UNITED STATES OF AMERICA

           FOOD AND DRUG ADMINISTRATION

 

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            NEUROLOGICAL DEVICES PANEL

                      of the

        MEDICAL DEVICES ADVISORY COMMITTEE

 

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                Seventeenth Meeting

 

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                      TUESDAY

                   JUNE 15, 2004

 

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            The Panel met at 8:00 a.m. at the Holiday Inn Gaithersburg, Walker/Whetstone Rooms, Two Montgomery Village Avenue, Gaithersburg, Maryland, Dr. Kyra J. Becker, Chairperson, presiding.

 

PANEL MEMBERS PRESENT:

 

KYRA J. BECKER, M.D., Chairperson, University of

      Washington School of Medicine, Seattle, WA

ANDREW K. BALO, Industry Representative, DexCom, Inc.

      San Diego, California

JONAS H. ELLENBERG, Ph.D., Voting Member, Westat,

      Rockville, Maryland

LAURA J. FOCHTMANN, M.D. Deputized Voting Member,

      State University of New York, Stony Brook, NY

ANNAPURNI JAYAM-TROUTH, M.D., Voting Member, Howard

      University College of Medicine, Washington, DC

RICHARD P. MALONE, M.D., Deputized Voting Member, MCP

      Hanneman University, Philadelphia, PA

IRENE E. ORTIZ, M.D., Deputized Voting Member,

      University of New Mexico, Albuquerque, NM

MARY LEE JENSEN, M.D., Director of Interventional

      Neuroradiology, University of Virginia

PANEL MEMBERS PRESENT:  (continued)

 

PHILIP S. WANG, M.D., MPH, Dr.PH, Deputized Voting

      Member, Brigham and Women's Hospital, Boston,MA

CRISSY E. WELLS, R.T., MBA, MHSA, Consumer

      Representative, University of Virginia Health

      Sciences Center, Charlottesville, VA

 

ALSO PRESENT:

 

DELIA WITTEN, Ph.D., M.D., Food and Drug

      Administration, Division Director, General

      Restorative and Neurological Devices

 

SPONSOR PRESENTERS:

 

RICHARD L. RUDOLPH, M.D., Vice President, Clinical and

      Medical Affairs and Chief Medical Officer,

      Cyberonics

A. JOHN RUSH, M.D., Principal Investigator, University

      of Dallas Southwestern MC, Dallas, TX

ALAN TOTAH, Vice President, Regulatory Affairs,

      Cyberonics

 

FDA PRESENTERS:

 

CHANG LAO, Ph.D., Statistical Reviewer

CARLOS PENA, Ph.D., Neuroscientist, VNS Studies,

      Efficacy Reviewer

MICHAEL SCHLOSSER, M.D., Neurosurgeon, Safety Reviewer

 

PUBLIC SPEAKERS:

 

MARNA DAVENTORT, patient in the study

CHARLES DONOVAN, patient in the study

COLLEEN KELLY, patient in the study

LYDIA LEWIS, President, Depression and Bipolar Support

      Alliance

KARMEN McGUFFEE, patient in the study

IRVIN J. MUSZYNSKI, J.D., Director of the Office of

      Health Care Systems & Financing, American

      Psychiatric Association

LAURI SANDOVAL, patient in the study

                     I N D E X

 

                  AGENDA ITEM                 PAGE

 

Call to Order                                    4

Conflict of Interest and Deputization

Panel Introductions

Update since February 23, 2004 Meeting

  Theodore Stevens, Chief, REDB

 

1^st Open Public Hearing                          13

 

Sponsor Presentation                            63

  Alan Totah, Cyberonics, Inc.

  A. John Rush, U. of Texas Southwestern

  Richard L. Rudolph, Cyberonics

 

FDA Presentation

  Carlos I. Pena, PhD                          149

  Michael J. Schlosser, M.D.                   160

  Chang S. Lao, Ph.D., Division of             178

      Biostatistics

 

Panel Deliberations                            197

  Philip S. Wang, M.D., MPH, Dr.P.H.

 

2^nd Public Hearing                              368

 

FDA and Sponsor Summations                     369

 

Panel Vote                                     385

 

Adjournment                                    433

               P R O C E E D I N G S

                                  Time:  8:05 a.m.

