Disposable Heroes

The Use of Veterans and Military Personnel as Research Lab Rats by the U.S. Veterans Health Administration

1. Timeline
2. Diagram
3. Select bibliography
4. Binder with supporting research documentation

I. TIMELINE:

November 11, 2001   James G. Elliott enlist date- U.S. Army

James Elliott‘s Experience while under the care of Washington VA Psychiatric Staff

October 30, 2007

A prescription for Varenicline was issued for James G. Elliott by the Washington VA Psychiatric Department after he was talked into enrolling into a study entitled ‘PTSD and Smoking Cessation Study #519’.  His prescribing physician, Hallie Lightdale, informed James that he was a ‘good candidate for the study’ because he ‘gives her good feedback’. 

November 5-6, 2007

James received the prescription and began taking as prescribed. 

 Nov 12-13 (approx.), 2007

James began experiencing dermatological side effects (i.e. hives, uncontrolled itching) on the first day he took the full dose.  The dosage instructions were to take ½ tablet by mouth every morning for 3 days, then take ½ tablet twice a day for 4 days, then take 1 tablet twice a day.  James was experiencing serious dermatological side effects by the time he achieved the full dosage regimen as prescribed.   As a result, he quit taking the medicine briefly until an appointment with his primary care physician, Dr. M. Villaroman, who advised James to cease taking Varenicline. 

NOV 20 2007 1st FDA warning on Varenicline regarding serious neuropsychiatric symptoms experienced in patients taking Varenicline.

VA does not notify study participants.  James receives no warning, but continues to receive mailed appointment reminders from the Washington VA to come in personally in order to complete the monthly study questionnaire.

Mid-December 2007

James attends his regularly scheduled appointment with Dr. Hallie Lightdale, his prescribing psychiatrist for Varenicline.  She advised him to resume Varenicline at a reduced dose and dismissed side effects as temporary.  James resumes taking Varenicline.

Early January 2008

James attends couples counseling with his fiancée due to his erratic behavior.  The appointment is at the Silver Spring Vet Center with Gil Becker.  Counseling was not successful because James’ behavior during the session was not conducive to therapeutic interaction.  His erratic behavior and emotional crisis continues to spiral downward.

Mid-January 2008

James attempts, in person and in an extremely agitated state, to see his psychiatrist Dr. Hallie Lightdale.  He speaks with the receptionist Evelyn Littlejohn, who says she will relay the message.  He tells Ms. Littlejohn that it is an extreme emergency and that he must see a doctor.  Ms. Littlejohn takes notes and James leaves without emergency treatment.

-February 1st 2008, second FDA safety advisory on Vareniclin/Chantixregarding serious neuropsychiatric symptoms experienced in patients taking Varenicline.   VA does not notify study participants.  James receives no warning, but continues to receive mailed appointment reminders from the Washington VA to come in personally in order to complete the monthly study questionnaire.

February 5, 2008

James’ behavior has become so erratic that his fiancée feels that the car keys need to be secured.  He will not comply with her requests for the car keys, so she calls Montgomery County Police Department for assistance.  James is then involved in a near-death situation/standoff with the police.  He is tased for his own safety and secured by the police.  He is hallucinating and reverts to combat-oriented behavior out of survival instinct.  He does not recognize his own fiancée.  His concept of time is so skewed that he perceives a 20-minute standoff with police as happening in a matter of minutes.  He does not remember the entire event to this day.  A straight-A, PTSD success story, Mr. Elliott is days away from a gala event for which he has been chosen to meet Colin Powell as a representative of successful, recovering veterans returning from theatre.  Now, he is on the ground, tased and lucky to be alive.

February 8, 2008

Gil Becker, Silver Spring Vet Center Counselor, takes James Elliott from Montgomery County Jail to Washington VA.  In a meeting with Dr. Stacey Pollack, Dr. Hallie Lightdale, and Gil Becker, he is told by Dr. Lightdale that the Chantix/Varenicline is the likely cause of the episode.  She stated “There had been problems with other people, but I never thought it would happen to you.  I am so sorry Mr. Elliott (para.)”.  This is the only time to date that the Washington VA psychiatric department has admitted that Varenicline caused Mr. Elliott’s February 5th psychotic episode.

February 9 , 2008

James fiancée, after close review of his medical files, realizes that he has been participating in a dubious research study.  She meets with VA doctors, including Dr. Stacey Pollack and Dr. Hallie Lightdale.  They offer no explanation for James’ psychotic break.  They accuse Ms. Hilburn of being controlling and overbearing.  James is still suffering from Varenicline withdrawal.  He is also overdosed on extended-release morphine that he is usually allowed to take as needed at home.  He is forced to take 150 mg of extended-release morphine per day while hospitalized at Washington VA.

