shiny object. I don't care how many
    bright, shiny objects you tell us to look at, your PR firm and
    your lawyers, to draw attention away from the real issue, your
    company still has to answer for this decision that would have
    allowed patients to spend 5 months taking a fake and
    potentially lethal product from a fake company with a fake
    doctor.
        And to HHS, what in the devil is going on in your agency
    that allows you to think you can ignore the law and regulations
    regarding adequacy of IRBs and simply enter whatever is e-
    mailed your way and put the U.S. Government stamp of approval
    on an IRB? You have three federal employees signing up 300 new
    IRBs a month, according to the GAO, and the leadership of this
    agency says it is not important to follow the federal rules
    regarding a test of adequacy? Nobody picked up on names like
    Phake Medical Devices, April Phuls, Timothy Wittless, and Alan
    Ruse, or the town of Chetesville, Arizona? This didn't raise a
    flag? And yet you give out the HHS stamp of approval. It is
    unbelievable. Moreover, it could be lethal.
        Is it any wonder the GAO says this system is vulnerable to
    manipulation? I understand that more than 10 years after the
    Inspector General's report, FDA recently announced a final rule
    with respect to the IRB registry system that will go into
    effect this summer. I am curious whether our witnesses believe
    this new rule will address any of the problems we will hear
    about today. It is our solemn duty to ensure that those who
    participate in clinical trials can have confidence that their
    safety is in trustworthy hands and that government
    certification means something. We want to encourage
    participation and support of clinical trials by protecting the
    integrity of these studies and strengthening the public trust.
    Thank you again, Mr. Chairman, for convening this hearing. I
    look forward to today's testimony, and I yield back my time.
        [The prepared statement of Mr. Walden follows:]

        Mr. Stupak. Thank you, Mr. Walden. Ms. DeGette, for an
    opening statement, 3 minutes, please.

     OPENING STATEMENT OF HON. DIANA DeGETTE, A REPRESENTATIVE IN
                  CONGRESS FROM THE STATE OF COLORADO

        Ms. DeGette. Thank you, Mr. Chairman. Chairman, patient
    safety and research situations for this committee is really
    like food safety. One thing you can be sure of is that a crisis
    is looming just around the corner. In 1999, a young man named
    Jesse Gelsinger died while participating in a gene therapy
    trial at the University of Pennsylvania. An FDA investigation
    concluded the scientist involved in the trial, including the
    lead researcher, who had a potential financial interest in the
    results of the trial, broke several rules of ethical conduct
    including inadequate informed consent procedures. In 2006 the
    antibiotic, Ketek, caused liver failure and death in patients
    who used it. An investigation showed that investigators had
    given fraudulent data to the FDA to gain approval of Ketek.
        A whistleblower who learned of the fraud contacted the
    Institutional Review Board that was responsible for approval of
    the Ketek clinical trial, but the IRB allegedly did nothing to
    report the fraud and stop the use of Ketek. And now here we are
    again today. Research is the key to innovation and discovery
    including curing deadly diseases, but as this whole panel
    agrees, the research must be conducted ethically so that
    participants understand the risk and make informed decisions
    about volunteering. That is why we need to upgrade our entire
    patient protection system in this country.
        Mr. Chairman, I have introduced legislation in the last 6
    sessions of Congress, the Protection for Participants in
    Research Act, and it reforms federal regulation and oversight
    of research on human participants by making federal regulations
    applicable to all research that is in or affects interstate
    commerce, that strengthens the education and monitoring of
    Institutional Review Boards, that harmonizes FDA regulations
    and the common rule, the two major sets of federal regulations
    governing research participant protection, that strengthens
    protection against conflicts of interest by investigators or
    IRB members, that improves monitoring of research risks and
    reporting of adverse events and unanticipated problems.
        We have reintroduced this legislation this session of
    Congress, and I would urge every member of this subcommittee on
    both sides of the aisle to look at the bill and think seriously
    about co-sponsoring it. The last session of Congress, we came
    close to passing the legislation on the suspension calendar
    because I think one thing we can all agree on in a bipartisan
    way is that we need to encourage medical experimentation but we
    need to do it in a way that both protects the patient and gives
    them informed consent about what they are getting into. Mr.
    Chairman, I don't want to be here for 13 hearings like we have
    been on food safety. I want to get this done. We have been
    working on it a number of years. We know the problem. We know
    the solutions. And I am looking forward to working with
    everybody on this committee to improving research so that we
    can have a robust system but at the same time protect the
    participants. Thank you, Mr. Chairman.
        Mr. Stupak. Thank you. Mr. Burgess for opening statement,
    please.

    OPENING STATEMENT OF HON. MICHAEL C. BURGESS, A REPRESENTATIVE
                  IN CONGRESS FROM THE STATE OF TEXAS

        Mr. Burgess. Thank you, Mr. Chairman. In a surprise move, I
    am going to agree with the other side of the dais about the
    number of hearings, not wanting to have the numbers of hearings
    we have had on other areas before we do something. You know,
    today's economic environment, there is a lot of investigative
    activity that we could focus on, and we continue, continue, to
    have FDA-related hearings. I mean this is the Committee on
    Oversight and Investigations, not the committee to investigate
    the FDA. But I believe this subcommittee has some jurisdiction
    on what has happened with the financial services in this
    country, and we have had no hearings on that. Secretary
    Geithner might enjoy a visit to our committee and I would enjoy
    having the opportunity to question him. So the extent that this
    subcommittee has jurisdiction over the troubled asset relief
    program, I believe we ought to be involved.
        The Department of Energy, we had two hearings in this
    subcommittee last Congress on the security of our national
    labs. I recall us having questions for the head of the Lawrence
    Livermore laboratory. Well, it turns out now he is just right
    down the street at the Department of Energy. When are we going
    to go have Secretary Chu in to provide answers to that
    questions that we couldn't get answered last fall? Instead, we
    are having yet another hearing on the Food and Drug
    Administration, an agency that we all know is in desperate
    shape, is broken. The morale of its workers is precariously
    low. We acknowledge it. We are part of the cause. It is a 20th
    century agency operating in a 21st century world, a world that
    is global, commercial, and innovative with regards to food,
    drugs, and medical devices, but it is regulated by an agency
    that is underfunded, understaffed, under supported, and what
    meager funds we do provide them, they have got to expend
    preparing for the next congressional hearing.
        Now these issues relating to the Institutional Review
    Boards are serious. Any human subject testing should be
    carefully overseen by the federal government to prevent abuses.
    The types of products that were being discussed in the issues
    before us today are products that I would have used in my--
    might have used in my former life, so I understand the
    seriousness of this issue, but I can also remember back right
    before I started medical school hearing about the experiments
    going on in Tuskegee, Alabama, with the former Department of
    Health, Education, and Welfare and their involvement. That is
    why the government now has the common rule to govern 17
    different departments and agencies within the federal
    government on human testing and why the Food and Drugs
    Administration has similar regulations governing human subject
    testing for medical devices and drugs.
        There must be ongoing scrutiny of the internal review
    boards. We must make certain the science is unfettered and
    rigorous and the Office of Human Research Protection needs to
    have the appropriate oversight. We need to make certain that we
    don't politicize the process, that conflicts of interest are
    being avoided, and all adverse events are thoroughly evaluated
    and that there is a clear avoidance of the IRB shopping where
    an Institutional Review Board will be removed from one
    institution to another because the results were not favorable.
    I am particularly concerned about the interaction of the common
    rule with the Food and Drug Administration regulations
    governing the investigational new drug applications. We all now
    the failures of the IRB and Ketek. Their failure was the
    impetus behind the GAO report being presented to us today
    regarding the review and oversight of the Institutional Review
    Boards.
        But this is a problem that can be fixed. Let us fix it and
    move on to the next thing. We should hold a hearing on the
    entire approval process at the FDA. The IRBs, certainly they
    need to be investigated, the registration system, but what
    about the 510K exception for new drugs and the alleged
    revolving door where FDA employees go straight to the drug
    companies and then come back. We owe it to the American people.
    We owe it to the scientific community to fix the FDA and fix it
    right. Let us get on with that task. I yield back.
        Mr. Stupak. I thank the gentleman. I would also note this
    week you addressed to a letter to us on wanting to do hearings
    on medical devices with the FDA, and that is something that we
    are looking at closely so just so the record is clear, we will
    probably have more FDA hearings unfortunately. Ms. Christensen
    for opening statement, please.

           OPENING STATEMENT OF HON. DONNA M. CHRISTENSEN, A
           REPRESENTATIVE IN CONGRESS FROM THE VIRGIN ISLANDS

        Mrs. Christensen. Thank you, Mr. Chairman. This is a very
    important hearing, and I thank you, Chairman Stupak and Ranking
    Member Walden for holding it. Because of the differences we
    have seen in response to medications and other treatments by
    African Americans, we, including the National Medical
    Association who I see in the audience, have been encouraging
    individuals and providers in our communities to become involved
    in clinical trials. I even participated in one briefly before
    coming to Congress. But in our community the specter of
    Tuskegee still looms large in our minds, and then there have
    been more recent incidents. I recall joining with other members
    of the House to stop the testing of pesticides in children,
    mostly African American poor children, just a few years ago.
        So if we though that this was an aberration or that
    Tuskegee could not happen again, obviously as we try to
    convince our communities the GAO report tells us that we were
    badly mistaken. The IRB process is supposed to ensure the
    health and safety of individuals in clinical trials. We, who
    have apparently misplaced our trust in the system are outraged
    at the failures that are documented in the GAO report. This
    system needs to be fixed, and I for one cannot in good
    conscience encourage another person to participate in a
    clinical trial until it is. Thank you, Mr. Chairman. I yield
    back.
        Mr. Stupak. Thank you, Ms. Christensen. Mr. Gingrey,
    opening statement, please.
        Mr. Gingrey. Mr. Chairman, thank you. Today this committee
    has an opportunity to make sure that Institutional Review
    Boards are taking every possible step to ensure the safety of
    those who agree to participate in biomedical research.
    Biomedical research and clinical trials are critical to
    developing and perfecting the next generation of life saving
    medicine and devices. Without question, the potential benefits
    must outweigh the potential risks to participants. However,
    these individuals must also be made fully aware of the
    potential risks when they agree to participate. Mr. Chairman, I
    look forward to listening to the testimony, and I would like to
    reserve the balance of my time for questions, and I yield back.
        Mr. Stupak. Thank you, Mr. Gingrey. Mr. Green for opening
    statement, please.

       OPENING STATEMENT OF HON. GENE GREEN, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Green. Thank you, Mr. Chairman. I thank you for having
    this hearing today on the Institutional Review Boards, the
    IRBs, and the federal government's oversight of these boards.
    IRBs were created to protect individuals from harm or death
    during an experiment and ensure individuals give informed
    consent to the researchers. IRBs are in place to minimize the
    risks to the subjects, that the risks of the study are
    reasonable in anticipation of the benefits. Protection for
    subjects during experimental research are vital. Unfortunately,
    we have two painful incidents in our past to remind us just how
    necessary these protections are, the formaldehyde distribution
    in 1960 and the Tuskegee study in 1974. Both of these incidents
    serve as painful reminders of the wrongdoing of researchers at
    the expense of the health and well-being of the subjects.
        Most recent, we have the Ketek incident, which the IRB
    failed to investigate a whistleblower's allegations during
    continuing review of the application. I was on this
    subcommittee when we investigated Ketek and the flawed review
    process that enabled the drug to come to market. Several deaths
    have occurred during studies that received IRB approval. In
    recent years, many called for reforms to the IRB system. IRB
    regulations were created in the 1970's and have not been
    reformed in recent years. Currently, HHS and the Office of
    Human Research Protection has the jurisdiction over IRBs for
    studies with federal funding. FDA has jurisdiction over testing
    for medical devices and drugs.
        HHS requires IRBs but the FDA does not. However, the FDA is
    developing an IRB process. There are also independent IRBs not
    affiliated with any institution operating in the U.S. These
    IRBs are associated with the industry. The GAO and HHS have
    issued several reports documenting problems with the current
    IRB process. In 1998, GAO issued several recommendations for
    IRB reform, and to date none of these recommendations have been
    adopted by HHS or FDA. I am looking forward to the testimony of
    the witnesses, particularly GAO, so we can see if our oversight
    of IRBs is adequate and whether reforms of the system need to
    be made. And I yield back my time.
        Mr. Stupak. Thank you, Mr. Green. Member of the
    subcommittee, Mr. Markey, for opening statement, please.

    OPENING STATEMENT OF HON. EDWARD J. MARKEY, A REPRESENTATIVE IN
            CONGRESS FROM THE COMMONWEALTH OF MASSACHUSETTS

        Mr. Markey. Thank you, Mr. Chairman, very much. While
    legitimate research is vital, human experimentation must be
    conducted under the highest ethical standards. This is a very
    important issue to me. In November of 1986, as chairman of the
    Energy and Commerce Subcommittee on Energy and Power, I
    released a report describing radiation experimentations on
    human subjects by American scientists between the 1940's and
    the 1970's. The people tested in these experiments were used as
    nuclear human guinea pigs to determine the effects of exposing
    humans to nuclear radiation. Most of those experiments provided
    little or no medical benefit to the patients. In many cases
    informed consent was not granted, yet, these individuals were
    asked to ingest, inhale, or be injected with radioactive
    materials, materials whose safety was not yet determined.
        These scientists recklessly endangered human lives and much
    of their work was kept hidden from the public until the 1980's
    and 1990's. The good news is that although when I released my
    report in 1986 the Reagan and then Bush administrations refused
    to respond to it. President Clinton, in 1994, upon my urging
    established the Presidential Advisory Committee on Human
    Radiation Experiments, which issued this report which led to
    the strengthening of regulations for research with human
    subjects.
        We are here today to discuss IRBs. IRB is supposed to stand
    for Institutional Review Board. Unfortunately, with some
    experiments, IRB stands for irresponsible, reckless behavior.
    Unscrupulous IRBs have followed lax review procedures and
    unethical practices when assessing the safety of clinical trial
    experiments. As a result, participants have been put at risk of
    injury or worse, death. Without proper review from IRBs, the
    scientific integrity of clinical research work has been
    compromised. This can lead to faulty evidence regarding the
    safety of drugs and devices, and can further endanger the
    safety of the public at large if these products gain approval
    by the FDA.
        When it comes to protecting the safety of consumers, we
    must have the highest standards. In February of 2007 when I
    called on the FDA through several of my letters and a hearing
    by this subcommittee, and, again, Mr. Chairman, you have been a
    real leader on this, to answer questions regarding the safety
    of the antibiotic Ketek, the FDA approved Ketek partly based on
    fraudulent studies of its safety. Later, we found that Ketek is
    linked to severe liver damage and death. In this case, the IRB
    responsible for approving the clinical trials of Ketek ignored
    warnings from a whistleblower.
        Mr. Chairman, you have really been a policeman, a watchdog,
    on this issue. This hearing is another in the long process that
    you have conducted, and I want to congratulate you for that. I
    yield back the balance of my time.
        Mr. Stupak. Thank you, Mr. Markey. Ranking member of the
    full committee, Mr. Barton, has joined us. Opening statement,
    please, Mr. Barton.