            MS. SCUDIERO:  Good morning.  We are ready to begin now.  Sorry for a little delay.

            I am Jan Scudiero.  I am the Executive Secretary of this panel and a reviewer in the Division of General Restorative Neurological Devices.

            The usual housekeeping matters:  If you haven't signed in at the door, please do so, and pick up agendas and other meeting related information.

            Before I turn over the meeting to Dr. Becker, I am required to read three statements into the record.  There are two deputization of temporary voting member statements and a conflict of interest statement that were prepared for this meeting.

            The first:  Pursuant to the authority granted under the Medical Devices Advisory Committee charter dated October 27, 1990, and amended April 20, 1995, I appoint the following person to be a voting member of the Neurological Devices Panel for the duration of this meeting on June 15, 2004:  Laura Fochtmann, M.D.

            For the record, she is a Special Government Employee and is a consultant to this panel or another panel under the Medical Devices Advisory Committee.  She has undergone the customary conflict of interest review and has reviewed the material to be considered at this meeting.  Signed by Daniel G. Schultz, M.D., Acting Director, Center for Devices and Radiological Health, on June 9th of this year.

            The other:  Pursuant to the authority granted under the Medical Devices Committee charter for the Center for Devices and Radiological Health dated on October 27, 1990 and amended August 18, 1999, I appoint the following individuals as voting members for the Neurological Devices Panel for the meeting on June 15, 2004:  Richard P. Malone, M.D., Irene E. Ortiz, M.D., Richard S. Wang, M.D. MPH, Dr.Public Health.

            For the record, Doctors Malone, Ortiz and Wang are members of the Psychopharmacologic Drugs Advisory Committee of the Center for Drug Evaluation and Research. They are Special Government Employees who have undergone the customary conflict of interest review and have reviewed the material to be considered for this meeting.  This is signed by Peter J. Pitts, until recently the Associate Commissioner for External Relations, on June 4th of this year.

            The conflict of interest statement:  The following announcement addresses conflict of interest issues associated with this meeting and is made part of the record to preclude even the appearance of an impropriety.

            To determine if any conflict existed, the agency reviewed the submitted agenda for this meeting and all financial interests reported by the Committee participants. 

            The conflict of interest statutes prohibit Special Government Employees from participating in matters that could affect their or their employers' financial interest. However, the agency has determined that the participation of certain members and consultants, the need for whose services outweighs the potential conflict of interest involved, is in the best interest of the government.

            Therefore, waivers were granted to Doctors Kyra Jo Becker and Laura Fochtmann for their interest in firms and issues that could potentially be affected by the panel's recommendation.

            Dr. Becker's waiver involves an imputed interest, a contract to her institution for the sponsor's study in which she has no involvement and is uncompensated.  Dr. Becker's waiver allows her to participate fully in today's deliberations.

            Dr. Fochtmann waiver involves a contract to her institution for the sponsor's study in which she has no involvement and is uncompensated.  Dr. Fochtmann waiver allows her to participate fully in today's deliberations.

            Copies of these waivers may be obtained from the agency's Freedom of Information Office, Room 12A-15 of the Parklawn Building.

            We would like to note for the record that the agency took into consideration certain matters regarding Dr. Mary Jensen.  She reported an interest in a firm at issue but not in matters related to today's agenda.  The agency has determined, therefore, that she may fully participate in all discussions.

            In the event that the discussions involve any other products or firms not already on the agenda for which an FDA participant has a financial interest, the participant should excuse himself or herself form such involvement, and the exclusion will be noted for the record.

            With respect to all other participants, we ask, in the interest of fairness, that all persons making statements or presentations disclose any current or previous financial involvement with any firm whose products they may wish to comment upon.

            I wish to announce that the August 5th and 6th tentatively scheduled meeting for this Panel was canceled, because there is no agenda for a meeting.  The remaining tentatively scheduled Panel meeting for this calendar year is October 28th and 29th.

            Please remember that this is a tentative date, and monitor the CDRH Panel website for updated Panel meeting information.

            I would now like to turn the meeting over to our Chairperson, Dr. Kyra Becker.