During the meeting, Ms. Hilburn holds up the booklet for study #519 and states that this is the ‘most heinous s*** I have ever seen”.  She also states “my lawyer will kill me for saying this, but if it keeps you from prescribing Chantix to even one more veteran, it will be worth any trouble we go through”. The doctors rise and state that the meeting is over.  They refuse to talk with Ms. Hilburn and shuffle James down the hallway.  James is confused and unaware of the situation. 

February 15, 2008

While hospitalized, James is forced to daily take 150 mgs extended-release morphine at full dosage, even after VA doctors and staff were informed that he was allowed after a pain management class to take morphine as needed.  James usually takes 50 mg extended release morphine every two days for severe, demobilizing back pain related to an inoperable combat-related injury (fall from roof through third floor of mortar-damaged house while on night raid).  By February 14, James has ceased passing stool and has begun to have problems urinating, signaling potential kidney failure.  Ms. Hilburn is advised by outside medical counsel to have James signed out and examined by private medical facility.  Washington VA doctors force James to sign out AMA.  Upon examination at a private medical facility, James is found to have a possible bowel obstruction and enlarged spleen.   James is forced, due to legal constraints, to stay in a hotel, with no contact verbally or physically, from his fiancée, for over a month.  He cannot return home.  He is alone, scared, wounded and betrayed by the VA.  The Washington VA Psychiatric staff is, by this time, only concerned with appearances and covering any indication that they were at fault.  James is highly unstable, alone, and suffering withdrawals from a myriad of substances administered by the Washington VA. 

James is lucky to be alive.  There are likely many veterans who are not due to this type of abuse at the hands of VA researchers.

We submit to the U.S. House of Representatives Committee on Veterans Affairs this documentation in the hope that it will receive the deep investigation that it warrants.  The actions taken by U.S. House of Representatives Committee on Veterans Affairs in relation to this submitted evidence will be judged by the American public and the International community and will determine, it is hoped, a new standard by which we care for our veterans and military staff in the United States.

The Hippocratic Oath is not alive and well in the Washington VA Psychiatric Department.  We hereby ask for a criminal investigation in any death, suicide, attempted suicide, violent act or act suffered at the hands of any veteran or military personnel, civilian dependents or spouses that were enrolled in research programs conducted by the Veterans Administration to ensure that these situations were not caused by the same lapses in ethical medical conduct that were experienced by Mr. James Elliott.  James Elliott was asked twice in closed offices ‘what it would take to make him happy’.  Each time he told those that were asking this question that he wanted the testing to stop.  He said that he wanted them to quit killing his friends.

Please see the attached diagram for additional details regarding what Mr. Elliott and Ms. Hilburn learned after conducting research on Mr. Elliott’s participation in the study, past VA studies and the ruse of smoking cessation as a benign and benevolent goal of VA medical staff.  The information learned indicates unethical relationships between the U.S. Veterans Administration, Pfizer, its endowed universities and subsidiaries.  The diagram details the research food chain in which Mr. Elliott found himself suspended without any recourse to due process.

Sadly, Mr. Elliott and other veterans were unwittingly used in this Nazi-like human medical research nightmare. 

We maintain that the Veterans Health Administration should not be participating in medical testing on human subjects that have served our country.  The Veterans Health Administration should be a place for veterans to heal, not heel.

James Elliott officially submits this evidence and informationto the U.S. House of Representatives Committee on Veterans Affairs for action as deemed necessary.

7/9/2008

II. DIAGRAM:

III. BIBLIOGRAPHY:

Y. Tizabi1, John Mastropaolo2, Chan H. Park2, Raine L. Riggs2, D. Powell2, Richard B. Rosse2 and Stephen I. Deutsch2

(1)  Department of Pharmacology, College of Medicine, 520 W Street N.W., Howard University, Washington, DC 20059, USA Fax: +1-202-806-4453, US

(2) Psychiatry Service, Department of Veterans Affairs Medical Center, 50 Irving Street N.W., Washington, DC 20422, USA, US

Abstract  Dizocilpine (MK-801) administration to an outbred strain of NIH Swiss mice elicits discrete episodes of explosive jumping behavior designated as “popping.” This behavior may serve as a useful preclinical paradigm for the screening of potentially novel antipsychotic medications. Both nicotine and mecamylamine, a nicotinic antagonist, dose-dependently blocked dizocilpine-induced popping. The data suggest that nicotine may be of therapeutic benefit in the treatment of schizophrenia and that some of its effects may be mediated by non-nicotinic receptors.

