Chapter Twenty-Nine
“So it looks like there were quite a few problems with the Phase 2 trials for AZT. Back to you, Laura.”
Laura Begley is in her usual place behind the GNN news desk at the headquarters in Atlanta.
“Thank you, Rick. Rick Mann from the Federal Courthouse in Phoenix, Arizona, the site of the now infamous AIDS trial. Also with us again is Dr. Frank Keating, GNN's chief health correspondent. Dr. Keating, do you have any more information about the Phase 2 AZT trials?”
“Well, Laura, not about the Phase 2 trials, no….”
Apparently Laura wasn’t in the loop any more and didn’t know the script. Keating not only had his own camera again, but this time had his own set as well.
“That was covered fairly extensively in today’s testimony. But we heard Dr. Broad, the chairman of the FDA panel that approved AZT, also express his concern about the follow-up trials – those two-year studies that Burroughs Wellcome promised his panel. With me tonight is Leslie Grissom.” Keating reads from a note card on his desk. “From September of 1987 to March of 1990, Leslie was the Data Manager for one of the follow-up trials conducted at the Syracuse, New York clinic – the ones that led to the widespread prescription of AZT to HIV-positive individuals who were not sick. Is that correct, Leslie?”
“That's correct.”
Leslie Grissom is seated with Keating at a desk covered with stacks of paperwork. She looks and speaks like an Army sergeant, and is obviously obsessive-compulsive about detail.
“What exactly was your job?”
“I was supposed to collect all the data, to put together all the results of the drug trials and fill out all the necessary reporting forms and such.”
“And you say that you had some problems doing that?”
“That's an understatement. I would say that the data which came from the Syracuse site was absolutely worthless.”
“Why?”
Leslie is clearly pleased that she’s finally getting to publicly express her indignation and displeasure after so many years. She’s also quite happy with all the attention.
“The level of medical incompetence, unprofessionalism, unethical, dishonest, corrupt, illegal and immoral behavior was shocking and inexcusable. The data was so inaccurate and so full of holes that I often compared it to Swiss cheese. I felt like I was trapped in the middle of an awful movie about mad scientists. If there was a rule that could be broken, they broke it!”
Keating’s not sure what he’s gotten himself into. She seemed like she had some important information, but can he pull that out of her through all the emotion?
“Can you be a little more specific?”
“Well, both the Principal Investigator and the Study Coordinator – a doctor and a nurse – seemed to be more interested in enrolling as many patients as possible than they were in the research itself. Of course, they got $10,000 a patient from Burroughs Wellcome, so you can understand why. This led to subjects being routinely admitted to the program who failed to meet the eligibility requirements.”
“Such as...”
“I remember several cases.” Grissom looks at the stack of papers on the desk in front of her, finds what she wants, and begins to hold up handfuls of different reports each time she makes a new accusation. “One of the criteria was that all patients had to be HIV-positive, of course, to test the effectiveness of AZT. Well, I remember a female patient enrolled whose husband was HIV-positive, and she took the study drug for three weeks before anyone realized she was HIV-negative. She was also on oral contraceptives at the time, which was another eligibility violation. Then there was another patient enrolled who didn't have an HIV test at all, and another one whose test results were dated a month after his enrollment.”
“But that's not a serious breach of the study. That's just sloppiness, perhaps…?”
“Well, then, how about this?” She finds more papers in another stack. “Incorrect lab tests were routinely ordered – either required labs omitted or unrequired labs ordered by mistake – and the wrong prescriptions were routinely written. When I questioned these, and other similar mistakes, I would be chastised by the Principal Investigator and the Study Coordinator for being too ‘nit picky,’ or for inappropriately questioning someone's medical expertise.”
Keating is now sorry his staff ever found Grissom. If she would just calm down and present the facts without all the personal crap she’s adding to it.
“Anything else?”
Grissom looks at the stacks of documentation in front of her. “Have you got an hour?”
Oh my god, no, is what Keating thought. “No,” was all he said.
Grissom decides what she wants to talk about next and holds that up in the air as she speaks. “Well, let me just list a few of the worst cases. Deaths were being reported as what was called a ‘first event,’ even though there were clearly opportunistic diseases that came before the deaths. That changed the test results dramatically. There were countless unreported diagnoses, opportunistic infections, symptoms, concomitant medications, and adverse reactions. Lab results were routinely transcribed incorrectly onto the research forms by the Study Coordinator. Informed consent forms were routinely backdated, sometimes weeks or even months after enrollment. In at least one instance, a patient was asked to sign an informed consent form for the wrong study.”
How do I calm this woman down?
“I can see how all of this would affect the results of the drug trials. But these are still basically all paperwork mistakes.”
Grissom looks wounded, as if she wasn’t being believed – again. “Oh, trust me, the incompetence wasn't limited to paperwork. I personally witnessed a patient experience a severe toxic reaction to the study drug...”
Keating interrupts. “The study drug being AZT...”
“Yes, a severe reaction to the AZT. She had to be hospitalized for five days for what is called Grade IV toxicity. But no one – no doctor or nurse – showed any responsibility for, or any knowledge of, or any interest in, or any recognition of the importance of the explicitly defined adverse reaction and dose management steps and procedures outlined in the protocol. In other words, instead of being taken off the AZT, her dose was simply reduced, in complete violation of protocol requirements which require discontinuation of the study drug.”
Okay, there’s something concrete. Let’s try to stick with this, shall we?
“So what did you do about all of this?”
“Finally, in March of 1990, I couldn't sit by and watch any more. I resigned, and later I turned in a report to the FDA with all this documentation.”
“What happened to your report?”
“I'm not sure. I did get a phone call right away, thanking me for bringing these issues to their attention, but saying it would be unnecessary for me to forward copies of my documentation to the Site Monitor or to the National Institutes of Health. They also stated that they couldn't act directly based on my claims or supporting documentation, but that they would keep a close eye on the Syracuse site. The phone call ended by saying that they may not even need to call me again, except to clarify something. In other words, ‘don't call us, we'll call you.’ I never received a call from their office or anyone else associated...”