            CHAIRPERSON BECKER:  Good morning.  My name is Kyra Becker, and I am the Chairperson of this Neurological Devices Panel.  I am a neurologist, and I practice at the University of Washington in Seattle.

            At this meeting the panel will discuss, make recommendations and vote on a recommendation to the Food and Drug Administration on the approvability of premarket approval application supplement P970003/S50 for the Cyberonics Vagus Nerve Stimulation Therapy System.

            The System is indicated for the adjunctive long term treatment of chronic or recurrent depression for patients who are experiencing a major depressive episode that has not had an adequate response to two or more antidepressant treatments.

            We will have an open public hearing and the sponsor and FDA presentations before lunch.  After lunch, the Panel will deliberate on the approvability of the PMA.  Before the Panel votes, there will be another open public hearing and a time for the FDA and sponsor summations.

            Before we begin this meeting, I would like to ask for the Panel members, who are generously giving their time to help the FDA in the matter at hand, and the other FDA staff seated around this table to introduce themselves.  I think we are going to start at this end of the table, and I would like you to state your name, your area of expertise, your position and your affiliation.

            DR. ELLENBERG:  My name is Jonas Ellenberg.  I am a biostatistician.  I am on staff at Westat, a social services private research firm.  I am a Vice President and Senior Biostatistician.

            DR. JAYAM-TROUTH:  I am Annapurni Jayam-Trouth.  I am the Chair of Neurology at Howard University, Washington, D.C.

            DR. FOCHTMANN:  I am Laura Fochtmann.  I am a Professor in the Department of Psychiatry at the State University of New York at Stony Brook.

            DR. WANG:  I am Philip Wang, a psychiatrist and epidemiologist at Harvard Medical School.

            DR. JENSEN:  I am Mary Lee Jensen.  I am Director of Interventional Neuroradiology and a Professor of Radiology and Neurosurgery at the University of Virginia.

            DR. ORTIZ:  I am Irene Ortiz.  I am a geriatric psychiatrist at the University of New Mexico and with the Albuquerque BA.

            DR. MALONE:  I am Richard Malone.  I am a psychiatrist and professor of psychiatry at Drexel University, College of Medicine.

            MS. WELLS:  I'm Chris Wells, and I am the Consumer Representative on this Panel.

            MR. BALO:  I am Andy Balo, the industry rep, but I am Vice President of Regulatory Clinical at DexCom, Inc., in San Diego.

            DR. WITTEN:  Celia Witten.  I am Division Director of the reviewing division for this product at FDA.

            CHAIRPERSON BECKER:  Thank you.  I would like to note for the record that the voting members here at the Panel constitute a quorum as required by 21 CFR Part 14.

            Next Mr. Theodore Stevens,  Chief of the Restorative Devices Branch, will update the Panel on several matters deliberated on at the last meeting of the Panel on February 23, 2004.  Mr. Stevens.

            MR. STEVENS:  Okay.  I don't seem to have slides going here on the screen. 

            Hi.  I am Ted Stevens.  I am the Chief of the Restorative Devices Branch, and I will be giving a very brief update on the devices that were reviewed by this Panel previously.

            At the February meeting there was advice given to the reviewing branch on the concentric medical Mercy device that remains under review in the General Surgical Devices Branch at FDA.

            We have also recently published a draft guidance and a Federal Register notice for availability of vascular and neurovascular embolization devices.  The comment period for that draft guidance ended on May 25th.

            Finally, several devices have been cleared that are reviewed under the Orthopedic Devices Panel, but because they are devices that are also used by neurosurgeons and interventional radiologists, I thought it would be appropriate to mention them here.

            We have recently cleared several PMMA cements for use in pathological fractures of the vertebral body.  These 510k's were cleared based on the reclassification of PMMA bone cements.  That included pathological fractures in general for the specific indication of vertebral body fractures.  These 510k's included clinical data from the literature.

            That concludes the update.

            CHAIRPERSON BECKER:  Thank you, Mr. Stevens.  At this time we will proceed to the open public hearing portion of the meeting.  We ask at this time that all persons addressing the Panel speak clearly into the microphone, as the transcriptionist is dependent on this means of providing an accurate record of the meeting.

            Ms. Scudiero will now read a statement prepared for the open public hearings.