Key words Dizocilpine - MK-801 - Nicotine - Mecamylamine - Mice - Schizophrenia

Received: 17 December 1997/Final version: 10 March 1998

Select Bibliography

This bibliography is ordered in a timeline per category to show agency interest in psychosis and nicotinic receptors, historical perspective, and also corporate interest.  Therefore, it is not formatted in the typical, academic fashion, but rather to show collective interest and connections.  The research publications from a wider body of institutions and companies are submitted separately to the Committee in a binder prepared by Elliott and Hilburn. 

Categories of research abstracts

1. Historical Interest in the treatment of Schizophrenia in conjunction with nicotine – 1 abstract
2. Pfizer research on nicotinic receptors and Schizophrenia- 1 abstract
3. Research publications focusing on nicotinic receptors and the treatment of Schizophrenia published through Mental Health Service Line, Department of Veterans Affairs Medical Center, Washington, D.C. and Linthicum, MD in conjunction with Georgetown University and University of Maryland.- 7 abstracts
4. Research publications from the Department of Psychiatry, Veterans Affairs Medical Center, Denver, CO. with focus on the link between nicotinic receptors and Schizophrenia. – 7 abstracts – not cited below but included in submitted binder.

1. Historical Perspective

1. Treatment of schizophrenia with nicotinic acid and nicotinamide.  Hoffer A, Osmond H, et al.  J Clin Exp Psycohopathol.  1957 Apr-Jun; 18(2): 131-58.

2. Pfizer Research

1. Discovery of N-[(3R)-1-azabicyclo [2.2.2] oct-3-yl]furo[2,3-c] pyridine-5-carboxamide, an agonist of the alpha7 nicotinic acetylcholine receptor, for the potential treatment of cognitive defects in schizophrenia: synthesis and structure- activity relationship.  Wishka GD, Walker DP, et al.  J. Med Chem.  2006 Jul 13; 49 (14): 4425-36.

3. Washington VA Psychiatric/Mental Health Service Line, Department of Veterans Affairs research publications related to Schizophrenia and other neurodegenerative diseases in conjunction with interest in nicotinic and acetylcholine receptors.

1. Both nicotine and mecamylamine block dizocilpine-induced explosive jumping behavior in mice: psychiatric implications.  Tizabi, Mastropaolo, Park, Riggs, Powell, Rosse and Deutsch.  Psychopharmacology, Vol. 140, No. 2, November 1998.
2. Progressive worsening of adaptive functions in Down syndrome may e medicated by the complexing of soluble Abeta peptides with the alpha 7 nicotinic acetylcholine receptor: therapeutic implications.  Deutsch, Rosse, Mastropaolo and Chilton.  Clin Neuropharmacology.  2003 Sep-Oct; 26 (5): 277-83.
3.  Anabasine, a selective nicotinic acetylcholine receptor agonist, antagonizes MK-801-elicited mouse popping behavior, an animal model of schizophrenia.  Mastropaolo, Rosse, Deutsch.  Behav Brain Res.  2004 Aug 31; 153 (2): 419-22.
4. Behavioral consequences of methyllycaconitine in mice: a mode of alpha7 nicotinic acetylcholine receptor deficiency. Chilton, Mastropaolo, Rosse, Bellack, and Deutsch.  Life Sciences.  Vol. 74, issue 25, 7 May 2004, pp. 3133-3139.
5. Therapeutic implications of a selective alpha7 nicotinic receptor abnormality in schizophrenia.  Deutsch, Rosse, Schwartz, Weizman, Chilton, Arnold and Mastropaolo.  Isr. J. Psychiatry Relat Sci.  2005; 42 (1): 33-44.
6. Effects of CDP-choline and the combination of CDP-choline and galantamine differ in an animal model of schizophrenia: development of a selective alpha7 nicotinic acetylcholine receptor agonist strategy.  Deutsch, Rosse, Schwartz, Schooler, Gaskins, Long and Mastropaolo.  Eur Neuropsychopharmacol.  2008 Feb, 18 (2): 147-51.  Epub 2007 Jul 26.
7.  First administration of cytidine diphosphocholine and galantamine in schizophrenia: a sustained alpha7nicotinic agonist strategy.  Deutsch, Schwartz, Schooler, Rosse, Mastropaolo and Gaskins.  Clin Neuropharmacol. 2008 Jan-Feb; 31 (1): 34-9.

4. Research publications from the Department of Psychiatry, Veterans Affairs Medical Center, Denver, CO. with focus on the link between nicotinic receptors and Schizophrenia. – 7 abstracts.

IV. SUBMITED BINDER:

Please see submitted binder for these abstracts and a selection of other related research abstracts.  [The binder is being retained in the Committee files.]

Prepared by James G. Elliott and Tammy R. Hilburn