       OPENING STATEMENT OF HON. JOE BARTON, A REPRESENTATIVE IN
                    CONGRESS FROM THE STATE OF TEXAS

        Mr. Barton. Thank you, Mr. Chairman. Apparently, I am still
    in time to do the digital transition opening statement too if
    that subcommittee chairman is here for this hearing. I want to
    echo what Congressman Markey just said about your leadership
    and Mr. Walden's leadership on this issue in taking a look at
    the Institutional Review Boards. We are following up today on
    an issue that was uncovered during an investigation in the last
    Congress. The question is whether these Institutional Review
    Boards do a good job of protecting human subjects. When we
    started looking into this, we were concerned that some of the
    IRBs were not equipped to handle the amount of the complexity
    of the work that comes up during the clinical trials.
        As a part of our subsequent investigation was an undercover
    work that the GAO conducted over the last year. GAO made up a
    supposed clinical investigator, outfitted him with a
    transparently suspicious resume, assigned him a fake medical
    license number. GAO also concocted a verifiably false company,
    devised med systems as a sponsor of the fake study. The study
    protocol was straight from the Internet, and the device, the
    company, and the doctor were 100 percent fictitious. Once this
    particular IRB learned the committee was investigating to their
    credit it took them less than a day to decide that something
    was wrong. Instead of actually doing something, they put out a
    news release that acted as if they had just been stung by James
    Bond instead of the GAO.
        The IRB is here today to explain why it decided to approve
    the equally easy to detect fake protocol and whether it stands
    by that decision. I suspect that this subcommittee will have
    some very direct questions about the alleged science and the
    patently false protocol that Coast IRB rubberstamped and why it
    caused no apparent concern even though it had no supporting
    data from clinical trials and the study devised matched
    examples of significant risk devices on the FDA's own web site.
    I think we should be careful not to over emphasize or to under
    emphasize the significance of what this investigation has
    shown. Coast IRB was sloppy and/or negligent, perhaps just flat
    wrong, in its judgment about the protocol and the risk it posed
    to its study's subjects.
        But, fortunately, two other IRBs that were presented with
    the same protocol rejected it, one without even considering it.
    The vast majority of clinical trials, at least I hope, are
    conducted without harm to patients. Even so, I am bothered by
    the fact that two of the IRBs that GAO investigated and the
    other IRBs who advertised in trade magazines and on the
    Internet seemed to focus on the speed of their review and the
    guarantees of a quick turnaround time. In some of those ads,
    patient protection and safety seem almost like an after
    thought. The bigger issue today may not be that one IRB made a
    grade error and then tried to throw attention elsewhere, but
    that the current set of regulations does little to prevent such
    an error. That is our job if we need to review those
    regulations.
        We need to take a close look at those regulations and ask
    whether they are meaningful in the current research and
    clinical trial environment. Current regulations require that an
    IRB must make a number of determinations before approving a
    protocol, including that risks are minimized to the patient and
    that the patient has knowingly consented to participating in
    the study. But as GAO and the HHS Office of Inspector General
    have been reporting for years, there is basically no test that
    an IRB must pass before it opens for business to show that it
    is qualified to review such clinical trials. It is frustrating
    that the same problems keep popping up. These are problems that
    the GAO and the Inspector General have discussed in reports
    issued as long as 10 years ago.
        I know that the FDA recently announced a rule that would
    require IRBs to register with the FDA, but again that was a
    reform that was called for years ago, and I don't think that
    this rule would have made much difference with regard to
    solving the problems that the GAO has identified in its most
    recent undercover investigation. By putting the GAO findings in
    proper context, we can strengthen bio-medical research and
    innovation. If the public sees that our committee and federal
    agencies are ensuring that the research committee is looking
    out for the folks here confidence in clinical trials will be
    boosted and participation will increase. This should be a very
    meaningful hearing if we keep our discussion in perspective. I
    want to thank our witnesses for testifying today, and, again,
    you, Mr. Chairman, and Mr. Walden for leading on this issue. I
    yield back.
        Mr. Stupak. Thank you, Mr. Barton. That concludes the
    openings statements of members of the subcommittee. We have out
    first panel of witnesses before us. The panel that we have is
    Mr. Gregory Kutz, who is the Managing Director of Forensic
    Audits and Special Investigations at the Government
    Accountability Office, GAO, Dr. Jerry Menikoff, who is the
    Director of the Office for Human Research Protections at the
    Department of Health and Human Services, Dr. Joanne Less, who
    is the Director of the Good Clinical Practice Program at the
    Food and Drug Administration, and Mr. Daniel Dueber, who is the
    Chief Executive Officer at Coast IRB, LLC.
        It is the policy of this subcommittee to take all testimony
    under oath. Please be advised that you have the right under
    rules of the House to be advised by counsel during your
    testimony. Do you wish to be represented by counsel? If so,
    would you have them--would you state your counsel's name? Mr.
    Kutz. Dr. Less. Dr. Menikoff. Mr. Dueber.
        Mr. Emord. Jonathan Emord.
        Mr. Stupak. OK. During your testimony, if you want to stop
    and confirm with that, that will be fine. He cannot testify but
    he can give you advice. That is fine. It is the policy of this
    subcommittee to take all testimony under oath, so I am going to
    ask you to please rise, raise your right hand, and take the
    oath.
        [Witnesses sworn.]
        Mr. Stupak. Let the record reflect the witnesses replied in
    the affirmative. They are now under oath. We will proceed with
    your opening 5-minute statement. Mr. Kutz, we will start with
    you, please, sir.

     TESTIMONY OF GREGORY KUTZ, MANAGING DIRECTOR, FORENSIC AUDITS
     AND SPECIAL INVESTIGATIONS, GOVERNMENT ACCOUNTABILITY OFFICE;
       JERRY MENIKOFF, M.D., DIRECTOR, OFFICE FOR HUMAN RESEARCH
     PROTECTIONS, DEPARTMENT OF HEALTH AND HUMAN SERVICES; JOANNE
     LESS, DIRECTOR, GOOD CLINICAL PRACTICE PROGRAM, FOOD AND DRUG
      ADMINISTRATION; AND DANIEL DUEBER, CHIEF EXECUTIVE OFFICER,
                             COAST IRB, LLC

                       TESTIMONY OF GREGORY KUTZ

        Mr. Kutz. Mr. Chairman and members of the subcommittee,
    thank you for the opportunity to discuss Institutional Review
    Boards. Our investigation relates principally to private IRBs
    that authorize human subject testing. Today's testimony
    highlights the results of our investigation of the IRB system.
    My testimony has 2 parts. First, I will provide some very brief
    background, and, second, I will discuss the results of our
    investigation. First, as several of you have mentioned, federal
    regulations governing human subject testing evolved from
    society's horrified reaction to several cases.
        For example, there were the forced medical experiments on
    countless Holocaust victims. In the U.S., we had the 40-year
    Tuskegee study. In this case, hundreds of poor, mostly
    illiterate African American men, were not properly treated for
    syphilis so that the effects of this disease could be studied.
    Today, IRBs play a critical role in the safety and protection
    of human subjects. With this background in mind, let me move on
    to our results. Our investigation found that the current system
    is highly vulnerable to unethical or incompetent actors. We
    tested the IRB system with 2 separate but related undercover
    operations. The objective of the first operation was to see if
    an actual IRB would authorize our bogus medical device company
    to conduct human subject testing.
        The objective of our second operation was to determine
    whether a real medical research company would hire our bogus
    IRB. If successful, this would show that the bogus IRB could
    have authorized human subject testing. First, our bogus medical
    device protocol was approved by a real IRB even though we had
    no medical expertise. Our bogus device, which we called
    adhesive block, was a post-surgical healing device for women
    that matched several FDA descriptions of a significant risk
    device. We created our protocol and fictitious device using
    information that was publicly available and on the Internet.
    The monitors show excepts from the IRB board meeting where our
    protocols were unanimously approved and adhesive block was
    referred to as being probably very safe.
        As shown on the monitors, some due diligence would have
    shown a mailbox as our suite or office, a fictitious lead
    researcher with a fabricated medical license and resume, a
    fabricated FDA marketing approval for our device, and a cell
    phone as the only number we provided. The next picture on the
    monitor shows a coupon that this IRB provided which got our
    attention. Given that we are dealing with experimental research
    on human beings, we were surprised that anybody would offer
    discount coupons for this service. This IRB is no fly by night
    operation. They are currently the IRB of record for over 70
    federally-funded projects, and according to their own press
    release have overseen thousands of trials.
        Two other IRBs we sent these very same protocols to had a
    very different response. The monitor shows examples of their
    comments, including this protocol was awful and a piece of
    junk, the riskiest thing I have ever seen, the odds of approval
    were 0 percent, and my favorite comment, if somebody approves
    it, oh, boy. For the IRB that approved our study, the only due
    diligence they appeared to perform was after they received a
    letter from this subcommittee. After receiving this letter, the
    IRB was able to determine, for example, that our lead
    researcher and FDA marketing approval were, in fact, bogus.
    However, this IRB had already approved our bogus device for
    human subject testing 4 months before receiving your letter.
        For our second operation, we created a bogus private IRB.
    Once again, we used phony company officials and a mailbox as
    our business address. We registered our IRB on line with HHS
    and created a web site that looked like the web sites that
    other IRBs used. Then we went fishing. We advertised our
    services on the Internet and in newspapers to see if a real
    researcher or researchers would contact us. The monitors show
    our advertisements. Notice that we emphasized the speed of our
    reviews, our HHS approval, and guaranteed results. We did
    refrain from offering discount coupons as part of our
    advertising campaign.
        In response to these ads, our bogus IRB received protocols
    from one company and inquiries from five others. The company
    sending us its protocols was seeking approval to add a new test
    site for ongoing trials. Our bogus IRB, which as I mentioned
    had absolutely no medical expertise, could have authorized
    human subject testing at this site. However, we told this
    company that we couldn't review their protocols because we were
    experiencing significant financial problems due to the current
    economic crisis. In conclusion, every year millions of
    Americans submit themselves to experimental research. These
    people are among our nation's poorest and most vulnerable. I
    can't tell you whether our 2 undercover successful tests are
    isolated cases or the tip of the iceberg.
        What I can tell you is given the history of human subject
    testing, it is hard to believe that anybody could be
    comfortable with the integrity of the current system. Mr.
    Chairman, that ends my statement and I look forward to your
    questions.
        [The prepared statement of Mr. Kutz follows:]

        Mr. Stupak. Thank you, Mr. Kutz. Dr. Less, your opening
    statement, please. And for all the witnesses if you have a
    longer statement than 5 minutes, it will be included in the
    record.

                        TESTIMONY OF JOANNE LESS

        Ms. Less. Good morning, Mr. Chairman, and members of the
    subcommittee. I am Joanne Less of the Good Clinical Practice
    Program at the FDA. I appreciate your invitation to appear here
    today to discuss FDA's role in overseeing Institutional Review
    Boards. For over 40 years, FDA has been committed to protecting
    the rights, safety, and welfare of subjects who participate in
    clinical trials of FDA-regulated products. The obligation to
    protect individuals who volunteer for research and assume
    research risks in order to advance public health and bio-
    medical knowledge is integral to FDA's mission, and the agency
    continually strives to strengthen and promote the human subject
    protections. While measures to protect subjects are
    incorporated into all aspects and all stages of clinical trial,
    perhaps human subject protection is most clearly embodied in 2
    critical activities.
        The first is the requirement to obtain voluntary, legally
    effective informed consent from each study subject. The second
    is a requirement for independent ethical review of each
    clinical trial. The responsibility for human subject protection
    is one that FDA shares with sponsors, clinical investigators,
    study monitors, and IRBs. Every party with a role in the
    conduct and management of the trial has clearly defined
    responsibilities under FDA's regulations. All of these parties
    must fulfill those duties and be vigilant in doing so or
    subjects could be put at risk. This network of overlapping
    responsibility is key to protecting the rights, safety, and
    welfare of subjects who participate in FDA-regulated trials.
        IRBs are a critically important component of this
    collaborative oversight system. The primary purpose of IRB
    review is to assure the protection of the rights, safety, and
    welfare of human subjects. An IRB has the authority to approve,
    require modifications in or disapprove research. To approve a
    study, the IRB must determine that all of the following
    criteria are met. The risk to subjects are minimized, the risks
    are reasonable in relationship to anticipated benefits,
    selection of subjects is equitable, and informed consent will
    be obtained and documented. The IRB may require modifications
    to the protocol, informed consent or study procedures before it
    approves the study.
        An IRB may disapprove a study due to protocol deficiencies
    or for reasons such as limited availability of suitable
    subjects. Once a study begins, IRBs are responsible for
    reviewing changes to research. IRBs have the authority to
    suspend or terminate approval of research that has been
    associated with unexpected serious harm to subjects. There are
    different types of IRBs. Most IRBs are established and operated
    by universities, hospitals, and other institutions. These IRBs
    are comprised primarily of volunteers from the institution's
    faculty and staff. A small number of IRBs, often referred to as
    independent IRBs, are not affiliated with such an institution.
        Independent IRBs may provide reviews for industry-sponsored
    projects conducted outside a university or hospital, for
    example, in a doctor's office. FDA applies the same oversight,
    scrutiny, and inspectional practices to all types of IRBs. The
    agency places a higher priority on inspecting IRBs that are new
    that have not been previously inspected, that have previously
    been found to be out of compliance or that are reviewing
    research involving high risk products or vulnerable
    populations. During these inspections, FDA investigators select
    one or more studies in the IRBs inventory. The inspector
    reviews the IRB procedures and records, follows the selected
    studies through the entire process, and interviews key staff.
        FDA also conducts for-cause inspections of IRBs for which
    there have been complaints. During a for-cause inspection, FDA
    focuses on the issue identified in the complaint and determines
    if there is evidence to substantiate it. If an FDA investigator
    uncovers a regulatory violation, the agency may take further
    action. For minor deviations, FDA generally issues a letter
    describing the deficiency and provides reference to the
    relevant regulations or guidance. For more serious violations,
    FDA may issue a warning letter requesting that the IRB submit a
    corrective action plan within 15 days.
        FDA generally conducts a follow-up inspection to ensure
    that the violations were corrected. The agency may also impose
    administrative sanctions on an IRB. For example, FDA may
    withhold approval of studies that are reviewed by the IRB,
    direct that no new subjects be enrolled in ongoing studies, or
    terminate all ongoing studies. Because the clinical trials
    process has significantly evolved since FDA issued some of its
    regulations, FDA launched an initiative aimed at modernizing
    and strengthening the agency's oversight of clinical trials.
    FDA issued a number of guidances with the expectation that they
    will reduce burdens, improve IRBs efficiency, and allow IRBs to
    give more attention to critical human subject protection
    activities.
        Earlier this year, FDA issued regulations that would
    require all IRBs to register through an electronic system. This
    will enable the agency to more precisely identify IRBs that
    review FDA regulated research, assist us in providing
    educational information, and help us to identify IRBs for
    inspection. DA has also established a task force to ensure that
    all pending and future recommendations related to the agency's
    oversight of clinical trials raised by Congress, the HHS Office
    of the Inspector General, and the General Accountability Office
    are fully addressed.
        Finally, although FDA has traditionally conducted a
    majority of its inspections in association with the submission
    of a marketing application, the agency has been shifting more
    of its resources to inspections of ongoing studies. This will
    allow the agency to identify potential problems while the study
    is still active enabling implementation of corrective actions
    to minimize risk to subjects and preserve the integrity of the
    trial. FDA has also been improving its follow-up of violative
    inspections and working to identify alternative methods to
    select IRBs for inspection. It is FDA's strong belief that
    educating IRB members, chairs, and administrators fosters
    understanding of the human subject protection regulations and
    enhances their ability to protect subjects participating in
    research.
        To that end, in partnership with OHRP and other
    organizations, FDA participates in numerous national and
    regional conferences and workshops. In conclusion, FDA remains
    committed to strengthening human subject protection and
    improving its oversight of IRBs and other parties that conduct,
    oversee, and manage clinical trials. FDA has taken steps to
    ensure that recommendations regarding the agency's oversight of
    clinical trials, including IRBs, are fully addressed. While FDA
    has already implemented a number of changes to its clinical
    trial oversight activities, the agency continues to look for
    and welcome input about new approaches to fulfill these
    responsibilities. This concludes my statement. I would be happy
    to answer any questions.
        [The prepared statement of Ms. Less follows:]

        Mr. Stupak. Thank you. Dr. Menikoff, your opening
    statement, please, sir.

                   TESTIMONY OF JERRY MENIKOFF, M.D.

        Dr. Menikoff. Good morning, Mr. Chairman, and members of
    the subcommittee. I am Jerry Menikoff, Director of the Office
    for Human Research Protections which is within the Department
    of Health and Human Services. I previously served as director
    of the office that oversees the NIH's human research protection
    program. Before that, for almost a decade, I chaired the
    Institutional Review Board at the University of Kansas Medical
    Center. The department's commitment to human subject
    protections spans more than 3 decades. In 1974 what was then
    known as the Department of HEW issued its first department-wide
    human subject protection regulations. OHRP is charged with
    enforcing the current regulations which are in 45 CFR part 46.
        OHRP's mission is to protect the rights, welfare, and well-
    being of subjects involved in research conducted or supported
    by the department. The responsibility for protecting research
    subjects is one that OHRP shares with the FDA, agencies that
    fund research, institutions that conduct research,
    investigators who carry out that research, and the IRBs that
    review it. Everyone with a role in human subjects research must
    fulfill their duty to protect the subjects or else those
    subjects could be at undue risk. The core provisions of the
    department's current human subjects regulations cover three
    major areas. First, institutions conducting HHS funded research
    must enter into an agreement called an assurance agreeing to
    comply with the regulations. Second, a committee called an
    Institutional Review Board or IRB must review and approve the
    research before enrollment of any subject. The IRB plays a
    central role in ensuring that the rights, safety, and welfare
    of subjects are adequately protected.
        Third, the research must be conducted consistent with the
    regulations, which generally require obtaining the informed
    consent of the subjects and the IRB's continuing review of the
    research. The department's regulation in addition provides
    special protections for various populations considered to be
    vulnerable. Besides the regulations administered by OHRP, there
    are other federal regulations protecting research subjects. The
    FDA has its own set of regulations. These apply to clinical
    trials involving products regulated by FDA. These regulations
    are substantially similar to those administered by OHRP, though
    there are some differences.
        In 1991, 14 other federal departments and agencies joined
    HHS in adopting a uniform set of regulations that are identical
    to the core portion of the HHS regulations. This set of
    regulations is often referred to as the common rule. For all
    participating federal department and agencies the common rule
    outlines the same basic provisions for IRBs informed consent
    and assurance agreements. As I noted, the department's
    regulations require that institutions that are engaged in HHS
    funded research must sign an agreement with OHRP known as an
    assurance. Through this assurance the institution commits
    itself to have all its HHS-funded research conducted in
    compliance with the regulations.
        Assurances must also include designation of one or more
    IRBs that will review the research covered by the assurance.
    The institution holds primary responsibility for ensuring that
    the IRBs it designates are appropriately qualified to review
    the types of research studies it conducts. The Federalwide
    Assurance, or FWA, was introduced in 2000 and has been the only
    type of assurance accepted by OHRP since 2005. Previously, OHRP
    reviewed assurances using procedures that often involved
    lengthy discussions with institutions. In 1998, the HHS Office
    of Inspector General recommended that OHRP shift its focus and
    resources to other parts of the system so as to better protect
    research subjects. The current largely automated system for
    processing FWAs was implemented as a response to that OIG
    report.
        With the adoption of the FWA system in 2000, a new
    requirement was added. Any IRB designated under an FWA must be
    registered with OHRP. The process for registering an IRB with
    OHRP is separate from the process for obtaining FWA but the two
    are related. This registration process was implemented in
    response to a recommendation from that same OIG report. The
    report recommended a simple registration system which would
    collect minimal descriptive information such as location and
    contact information. This simplified registration system would
    still allow OHRP and FDA to communicate effectively with IRBs
    while maintaining the standards of protection for research
    subjects.
        The IRB registration process requires among other things
    submission of a list of IRB members identified by name,
    qualification, and affiliations. OHRP generally accepts all IRB
    registration applications that include information showing
    compliance with the following requirements, that there are at
    least five IRB members, there is at least one person designated
    as a non-scientist and one designated as a scientist, and then
    there is at least one member designated as not affiliated with
    the institution. On January 15 of this year both OHRP and FDA
    issued IRB registration rules. The two sets of registration
    rules are quite harmonious and will be implemented through a
    single web-based IRB registration system.
        In conclusion, the protection of research subjects remains
    a highest priority for both the department and for OHRP. We
    continue to work on ways to better achieve that goal and very
    much welcome any recommendations that the subcommittee may
    have. Thank you for this opportunity to address you. I will be
    pleased to answer any questions.
        [The prepared statement of Dr. Menikoff follows:]

        Mr. Stupak. Thank you, Dr. Menikoff. Mr. Dueber, your
    opening statement, please, sir.