            MS. SCUDIERO:  Both the Food and Drug Administration and the public believe in a transparent process for information gathering and decision making.  To ensure such transparency at open public hearing sessions of the Advisory Committee meeting, FDA believes that it is important to understand the context of any individual's participation.

            For this reason, FDA encourages you, the open public hearing speaker, at the beginning of your statement to advise the committee of any financial relationship that you may have with the sponsor, its product and, if known, its direct competitors.

            For example, this financial information may include the sponsor's payment of your travel, lodging or other expenses in connection with your attendance at the meeting.

            Likewise, FDA encourages you at the beginning of your statement to advise the committee if you do not have any such financial relationship.  If you choose not to address the issue of financial relationships at the beginning of the statement, it will not preclude you from speaking.

            CHAIRPERSON BECKER:  Prior to the meeting, there were seven requests to speak in the open public hearing, and each person has ten minutes to address the panel.  They will speak in the order that the FDA received their requests to present to the panel.

            Ms. Colleen Kelly, who is a patient in the study, will be the first speaker, if you want to come forward.

            MS. KELLY:  Hi.  Is it possible for me to sit?

            CHAIRPERSON BECKER:  Certainly, yes.

            MS. KELLY:  You can hear me okay?  Thank you.  I am Patient 012 from Site 050 of the D-O1 study for Vagus Nerve Stimulation for the treatment of major depressive disorder.  I am here unsolicited to ask you to approve the VNS in its application to depression.

            I was not approached by my study site nor by Cyberonics to speak to this panel.  I am here upon my own accord, inspired by my own experience, and  driven by the necessity that viable alternatives must be offered to persons suffering from treatment resistant depression.

            I have secured and paid for my own travel here.  In fact, it would behoove me financially if this panel stalled he approval process.  I have had the device for four and a half years and, based on my parameter settings, replacement surgery is imminent.

            As long as I am in the study and as long as the study lingers, Cyberonics will be responsible for the cost of replacing my generator battery.  So, actually, I am shooting myself in my financial foot by encouraging you to approve this device.  Upon approval, I would become completely responsible medically and financially.

            That said, my case and testimony may be of particular interest to this panel.  I went into the study on no medications, remained off medications throughout the study, and am still on no medications.

            There is no other explanation for my response other than the device itself.  It is good science.  Turn the device up; I respond.  Turn the device down; I decline.

            Let me assure you that my stoicism with medications is not noncompliance.  Neither is it an indicator that I am only mildly affected with the illness and, therefore, can exist without medications.  In short, I had exhausted them as well as every other treatment currently available to people with illness at this level, as did so many of my peers in this study.

            I realize that most on this Panel and most in attendance here are experts in their field, be it neurology, psychology, psychiatry, or mental health administration; but there is one thing I can offer you about which you may know nothing.  That is first hand knowledge of what it is like to have severe recalcitrant depression.

            To do so, I ask you to imagine the unimaginable, to think the unthinkable, to experience second degree emotional burns with third degree prognosis.  All you experience is pain, but with no cure.  In fact, there is no viable treatment.

            You can attempt to salve it.  Only death solves it.  But the medical community does not accept death as a cure.  It asks us to continue to hang on and to continue to live, yet offers us no viable treatments.  Trust me, it is not that we don't want to live.  It is that we don't want to live like this.

            Our illness is embedded in our physical bodies, ourselves.  We are prisoners there, and our sentence is life.  Menacing insomnia, isolation, fear, anxiety, sadness, hopelessness, general malaise, malingering fatigue, physical exhaustion, apathy, lack of motivation, concentration and focus, absence of pleasure, amplification of pain, agitation, sensitivity to criticism, thoughts that life isn't worth living -- You are all familiar with this short sheeted laundry list of symptoms.

            Now imagine having them all at once.  Imagine passing from one room to another in the house of pain where some symptoms are more prevalent than others, sometimes exacerbated by the very medications that were meant to alleviate them.

            I will not bore you with the details of the pharmacopoeia that I have tried and then have failed, not to mention the acupuncture, homeopathy, herbal remedies, extreme dietary changes and supplements, light therapy, counseling, yoga and, of course, religion.  What god would let a child suffer like this?

