Office for Human Research Protections --By fax 301-402-0527
Department of Health and Human Services
6100 Executive Boulevard, Suite 3B01, MSC-7507
Rockville, MD 20892-7507
Re:Human Experimentation/Lack of Informed Consent in an Urban Sliding-Scale Outpatient Clinic: University of Maryland Outpatient Department, Department of Psychiatry: A Personal Account
Sir or Madam:
Reference is made to Grimes v. Kennedy Krieger Institute, Inc., No. 128 September Term, 2000 (Md. 08/16/2001 with regard to non-therapeutic experimentation on vulnerable persons (children) coupled with failure of informed consent. The court noted:
Additionally, the Nuremberg Code, intended to be applied internationally, and never expressly rejected in this country, inherently and implicitly, speaks strongly to the existence of special relationships imposing ethical duties on researchers who conduct nontherapeutic experiments on human subjects. The Nuremberg Code specifically requires researchers to make known to human subjects of research "all inconveniences and hazards reasonably to be expected, and the effects upon his health or person which may possibly come from his participation in the experiment." ... (emphasis added)
... Such legal duties, and legal protections, might additionally be warranted
because of the likely conflict of interest between the goal of the research
experimenter and the health of the human subject, especially, but not exclusively,
when such research is commercialized. ... There is thus an inherent reason
for not conveying information to subjects as it arises, that might cause the subjects
to leave the research project. That conflict dictates a stronger reason for full and
continuous disclosure.
The purpose of this letter is to bring to your attention a pernicious yet widespread practice of pharmaceutical companies coupled by first-, second- or third-year residents to "test market" their wares on a vulnerable population and to help promote sales especially among persons on Medicaid or otherwise holding "Pharmacy" cards. [Footnote 1: In Maryland, a "Pharmacy" card allows the holder to procure a prescription drug þ no matter how costly þ for a small copay. Medicaid and the State pick up the difference.]
Because I was impoverished and could not afford a competent psychiatrist nor drugs touted by major pharmaceutical corporations, I enrolled at the University of Maryland Outpatient Department of Psychiatry and was approved for a small copay. In late 1999, I ended up being hospitalized, in part because of the rotation of residents who, after all, were participants in a training program. I saw a doctor named Doris Balis, M.D. once and then decompensated. Upon admission, one of my complaints was, "I didn't want to train another little girl."
My diagnosis was Axis I: Bipolar I disorder, Axis II: Substance Abuse (beer). Upon discharge, I spent about six weeks with the Adult Day Hospital, under the direction of Elise Brown, R.N. The attending physician was Philip Grob, M.D. It was during this period, on November 1, 1999, I submitted reorganization plans for the Maryland Department of Public Safety and Correctional Services (the results of which have been posted on the Internet) and produced the newsletter, a copy of which shall be appended here.
After discharge from the Adult Day Hospital, I was reassigned back to the Outpatient Clinic and was assigned to resident Ivana Iacopovich, M.D. It was also about this time I was also assigned for adjunctive therapy to Sharon Lerner, LCSW-C.
During the first visit with Iacopovich, she stated that she didn't want to go over the records but that she wanted to hear the situation from the patient herself. I gave her some biographical information and told her, as an inpatient, Risperdalþ gave me a rash and they switched to loxapine succinate after I called my pharmacist and found Risperdalþ cost $300 or more a month. The tardive dyskinesia set in from the loxapine because the book said 20 mg was the adult dose and I was used to 5 mg. She wrote out a prescription for 30 x 10 mg loxapine and told me that I could get Neurontinþ on a $5 copay from the Hospital's pharmacy. [Footnote 2: Lithium 300 mg / 1500 qd continued throughout.]
At the very next visit, Iacopovich brought up that she wanted to put me on a drug named Zyprexaþ. She proffered a booklet from the Eli Lilly Company written for Spanish-speaking patients. Since I had had high school Spanish and had gone on a two-month trip to Mexico twenty years earlier, I said, "Es posible que usted tenga s¡ntomas psic¢ticos como alucinaciones." didn't apply to me. As it turned out, Ivana Iacopovich, M.D. was fluent in Spanish. She directed me lower on the page, "... el pensamiento desorganizado (ideas confusas o que corren por la mente) ..." [Footnote 3: See below about "disheveled".] I asked her what country she was from ("De qu‚ pais es?") "Uruguay", she replied with perfect pronunciation. "It clears the thoughts", she said with enthusiasm in English. This was the only other information she gave me. [Footnote 4: I recently visited Eli Lilly's website: Zyprexaþ is indicated for schizophrenia or acute phases of mania that they admit to.] I acceded ambivalently but I acceded. Ivana was quite pleased.