                       TESTIMONY OF DANIEL DUEBER

        Mr. Dueber. Good morning. Coast IRB recently submitted the
    product in question, Adhesiabloc, to an independent forensic
    toxicological lab. That lab determined, as we did, as our board
    did on October 30, that the product was safe. Here is the
    conclusion by two top forensic toxicologists in the United
    States. It is my opinion within a reasonable degree of
    scientific certainty there is no sound scientific foundation
    for finding the constituents in the Adhesiabloc gel described
    in clinical study protocol pilot study of safety and efficacy
    of 2.5 percent Adhesiabloc gel to reduce adhesions following
    peritoneal cavity surgery, device clinical study protocol
    number P-D-15 version 1.4, unsafe at the dose recommended for
    testing.
        In October of 2008, the Government Accountability Office,
    at the behest of this committee, perpetrated an extensive fraud
    against my company, Coast IRB, LLC. It did so without probable
    cause that Coast had committed any crime. Indeed, no one at
    Coast has committed any crime. It did so without involving the
    executive branch. It did so without satisfying any of the legal
    safeguards that the Department of Justice and the federal
    courts have in place. It acted without probable cause that a
    crime had been committed.
        If this committee's objective with this fraudulent and
    illegal GAO sting operation was to demonstrate that IRBs need
    to do more checking and verification of sponsor and PI
    licenses, verify the existence of companies and so on, fine, we
    will do that. And we have changed our SOPs to do just that
    because of this illegal fraud. But did you have to take the
    extremely negative approach of setting up an elaborate,
    expensive fraud? Yes, your fraud was very sophisticated, and
    you pulled the wool over our eyes. Congratulations. But you
    need to understand the effects of this charade. I personally
    have wasted 5 weeks of my valuable time defending the honor,
    integrity, and reputation of both our company and of me. We
    have spent many years building that.
        My company has now spent over $100,000 defending itself,
    and do you know what that means? That means that we now have to
    lay off at least five people at our company to pay for this. A
    much better and positive approach would have been for you to
    call a conference together of key IRB industry leaders, FDA,
    OHRP, and the committee to identify what needs to be fixed and
    what laws, regulations are needed to fix the problem. No one
    would have had to have been harassed as Coast has with this
    sting. The GAO posed as a private business seeking review by my
    company of a medical device. It represented the medical device
    to be one that was substantially equivalent to a device
    approved for market by FDA.
        In an elaborate scheme, GAO violated federal and state
    laws, one, by falsely representing itself to be a medical
    device company, two, by submitting a fake clinical trial
    address, three, by submitting a fraudulent protocol for a
    fraudulent medical device, four, by submitting a forged CV for
    a fake principal investigator, five, by falsely representing
    the medical device to be substantially equivalent to a device
    approved by FDA for market, six, by submitting a fraudulent FDA
    510(k) number for the device, seven, by submitting a fraudulent
    Federalwide Assurance number, and eight, by forging a
    Commonwealth of Virginia medical license and license numbers
    for its supposed principal investigator.
        GAO also engaged in extensive verbal and e-mail
    correspondence with Coast IRB in furtherance of the fraud. The
    fraud would have persisted to this day had I not discovered it
    and had Coast not terminated the clinical trial. Had I not
    discovered it following receipt of this committee's request for
    documents, I am confident it would have been discovered before
    its next scheduled review of the trial in April, next month.
    Mr. Chairman, it is the exclusive duty and province of the
    executive branch of this government to engage in law
    enforcement actions. By well settled precedent that branch
    alone may engage in clandestine stings upon probable cause that
    a crime has been committed. Innocent citizens of this country
    cannot be lawfully defrauded by their government. To hold
    otherwise replaces the rule of law with tyranny.
        Mr. Chairman, what the GAO has done at the request of this
    committee is unlawful. The actions here involve mail fraud,
    wire fraud, forging of a Commonwealth of Virginia medical
    license, false presentation of license numbers and 510(k)
    numbers, and false holding out of people to be physicians in
    the Commonwealth of Virginia. Coast has notified federal and
    state law enforcement of these crimes. These are crimes whether
    committed by the GAO or anyone else in the absence of probable
    cause. They are crimes for which those responsible should
    answer. Although we have informed law enforcement that GAO is
    behind them, a fact never affirmatively confirmed by your
    committee staff to me, we have asked that the crimes be
    investigated and that those responsible be prosecuted.
        Mr. Chairman, the question confronting me, and which I hope
    will occur to you, is whether this committee and the GAO have
    the lawful authority to defraud an innocent party to prove a
    political point. My question, sir, is whether this committee
    and the GAO are above the law. You know, I am just very, very
    saddened and disappointed in our government right now. I cannot
    believe my government did this to me and my company. It is
    unconscionable. But Coast IRB shares everyone's concern in this
    room about the need to improve our oversight system. We have
    been at the forefront in the past about documenting the need
    for improvements in ICFs and IRB shopping and other categories.
    We want to work with FDA and this committee to improve the
    system in a positive way. Thank you, and I will be happy to
    answer any questions.
        [The prepared statement of Mr. Dueber follows:]