            Then comes the inevitable, electroconvulsive therapy, ECT, a therapy so beyond the vernacular that it doesn't even pass an automated spellcheck.  I would stop at the word, too, but as a person with treatment resistant depression, I could not stop. 

            I relented to this FDA approved treatment as a last resort.  Average session:  Three to five treatments.  I had 33 nearly consecutive treatments.  I lost retrograde 20 years of my life through memory loss, a dismal blessing.  At least I could not remember the horrific pain that preceded it for years.

            I asked you to imagine the unimaginable, to think the unthinkable.  I also mentioned that you are experts in your field.  What if, after battling an abusive lifelong illness, after enduring medication where side effects trumped minimal benefit, after relenting to a final last resort -- what if all that is wiped out?  You are etherized on a tabula rasa, alive, yes, but no more FDA hearings, no more status, no more career.  No more.  Someone helps you remember where the soap is kept and helps you into the shower.

            I am not here to blast the approval of ECT.  Obviously enough, for better or worse, I am still here.  I am here, however, to say that I am here today because of the VNS, and I ask you what do you offer someone after the last resort?  What do you offer someone for whom ECT has failed? 

            I had an experimental study.  What will the next guy get? 

            I would be remiss if I did not mention the epileptic community who has blazoned the way for efficacy and safety of the VNS device.  For that, I am grateful. 

            They have shown us the risks and side effects involved since the FDA approved the device for them in 1997, and my personal heartfelt thanks go to those who engaged in experimental implantation even prior to that date.  I offer my gratitude, and I share their cautious hope.  

            I would also like to thank them for their honesty and candor, which I found on the Cyberonics bulletin board.  Without their shared experience, I know for a fact I would not have attained the success I have had with this device.

            I followed their histories.  I tracked and evaluated their settings and results, and I searched and researched my side effects and remedies through their personal experiences.  Their trial and error resulted in my trial and success.

            Because of what I learned on the chat board, I was eager to boost my amplitude to higher than 1.0 in the first three weeks of the initial depression study, and keep my settings above what later became known as efficacy threshold.  As a result, I was one of the first to respond at my study site, and I continue to reap benefit from the device.

            I encourage Cyberonics to reopen their bulletin board.  I understand the risks involved and the abuses that were made to it, but I challenge the company to research and execute a safe environment where patients can exchange information regarding this very new modality of treatment, especially in its application to depression.

            It was critical in my success.  I know it would increase the success of others exploring the device as a possible treatment. 

            I am not going to idealize nor sentimentalize the device.  I know I am one of a third who have responded to it.  I know there are others who continue to suffer the burden of treatment resistant depression.  I see it in their faces as I sit in the lobby and wait my turn at the site. 

            I know that pain.  I suffered it prior to the VNS.  Still, I have windows of it now and again.  I am passionate, yet realistic, about the device.  I do not romanticize its results for me nor dismiss its lack of results for others.  I am well aware of its side effects, shortcomings, and its current experimental status.  But I do know one thing.  We need viable treatment options for those with recalcitrant depression, and VNS has worked for me.

            In closing, I encourage this Panel to let the mental health community, both administrators and recipients, review the data and search the testimonies to decide if this is an appropriate treatment for their patients, their loved ones, themselves.

            This is an option only you can provide by approving the device for its application to depression.  Give us a choice, a possible key, a parole to our life sentences of depression.  Thank you.

            CHAIRPERSON BECKER:  Thank you, Ms. Kelly.

            Our next speaker will be Ms. Lydia Lewis, who is President of the Depression and Bipolar Support Alliance.

            MS. LEWIS:  Good morning.  I want to thank the Advisory Panel for this opportunity to talk about the critical issue of treatment resistant depression.  I am Lydia Lewis, and I am here as President of the Depression and Bipolar Support Alliance, a national patient-run advocacy organization representing the more than 25 million people living with depression and bipolar disorder.

            I did not receive any financial support nor do I have any financial arrangement with any company for my work on behalf of patients with mood disorders.  The Depression and Bipolar Support Alliance does, however, receive financial support in the form of program grants, honoraria, consulting fees or in-kind donations from Cyberonics, Inc. and a number of pharmaceutical companies.  My travel to Maryland today was not paid for by Cyberonics, and I am not here to advocate for any particular therapy, including VNS, but rather for the critical need for new therapies.