Apparently the manufacturer's rep for Eli Lilly had been through there. Iacopovich had a whole bottle of Zyprexaþ -- two months' supply -- free to give me right there -- no copay and no waiting around the Hospital pharmacy five blocks away. [Footnote 5: The bottle had a Product Insert attached but I couldn't make head nor tail of it. Ivana didn't keep it for her own records.] The clock she watched over my head as we talked featured Prozacþ and some other Eli Lilly pharmaceutical. The front office sports a similar clock.
Needless to say, by the next appointment two weeks later, I had been in a quasi-suicidal depression, had projectile diarrhea and had urinary incontinence. I was unable to pursue my normal daily activities. All of which I reported to her and to social worker Lerner. The symptoms continued through January, throughout February and into March of 2000.
Finally, I turned up for a regular appointment with Iacopovich, again complaining about the Zyprexaþ and she said with finality, "I wanted to give it a two month trial." I looked up and she was holding up in her left hand a white plastic pillbox emblazoned with the Seroquelþ trademark and colorful logo. I regarded her cynically. My weight had gone from 128 lb. to 148 lb. [Footnote 6: Iacopovich weighed in at about 230. Twenty pounds in two months was probably irrelevant to her.], [Footnote 7: There were no scales in the Clinic. Patients were not weighed and their weights on admission or discharge are not noted.] None of my clothes would fit me and I had no money to get any more. The sight of myself in a mirror disgusted me. My self-esteem was at a low ebb. "I'm not taking any more antipsychotics", I said flatly.
It was perhaps my accurate observation at this point that this girl didn't know what she was doing and didn't care. [Footnote 8: At that point, I had never heard of Seroquelþ but was not about to find out. The girl was learning her dosages from manufacturers' reps as well.] The Zyprexaþ episode was apparently just for her personal edification. "Pamelorþ," I said, "What happened to Pamelorþ?! My old doctor had me on Pamelorþ!" "At what dosage?", she replied. "Fifty," I said.
As luck would have it, Ivana had a set of sticky notes featuring the Pamelorþ trademark ("nortriptyline" in small letters, of course). With a flourish, I got a written prescription for that drug, fifty, of course. I hadn't told her that it was out of patent, that the generic was freely accessible and affordable and that it was known to be safe and effective [Footnote 9: In the right hands.]. Iacopovich, handing me the prescription, was encouraging: "You'll be happy to know -- it's constipating."
My depression was gone by the very next morning, and so did the diarrhea and urinary incontinence. In the presence of lithium, Pamelorþ is not constipating and I went back to my normal work the very next afternoon.
Ivana Iacopovich either rotated to another phase of her residency or was given her walking papers by the University of Maryland Department of Psychiatry. I was then assigned to Denise de Guzman, M.D. ("stupid is as stupid does", but that is another story for another regulatory agency and another letter). She did at one point make the statement, "I can get Risperdalþ for free.", but I declined the offer. De Guzman -- blessedly -- went out on maternity leave after a few too many bloopers, bleeps and blunders. [Footnote 10: I had made the statement to social worker Lerner that, "While Iacopovich was incompetent, de Guzman was a 'blithering idiot'". Lerner then gave me advance notice (one month's) of the anticipated blessed event.]
Where was the IRB? Where was the Internal Review Board? Might you ask. That, to my knowledge, consisted of the Attending Physician for Psychiatry OPD, Theodora "Doris" aka "Doris" Balis, M.D.
It was during the de Guzman phase that my insurance company asked for medical records from the time of my "first" hospitalization at UMMS and extending through my outpatient treatment. This was a claim for items stolen while I was out of my house. The insurance company wanted to question me about the facts and circumstances thereof ("Examination under Oath"). Without the records, the claim could not proceed. The insurance company sent a Release form to sign and return.