        Mr. Stupak. The members will be recognized for 5 minutes
    for questions. I will begin. Mr. Dueber, I have to tell you how
    disappointed I am, I think Mr. Walden said the same thing, and
    the other members who are up here, with your opening statement.
    Coast IRB could have come forward this morning and admitted
    that they made numerous mistakes by not checking into the
    credentials of a fake company, a fake doctor, and a fake device
    that Coast ultimately approved for use in human testing.
    Instead, like a kid who has got caught with his hand in the
    cookie jar, you now come before Congress today to complain that
    you were caught. Nowhere in your opening statement is there any
    sense of concern that your company's approval could have led to
    human subjects being exposed to a dangerous substance without
    testing. Lives could have been injured or lost as a result of
    your company's action, and all you do is complain that you were
    caught.
        Where is the first responsibility and where is the
    corporate responsibility? So let me ask you this, Mr. Dueber,
    you were interviewed on the record by committee staff last
    week. They asked you some basic questions about your medical
    review of GAO's experimental testing protocol. And let me put
    them on the screen. Here are your answers. When our counsel
    asked you, do you feel your company's medical review of the
    protocol was adequate, you indicated yes. So is it fair to say
    that none of the board members, including Dr. Dodd, who did the
    primary medical review, has raised concerns with the medical
    review of this protocol? Is that fair to say that you have no
    concerns about the protocol?
        Mr. Dueber. This was a sophisticated fraud, sir.
        Mr. Stupak. My question is, is it your opinion that the
    medical review was fair in this case?
        Mr. Dueber. We reviewed--we did a safety review. Dr. Dodd
    looked at the protocol.
        Mr. Stupak. And you feel it is safe?
        Mr. Dueber. We checked with--Dr. Dodd made the conviction--
    made the conclusion that it was safe, and we have just proven
    that it is safe with an independent review of----
        Mr. Stupak. Sure, your independent review, you talk about
    the 2.5 percent of the Adhesiabloc. What about the 97.5 percent
    of the liter that would be left in the woman's abdomen? What
    about that 97 percent? You don't even know that it is, so how
    can you test to see if it is even safe in your little report
    you have there from your expert?
        Mr. Dueber. He looked at it and he said that----
        Mr. Stupak. He looked at what? 2.5 percent, that is what he
    looked at.
        Mr. Dueber. He looked at the whole device.
        Mr. Stupak. Look at your protocol. You are going to leave 1
    liter behind. What about the other 97.5 percent of the liter
    that you have no idea what it was in our protocol because you
    never asked.
        Mr. Dueber. Well, sir----
        Mr. Stupak. So, therefore, you can't sit here and say the
    other 97.5 percent has been tested and safe when you don't know
    what the tests were because you don't know what the product
    contains.
        Mr. Dueber. Sir, I am not a scientist. I did not do the
    primary----
        Mr. Stupak. Neither am I.
        Mr. Dueber. But what I can tell you is that Dr. Dodd told
    me when I talked to him about this that this propylene glycol
    substance----
        Mr. Stupak. Which is 2.5 percent, 1 liter, is safe. Didn't
    the doctor tell you what the other 97.5 percent was?
        Mr. Dueber. We didn't discuss----
        Mr. Stupak. You didn't ask? What if it is poison? So let me
    go on. GAO submitted this fake protocol to 2 other IRBs that
    came to exactly the opposite conclusion than you did. They both
    rejected the study. The first IRB that rejected the study was a
    company called Argus IRB. Here is what they said. We realized
    it was a terrible risk for the patient. The concept of the
    study was risky. It is the worse thing I have ever seen. Doing
    a surgery, a major surgery, on a patient, then a mystery guy
    walks in and dumps a solution in the body. Where is the safety
    for the patient? Who is overlooking all these parts? Who is
    looking for the patient--who is looking out for the patient? I
    had a problem with propylene glycol gel. They said it was a
    safe substance. I didn't see any data on it. There was no data
    in the protocol indicating that propylene glycol gel was safe
    internally. It was a serious problem.
        Mr. Dueber, how is it possible that your company found that
    this study wasn't risky at all when other IRBs rejected it? And
    actually a second IRB called Fox Company, they said I could
    have sent the protocol to Board of Review but I spared wasting
    their time. There was no monitoring for safety. It appeared
    that people were just going to go out and start injecting
    people. Mr. Dueber, given what the other IRBs found, don't you
    think your company made a major mistake here?
        Mr. Dueber. Our company followed the regulations that FDA
    requires.
        Mr. Stupak. Really? Where is the due diligence in your
    company? Where is the safety of the patient by injecting them
    with a liter bottle and 97.5 percent----
        Mr. Dueber. It had a 510(k) exemption for one thing.
        Mr. Stupak. Did you go check that 510(k)?
        Mr. Dueber. No, we did not.
        Mr. Stupak. Is that part of due diligence, checking a
    510(k)? You relied on it.
        Mr. Dueber. It is now. We have changed our SOPs to
    incorporate those since we have been now hoodwinked by our
    government.
        Mr. Stupak. My time is up. Mr. Kutz, let me ask you this
    last question, if I can. Do you believe Coast's medical review
    was adequate? Do you agree with Mr. Dueber that there was no
    risk involved with injecting a liter of this mystery substance
    into a woman's abdominal cavity?
        Mr. Kutz. I don't have the expertise to say that, but what
    I would say is this is if you have a system where two companies
    can say this thing is the riskiest thing they have ever seen
    and they rejected it even in some cases before it got to the
    board, and at the same time we have an IRB that says this is
    perfectly safe, we got a real problem here. So I think that
    would be what I can say based on my expertise.
        Mr. Stupak. Thank you. And I recognize Mr. Walden for 5
    minutes, please.
        Mr. Walden. Thank you, Mr. Chairman. Mr. Dueber, I want to
    go to this report from I guess it is Kupeck Group, LLC, because
    he says in my opinion within a reasonable degree of scientific
    certainty there is no sound scientific foundation for finding
    that constituents in the Adhesiabloc gel described in clinical
    study protocol pilot study, blah, blah, blah, are unsafe at the
    dose recommended for testing. Is that the same thing as saying
    the entire grouping of those items in this proposed gel are
    safe? Does his report actually say or this company's report
    actually say that the entire compilation and usage of the gel
    was safe or just that the two constituent ingredients alone are
    safe?
        Mr. Dueber. That is our understanding. We asked him to
    review the gel at the 2.5 percent for this study and for the
    amount left in the cavity and he said that it is not unsafe at
    this dose recommended for testing.
        Mr. Walden. And so is he saying to you then that he would
    have approved it for use in human subjects?
        Mr. Dueber. That is the way we understood it, yes.
        Mr. Walden. And left in their stomach, sir, their belly for
    up to 5 months?
        Mr. Dueber. Yes.
        Mr. Walden. Where does it say that in the report? I don't
    see it in the conclusion, and where does it discuss the
    procedures involved?
        Mr. Dueber. I haven't had the opportunity to read the whole
    report.
        Mr. Walden. When did you ask for the report, sir?
        Mr. Dueber. Several days ago.
        Mr. Walden. So what report did you ask for that would have
    shown this was safe when your board approved this gel 70?
        Mr. Dueber. Well, as I--excuse me.
        Mr. Walden. While you are consulting with counsel, I will
    go to Dr. Menikoff. You can continue to consult if you need to.
    Dr. Menikoff, obviously you are representing HHS. You heard my
    comments. I heard yours in terms of more of a recitation of
    what the rules and the procedures are for your agency and the
    same from Dr. Less for FDA. What troubles me greatly, and I
    think what troubles the people I represent, is that virtually
    anybody even with the most silly of applications can register
    as an IRB simply by e-mailing your agency and it gets entered
    even if the name of the town you are from is Chetesville,
    Arizona for which I assume there is no zip code. Is this
    preventable?
        Dr. Menikoff. Congressman, it is true that anybody could
    enter information into the registration system. The
    registration system was a response to the very OIG report that
    several of you commented on, and it basically established the
    registration system, a method of collecting minimal information
    so there would be a list of IRBs.
        Mr. Walden. What do you do with that information mostly?
        Dr. Menikoff. We use it to contact IRBs to send information
    to them.
        Mr. Walden. Information about that?
        Dr. Menikoff. About a change in the system. There may be a
    compliance allegation alleged against a particular IRB, so we
    will contact them using the contact information.
        Mr. Walden. Do you use it to contact them about conferences
    and things?
        Dr. Menikoff. It could sometimes be used for that.
    Absolutely.
        Mr. Walden. Mr. Dueber, let me go back to you because I
    sense you may have an answer to my question.
        Mr. Dueber. Yes, sir. The primary reviewer on this, Dr.
    Dodd----
        Mr. Walden. Very distinguished credentials, by the way.
        Mr. Dueber. Yes. And he is very familiar with propylene
    glycol which is the basis of this substance, and he told me
    that propylene glycol can be ingested in large amounts in the
    body and is not toxic and that it is proven to be non-
    cancerous. There has been no question about its toxicity in any
    part of the body even remaining in the body for a period of
    time. He is an expert medical reviewer for the California
    Medical Board. He is chief of staff at the Lodi Medical
    Hospital. He is chairman of his Institutional Review Board at
    Lodi Medical Hospital. He is an OB/GYN also. He knows his
    stuff.
        Mr. Walden. All right. I am sure he does. Dr. Less, since
    you are FDA, is there any problem with ingesting this chemical
    in your body and having it sit there for 5 months and in
    concert with the surgeries and all?
        Ms. Less. Having not----
        Mr. Walden. You can't answer that?
        Ms. Less. I was just going to say having not seen the
    device description pre-clinical test and by compatibility
    testing, we wouldn't be able to comment on that.
        Mr. Walden. Mr. Kutz, maybe you can help us here. What did
    the other IRBs say about this procedure and the protocols and
    the tests and all?
        Mr. Kutz. I think it is important to know that because it
    goes beyond just is the product safe. If could read a few of
    their comments to you, if that is OK.
        Mr. Walden. Please.
        Mr. Kutz. The first one, as you mentioned, said that our
    submission was so bad they weren't even going to give it to the
    board. They also said that our protocol showed no evidence of
    quality control for sterility or consistency of the product.
    The next comment is very, very important. They said there was
    no prior investigation report of the pre-clinical animal
    studies we claimed to have performed, and they wanted to know
    whether there had been any adverse events, whether our product
    killed animals or hurt animals.
        The second IRB said who is the manufacturer of Adhesiabloc
    and where is it made? It seems like a logical question. We
    didn't put that in our protocols. Where will these surgeries
    take place? That wasn't in our protocols. How are the hospitals
    and surgeons being selected? That wasn't noted. Has the surgeon
    or hospital read the protocols and do they agree? We didn't
    answer that. Provide the diagram used to record the incision
    lines. And the last one that seems fairly relevant when you are
    discussing it, who will be performing and taking the tissues
    and biopsies? So those are some of the substantive comments.
        Mr. Walden. Mr. Kutz, did this IRB, which by the way made
    itself known to the public through their public relations
    outreach efforts, you didn't do that, did you?
        Mr. Kutz. No, we never used----
        Mr. Walden. And we did not. And so did this IRB come back
    to you with any questions about the protocols, any questions
    about----
        Mr. Kutz. Their initial focus was on the consent form, and
    they wanted us to, if you will, dumb it down so 5th grade level
    of reading could be done, so they were very focused on the
    consent form, which is part of their--not a lot of substance on
    the actual medical or the issues of the hospitals, who were
    these surgeons, who is this person actually putting the item
    into the woman's pelvic region after open surgery, no questions
    at all of substance like that.
        Mr. Walden. My time has expired.
        Mr. Stupak. Thank you, Mr. Walden. Ms. DeGette for
    questions, please.
        Ms. DeGette. Thank you, Mr. Chairman. Mr. Dueber, how long
    has Coast been in business?
        Mr. Dueber. Since 2002.
        Ms. DeGette. Since 2002. And since that time, you have
    reviewed 352 protocols, correct?
        Mr. Dueber. No. I don't know exactly how many we have
    reviewed.
        Ms. DeGette. OK. Have you declined any of the protocols
    that you have reviewed?
        Mr. Dueber. My understanding is yes, but I don't know how
    many.
        Ms. DeGette. OK. Mr. Chairman, I would ask unanimous
    consent that Mr. Dueber supplement his response to tell this
    committee how many protocols that they have reviewed and how
    many they have approved and how many they have rejected.
        Mr. Stupak. Without objection.
        Ms. DeGette. Thank you. Now with this particular protocol
    you took this on 5 months ago, correct?
        Mr. Dueber. Correct.
        Ms. DeGette. And you approved the protocol for testing on
    humans within 48 hours, didn't you?
        Mr. Dueber. On this particular study, I am not sure what
    the turnaround time was.
        Ms. DeGette. Well, your company advertises a 48-hour
    turnaround on most cases, correct?
        Mr. Dueber. What that refers to, ma'am, is that----
        Ms. DeGette. Yes or no.
        Mr. Dueber. I can't answer yes or no because I need to
    explain it.
        Ms. DeGette. All right. Go ahead.
        Mr. Dueber. The turnaround time refers to the amount of
    time it takes for the Coast administrative staff, which is
    separate from the board, to review the documents presented by
    the protocol sponsor and----
        Ms. DeGette. OK, I got you. So it is the administrative
    turnaround. How long and on average per protocol does it take
    you to approve this protocol for human testing?
        Mr. Dueber. I am not sure because the board--every member
    of the board has to review thoroughly the protocol.
        Ms. DeGette. So can you give me--how long did it take on
    this case? Did it take 48 hours to approve it for human testing
    on this case?
        Mr. Dueber. Well, it probably took longer than that
    because----
        Ms. DeGette. Well, how much longer?
        Mr. Dueber [continuing]. There were two board----
        Ms. DeGette. Three days, 4 days, 5 days?
        Mr. Dueber. Well, there was a week between the preliminary
    approval and the final approval.
        Ms. DeGette. A week. OK. Now, excuse me, sir, we can swear
    in your lawyer if he would like to testify, but I would like
    you to answer. Now so it took a week to approve this protocol.
    At the time that the protocol was approved for human testing,
    the report that was prepared by this very fine doctor that you
    talked about, did he prepare that report at that time that the
    protocol was approved?
        Mr. Dueber. Are you referring to the minutes of the board?
        Ms. DeGette. I am referring to the Kupeck Group LLC report
    that you provided to this committee late last night.
        Mr. Dueber. You are asking how long did it take him to do
    this?
        Ms. DeGette. No. I am saying did he prepare this at the
    time, 5 months ago, when it was approved?
        Mr. Dueber. No.
        Ms. DeGette. No. Was there a written report by him approved
    that went through all the scientific basis 5 months ago?
        Mr. Dueber. No.
        Ms. DeGette. Was there anything in writing analyzing the
    scientific evidence and the risk and benefits?
        Mr. Dueber. There was extensive discussion at the board
    meeting itself between----
        Ms. DeGette. Was there any written report prepared at that
    time?
        Mr. Dueber. There were minutes prepared for that.
        Ms. DeGette. Does this committee have copies of those
    minutes?
        Mr. Dueber. Yes.
        Ms. DeGette. OK. I would ask our committee staff if I could
    get a copy of those minutes, please. Now this report, when was
    this prepared, the report that you keep referring to as to the
    scientific efficacy of the protocol, prepared?
        Mr. Dueber. Yesterday.
        Ms. DeGette. And why was it prepared yesterday?
        Mr. Dueber. Because we contacted----
        Ms. DeGette. Because you were coming in to testify today,
    right?
        Mr. Dueber. We contacted this individual and asked if he
    would review this because we were----
        Ms. DeGette. Because you were coming in to testify today,
    right?
        Mr. Dueber. Well, we were convinced because Dr. Dodd was
    convinced that this substance was safe. He made that
    determination. The board agreed. We have five doctors, high
    quality doctors, on our board, and they agreed it was safe.
        Ms. DeGette. OK.
        Mr. Dueber. We just wanted before we came here to find out
    if that was----
        Ms. DeGette. To find out, in fact, if it was safe?
        Mr. Dueber [continuing]. In fact the case.
        Ms. DeGette. We could have been doing human testing for 5
    months without that report.
        Mr. Dueber. But, ma'am, no one in--we have never at Coast
    ever had a fraudulent study submitted to us. There is no
    economic reason for anybody to do such a thing.
        Ms. DeGette. OK. I am sorry. First of all, let me stop you
    and say I now have the minutes in front of me, and the whole
    discussion is about a paragraph long. But as the chairman is
    saying, the paragraph never talks about what is in that 95
    percent of the substance, so how would they possibly know if
    this would be safe?
        Mr. Dueber. It is based on propylene glycol which is proven
    to be safe.
        Ms. DeGette. But that is 2.5 percent.
        Mr. Dueber. Propylene----
        Ms. DeGette. What is in the rest?
        Mr. Dueber. The board reviewed that and felt that it was
    safe and there was----
        Ms. DeGette. OK. I am going to----
        Mr. Dueber. --a 510(k) device upon which they were basing,
    you know, the fact that that existed and therefore it should be
    safe. And, of course, we didn't check the 510(k) device to see
    if it was real, but we never had reason to do that, ma'am.
        Ms. DeGette. Let me just stop you. Now Ms. Christensen-
    Green and I are sitting here looking at this going we sure
    don't want this in our abdomens, and I think all the other
    women sitting here today are thinking that. That is the thing
    about IRBs. We think that when we approve--when we ask IRBs to
    review a protocol, we are doing it so that they can review the
    safety of the entire protocol. And we have had situations like
    this where--we had one situation where an IRB approved a
    protocol where they performed one type of plastic surgery on
    one-half of someone's face and another type on another half,
    and that person was grossly disfigured. What would have
    happened if this actually would have gone into human testing,
    and they would have put something poisonous as the other 97.5
    percent into women's abdomens?
        Mr. Dueber. I can't speculate on what would have happened.
        Ms. DeGette. I can't either. Dr. Menikoff, would you agree
    that is a problem?
        Dr. Menikoff. Congresswoman, this study is outside OHRP's
    jurisdiction. It was not federally funded.
        Ms. DeGette. Well, I understand that, but if there was a
    study that put 97.5 percent of a substance as part of a human
    trial into someone's abdomen, that would seem to be a problem?
        Dr. Menikoff. Again, this is not under our jurisdiction. I
    think FDA is in a better position to comment on the facts. We
    saw no protocol.
        Ms. DeGette. So you don't--OK. Dr. Less, what is your----
        Ms. Less. We have not seen the protocol or device
    description either. We would need to know what is in the
    product before we could comment.
        Ms. DeGette. Right, but you certainly wouldn't think that--
    you certainly wouldn't approve some kind of a drug that put a
    whole bunch of fluid like this where it wasn't specified what
    it was as part of a surgical operation?
        Ms. Less. We would need to know what is in the product, how
    it is being used, a full device description.
        Ms. DeGette. I just have----
        Mr. Stupak. No, no, we got to move on. We have both former
    chairs who would like to ask questions. Mr. Barton for
    questions, please.
        Mr. Barton. Thank you. You talk about a target rich
    environment for questions. My first question is to our
    representative from the GAO. The protocol and the device that
    you all chose, you, not you personally, but your organization
    consciously picked one that the FDA had already rejected and
    then changed it to make it even worse, isn't that correct?
        Mr. Kutz. We picked something that was available on the
    Internet and altered it significantly. The 3 components of the
    actual gel, we made up from stuff on the Internet so we had
    never mixed it together. I can't--we don't know if it works or
    doesn't work. We just put it together on paper.
        Mr. Barton. But you tried to make it very easy for anybody
    that was really trying to review the protocol to figure out
    that it was terrible and reject it, which 2 of the IRBs did.