            While I have suffered from treatment resistant depression for my entire life and I have taken more than 20 different medications over the past 36 years, I am not here to tell my story.  I am here to represent the millions of people with mood disorders who can't get well, people who desperately need better medications and treatment modalities other than pharmaceuticals.

            Just about 4 million people directly contact DBSA every year.  Connecting with millions touched in some way by Depression and Bipolar Support Alliance -- by depression and bipolar support make us particularly qualified to speak on their behalf.

            As we all know, more than 30,000 people in the United States take their lives every year, not because they are weak or because they have a character flaw. They take their lives because they do not respond to any of the treatments currently available for depression or bipolar disorder.

            At DBSA we know that new drugs and nonpharmacologic treatments are desperately needed.  Far too many people are dying or living lives of quiet desperation, because they can't get sufficient relief form their symptoms of depression.  The more treatments the FDA makes available, the more lives that will be saved.

            Today I want to put a human face on the tragedy of treatment resistant depression.  We can talk science all we want, but science will never drive home the devastating consequences our illnesses can have, if they are not treated.

            The human face I want to share today is Barbie's, and I have given you all a picture of Barbie.  It is on the last page of my testimony, and it is important, if you would, to look at this while I speak.

            Barbie has three kids, two girls and a boy.  She works as an oncology nurse.  She is very patient, very smart, very kind, very funny, and very gentle.  She is the nurse of choice, requested by more doctors when they admit a patient onto her unit.

            People report that her care made the difference in their fight with cancer.  Barbie was finally diagnosed with bipolar disorder after having been treated for depression for more than 15 years.  She has been hospitalized five times for her depression. 

            The first two times her insurance covered some of the costs.  The last three times it covered nothing.  She has run through all of her retirement savings.  Her last hospitalization was at a state facility and, although many of them are quite good, this one was so horrible and so scarring that she refuses to ever be hospitalized again.

            She runs through the insurance money for her medication within the first two months of every year.  Her parents use much of their retirement savings to help pay for her meds, and her siblings contribute as much as they can.

            She has been prescribed a variety of medications.  Sometimes she shakes.  Sometimes she drools.  A time or two she has found herself somewhere with no idea how she got there, because her mind was so fuzzy from her medication.

            She balloons up in weight even though she eats next to nothing.  She has no appetite at all.  It is hard to find a nurse's uniform that fits.  She gets very little sleep, 15 minutes, an hour at a time, no more.  But she also can't concentrate enough to watch TV, read a book or anything else.  So she lies there worrying, thinking about the patients she is trying to care for, even though she herself is very, very ill.

            Once a week she summons up all her courage and drives, shaking and drooling, to a therapist more than an hour away.  There is none closer.  Every month it takes even more courage to drive two hours away to see her psychiatrist for 15 to 20 minutes.  There is none closer.

            They do the best they can to treat her at reduced fees, but she can still barely pay for their time, and nothing helps.  Quite simply, her life is hell.  She can't sleep.  She can't eat.  Her phone rings with creditors.  She feels bad and ashamed about what her family has been forced to go through with her.

            Her medication barely touches her symptoms, and because of her illness, everything she does takes tremendous courage.  Let me tell you, it is exhausting to never get better.  When no treatment works or you can't afford something that does, you can reach a place where there doesn't seem to be any exit.

            If you haven't been there yourself, count yourself lucky.  I have been there, and it is dark and full of pain and hopelessness.  It is joyless and a place where nothing matters.

            You can be young or old, beautiful or plain, rich or poor, erudite or illiterate.  Everyone who ends up in this place feels the shame.  It's hell on earth.

            Barbie found herself in this place, because no matter how hard the doctors tried, nothing helped; and regardless of her kids, her husband, her wonderful parents and siblings, and the job she found so important, the despair of that place was too overwhelming.

            Barbie isn't just any patient to me.  She is my co-worker's sister, and I am sorry that we never met, because I know I really would have liked her.  Barbie took her life three months after this picture was taken.  She was 49 years old.