I called Dr. Balis and explained the circumstances. Her response was, "Medical records are a 'team' project. Make an appointment with Dr. de Guzman and we three will decide which records go to the insurance company."
Already having been exposed to "stupid is as stupid does" but wanting to settle the insurance claim (the lawyer for the insurance company said they "have to" come up with the records), I signed the release and added the patient number and faxed it back to him.
For all the inpatient treatment and all the visits with Iacopovich and Sharon Lerner, the social worker, the insurance company received exactly seven pages back -- chart notes by Iacopovich. The insurance company wrote me a letter about the lack of medical records from UMMS in general and the fact the Examination Under Oath could not proceed without them. Furthermore, all through the Zyprexaþ phase, consistently, Iacopovich's only comment was that I appeared "disheveled". There was nothing about the quasi-suicidal depression, the diarrhea, the urinary incontinence or the massive weight gain. In addition, there were no social worker notes and there were no lab results.
After de Guzman blessedly went out on maternity leave, I was on a regular appointment with social worker Lerner when Dr. Balis came in and sat down in Lerner's office. De Guzman had refused to prescribe Ambienþ or take any other action when I reported I was having trouble getting to sleep (Neurontinþ was discontinued when the Hospital pharmacy ran out). I had reported to Lerner that "I went back to an old prescription." (specifically, the 10 mg loxapine prescribed by Iacopovich a week before switching to Zyprexaþ).
Somehow the topic of Zyprexaþ came up so I told Balis, "Zyprexaþ is poison -- it causes suicidal depression, projectile diarrhea, urinary incontinence and massive weight gain." Social worker Lerner was nodding slowly at Balis as Balis said, "I never heard that!" I would appear from that statement that perhaps Balis was not in communication with Iacopovich or Lerner during the Zyprexaþ episode. It would also appear, by Balis' demeanor, that Zyprexaþ, whether free from the manufacturer or paid for with a Pharmacy card or Medical Assistance, was in common use at that Clinic. It is not known what feedback is brought to bear back to the manufacturers' reps or is reported in any other channel.
The story does not conclude here. The letter above contains only that recounting of events relevant to the Office of Human Research Protections for, surely, powerful psychiatric drugs distributed without cost into the hands of young, inexperienced persons lacking in judgment, insight and wisdom constitutes "research" in its crudest and basal level. And this letter does not go into the "freebies" that accompany these drugs. "Freebies" known to me are clocks, sticky notes, paperweights, other miscellaneous geegaws and food when little is accessible or available. [Footnote 11: A later letter shall describe the uses and abuses of Risperdalþ at the inpatient level.]
This letter and other materials are posted at www.ematic.com/Nancy550/ especially at "Healthcare, Collections, and Psychiatry".
It would be good of you to acknowledge receipt of this correspondence.
If you have any questions or comments or require further information, please do not hesitate to contact me.
Sincerely,
Nancy Moran
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Distribution List next page
To follow:
A - email "Bipolar Realities" (1 sheet)
B - Newsletter (satirical) done prior to administration of Zyprexaþ (5 sheets)
C - Baltimore Sunpaper article on Eli Lilly Corporation (2 sheets)
D - Copy of proposed legislation seeking sponsors [Footnote 12: A later letter shall describe the uses and abuses of Risperdalþ at the inpatient level.] (2 sheets)
DISTRIBUTION (by fax where possible)
Governor Parris Glendening
f410-974-3275
Mr. Karl S. Aro
Executive Director
Department of Legislative Services
f410-946-5205
Georges C. Benjamin, M.D.
Secretary, Department of Health & Mental Hygiene
f410-767-6489
Brian Hepburn, M.D.
Clinical Director
Maryland Mental Hygiene Administration
f410-333-5402
Steven Baron, M.D.
Baltimore Mental Health Systems, Inc.
f410-837-2672
C. Irving Pinder, Jr.
Executive Director
State Board of Physician Quality Assurance
f410-358-2252
Ms. Barbara Bellack
Executive Director
National Association of the Mentally Ill
f410-467-7195
State Senator Thomas Bromwell
f410-946-5080
Anthony Lehman, M.D.
Chairman, Department of Psychiatry
University of Maryland Medical System
f410-328-3693