        Mr. Kutz. Yes. We didn't know what we were doing.
        Mr. Barton. And then this one rubberstamped it almost
    before they got it, is that a fair statement?
        Mr. Kutz. Well, they actually--I mentioned a coupon in the
    opening statement. They gave us a pre-review with the coupon
    and then the final review was where they authorized the
    informed consent and than the actual protocols.
        Mr. Barton. How did you pay for their review?
        Mr. Kutz. Well, we gave them our credit card number. As it
    turns out, they never actually charged us.
        Mr. Barton. Really? I would have thought they would have
    cashed the check almost as quickly as they certified approval.
        Mr. Kutz. We were surprised they didn't. Everybody else
    did.
        Mr. Barton. Dr. Less and Dr. Menikoff, what can be done to
    decertify this company right now? Why are they still in
    business?
        Ms. Less. Again, we don't have the--we have not seen the
    GAO's report to be able to comment on what actually transpired.
        Mr. Barton. I am not asking you about that. I mean I am so
    mad at the company, I can hardly be civil, but I am almost as
    upset with our government folks who are supposed to oversee
    these IRBs, and this company has gotten 4 or 5 notice letters
    in the last 2 to 3 years, and yet they are still in business,
    and they have the gall to come here and threaten to sue the
    government. They ought to have their butt being kicked out the
    door within the week.
        Ms. Less. I could provide some background to you on how the
    process would generally work for a product such as this. This
    would be considered a significant risk product subject to FDA's
    jurisdiction that would require an investigational device
    exemption in order for the study to proceed.
        Mr. Barton. So basically as the representative of the FDA
    you just say business as usual.
        Ms. Less. No.
        Mr. Barton. These folks are going to stay in business for
    another 4 or 5 years, maybe approve a product that kills some
    innocent person, and then we will have another oversight
    hearing 3 or 4 years down the road. What steps are being taken
    right now to decertify these charlatans that raised $4 million
    in revenue last year scamming the public?
        Ms. Less. Congressman, what I wanted to explain to the
    committee is that for significant risk products such as this
    there should have been FDA oversight as well as IRB oversight.
        Mr. Barton. There wasn't.
        Ms. Less. No. This product should have been submitted to
    the FDA so we could have reviewed the product, looked at what
    it was made of by compatibility testing, sterility testing, all
    of that. That piece of this picture was not part of the
    operation, so that piece of the human subject protection was
    not invoked.
        Mr. Barton. As the FDA representative, what are you going
    to do to use whatever enforcement mechanisms the FDA has to
    hold this particular IRB company accountable?
        Ms. Less. We would have to go and look at----
        Mr. Barton. What are you going to do?
        Ms. Less. We need----
        Mr. Barton. Are you going to do anything at all? Are you
    going to make a report? Are you going to make a recommendation?
        Ms. Less. We will take the information from the GAO, fully
    evaluate it, do our own investigation and see what needs to
    happen.
        Mr. Barton. You will do that?
        Ms. Less. We need to see the GAO's findings and see exactly
    what happened and evaluate it and see what we need to do.
        Mr. Barton. Do you have any sense of outrage about this?
        Ms. Less. Without knowing exactly what went on----
        Mr. Barton. So the answer to that is, no, you don't?
        Ms. Less. We do. We are very concerned with human subject
    protection.
        Mr. Barton. Dr. Menikoff, you represent HHS. Do you have
    any sense of outrage about this? Are we the only people--the
    people that are elected, are we the only ones that seem to be--
    --
        Dr. Menikoff. First of all, I would certainly welcome on
    OHRP's behalf obtaining information about what happened. We
    have yet to see any actual information or documentation of what
    happened. We would welcome obtaining that and reviewing it and
    taking appropriate action.
        Mr. Barton. So you are in a passive mode also? If we bring
    a dump truck load of documents, you will review them? Are you
    going to be an advocate for investigation, use the authority of
    the Health and Human Services?
        Dr. Menikoff. OHRP is an advocate for improving the
    protection of research subjects. Again, nobody has provided us
    yet any document that information about what happened. We
    welcome that. We are eager to get it even before this hearing,
    and we would welcome receiving it, and we have appropriate
    procedures to protect subjects, and we would implement those
    procedures and determine appropriate action.
        Mr. Barton. Well, my time has expired, Mr. Chairman, but I
    am outraged, and I am going to encourage you and Mr. Waxman and
    Mr. Walden to use every authority of the United States Congress
    and the Energy and Commerce Oversight and Investigations
    Subcommittee to eliminate these bad actors. I have a sister-in-
    law who is undergoing cancer therapy treatment. She is Stage IV
    right now. And she is looking at submitting to some protocols
    for some experimental drugs that would be subject to an IRB
    approval, and it appalls me, it appalls me, that, you know, it
    is apparently with the exception of GAO who seems to be pretty
    intense about this, FDA and HHS appear to be almost
    indifferent, and of course the IRB president is incense that we
    are even asking questions. I mean that is just outrageous. So I
    will work with you, Mr. Chairman, and we will----
        Mr. Stupak. Mr. Kutz, if you want to respond to Mr. Barton.
        Mr. Kutz. Yes. We have actually sent a letter to FDA as of
    yesterday requesting them to do an investigation. The
    interesting point is when the letter was sent by the committee
    and Coast made the allegations against us, FDA had an
    investigator with the U.S. Attorney to go after charges after
    our fake company, so they were very aggressive at that point in
    time----
        Mr. Barton. Bless their little hearts.
        Mr. Kutz [continuing]. About going after--without any
    evidence except a letter from Coast they were ready to go to
    the U.S. Attorney to go after us, so I just wanted to make sure
    you understood that, Mr. Barton.
        Mr. Barton. We have a company here that has received three
    or four notice letters in the last several years. I mean it is
    just ridiculous. I yield back.
        Mr. Stupak. We thank the gentleman. Our hearing is going to
    continue. As the former chairman noted earlier, this is our
    second hearing on IRBs and something we have an interest in.
    There will be legislation. I know Ms. DeGette has legislation.
    There will be other legislative proposals after this hearing, I
    am sure. We have seven votes on the floor. I am going to ask
    members' patience and ask them to come back in approximately 1
    hour. We will be in recess for 1 hour, and then we will come
    back and continue this hearing. Thank you.
        [Recess.]
        Mr. Stupak. This meeting will come back to order. Witnesses
    are reminded they are under oath. And, Mr. Dueber, Ms. DeGette,
    hopefully she is going to come back, but she had asked you if
    it was your policy to prove the protocol to board members
    within 24 or 48 hours. You said, no, it was longer. She asked
    specifically about this one but under testimony before the
    committee the record should reflect on page 27 the question was
    you tried to do this once if a protocol goes to the board or
    board members turn around and make a decision within 24 to 48
    hours, is that correct? Your answer was right, right, yes.
        Mr. Dueber. Yes. I checked into that. Again, I am new to
    the company. I have been there 5 months.
        Mr. Stupak. Well, you shouldn't be new to the truth. Either
    it is yes or not. I mean you have your testimony. Your attorney
    has it. Just a caution, that is all.
        Mr. Dueber. I was not intentionally telling----
        Mr. Stupak. I didn't think so. OK. Ms. Christensen for
    questions, please.
        Mrs. Christensen. Thank you, Mr. Chairman. This is one of
    my first hearings on the Institutional Review Boards, and I am
    really shocked at some of what I am reading and hearing. And I
    am concerned that the IRB can be listed and then utilized by
    researchers without the Department of Health and Human Services
    even having to do a cursory check and that if federal funds are
    not involved or an FDA-regulated product is not involved there
    doesn't have to be any federal oversight or research if I am
    understanding correctly. And I also wonder listening and
    reading if there should even be private for-profit IRBs. Maybe
    they ought to be university-based or somehow more directly
    under the purview of the department.
        My first question, I will begin with you, Mr. Dueber. When
    the committee staff interviewed you last week, you acknowledged
    that your company did not verify the physicians leading these
    experimental studies or that their credentials were accurate.
    In fact, when the GAO submitted its fake protocol to your
    company you didn't verify that Jonathan Kruger, the person
    listed as the primary clinical investigator, in fact, had a
    legitimate medical license, is that correct?
        Mr. Dueber. Yes. What we did was we have never had the
    experience of having a fraudulent group of people lying to us
    about their existence and about their licenses. They did submit
    a license copy but it turned out to be fraudulent too. So what
    we have learned from this is we need to start checking that. We
    have changed our SOPs accordingly, but we did in our review
    what was required by regulations, and regulations do not
    require that that be done but regardless of whether it is
    required or not, we are doing that now.
        Mrs. Christensen. But you did eventually once you were
    asked to testify checked on the doctor. How long did it take
    for you to make that determination?
        Mr. Dueber. Well, this whole thing didn't come up until I
    got the letter from the subcommittee on the 23rd of February so
    some time after that, a day or two after that, we started
    checking into----
        Mrs. Christensen. Was it a long process to check to
    determine whether he was----
        Mr. Dueber. Well, the date that sticks in my mind where
    most of the work was done was March 5, and it took a team of us
    about maybe 3 to 4 hours to check all these things out, the
    existence of the company which didn't exist, the phone numbers,
    the licenses, and all that. It took quite a bit of time to just
    go----
        Mrs. Christensen. For all of it, but probably checking to
    see whether the doctor was a duly licensed physician----
        Mr. Dueber. That doesn't take long. That is why--you know,
    that is prime example of why we are going to start changing
    that and start doing it.
        Mrs. Christensen. Mr. Kutz, let me turn to you. You
    submitted a fake medical license to Coast IRB on behalf of Dr.
    Kruger. I think it is in the binder that you might have there.
    It is tab 2. It is the State of Virginia. The date on the
    license is 1990.
        Mr. Kutz. That is correct. I don't have the binder but that
    is correct.
        Mrs. Christensen. But Virginia requires medical doctors to
    obtain a new license every 2 years like most places do so this
    19-year old license would have expired back in 1992. Isn't that
    something that the IRB should have caught?
        Mr. Kutz. Since they weren't looking at that, I guess they
    wouldn't have caught it, but certainly if they understood that
    they had to be done every 2 years that would be something that
    they could put in their protocols.
        Mrs. Christensen. Well, Mr. Dueber, how come the company
    did not catch the fact that this was an expired license? I am a
    physician, so I am very sensitive to issues relating to
    physicians.
        Mr. Dueber. I don't know. I wasn't there. I don't know why
    it wasn't caught.
        Mrs. Christensen. But you would agree that if a doctor had
    engaged in malpractice or had lost their license that it would
    be the job of the IRB or Coast in particular to check that?
        Mr. Dueber. After this experience, I would agree, yes.
        Mrs. Christensen. And you would agree that if you realize
    that that license had expired 19 years before that you would--
    would you have approved that study if you had picked up that
    the license had expired or that the person--well, that the
    license had expired, just simply that?
        Mr. Dueber. Well, that is speculating but if someone
    submitted something like that and then it had expired we would
    do a lot of other things then to check into the validity of
    other things sent to us, which could end up resulting in us not
    taking on the study or not approving it.
        Mrs. Christensen. But the principal investigator not having
    a valid license would be a reason to not approve, wouldn't it?
        Mr. Dueber. Yes.
        Mr. Stupak. Gentlewoman, would you yield on that point?
    This license was invalid on its face, was it not? You didn't
    have to check. It was invalid, 17 years old, 10 years old, so
    it was invalid. There was no checking to be done.
        Mr. Dueber. Yes, that is correct.
        Mrs. Christensen. My time has expired, Mr. Chair. Thank
    you.
        Mr. Stupak. Any other questions?
        Mrs. Christensen. I did have another one.
        Mr. Stupak. Go ahead.
        Mrs. Christensen. OK. To Dr. Less. In April of 2007, well
    before our investigation of Coast began, HHS received a letter
    containing allegations about Coast. They turned the letter over
    to FDA because the accusations related to FDA-related research.
    FDA initiated an inspection of Coast in July, 2007. In March,
    2008, FDA issued a warning letter to Coast finding that Darren
    McDaniel, who was the CEO at the time, improperly assigned
    someone with only a high school education to conduct an
    expedited review of a human testing protocol.
        Dr. Less, I think it is commendable that the FDA took
    action to investigate and address this allegation, but as the
    GAO investigation has shown, Coast had numerous other problems
    including a review process that approve protocols based on a
    19-year old medical license, board members don't read
    protocols, and these coupons that explicitly encourage IRB
    shopping. Why didn't FDA identify some of these other clear
    deficiencies at Coast?
        Ms. Less. Congresswoman, FDA, when they go out and do an
    inspection they generally spend a few days inside and they pull
    two or three studies, follow those studies from approval
    through continued review, look for adverse events, see whether
    or not the IRB had appropriately addressed those adverse events
    or changes to the protocol. When we went out on this, it was a
    for complaint--a for-cause inspection. We had been out there
    several times before, had not identified problems. So for this
    case we went out specifically to look into the allegations that
    expedited review had not been used properly, so we were
    investigating that. And we did issue a warning letter and we
    imposed sanctions because we had been out there before and had
    found some minor violations so we imposed sanctions that they
    not use expedited review anymore.
        And generally what we will do when we do issue a warning
    letter is follow up. We make sure that the IRB institutes a
    corrective action plan within 15 days. We review that, look to
    see if it has adequately addressed everything that we were
    concerned about, and then we put them on our list for follow-up
    inspection.
        Mrs. Christensen. So you don't do a comprehensive review
    generally when you visit an IRB, you just review the specific
    complaints?
        Ms. Less. It depends on why we are out there because we had
    been there several times before and had done a more
    comprehensive review and pulled a number of studies and looked
    at those other studies. But in this particular case we just
    focused on the complaint.
        Mrs. Christensen. But the original letter also identified
    other concerns including back dating, changing board meeting
    minutes and not following through with board requests that the
    FDA inspection investigate those issues while you were there?
        Ms. Less. We did look into all of those. The ones that we
    identified in our warning letter, I believe, were all related
    to the abuse of expedited review and potential conflict of
    interest that the CEO had inserted himself into the process and
    had inappropriately used expedited review, and so we focused on
    those issues.
        Mrs. Christensen. Including the back dating and changing of
    the board--you did. And, Dr. Menikoff, did the allegations
    result in an evaluation of Coast's internal practices and
    procedures?
        Dr. Menikoff. Are you talking about the current
    allegations?
        Mrs. Christensen. No, the ones that I just referred to, the
    19 year old doing the expedited review and the backdating,
    changing board meeting minutes, not following board requests.
        Dr. Menikoff. Well, Congresswoman, as noted earlier, OHRP
    and FDA have separate jurisdiction. They began this
    investigation on a study which was under FDA jurisdiction and
    was not under OHRP jurisdiction. FDA and OHRP regularly
    communicate, and we discuss issues relating to actions that one
    agency or the other takes, and we will deal appropriately and
    generally do deal appropriately in terms of this.
        Mrs. Christensen. Well, I am going to stop here but my
    question really was did you do an allegation as a result of
    those set of allegations? Did you do an evaluation related to
    this?
        Dr. Menikoff. The evaluation was under FDA's jurisdiction
    at the time, and we would normally at that point--it is the
    same set of regulations. We would normally allow FDA to conduct
    an appropriate investigation.
        Mrs. Christensen. Thank you, Mr. Chairman. I appreciate the
    additional time. Thank you.
        Mr. Stupak. Thank you. Mr. Dueber, if we go back to that
    license, that license that was 19 years old, if you could put
    that back up on the board, could also indicate that maybe the
    doctor had been malpractice, no longer licensed to practice
    medicine, could it not, if the license was 19 years old?
        Mr. Dueber. It could have been anything. The fact that we
    didn't catch that it had expired was something we should have
    caught.
        Mr. Stupak. Right. Right. And the reason why we are doing
    these hearings, and I have been on this committee now for 15
    years, and Mr. Walden for quite a while too, back in 2002 we
    had a veteran die during experimental drug testing conducted by
    someone who was not credentialed to practice medicine in the
    United States like this Jonathan Kruger technically is not
    because his proof of license is 19 years old. So your
    responsibility as an Institutional Review Board is to do due
    diligence to protect the health and safety of the patient. You
    are the gatekeeper between medicine and the patient. And you
    testified earlier you had four--I think you had five, you have
    four doctors and one registered nurse and two other people in
    reviewing this. I am baffled as to why there is no due
    diligence and why things like this are not caught.
        If I had four doctors looking at a license, I think someone
    would have caught it. You might talk about 2\1/2\ percent of
    Adhesiabloc but 97.5 percent of it, we don't know what it is,
    and then you are going to put this in a lady's abdominal cavity
    but not by the doctor who performed the surgery but by an
    assistant according to the protocol, and the doctor wouldn't
    even know. And if I was a patient and I became sick after you
    dumped this liter bottle in me, I would go to the doctor, and
    the doctor who performed the surgery wouldn't know anything
    about it because the protocol was real specific that the doctor
    had to be out of the room when they applied the Adhesiabloc gel
    to the patients. I would have thought someone--I am not a
    doctor, but I thought that is pretty strange, isn't it, because
    when I get sick, where am I going to go? I am not going to go
    to the assistant who put the gel in me because I don't know who
    it is because I am under anesthesia and I am out. I am going to
    go back to my doctor. My doctor isn't going to know anything
    about it according to this protocol. That is crazy, isn't it?
        Mr. Dueber. I spoke further with Dr. Dodd, and he told me
    that he was familiar with a product called Hisken. He said it
    is a similar product used in surgeries, and is added to the
    abdominal cavity in the same relative volumes as the protocol
    here. Dr. Dodd said he is very familiar with Hisken and was
    comfortable with that volume so----
        Mr. Stupak. But you never verified the 510(k) process to
    see what this junk is I am dumping in the woman's body. You
    never looked. Now there might be something out there that maybe
    in the surgical field someone may use but remember you are the
    gatekeeper. You are the person who is protecting the patient
    from some doctor whose license is 19 years old and you are the
    gatekeeper, so just because there might be something out there
    but since you don't know what 97.5 of this stuff is, you really
    can't say it is safe.
        Mr. Dueber. Well, that is precisely why after having
    experienced this whole episode that we have gone through, we
    have changed our SOPs to check the 510(k), to check on the
    predicate device it is based on, to check the doctor's
    credentials, to check the existence of the company.
        Mr. Stupak. So what about the--you said you have done
    thousands of these trials. Currently you are in 70 clinical
    trials. Did you do those in those others? Did you check the
    doctor's credentials? Did you check to see what the licensing
    regulations are, the 510(k), whatever you call it?
        Mr. Dueber. We did not, and, you know, we have never had a
    fraud like this perpetrated on us. We have had----
        Mr. Stupak. It is not a fraud on you. You didn't do your
    work. We caught you. That is all. It is not a fraud. Where is
    the fraud?