            It is a profound honor to speak for Barbie who can no longer do so, and I hope her death will have some purpose.  No one should have to live with pain like Barbie's.  No one's family should have to suffer like hers, impotent to help through the long journey of one failed treatment after another.s

            The suffering doesn't end when someone's life ends.  Barbie's loved ones still suffer, because even in this day and age, there was nothing that could keep her from that dark place.

            Tragically, aspects of Barbie's story still ring true for so many.  No one's life should be wasted or ended because efficacious treatment isn't available.  This is why we are all here.  This is why we all must remain here.

            It is too late for Barbie, but it is not too late for us to learn from her life and from her death.  Her struggles and loss should inspire all of us to work tirelessly to bring better treatments to the millions of Barbies still suffering.

            That is why I am here today, and why I am asking the FDA to remember those of us who desperately need better treatments.  It is a race against time, and I ask you on behalf of the millions of people suffering with treatment resistant depression to please do everything you can to help us.  Thank you.

            CHAIRPERSON BECKER:  Thank you, Ms. Lewis.  The next speaker will be Ms. Laurie Sandoval, who is also a patient in the Cyberonics study.

            (A SHORT VIDEO WAS SHOWN.)

            MS. SANDOVAL:  First of all, I have had no financial involvement with Cyberonics except travel and hotel accommodations.

            Someone once said depression is like being a prisoner of the mind.  It could not have been said better except in that prison I was in solitary confinement. 

            The video you just saw was me five years ago.  No longer able to keep my depression at bay, I had just resigned the job of my dreams and lost any hope of living.  At that time I was under the care of Dr. Lauren Marengel of Baylor Medical College for treatment resistant depression in which medications, therapy and, in some cases, electric convulsive therapy had not worked.

            Dr. Marengel explained an experimental study for depression that Baylor was undertaking with Cyberonics using a vagus nerve stimulator device, and would I be interested in participating.  Sign me up yesterday, Doc. 

            Living in Nevada and without -- and having the VNS device five years now, life had been wonderfully normal, without suicidal depression.  That is until three months ago. 

            I started feeling down, rarely leaving the house, turning off the phone, and only getting out of bed to let the dogs out.  Normally, when the VNS device goes off, it causes a tickling sensation in the throat, but latterly there was no sensation at all, and I prayed the battery was dead.

            Calling Dr. Marengel's office, they couldn't say for sure if the device wasn't working until the battery was tested.  My appointment wasn't scheduled for another month, and I wondered if i could hold on that long.  I was once again a prisoner of the mind.

            In Houston, I told the doctors I felt desperate, and my only hope was that the depression was being caused because the VNS battery died.  Scared, I checked myself into Methodist Hospital psychiatric ward.

            The good news is two days later, thanks to the incredible teams at Baylor and Cyberonics, I had surgery for a new and improved VNS device.  This battery is expected to last eight to ten years.

            Every day I wake up with a bead of joy in my heart, or maybe that's the pulse of my new battery.  Anyway, I have no doubt that, if it were not for Cyberonics' innovation and Baylor's tireless dedication, I would not be here today.  Thank you.

            CHAIRPERSON BECKER:  Thank you, Ms. Sandoval.  I want to apologize up front if I mispronounce the next speaker's name, Mr. Irvin Muszynski, who is the Director of the Office of Health Care Systems & Financing of the American Psychiatric Association.

            MR. MUSZYNSKI:  Your pronunciation is perfect.  Thank you. 

            Good morning, and I, too, would like to thank you for the opportunity to offer a few remarks here this morning about your considerations about the Cyberonics application.

            As indicated, my name is Irvin Muszynski. I am the Director of the Office of Health Care Systems & Financing at the American Psychiatric Association.  In that capacity, my key job responsibilities are ongoing liaison on behalf of the psychiatric community and its patients, with third party patients in both the public and private sector.  That includes employers.  It includes Medicare and Medicaid, insurance companies, both health and disability. 

            In that capacity, I would simply indicate to you that the question of chronic mental illness conditions, particular the depressive disorders, is a recurring issue in questions I get -- or I get questioned about all the time, and what can the psychiatric community do, and so on.

            In fact, part of my monitoring of the evolution of the vagus nerve stimulation approach