I have a relative who is an intelligent woman, now 33, who went to Stanford for one year, and then her bipolar disorder went wild, and has been hospitalized several times. When she's on her meds, she's an intelligent, rational person. If not, she can descend into being a totally insane being.
Here's a letter that I wrote concerning her.
March 5, 1999
Western Institutional Review Board (WIRB)
3735 7th Avenue SW
Olympia, WA 98502
Dear Sir or Madam:
I am writing to report a severe breach of medical ethics. This concerns the following study:
WIRB/ABBOTT/980311/04-24-98/jj/hk
mod 5-18-98/jtw
12-08-98/mg
1-12-99/am Protocol Number: M97-696 WIRB 980311A
Overview
L suffers from bipolar disorder. On approximately February 11, she was hospitalized following episodes of psychotic behavior. On February 13, I discovered that L had been entered into the above-mentioned study based on her signature on a consent form. As I describe below, L was not capable of giving informed consent at that time. She was totally incapable of understanding what the study was about or what benefit it held for her.
Chronology
L was diagnosed with bipolar disorder several years ago. Although she has been hospitalized because of this disease several times, her condition is well-controlled with medication. She functions as a normal member of society, and holds a paying job.
At the end of January or early February, her new doctor ,<deleted>, began reducing her medication. On February 10th or 11th, she caused a disturbance at a local store and was taken by ambulance to <deleted> hospital in Berkeley. I had a hard time finding out what was happening, since she was incapable of signing release forms that allowed the doctors to talk with me. She was also incapable of signing forms authorizing medications. I was able to find that she was incontinent of bowel and bladder, and had thrown her food tray across the room.
She was transferred to <deleted> Hospital on Feb 12th, and placed under the care of Dr. <deleted>. On Feb 13, she signed the above-mentioned form consenting to take part in a study of a new form of Depakote. At that time, she was transferred to the care of Dr. <deleted>. The study involved a washout period during which she received no medication, followed by a period during which she would receive the new drug or a placebo.
The doctors made no attempt to discuss the study with L's mother or me.
I found out about the study, and on Feb 14, I was able to talk to L on the phone on her ward. It was clear that she was not coherent. I asked her about the study, and its benefits to her. Here are my notes which paraphrase her response:
2/14/99 2:40 PM
L told me that she understood that she was currently a voluntary patient, and that if she didn't agree to be in the study, she would either have to leave the hospital or become an involuntary patient.
I asked L how the study would benefit her, and she replied that she would get $50 and that she could use that $50 however she wanted, or give it back if she wanted. She said that the study would pay for the hospitalization. When I told her that I thought her insurance covered the hospitalization, she explained that the money would go into some account with the government, and that she would be able to draw on it later. I asked her whether the doctors told her that, and she said, no, she just figured it out herself.
My subsequent visits with L confirmed that she was incapable of making an informed decision about the study. Her mother, <deleted>, <deleted>; and her friend and landlord, <deleted>, can all confirm her confused mental state at this time.
I've also attached a written indication of L's mental state. The attached pages include the signature pages of the consent form. [It shows mostly squiggles over the entire page]. L tells me that when the doctor asked her to sign it, she, instead of signing her own name, copied the signature of Dr. <deleted>. She was told that she had to cross it out and sign her own name. Thus, on page 9 of the form, you can see that Dr. <deleted>' signature was copied and then crossed out.
At 3:25 PM on Feb. 14th, I was finally able to reach Dr. <deleted>, and told her that we did not want L in the study. L was removed from the study, returned to the care of Dr. <deleted>, and started receiving medication that night.
L improved rapidly from that point on, and was released on approximately Feb. 25. I have seen her and she is her normal self and has returned to work.
Summary
When L's mother, first told me about what she thought was happening, I said "No, that's not possible, there are very strict ethics rules in medicine." I have worked in research, and have seen the measures that need to be taken to insure that the patient understands the risks and benefits of a scientific study. Apparently something went wrong in this case.
I'm sure you can appreciate the seriousness of my charge. L signed away her access to the medicine that would make her sane without knowledge of what she was doing. Had we not intervened, she might have spend several weeks in the hospital on a placebo. Although we are not currently considering legal action, I want to make sure that this event is investigated.
Sincerely,
<deleted>
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I never heard anything more about this.