        Mr. Dueber. No, that is incorrect, sir. We did our job. We
    did what FDA regulations require.
        Mr. Stupak. Really? I thought you said your job was to do
    due diligence and protect the patient. How did you protect the
    patient in Coast's IRB with this protocol?
        Mr. Dueber. We were following the regulations that were
    outlined in the FDA's regulatory----
        Mr. Stupak. Does the FDA license say--regulations say you
    have to check the credentials of the doctor?
        Mr. Dueber. No.
        Mr. Stupak. Does it say you have to check the substance?
        Mr. Dueber. We never had to, sir, because we have never had
    anyone try to----
        Mr. Stupak. What expertise do you have, if you say now when
    you are caught, well, the FDA didn't tell me to do this, but
    the FDA doesn't tell you the basic stuff, so what is the
    expertise of your Coast IRB to even run to review protocols? If
    you can't catch simple things like this and if the FDA doesn't
    tell you and you can't think of it, what qualifications then do
    you have to be an IRB?
        Mr. Dueber. We have a great deal of qualifications. We have
    got some outstanding very educated, very experienced doctors
    and nurses and laypeople on our board.
        Mr. Stupak. Then why didn't they catch it? You had more
    medical people, and I have looked at a lot of IRBs, of the
    seven people, five of the seven have medical backgrounds and
    they never catch any of this stuff. That is amazing, especially
    since our protocol, as testimony was earlier, Mr. Kutz had
    indicated, is truly based on a real study of a product that
    killed people.
        Mr. Dueber. Our review--well, this product wouldn't kill
    people, and we know that. Our procedures are----
        Mr. Stupak. Tell me what is in this bottle. How do you know
    this won't kill anybody?
        Mr. Dueber. I am not a scientist. I can't answer that.
        Mr. Stupak. Well, you keep saying this product wouldn't
    kill anybody, Adhesiabloc wouldn't kill anybody. You don't even
    know what is in it. See, that is the part that baffles us up
    here. You act like you did nothing wrong, it would not harm
    anybody, but you don't know what is in here. Isn't that your
    responsibility again to protect the patient? Isn't that your
    responsibility? How can you protect the patient if you don't
    know what is in it? I mean the other two IRBs that we have
    spoke of and Mr. Kutz has talked about, man, that just said
    this is crazy. You shouldn't do this. There is no patient
    safety. We don't know what the substance is. No one should do
    this. And then when they finally realize someone approved it,
    they said, oh, boy. That was your famous quote, I think, there,
    Mr. Kutz.
        Mr. Dueber. We have had--you know, Dr. Dodd was the
    original expert that reviewed this, and now we have this other
    outside party that reviewed it who is an expert and----
        Mr. Stupak. This outside party, did he review--he reviewed
    Adhesiabloc, he reviewed this, your expert there you mentioned?
        Mr. Dueber. The expert reviewed that, yes.
        Mr. Stupak. Oh, yes? What is in here? What does your expert
    say is in here?
        Mr. Dueber. I don't have his report in front of me.
        Mr. Stupak. You just paid for another bad report because no
    expert has ever reviewed this. You know why? Because we made it
    up last night. There is 2.5 percent, the stuff on the top, we
    made this up. So if your expert--if you paid someone money to
    review this they never contacted us to get what the contents we
    are talking about. How can you review something if you don't
    even know the chemical formula of the stuff you are supposed to
    be reviewing? Let me ask you this. Let me ask you something you
    should know something about. This is your coupon that Mr. Kutz
    testified to that was delivered to him after you had your first
    contact with him where Coast, here is your coupon, good for one
    time research protocol review worth $1,300. Take a free test
    drive on us. And here is the back of your coupon.
        So let me ask you, take a free test drive. There is a
    picture of a car and all that here, and there is a smiley face
    looking--here is the car. Here is the smiley face looking at me
    in the rear view mirror in my car, and it says coupon good for
    one time research protocol review worth $1,300. And then it
    says coast through your next study. So it sounds like to me
    that your study is more likely to be approved if you go with
    Coast. Am I reading that wrong?
        Mr. Dueber. No--yes, you are reading it wrong because what
    that is is a marketing piece. It is just trying to get
    different companies, new companies, to try out Coast and try
    out Coast's customer service. You know, there is nothing wrong
    with using some kind of a promotion to gain new business. It
    doesn't have anything to do--this is the business side of the
    business. This has nothing to do with the review board and the
    decisions they make. Those are 2 separate businesses.
        Mr. Stupak. Coast through your next study. We coasted
    through in 48 hours and there are all kinds of problems with
    our study, right?
        Mr. Dueber. We are not using that marketing piece anymore
    but, you know, that is just a piece that was used to try to
    generate some new business. It has nothing to do with the
    actual review of the studies. That is done by a separate review
    board that are independent contractors, and they have nothing
    to do with the business side. They don't know anything about
    money that we make or money that we don't make. They are not--
    --
        Mr. Stupak. Well, speaking of the money you make, you made
    what, grossed $9.3 million last year. At $1,300 a pop, that is
    a heck of a lot of reviews.
        Mr. Dueber. Most of them are a lot more than that because
    that is a single study rate. You know, there are protocols that
    have hundreds of sites, generate a lot more revenue because
    there is a lot more work involved to review it.
        Mr. Stupak. Sure. Let me ask FDA or HHS, how many
    Institutional Review Boards come on line every month?
        Dr. Menikoff. Each month we process about 300 applications.
    Some of those are amendments or renewals.
        Mr. Stupak. So basically how many are new ones a month?
        Dr. Menikoff. I don't have an exact number on that.
        Mr. Stupak. Are you concerned that people are seeing this
    as sort of a quick way to get rich? Do you need 300 a month?
    That is 3,600 a year.
        Dr. Menikoff. Again, Mr. Chairman, many of those are likely
    to be amendments or renewals of an existing IRB.
        Mr. Stupak. But don't you think we should have some kind of
    limitations on IRBs? Shouldn't they have some qualifications
    before you become an IRB?
        Dr. Menikoff. If you would like me to address the
    registration system, the registration system that OHRP runs was
    put into place as a result of the OIG 1998 report. The goals of
    the registration system were modest to have a list of the
    number of IRBs out there and to have some contact information.
        Mr. Stupak. This is your registration system. This is
    Trooper dog, remember, at Maryland House?
        Dr. Menikoff. Mr. Chairman, the system is such that we
    verify that people put in the information for requested piece
    of information.
        Mr. Stupak. Really? How do you verify it with Trooper dog
    here?
        Dr. Menikoff. By registering an IRB the government, federal
    government, is in no way endorsing that IRB or in any way
    saying that IRB----
        Mr. Stupak. Don't you think when an IRB is registered with
    the HHS there is sort of like a seal of approval authentic
    because I have this approval, like fake medical devices sent up
    by Mr. April Fuhl.
        Dr. Menikoff. OK. Mr. Chairman, again, we in no way--the
    system is not designed to be any endorsement of an IRB, nor do
    we intend it to be, and to the extent any of the evidence you
    revealed during this hearing or the GAO has revealed----
        Mr. Stupak. Yes, but my question was doesn't it give people
    an aura of authenticity because you----
        Dr. Menikoff. I understand that. We were not aware that
    this was a problem that people out there were thinking----
        Mr. Stupak. Really?
        Dr. Menikoff [continuing]. Because an IRB was registered
    that the federal government was endorsing it. The federal
    government has many systems by which it has lists of--again,
    this is sort of like a contact phone book.
        Mr. Stupak. This is an IRB that is supposed to be set up to
    protect patient safety. This isn't a phone book.
        Dr. Menikoff. I understand that, and there are many parts
    of the system that actually help ensure that IRBs are operating
    appropriately. The registration system----
        Mr. Stupak. Tell me one thing you do after you register an
    IRB, what do you do to make sure they are valid IRBs or doing
    it properly?
        Dr. Menikoff. OHRP has several divisions that work at this.
    We have a compliance division that we accept reports of non-
    compliance from anybody who wants to report.
        Mr. Stupak. So nothing until somebody complains like if
    someone dies?
        Dr. Menikoff. If you are asking whether the current system
    basically puts a stamp of approval on an IRB at the moment it
    is created, it was not designed to do that.
        Mr. Stupak. Mr. Kutz, what did your investigation find when
    people would register? Was that a seal of authenticity,
    approval or something? Why did you undertake that part of
    registering fake IRBs with HHS?
        Mr. Kutz. Obviously, he is saying it is not intended to,
    but one of the IRBs, for example, that we submitted our
    protocols to, said that it gave us an aura of legitimacy. And
    so, yes, I believe people out there would--and plus it is
    called assurance, but it is really self-assurance, and so it
    doesn't really provide anything except registration, as he
    said, of what is in the system. So maybe we shouldn't be
    calling it assurance either. It depends on how you perceive
    that. I could perceive assurance to mean someone has actually
    reviewed and approved an application.
        Mr. Walden. Mr. Chairman, will you yield on this point
    because I thought the CFRs, the regulations of the federal
    government in 45 CFR part 46.101(d) state that as part of
    evaluating assurances the department ``will take into
    consideration the adequacy of the proposed IRB in light of the
    anticipated scope of the institution's research.'' Is that not
    part of your rules?
        Dr. Menikoff. Yes. Now that rule dates back to 1974. It was
    implemented at a time when this whole system was first being
    created and people didn't understand the complexity of how the
    system works, how you best protect research subjects, and how
    an IRB should function. Over the decades as the system was
    implemented, people discovered basically that the efforts being
    spent in implementing that provision essentially amounted to
    verifying, for example, that an IRB that reviewed medical type
    studies had one or two doctors on it, and a lot of effort was
    being spent at assuring that fact. This was then reviewed by
    the OIG in the 1998 report I described, and it actually
    concluded that the way that provision was being implemented was
    not actually advancing human protections, that a better way to
    do this was to create a more streamlined system that basically
    what you needed was----
        Mr. Walden. And we are 10 years later, and that system is
    due to come on line this summer?
        Dr. Menikoff. No. Part of that system have already been
    implemented.
        Mr. Walden. And so if you had had to follow this regulation
    that is still on the books, correct?
        Dr. Menikoff. Yes.
        Mr. Walden. Would not that check of assurance to make sure
    that the fake IRB created by GAO was legitimate, wouldn't that
    regulation have caught that? These folks listed themselves as
    from a city in Arizona named Chetesville. I mean come on. Do we
    have nothing in place that would have caught a fake IRB?
        Dr. Menikoff. Congressman, the system is currently designed
    in a way that you gave a registration with some cute names that
    again had spelling errors and other things that unless somebody
    sat there and tried to pronounce the names and the addresses,
    they would not pick up the things that seem incredibly obvious
    right now, and the system wasn't designed to do that. We do not
    have our staff going through the names to see whether people
    have put funny names on the list, nor indeed would we know
    what----
        Mr. Walden. So what good is it to register with your agency
    when you put a stamp of approval on an IRB that then is system
    wide usable for others to go through to certify human tests? Is
    it a pointless purpose?
        Dr. Menikoff. Congressman, we are not putting a stamp of
    approval on the IRB. If the federal government----
        Mr. Walden. But people market it that way. We have examples
    of advertisement where they say, this one, I won't read you the
    name, you can count on IRB standard for high quality review and
    documentation, full AAHRPP accreditation, good standing with
    FDA, registered with OHRP.
        Dr. Menikoff. OK. And, again, it is mentioning several
    other entities. One of those is AAHRPP which is an
    accreditation entity that is in the business of accrediting
    IRBs. But in terms of the federal government aspects of this,
    we are not in the business currently--that would be a different
    system, and we welcome your input in terms of whether or not
    you think that would be a good thing to do. That would be a
    dramatic change from the system. The system is never designed
    to basically have us from the outset endorsing and putting some
    sort of stamp of approval----
        Mr. Walden. So you think the system works well today?
        Dr. Menikoff. Right now we think we have a well-functioning
    system. There is certainly room for improvement but in terms of
    the part of the system that OHRP deals with, it is interesting
    that GAO, for example, we deal with the funded studies. GAO was
    not able to create a fake study that went through and got
    federal funding.
        Mr. Walden. No, but GAO could have created a privately--a
    study through private funding that would have your HHS stamp of
    approval on an IRB, right?
        Dr. Menikoff. Again, it is not a stamp of approval. It is a
    registration.
        Mr. Walden. Well, you don't call it that but you could say
    I am registered with HHS.
        Dr. Menikoff. You are a problem. We welcome the information
    and we will look into this in terms of making sure that people
    out there know that the government currently is not putting a
    stamp of approval. It is a registration list. Anybody could
    sign up on the list. That is exactly what----
        Mr. Walden. Clearly.
        Dr. Menikoff [continuing]. OIG intended when it asked for
    this list to be created. They wanted a quick and dirty way to
    put people on our list so we would know vaguely how many IRBs
    are out there and contact information.
        Mr. Walden. Mr. Kutz.
        Mr. Kutz. Well, I think the Federalwide Assurance which
    includes the IRB and the medical device company, this is
    necessary for federally funded research so it is, I assume,
    meaningful for federal people applying for federal grants with,
    I believe, 19 agencies, so I would believe those agencies
    potentially put some credibility behind people that have
    Federalwide Assurance.
        Mr. Walden. Because what you are getting when you register
    with Mr. Menikoff's office is Federalwide Assurance.
        Mr. Kutz. Correct, for federal funded projects.
        Mr. Walden. That is the gate. You got to get through that
    gate in order to even go to the next step, right?
        Mr. Kutz. Correct.
        Mr. Walden. And then there may be a check or balance that
    catches you there?
        Mr. Kutz. There could be beyond that, yes, but just to get
    that--you have to get that to even apply is my understanding.
        Mr. Walden. So it does serve more than just a place to
    register to get mail for future conferences or other updates.
    It is actually something that is required elsewhere in the
    government?
        Mr. Kutz. For federally-funded projects, not for privately
    funded. That is my understanding.
        Mr. Walden. Do you disagree with that?
        Dr. Menikoff. OK. If I could clarify, we are talking about
    two things here. There is a registration system which is a
    registry, a list of some information about each IRB. There is
    an assurance process, the Federalwide Assurance. They are
    different things. The registration list, yes, an IRB to be used
    by an entity that wants to get federal funding or HHS funding
    has to be listed on the registration list. If I could describe
    the Federalwide Assurance, that is essentially an agreement by
    which before you take federal funding, you have to agree, you
    have to sign on the dotted line that your entity agrees to
    abide by the federal regulations. So essentially by getting
    Federalwide Assurance an entity is actually committing itself
    and putting itself under a legal burden that it will abide by
    the regulations.
        The federal government is in no way endorsing the entity,
    but it is just that a federal funding agency at HHS cannot give
    funds to them until it has basically sworn and said, yes, we
    will protect human subjects. We agree that we will have to
    abide by the federal regulations. That is a good thing, and the
    intent of the system is to encourage, make sure people could
    get Federalwide Assurance and could basically be willing to
    swear that they will indeed abide by the federal regulations.
        Mr. Walden. I will tell you, I guess when I get back home
    and try and explain how you register an IRB or whatever you
    want to call it, and it is up here on the chart, fake medical
    device, easy reviews. They are clever names, I don't doubt
    that. And that that gives you then the authorization to oversee
    the protocols on the human tests and that that seems to be all
    it takes.
        Dr. Menikoff. If I could clarify, in terms of the
    jurisdiction side that OHRP deals with a major part of the
    picture has been left out, which is that the IRB is not working
    in a vacuum. As we noted again, GAO was actually not able to
    get federal funding. An IRB reviewing a study, is it hard to
    get federal funding.
        Mr. Walden. But they did get approval on the other side of
    the coin. They were able to go to an IRB and get approval for
    human tests.
        Dr. Menikoff. Yes. And I am just pointing out an IRB that
    is reviewing a study that is getting federal funding, getting
    federal funding itself involves a very detailed process of
    checks and balances----
        Mr. Walden. I understand that.
        Dr. Menikoff [continuing]. That again that is a part of the
    research world that is under OHRP's jurisdiction. Much of the
    vetting that you are concerned about will actually happen, for
    example, before NIH gives funds. Barely 20 percent of the
    studies actually get funded these days. It is very competitive.
    These things are reviewed by panels of the most eminent----
        Mr. Walden. So you don't see that there is any real problem
    with what you have learned from GAO, is that----
        Dr. Menikoff. Up to now, everything you have indicated GAO
    has done, I would think would be highly problematic for that to
    have happened in terms of the studies that get federal funding.
    Again, we are open to looking at the information on what
    happens but----
        Mr. Kutz. We didn't apply for federal funding and I am not
    sure--and I don't think we actually would because we might
    actually displace a legitimate applicant so that would not be
    necessarily an appropriate undercover test in this case, but we
    didn't apply. So I am not sure if we couldn't but we didn't
    apply, and I assume there are a lot of other controls there
    that would have had to have been tested, but just for the
    record we did not try to get federal funding. We just used this
    to give us an aura of credibility up there amongst the people
    that were medical device and IRB companies.
        Mr. Walden. So where in your fake IRB ad, you felt like you
    got that stamp of approval, and it meant something in the
    marketplace when you advertised?
        Mr. Kutz. We used it as that, and certainly again as I
    mentioned at least one of the IRBs that we sent our protocols
    to said it gave us legitimacy. And I understand what HHS is
    saying here, but that is the perception out there, so that is
    an important--whether they like it or not that is what the
    reality is out there amongst people.
        Mr. Walden. Thank you, Mr. Chairman.
        Mr. Stupak. Mr. Burgess, questions?
        Mr. Burgess. Thank you. Mr. Dueber, let me just ask you,
    was this product ever used? Are there any patients who received
    this product?
        Mr. Dueber. No, not that I know of.
        Mr. Burgess. The board approval came in October, the end of
    October.
        Mr. Dueber. The first approval did and then November 6 they
    approved the total project including the ICF form.
        Mr. Burgess. But no patients had been enrolled? Is there
    any way to know that absolutely for certain?
        Mr. Dueber. No. We have not--we did not receive any SAEs or
    PD, protocol deviations, or anything of that sort like a
    sponsor would be required to send us if there was a need to
    send that to us.
        Mr. Burgess. But say there wasn't any protocol deviation.
    Say everything went just as smooth as silk. Would you know that
    a patient had or had not received the 4 250 milliliter vials of
    stuff?
        Mr. Dueber. Not until we did a continuing review, which the
    board set for 6 months later, which would be next month, then
    we would have to go back and have resubmission to us of all the
    documents. It basically is a full review again of the protocol
    and the ICFs and what not.
        Mr. Burgess. Well, Mr. Chairman, I am going to ask that
    that information be made available to us, and I would hope it
    would be made available to us before a month from now. In light
    of everything that we have heard today, patient safety should
    be critical and uppermost in everyone's mind. If we have got
    people out there who have been treated with a product that
    wasn't even a product----
