‘Examiner’s Statement’ by Dr. Olson stating Dan lacks capacity; that he does not believe he has a mental illness, and ‘Neuroleptic Medication’ form that states one lacks capacity to give informed consent if they do not believe they have a mental illness.
April 7, 2008
Senator Charles Grassley
135 Hart Senate Bldg.
Washington D.C. 20510-1501
Dear Senator Grassley:
Two Special Agents from the FDA suggested I contact you. I cannot name them as they are prohibited from advocating for any bill. However, I am hoping that after reading my story, you will be interested in helping.
My son, Dan Markingson, died May 8, 2004 while in a psychiatric clinical study that I had tried for five months to get him out of. (I believe you may even have talked to my attorney, Gale Pearson, recently.) Dan was given a stay of civil commitment provided he follow the direction of his ‘treatment team’. His treatment team, led by Dr. Stephen C. Olson, against whom I have just settled my civil lawsuit, coerced Dan into his lucrative clinical study under threat of going to Anoka Regional Treatment Center for six months. While in the study Dan continued to deteriorate, and despite my asking them if Dan “had to kill himself or someone else before anyone does anything”, (which they recorded in their file) the answer was yes.
Since his death I have been trying, unsuccessfully, to get the enclosed bill passed in Minnesota which would prohibit anyone on a stay of civil commitment from entering into a psychiatric clinical study, but instead require them to get ‘treatment’ as the court had obviously intended.
Please read the bill. It is very simple. As Arthur Caplan, Bioethicist at the University of Pennsylvania has noted, ‘animals often get better protection in studies than do humans’.
I have the depositions of the doctors involved and the affidavits of the expert witnesses which I could e-mail to you. I am also enclosing in addition to the Bill other pertinent information relative to my son’s death in the CAFÉ Study:
- Dan Markingson – Wrongful Death – Overview
- Dan Markingson – Timeline
- Notes from Regions Hospital suggesting bipolar disorder and Dr. Olson’s same thoughts
- Court Commitment directing Dan to following orders of his doctor
- Discharge Plan from hospital directing him to attend CAFÉ Study (or go to state hospital)
- “Examiner’s Statement” by Dr. Olson stating Dan lacks capacity; that he does not believe he has a mental illness, and ‘Neuroleptic Medication’ form that states one lacks capacity to give informed consent if they do not believe they have a mental illness.
- Consent form
- Errors and Omissions sheet regarding consent form
- Protocol page: drug should start with one capsule “to minimize risk of adverse effects”
- Drug Accountability Log: this was not followed. Dr. Olson never even signed this Log
- CCM Contacts Report of D. Pettit, case manager: Re: Dan going back in hospital 12/9/03
- Page of study coordinator’s file: my asking “do we have to wait for him to kill himself…?”
- Early Warning Signs Questionnaire, regarding ‘his recent relapse’…?
- Progress Notes from L. Bennati, day therapist, showing (4/3/04) Dan’s deterioration
- Letter of 7/5/04 from Olson to Jo Zillhardt stating Pettit approved Dan entering study before he entered it on 11/21/03.
- Letter of 1/4/05 from Mary Jones, Dakota County: Pettit appointed Dan’s case manager 11/24/03, 3 days after Dan entered the study.
- Computer printout showing payments to Olson & Schulz by pharma (2007 not shown)
- Letter 10/25/04 from Dr. Olson stating no adverse events in clinical studies at University of MN and page from his deposition acknowledging signature, stating, when asked if he was denying writing it or saying he didn’t remember, that he didn’t remember writing it, rather than denying writing it. No adverse events? Totally impossible!
- Three letters from me to Dr. Schulz; no answer till third letter ten days before Dan died. Note in my third letter I again talked about the rage in Dan (akathisia, as I later learned, which is caused by the drug) and Schulz in paragraph 3 states, “You did indicate that you have told Jeannie Kenney that your son has a rage within him. It was not clear to me how you thought the treatment team should deal with this issue.” Who is the doctor here? But yes, I did say I thought he should be on an anti-anxiety medication. After being on Ativan, an anti-anxiety medication, the first night in the hospital, the next day he seemed like his old self. Dr. Olson even wrote in the hospital file he would lean toward bipolar because of Dan’s fast reaction to Ativan.
In same letter Dr. Schulz stated “Dan has not asked to be out (of the study).” Declaration of Helsinki, item 15 states the welfare of enrollee rests on medically qualified person and never on subject himself. Dan was too sick to ask to be out, and dead ten days later. Ethics codes do not apply to Dr. Schulz?
Senator Grassley, I am interested in getting this information out and the Bill passed so we can prevent this from happening again to other families. I appreciate the work you do for the humane treatment of the mentally ill! Let’s give them a chance to return to society!