        Mr. Stupak. Mr. Kutz could probably answer it.
        Mr. Burgess. That is a real issue.
        Mr. Kutz. But there is no real patients. The whole thing
    was bogus so there were no people signed up. Now they could
    have been but they weren't. There were no surgeries performed.
    Again, everything that we provided was fabricated.
        Mr. Dueber. And on March 6, I might add, we convened the
    board of our company not knowing that this was still--not
    knowing what this was, we convened the board and rescinded
    approval for the study and notified the study sponsor of that,
    but never could get hold of anyone on the phone or what not.
    And who we had to send it to was a post office box so it was a
    phony site to begin with.
        Mr. Burgess. So there was no actual product produced.
        Mr. Dueber. No.
        Mr. Burgess. This looks like a big----
        Mr. Dueber. This was all a big setup.
        Mr. Kutz. We never actually mixed the product together,
    never, ourselves.
        Mr. Burgess. OK. Now the issue that was of concern to
    people about the 2.5 percent active ingredient, the propylene
    glycol, and then I guess 97.5 percent diluent. Do we know, was
    that just made-up stuff too? There was no actual diluent that
    was used in those 250 milliliter vials?
        Mr. Kutz. Correct. We didn't say what the other 97.5
    percent was. Our protocols were silent on that.
        Mr. Burgess. OK. I will just point out that is unusual to
    pick a product up off the shelf and not know what the rest of
    it is because the vehicle is important to--it is important to
    be aware of what the vehicle is. Let me just ask you this. If
    this had gone forward, if this has been a real product or
    whatever, who would have paid for the surgery? This is a
    product that could only be placed at the time of an operation,
    presumably an anesthetic. Day surgery or hospitalization, all
    of that entails some cost so to get to that point where you can
    actually administer the product, who was going to pay for the
    rest of everything else that was happening that day, lab work,
    hospitalization, day surgery, surgeon's time, anesthesia time?
        Mr. Dueber. I believe the way this was set up was that the
    patients were people that were going to have surgery anyway,
    and they would have had to have paid for that surgery through
    whatever means they had to pay it. They were not receiving----
        Mr. Burgess. OK. Let me just interrupt you on that thought.
    Would you have actively excluded the patient on the Medicaid
    system? We made a big deal about no federal funds were used,
    but would you have excluded a Medicaid patient from this
    protocol?
        Mr. Dueber. That would have been the sponsor's decision,
    and we wouldn't have had any involvement in that, so I don't
    know.
        Mr. Burgess. So there could have been federal funds used in
    the installation of this product in the peritoneal cavity?
        Mr. Dueber. If it were a real--yes, that could be the case.
        Mr. Burgess. Right. It is hard when you are dealing with a
    make-up world, and I do understand that and I sympathize with
    you but we shouldn't be here in the first place, so I am going
    to press on. The second surgery, the second look operation 20
    weeks later, so 6 months later we are going to have another
    look to see whether or not our product worked, who is going to
    pay for that surgery?
        Mr. Dueber. I am not sure, sir. I don't know. I don't know.
        Mr. Kutz. I don't believe our protocol said. That was one
    of the questions we got from one of the other IRBs, who is
    paying for the surgery, who are the physicians, who are the
    surgeons, who are the people that are going to actually apply
    Adhesiabloc to the women's pelvic area. That was all silent in
    our protocols. Those were serious questions we got from the
    other IRBs.
        Mr. Burgess. It just struck me because that is not a normal
    course of events. You do a laparoscopy for pelvic pain
    diagnosis endometriosis. You are not necessarily going to be
    back in 20 weeks looking to see what things look like today, so
    that is a little bit of an unusual situation just from my
    recollection of clinical practice. I realize it has been a few
    years but that would be a deviation. Someone has to pay for it.
    Again, my concern there is if we involve the Medicaid system
    then again federal dollars are used in this test protocol so we
    can't really just say no federal funding was used so we can't
    be interested. I think we should be interested from a patient
    safety standpoint but there was a real possibility had this not
    been a fake study that federal funds might well have been used
    depending upon the part of the country where the study was
    conducted because obviously we heard on this committee time and
    time again about the greater and greater proportion of patients
    that are being covered by Medicare given the state of the--I am
    sorry, Medicaid, given the state of the economy.
        Is there--I am not sure whether I need to address this to
    Dr. Menikoff or Dr. Less, but here you have albeit a make
    believe company and it got one positive response to several it
    sent out. Does anyone sort of take the 30,000 foot level look
    at this and say, wow, two IRBs turned this down and one bit? I
    wonder why it only had a 33 percent acceptance rate out there
    in the universe of IRBs. Would that trigger a red flag on
    anyone's part in any of the federal agencies that have
    oversight not necessarily of the federal funding but of the
    patient safety aspects?
        Mr. Dueber. Yes, I think it has a big bearing with all due
    respect. I sit here, you know, feeling troubled that only three
    were selected, and we were one of the three. I mean why not
    select 40 or 50 of them? I mean I understand where you are
    going, and I honestly have to say I am on your side. I want my
    company to do an excellent job of protecting human subjects,
    and of course we have work to do. We are not perfect. No one is
    perfect.
        Mr. Burgess. I am going to interrupt you in the interest of
    time because the chairman is going to cut me off. He always
    does and I can't stop him. But, Dr. Menikoff or Dr. Less, is
    there any mechanism in place right now when you only have a 33
    percent uptake rate that that raises a red flag, that maybe
    this was a protocol that needs to be looked at more
    scrupulously?
        Ms. Less. Congressman, there is a check in place in our
    regulations that when a study for a medical device, when it is
    presented to an IRB, the IRB is supposed to make the
    determination of whether or not an IDE is needed. If the IRB
    disagrees with the sponsor who has presented it as a non-
    significant risk product, if the IRB decides it is not a non-
    significant and it is, in fact, significant risk, the IRB is
    supposed to tell the sponsor that and the sponsor is supposed
    to report it to FDA within 5 days. So there is that check in
    place. FDA would be notified if an IRB, as they were supposed
    to do, make a decision, and if they disagreed with the sponsor.
        Mr. Burgess. Did that happen in this make believe world
    that we are in today? Did any of that occur?
        Ms. Less. No, that did not occur.
        Mr. Burgess. I know I am a little slow on this, but who
    should have picked that up? Where should that have occurred?
        Ms. Less. Well, the sponsor, who was fake, should have been
    reporting that to FDA.
        Mr. Burgess. And does the FDA have any mechanism in place
    to know that, oh, my goodness, this sponsor did not make any
    sort of report at all. We wonder why. There is some curiosity
    to go back and look and see why no report was made.
        Ms. Less. We wouldn't necessarily know if the sponsor did
    not comply with the requirement and not make that report. We
    wouldn't necessarily know. If they did make the report then we
    would go out and look at the study, decide whether or not we
    agreed with the IRB or the sponsor, decide whether or not it
    did in fact need an IDE.
        Mr. Burgess. So there is no way to track, I will just call
    them dropped cases for want of a better word, if the
    investigations just don't come back to you, then you don't know
    why they weren't pursued?
        Ms. Less. Well, what could have actually happened if they
    were a real case if a sponsor goes to an IRB and says my
    product is low risk, the sponsor says, no, in fact, that is
    actually high risk, that sponsor then could not conduct the
    trial. They would make the report to us. They would not be able
    to start the trial. If they went--and so there is that check in
    place that they would be reporting to us and----
        Mr. Burgess. What is they were venue shopping on this and
    went to several IRBs simultaneously as the fake company did?
        Ms. Less. Well, hopefully when they went to the second IRB
    they wouldn't lie and say that it is still a low risk product.
    They would fix their protocol or go in and say this is a
    significant risk product because again that second IRB would
    have to ask the sponsor of the trial is this a significant
    risk, does it require an IDE? The product could not be shipped
    and the study couldn't be started without our approval too for
    this kind of product so there is that second check in place
    that the trial could never have gotten--or should never have
    gotten started without coming to FDA.
        Mr. Burgess. Mr. Kutz, was that your finding as well?
        Mr. Kutz. We said it was significant risk and for the one
    IRB we provided a 510(k) which would have been a prior
    marketing approval but, no, we said it was a significant risk.
    We did not say it was low risk.
        Mr. Burgess. So should the FDA have picked up on that fact
    and gotten back to you and said hold the phone?
        Mr. Kutz. We never contacted the FDA.
        Mr. Burgess. Oh, you did not?
        Mr. Kutz. No.
        Mr. Burgess. But in the real world it would be your
    obligation as an investigational company to contact the FDA?
        Mr. Kutz. I am not aware of the regulations on that.
        Mr. Burgess. Right, but it was GAO in charge of the fake
    company so you were CEO of a fake company. If you were a CEO of
    a real company, would that have been the obligation of the real
    company to do that?
        Mr. Kutz. FDA knows the--I don't know the answer to that.
        Mr. Burgess. I need a yes or no or the chairman is going to
    whack me.
        Ms. Less. Yes. The fake company should have reported to FDA
    that the product was determined to be a significant risk. These
    types of products, we have a guidance document that lists
    significant and non-significant risk products. This type of
    product is listed as significant risk.
        Mr. Burgess. It is voluntary at this point. No one is
    required to do that so if somebody slipping under the radar a
    time or two, we really got no way to go back and do any sort of
    internal check on that. I would be interested if I were the FDA
    today, are there any others that have slipped under our radar
    like this? How many other bad studies have we missed?
        Ms. Less. It is not voluntary. It is mandatory that the
    sponsor report to us within 5 days of the IRB tells them that a
    product that they presented to them is significant risk.
        Mr. Burgess. What penalty might they invoke if they don't
    report?
        Ms. Less. If they don't report, we would go after them. We
    could issue a warning letter. We would go out and inspect,
    issue a warning letter.
        Mr. Burgess. What if you found that federal funds were used
    such as in the Medicaid or S-CHIP system, would HHS become
    involved at that----
        Mr. Stupak. Last one now, Mr. Burgess. We have been more
    than generous with time. We have another member waiting.
        Mr. Burgess. All right. If the federal funds were used to
    pay for the surgeries or the procedures, Dr. Menikoff, would
    that get your interest?
        Dr. Menikoff. When you are referring to federal funds being
    used, the general sense of that is basically that the funding
    for the study taking place, in other words, an investigation
    that is funded by NIH or CDC or FDA itself may be running a
    study. Normally probably the fact that one of the procedures is
    paid through Medicaid, for example, wouldn't implicate that.
    The key is that somebody in getting federal funds to run one of
    these studies, if this study was done with NIH money, GAO again
    didn't fully respond, but the odds are extraordinarily low that
    any of this could have happened because in getting those funds
    the legitimacy of this entity would have been vetted this way
    and that. You would have had top scientists asking who is this
    person? What knowledge does he have to do this? Is he a well-
    trained physician? What papers has he written?
        Many, many parts of this system work together and
    particularly on the HHS funded side to make sure that we have
    legitimate things happening and this information then works
    together with the IRB in terms of making sure that there are
    substantial protections in place. So again the facts do speak
    for themselves. GAO didn't end up producing a fake, federally-
    funded study. I think it would have been very, very difficult
    to do that. There are many, many protections in place.
        Mr. Burgess. And yet still federal funds could have been
    put----
        Mr. Stupak. Mr. Burgess, I really do have to in all
    sincerity--Mr. Markey has been waiting patiently. You are more
    than 7 minutes over.
        Mr. Markey. Thank you, Mr. Chairman, very much. Mr. Dueber,
    based on the review that your company conducted here, would you
    have been comfortable with your wife or your mother being
    treated in her abdomen with the solution your company approved?
        Mr. Dueber. I can't answer that. I do not know.
        Mr. Markey. You don't know if you would be comfortable
    recommending to your wife and mother something that you
    recommended for all of these other----
        Mr. Dueber. You know, it is speculating. I would have to--
    you know, I don't know. The doctor that I talked to that was on
    our board that approved this does this surgery, uses a similar
    product. He felt it was safe. We have had it reviewed by an
    expert, outside expert, and he says it is safe. I mean the
    ingredients that supposedly were in it are supposed to be--the
    active ingredients are supposed to be safe. The inactive
    ingredients have no interference with the effectiveness of
    active ingredients so absent any other information to prove
    them wrong, I guess if I was in a decision-making mode, I would
    probably say, yes, go ahead and use it on them. But of course
    that is their decision, not mine.
        Mr. Markey. Well, if you look at your record the committee
    requested information on all of your reviews for the past 5
    years, and this is what you provided, that your company
    reviewed a total of 356 proposals for human testing, and you
    approved all of them. So that means you approved 100 percent of
    all the studies that you reviewed.
        Mr. Dueber. I am not sure the numbers you are looking at,
    356, what----
        Mr. Markey. You approved--356 protocols were approved and
    the board voted----
        Mr. Dueber. For what time period? I am sorry.
        Mr. Markey. Over a 5-year period.
        Mr. Dueber. No, we have approved more studies than that,
    sir.
        Mr. Markey. These are the records that you submitted to the
    committee, and I am working off of your documents that you
    provided to us.
        Mr. Dueber. I believe you may be looking at the audit
    numbers that we sent to you.
        Mr. Markey. We have every--you provided to us every vote
    which the board cast over the last 5 years, and of the 356
    protocols you approved every single one of them, 7 to 0 on each
    vote, except on one occasion when 1 single board member
    dissented, so that means out of 2,492 votes cast by board
    members all but one were in favor of approval.
        Mr. Dueber. We have been requested to provide you with a
    list of all of our protocols since the inception of Coast and
    which ones were approved, which ones were not approved, and we
    will work on that and send that information to you. I can tell
    you that we do audit a fair number of protocols. In the last 3
    years we have done about 50 to 60 audits, and some of those
    audits, we have overturned the original ruling of the original
    approval of those studies.
        Mr. Markey. Mr. Kutz, let me read to you from their web
    site. Here is what it says. It says Coast IRB's quick document
    turnaround will save you valuable time and ensure that you can
    seamlessly move on to the next steps quickly and efficiently.
    Our superior service guarantees your site approval documents
    will be sent to you the next day following every board meeting.
    In this case, do you believe that emphasis on speed contributed
    to the company's failure to conduct even cursory due diligence
    which if it had been done by the firm would have been as a
    result of a basic documentation review found that there was
    ultimately a fictitious nature to this entire enterprise?
        Mr. Kutz. The answer is probably yes. One of the reasons we
    picked the three we picked were because they appeared to have
    the less stringent documentation requirements. That is why we
    picked them. So we were testing the system. We were picking
    ones that we thought would have the less stringent paperwork
    requirements. And, in fact, as I mentioned also, the other
    thing that this IRB was selected is because they offered us a
    coupon.
        Mr. Markey. Well, I think that it is pretty clear that--I
    know Mr. Dueber doesn't see it that way at this particular
    point in time, but I think the GAO and this subcommittee are
    providing a real service to your company, sir. I think that we
    are trying to help to protect against such a lackadaisical
    system harming human beings. And you seem to be outraged
    actually in our pointing out this deficiency in the way in
    which your company conducts business. I just think it is
    important for you, sir, to reconcile yourself to this as an
    intervention in underlying corporate pathology and that we are
    trying to help you correct your business practice so that the
    public is protected.
        I know you don't see it that way right now, but I think
    when you look back years from now you will see it that way, and
    I just think that perhaps now you are being advised by counsel
    to take the position which you are taking in your testimony
    here today, but it is not helpful to you to be denying the
    obvious which the GAO and our subcommittee chairman have
    identified to you. That is my advice to you. Try to start out
    where you are going to be forced to wind up anyway. It is going
    to be a lot prettier. This testimony that you are delivering
    today is not helpful to yourself or to the cause of insuring
    that there are real processes that protect the public. Thank
    you, Mr. Chairman.
        Mr. Stupak. Thank you, Mr. Markey. A couple questions I
    want to ask to follow up Mr. Burgess, and I think Mr. Walden
    hit on it too. On IRB shopping, IRB shopping, this is a
    practice in which researchers shop their protocol around to
    different IRBs until they get an approval. In 2002 the previous
    administration considered issuing regulations to require
    researchers to disclose prior IRB decisions so people would
    know if the study had been rejected in the past. On January 17,
    2006, the previous administration withdrew this proposal,
    concluding that IRB shopping does not occur or does not present
    a problem to an extent that would warrant rulemaking at this
    time, so 4 years later they withdraw it.
        According to this decision, the administration apparently
    felt they had no reason to believe IRB shopping was occurring
    with any regularity. Dr. Less, that came out of the FDA. Who
    would have made that decision in the FDA? Would it have been
    the FDA, HHS, the administration, who would have made that
    decision to withdraw this form shopping--IRB shopping
    requirement?
        Ms. Less. Mr. Chairman, after we issued the Advance Notice
    of Proposed Rulemaking, we evaluated all of the comments
    received. We had a working group involving experts from across
    the agency including our Office of Chief Counsel, all of the
    centers, and we looked at the comments and made that decision
    based on the information that we received and also in light of
    current regulations and the protections that we think that our
    regulations offer.
        Mr. Stupak. So you asked IRBs and they said, no, we don't
    do that?
        Ms. Less. No. We put it out for public comment and we got
    55 comments. We reviewed all of those very carefully. We looked
    back at the IG report, which said that they were aware of a few
    case of IRB shopping, and the comments that we received, we
    also didn't have any real reason to believe that there was any
    concern over IRB shopping. There are a number of reasons why
    companies will go to multiple IRBs for legitimate reasons.
    Sometimes a company will go to more than one IRB at the same
    time simply to get their study up and running more quickly.
        That doesn't necessarily mean they are shopping for the
    fastest or the least stringent IRB. We also can--we were
    concerned with the burden that it would put on IRBs in the
    sense that if you had a study with multiple sites, say 10, 20,
    40 sites, if all of those IRBs had to share previous reviews,
    we felt it could overwhelm the system. And without knowing the
    other IRBs review practices, you would have no basis for
    deciding on the merit of that review. And we have seen that as
    an instance with say adverse event reporting.
        Mr. Stupak. So when Mr. Dueber--let me ask you this. We
    asked you when you were interviewed last week by the committee
    staff, you disagreed. You said that IRB shopping, and I quote--
    in fact, if you want to look at your testimony it is front of
    Dr. Menikoff there on page 83, I believe it is. It has a green
    tab on it there. When asked about IRB shopping, you said, ''Has
    been a problem of IRBs, I understand for quite some time.'' So
    IRB shopping is a concern then, right, amongst IRBs, that they
    are going to go get a bad decision from one IRB, so they go to
    another IRB until they get it, that is a problem?
        Mr. Dueber. From my perspective and my company's
    perspective, it is a problem and----
        Mr. Stupak. Then answer me this. This is your coupon that
    you gave out to Mr. Kutz. On the bottom of the coupon it says,
    and I am going to read directly now, it says Coast IRB's free
    test drive offer applies towards initial protocol informed
    consent form and investigator's drug brochure reviews only,
    $1,300 value. Coast IRB, LLC pledges to protect the full
    confidentiality of all research studies sent to us for review.
    In 2005, the FDA removed the guidance prohibiting IRB shopping.
    As such, you are free to use our free test drive offer to
    compare Coast services with another IRB's concurrently if after
    comparing our services to those of another IRB, you choose not
    to continue with Coast IRB, we will destroy all documentation
    we have on file associated with your study.
        Neither your money, research time or confidentiality will
    ever be at risk. It sounds like to me you are encouraging with
    this free coupon IRB shopping, the practice that you say you
    are against.
        Mr. Dueber. Sir, that marketing piece was created before I
    arrived at Coast, and we are no longer using that for that
    particular reason. But, you know, our position is that--and the
    company's position has been that IRB shopping is a problem, and
    there needs to be some kind of a database that everyone can
    refer to to see if someone has submitted--a sponsor has
    submitted a protocol to some IRB and other IRBs can check that
    before we approve a study because----
        Mr. Stupak. Do you think there should be a ban on IRB
    shopping, and if a stud is rejected should be sent to the FDA?
        Mr. Dueber. I think the last part probably, yes, but we are
    in favor of improving the system and making it more difficult
    for people to do that because obviously that is not healthy.
        Mr. Stupak. Right. Mr. Kutz, under current law if you had
    been a real company, you would have been allowed to ignore
    these two rejections you received and continue with your
    approval from Coast, isn't that right?
        Mr. Kutz. I believe so, and actually one thing I would
    mention on the shopping in our initial e-mails to the IRBs we
    sent this to, we said very specifically that we were shopping
    for an IRB.
        Mr. Stupak. OK. So they all knew you were shopping, you
    were IRB shopping?
        Mr. Kutz. That is what our e-mail said, yes, the e-mails
    from the requests you got from the IRBs.
        Mr. Stupak. OK. And after you got the approval from Coast,
    could you have begun your experimental testing on human beings?
    Would there have been any other steps in the FDA or HHS review
    before you started your experimental test on real people and
    putting this fluid here, our liter bottle of Adhesiabloc in the
    pelvic abdominal cavity of women?
        Mr. Kutz. As I mentioned, because there is no federal
    dollars associated with it, my understanding is yes.
        Mr. Stupak. Thank you. Mr. Burgess, I know you always have
    questions.
        Ms. Less. Mr. Chairman, if I could clarify.
        Mr. Stupak. Sure.
        Ms. Less. That study should not have been started. It was a
    significant risk product. It would have required approval from
    FDA so the sponsor should never have started the study without
    coming to FDA.
        Mr. Stupak. Who should have come to FDA?
        Ms. Less. The sponsor. The sponsor would go to the IRB, get
    IRB approval, and they also would be required to get FDA
    approval before that study could start and before any product
    could be shipped, so the sponsor----
        Mr. Stupak. What is the requirement to do that?
        Ms. Less. Pardon me?
        Mr. Stupak. What was the requirement to do that? I got my
    protocol approved. I got my consent form approved. So why would
    I have to go to the FDA?
        Ms. Less. Under the IDE regulations and investigational
    device exemption regulations at 21 CFR part 812 for a
    significant risk product, which this is, the sponsor would be
    required to get both FDA and IRB approval before it ships the
    product or starts the trial.
        Mr. Stupak. That is because Mr. Kutz misrepresented, but
    what if it was some other project already approved? There was
    no requirement to go to the FDA because we had what, a 510(k)
    there, right?
        Mr. Kutz. We faked the 510(k).
        Mr. Stupak. We had a 510(k) so we don't have to go to the
    FDA on this one. He could have started on real patients if it
    was a real one.
        Ms. Less. Well, hopefully the sponsor, if it was a real
    sponsor, would have understood that this product is not subject
    to 510(k).
        Mr. Stupak. And what do you do to make sure a real sponsor
    does that?
        Ms. Less. A real sponsor is supposed to come to FDA----
        Mr. Stupak. I know. There is a lot of assumption in these
    laws, aren't there, that people are being above board. We
    proved today they are not.
        Ms. Less. Actually we have a number of programs in place
    where sponsors can come to FDA, ask if they need an IDE. We
    have a pre-IDE process where they can submit a pre-IDE to us,
    have us look at the protocol, look at the device, look at the
    testing that they have done to see whether or not it needs an
    IDE.
        Mr. Stupak. With all due respect, FDA hasn't been doing
    their job. That is why we are having this hearing because when
    we did Copernicus study 3014 which there was criminal fraud and
    your own CID asked FDA to do criminal charges against
    Copernicus and the doctors who were doing this, FDA refused to
    do it. You rejected it. So there is very little faith on this
    side of the dais that FDA is doing it right. So when we suppose
    people are going to do it and we suppose the FDA is going to do
    their job, we know what the end results are. Unfortunately,
    people die. I will go to Mr. Burgess.
        Mr. Burgess. Mr. Kutz, let me just ask you, my
    understanding is you based this fictitious product on another
    product that actually existed but didn't have a good track
    record, is that correct?
        Mr. Kutz. We got it on the Internet off of FDA's web site
    and then we substantially altered the entire--we had a format.
    We didn't know what a protocol actually was supposed to look
    like so we got one just so we could know what it looked like,
    and then we changed it completely and then we actually made up
    the ingredients.
        Mr. Burgess. How many FDA protocols did you have to look at
    before you found one that struck you as a good one to proceed?
        Mr. Kutz. We just wanted one. I don't know if there were
    any more or not. We just found one on the Internet and once we
    found that, we just used the format. We didn't use the actual
    details of it. We created our own. It just showed us what one
    looked like.
        Mr. Burgess. Was it hard to find one that led you in the
    right direction?
        Mr. Kutz. Yes. I don't think there were a lot of them out
    there.
        Mr. Burgess. OK. Dr. Less, Dr. Menikoff, I am assuming that
    the Inspector General at HHS has been notified of this
    situation, is that correct? I mean does HHS have----
        Dr. Menikoff. No. We referred this to FDA's investigators.
        Mr. Burgess. OK.
        Dr. Menikoff. That is the letter we sent.
        Mr. Burgess. Will it at some point go to HHS IG?
        Dr. Menikoff. No, we plan to refer it to the FDA and we
    talked to the investigators that work under Dr. Less.
        Mr. Burgess. Had there been Medicaid funds used on any
    patient who received this compound inappropriately, would that
    have triggered HHS' involvement?
        Dr. Menikoff. I don't believe so. Again, the HHS
    jurisdiction that OHRP has relates to there being a funding
    agency for the study so basically NIH or CDC----
        Mr. Burgess. Or CMS?
        Dr. Menikoff. Excuse me?
        Mr. Burgess. Or CMS?
        Dr. Menikoff. CMS could act as a funding agency for the
    study. The fact that one patient in the study got paid and----
        Mr. Burgess. We heard testimony by Mr. Dueber that the
    funding for the study was going to come from the third party
    coverage of the patient essentially. Perhaps there was no
    charge for the study protocol or the protocol drug but there is
    a substantial amount of activity that has to occur to get to
    the place where the drug is administered and all of that
    activity was presumably going to be paid for by a third party
    payer, so in a way CMS would have been funding this study had
    it proceeded if Medicaid patients had been enrolled or S-CHIP
    patients.
        Dr. Menikoff. My understanding is that is not the way in
    which something becomes HHS funded in terms of OHRP's
    jurisdiction. The basic issue is has somebody applied for a
    grant from an HHS grant making agency and they then approve
    this. I mean that is the protection, and it is actually a very
    strong protection. Again, this would not have happened if
    somebody tried to get HHS funding. I think it is
    extraordinarily unlikely, and people who are enrolling in HHS
    funding studies should actually be relatively confident that--
    --
        Mr. Burgess. This whole deal is extremely unlikely and yet
    we find ourselves here in a parallel universe that the GAO made
    for us, and now we are having to try to pick our way through
    it. I just find it--I personally find it unbelievable that HHS
    is not more interested in the fact that funding sources could
    have been diverted into a bogus study and the patient required
    to have a second procedure, a second look procedure, 20 weeks
    later. I mean this is a big dollar item that we are talking
    about, 50 patients receiving a second look laparoscopy. There
    is no way to know how many of those would have been Medicaid,
    but that is a significant expenditure.
        Dr. Menikoff. Congressman, it sounds as if you are talking
    about use of federal funds for an inappropriate purpose, that
    is--I don't know what unit of HHS would deal with that
    basically. OHRP is dealing with the human subjects protection
    aspect of it, not misappropriation of federal funds or misuse
    of federal funds in some way. I can't comment on what part of
    HHS does deal with that.
        Mr. Burgess. Well, give us some comfort. Now what are the
    next steps that are going to be taken here? Clearly, there are
    things that need to be improved but are there some enforcement
    steps that are going to be taken? What happens next?
        Mr. Kutz. Only with respect to the one referral. I think
    the bigger picture is that you had the set of protocols that
    went to three IRBs and you get two completely different answers
    at the same time. That is the part I think that should concern
    the subcommittee here. On the one hand, two IRBs said this was
    a ridiculous protocol, unsafe to patients. It should have never
    been approved. Another one is still testifying as we speak that
    it was perfectly safe. It is hard to believe you could have
    that divergent of a situation and that raises questions to me
    about the whole IRB system, especially the private IRB system.
        Mr. Burgess. And, Dr. Less, would you concur that from
    FDA's perspective that there is reason to be concerned about
    the whole system?
        Ms. Less. No, sir, I would not. I think under this
    circumstance from what I have heard this product was a
    significant risk product. It should have been submitted to FDA
    for review. The study would not start without FDA and IRB
    review, and in this case there would have been that safeguard
    in place with having both the IRB approval and FDA approval
    needed before any patients could be put at risk or the study
    could have even started.
        Mr. Burgess. So any enforcement activity would be directed
    toward a company that doesn't exist that was made up by the
    GAO, would any enforcement activity be directed in Coast's
    direction for proceeding with a study with tenuous
    underpinnings?
        Ms. Less. Without seeing the report, I can't comment on
    that but in general FDA has taken action when an IRB has failed
    to make the determinations that it is supposed to make meaning
    they found significant risk determinations and looking to see
    whether an IDE is required for the study.
        Mr. Burgess. OK. Well, so what would happen? What would
    that action be?
        Ms. Less. We would go out and do an inspection of the IRB,
    look at their studies, their processes, see whether there were
    other studies that perhaps a wrong decision was made and if we
    found a problem, we would issue a warning letter. We could
    impose sanctions. And then we would see if they put a
    corrective plan in place to take care of that. If not, then we
    could pursue other activities.
        Mr. Burgess. Do you ever make a silent pact with yourself
    that we will never use this IRB again? Do you keep a list? Is
    there a watch list?
        Ms. Less. Well there is a--all of our warning letters are
    public. They are on the web site so any sponsor doing a study
    should be looking at that web site to see----
        Mr. Burgess. Is there any way to know that one side is
    talking to the other on this because this seems to be one of
    the problems we have encountered today. You had to say this was
    a bad deal, one said it is OK. Nobody talks about it, so it
    potentially could have gone forward with a very, very difficult
    study from the standpoint of a patient.
        Ms. Less. Well, warning letters are public. IRBs are
    obviously not happy to receive those. They take them very
    seriously and do some corrective actions. We require that they
    submit a corrective action plan within 15 days if we issue a
    warning letter, and we do follow up to make sure that those
    corrective actions are taken.
        Mr. Burgess. Well, now Coast had on its web site Q and A,
    have you ever been investigated from the FDA, and they said,
    well, they had but they got a commendation, but in fact that
    wasn't accurate, I understand now, is that correct?
        Ms. Less. I have not seen the information on their web
    site. I am sorry, Congressman.
        Mr. Burgess. This is again a printout of Coast's web site.
    Do we have that to project? The frequently asked questions----
        Mr. Stupak. Coast's web site, do you have it? No, they
    don't.
        Mr. Burgess. Under the frequently asked questions section,
    have you ever been audited by the FDA? Answer, December 15-17,
    2003, Coast IRB was selected for a routine surveillance
    inspection. We received a commendation from the FDA
    investigator regarding the thorough and effective oversight
    provided by our IRB operations. A follow-up audit was conducted
    in 2005 at which time no further action was required by the FDA
    investigator. Do you think that is a true statement?
        Ms. Less. We inspected Coast four times. The first three
    times we did issue letters saying that voluntary action was
    indicated, meaning that we found minor deviations from the
    regulations and we asked them to--in the letter we pointed out
    what those deviations were, pointed them to the appropriate
    regulation or guidance. They did submit a letter back to us
    stating that they had taken care of the issues that we
    addressed in each of those three letters.
        Mr. Burgess. Were those warning letters? Would those be the
    equivalent of warning letters?
        Ms. Less. No. they did not rise to the level of a warning
    letter. They were what we call voluntary action indicated. We
    have no action indicated, voluntary action, and then official
    action, which is the warning letter level.
        Mr. Burgess. Have they ever received a warning letter?
        Ms. Less. Yes. Their most recent inspection that we
    conducted in 2007, we issued a warning letter to the IRB.
        Mr. Burgess. And we had this approval in October, 2008 by
    the board so presumably they were under a warning when this
    study, proposed study, was to be undertaken, is that correct?
        Ms. Less. We had issued a warning letter, and they
    submitted a corrective action plan, told us that they had put
    training in place for their safe and were testing their staff
    on the conduct under the regulations of what would be required,
    and so we had reviewed all of that information. They had also,
    I believe, hired an outside consultant that was also supposed
    to be overlooking their processes.
        Mr. Burgess. Is that the basis on which you gave them a
    commendation?
        Ms. Less. We don't give commendations to anyone,
    Congressman.
        Mr. Dueber. In addition to that, Congressman, we----
        Mr. Burgess. But that is misleading statement on your web
    site then, isn't it? She said the FDA doesn't give
    commendations.
        Mr. Dueber. They sent us a letter reinstating our use of
    expedited review. We had given them a corrective action plan
    and acted very swiftly. In addition to that, our CEO----
        Mr. Burgess. OK. I am going to interrupt you because I am
    going to get cut off again. If you would be good enough to
    provide that letter to the committee, we would very much like
    to----
        Mr. Dueber. The committee already has that letter. We
    provided that in the package of materials we sent.
        Mr. Burgess. Thank you, Mr. Chairman. I will yield back in
    the interest of time.
        Mr. Stupak. Thank you, Mr. Burgess. Dr. Less, you said
    earlier that warning letters are more serious violations. In
    fact, the FDA issued a violation letter--a warning letter,
    excuse me, a warning letter on March 11, 2008, to Coast for
    three different parts on expedited review of IRBs, isn't that
    correct?
        Ms. Less. Yes, sir, that is correct.
        Mr. Stupak. And now Mr. Kutz has sent a letter about this
    situation and how Coast had reviewed this IRB--or this
    protocol, so will the FDA now invoke a more severe penalty then
    on Coast based--they already have a warning letter sitting
    there in their file. Now they got another allegation of
    wrongdoing. What will the FDA action be?
        Ms. Less. Congressman, we will need to take all that
    information into account and do a thorough evaluation.
    Normally, if we issue one warning letter, the next warning
    letter would include sanctions and we would take more serious
    action, but without knowing the specifics and having reviewed
    the entire case, I can't comment on this particular one.
        Mr. Stupak. Mr. Dueber, let me ask you this, and I will
    wrap up this hearing here. Are all of the seven people who
    approved this protocol, the bogus protocol, do they still work
    for Coast?
        Mr. Dueber. Yes, they do.
        Mr. Stupak. OK. Has anyone at Coast lost their job because
    of their failure to adequately review this protocol?
        Mr. Dueber. One individual is leaving the company shortly.
        Mr. Stupak. But not as discipline action for this matter?
        Mr. Dueber. No, sir.
        Mr. Stupak. OK. And how about the chair of the
    Institutional Review Board here, your chair of this board that
    reviewed this protocol. She indicated she didn't even read the
    protocol. Is she still working for you and she is still a
    member of the company?
        Mr. Dueber. Yes, she is. We evaluate our board members once
    a year.
        Mr. Stupak. OK. You said a couple times that you have
    changed your SOP. I take it that is standard operating
    procedure review process, right?
        Mr. Dueber. Right.
        Mr. Stupak. So it sounds like a lot of good changes have
    been implemented.
        Mr. Dueber. Yes, that is correct.
        Mr. Stupak. So a lot of good actually has come from being
    caught here on this bogus----
        Mr. Dueber. Yes, it has, and I might add that during our
    lunch break I talked to Dr. Less and I basically pleaded with
    her to bring FDA into my company and do a full top down, you
    know, front to back audit of our company because since I
    started with the company, I have done nothing but try to make
    sure that the company does exactly what it should be doing and
    do the best it can of any IRB.
        Mr. Stupak. And in all fairness, you have been there since
    December of 2008, right, basically 4 or 5 months?
        Mr. Dueber. I started at the end of September.
        Mr. Stupak. September.
        Mr. Dueber. And, you know, my track record is totally
    opposite of what we are talking about here so I need time to
    improve things, and we are improving. We have done--we have got
    an incredibly dedicated staff more so than I have ever seen in
    any company I have worked for before that they really--
    everyone, their first thing that they worry about is protection
    of human subjects.
        Mr. Stupak. Then how did they miss this one so bad? I guess
    that is the part that baffles us.
        Mr. Dueber. Well, we got hoodwinked. I mean, you know, this
    was a pretty good----
        Mr. Stupak. You didn't get hoodwinked. You took the bait
    hook, line and sinker. I mean in your testimony in all fairness
    you said that once you got the letter you started looking at
    it. It took seconds to figure out that something was wrong
    here. I think it was the doctor's credentialing that was 19
    years old. It took you seconds to do that just by going on the
    Internet. The procedure that we used, our magic elixir here,
    was actually found on the Internet. All this could have been
    discovered with a little due diligence. Hopefully, I am glad to
    hear some good things have come from all this whole thing also.
        Mr. Dueber. Definitely.
        Mr. Stupak. I want to thank you all for coming here and
    thank you for your testimony today. That concludes all
    questioning. I want to thank all of our witnesses for coming.
    The rules of the committee provide that members have 10 days to
    submit additional questions for the record. I am sure there
    will be some. I ask unanimous consent that the contents of our
    document binder on the desk there be entered in the record
    provided that the committee staff may redact any information
    that is business proprietary, relates to privacy concerns or
    law enforcement sensitive. Without objection, the documents
    will be entered into the record.
        [The information appears at the conclusion of the hearing.]
        Mr. Stupak. This concludes our hearing. The meeting of the
    subcommittee is adjourned.
        [Whereupon, at 1:55 p.m., the subcommittee was adjourned.]
        [Material submitted for inclusion in the record follows:]