Chapter Twenty-Eight
“I was the Chairman of a panel that was asked by the Food and Drug Administration to consider allowing the drug AZT to be sold as a treatment for AIDS.”
“When did you meet?”
“In January of 1987.”
Messick considered Dr. Broad to potentially be one of his best witnesses, and, he hoped, a powerful influence on the jury.
“Dr. Broad, did the panel discuss whether or not the virus called HIV caused AIDS?”
“No, that was not our job. Our job was strictly to decide whether the drug AZT should receive FDA approval to combat AIDS.”
“But wasn’t AZT being submitted as a treatment for AIDS because it killed the HIV?”
“Yes.”
“It wouldn’t have been a treatment for AIDS if HIV didn’t cause AIDS, then, would it?”
“No, but that question was not within our scope of consideration. We assumed HIV caused AIDS, based on what Dr. Gallo had said, and that was it. We were there to consider a treatment for HIV.”
Want to make sure I keep putting all this back in Gallo’s lap…but let’s get the jury focused on the FDA now.
“Okay. Dr. Broad, how does a new drug like AZT get approved by the FDA?”
“First, it has to go through different phases of study and experimentation.”
“Let's start with Phase 1.”
“Phase 1 is pretty simple. You have to prove that the drug is not harmful to human beings, that it is not so toxic that it does more harm than good.”
“That’s what Dr. Hoffmann just said, the previous witness. Did you hear his testimony?”
“No, I’m sorry. I didn’t.”
“That’s alright. So to your knowledge, was that true of AZT – that it did more good than harm?”
“You know, our panel didn't really deal with Phase 1. We concentrated on the Phase 2 trials. And you don't go to Phase 2 unless you've passed Phase 1. So I guess we assumed that AZT had passed Phase 1.”
Dr. Broad had brought a large folder with him to the stand. He began leafing through it.
“Did you bring some notes with you, Dr. Broad?”
“Yes, these are the original notes I took as Chairman of the committee. I haven’t looked at them for a while, and I was curious what, if anything, we might have said about Phase 1.”
“I’ll give you a minute if you want….”
“Yes, thank you.” Dr. Broad reads through a few pages of his folder. “Yes, here it is…. Apparently one of the things we discussed…oh, yes, now I remember. One of the things we discussed were some laboratory experiments published by Dr. Barry, Dr. Broder, and Dr. Bolognesi, not realizing at the time that they were all part of Dr. Gallo's inner circle, called the ‘Bob Club.’ They claimed to have proven that at least 1,000 times as much AZT was needed to kill T cells in a person's immune system as was needed to kill the virus causing AIDS. That meant a doctor would feel totally safe giving small quantities of AZT, knowing he couldn't harm the patient.”
“Was this true? Were the experiments done by Barry, Broder, and Bolognesi accurate?”
Dr. Broad reads further in his notes.
“Apparently not. Six independent studies published since then have found that AZT kills the immune system’s T cells just as fast as it does a virus. In fact, the real toxicity of AZT is 1,000 times higher than we were told at the time.”
“Forgive my ignorance, but wouldn't it be all right to kill some T cells if we are killing all the HIV at the same time? At least we’d be getting rid of AIDS.”
“The problem is, depending on who you listen to or believe, that only 1 in 500 T cells, or 1 in 10,000 T cells of an HIV-positive person is infected with HIV. So AZT must kill hundreds, or even thousands of good T cells to kill just one cell infected with HIV. That's not very good pharmacology.”
Messick knows immediately that the jury got lost in the numbers.
“We’re getting pretty technical now, Dr. Broad. Let me get back to the original question. You never saw the actual Phase 1 test results for AZT?”
“No, we didn’t.”
“And you didn’t ask for them?”
“No, we didn’t. My mistake. I should have.”
That’s nice of you to take the blame, but you’re not who I want the finger pointing to.
“Dr. Broad, here's what I'd like to know. AZT was first developed in the 1960’s in an attempt to find a treatment for cancer, correct?”
“From what I understand, yes.”
“It was never submitted to the FDA for approval at that time, was it?”
“No, not to my knowledge.”
“Do you know why?”
“No, I don't.”
“Our last witness, Dr. Hoffmann, told us that it flunked Phase 1 in 1964. That's why it never went into Phase 2.”
“That would make sense.”
“So, with absolutely no change in its chemical formula, how did it suddenly pass Phase 1 in 1986, twenty-two years later?”
“I can't answer that question. I don't know.”
Honest answer. Messick checks to make sure he’s covered everything he wants to about Phase 1. He has.
“Okay. Dr. Broad, let’s move on to the Phase 2 trials for AZT. When did those trials start?”
“In February of 1986.”
“What's involved in a Phase 2 drug trial?”
“It's called a double-blind study. That's where you take a certain number of volunteers who have the disease the drug is supposed to treat and you divide them into two groups. One group gets the drug and the other group gets sugar pills, called placebos. Basically the group taking the drug has to show significant improvement over the placebo group to prove that the drug has value in treating the disease.”
“It sounds like these kinds of double-blind studies have to be closely regulated and performed according to some pretty strict standards.”
“Yes, absolutely. At least, they're supposed to be.”
Oh yeah? Well let’s find out…
“Were the AZT double-blind studies done according to those standards?”
“No. And we knew that at the time the panel met.”
“What did you know, Dr. Broad?”
“Well, first of all, the study was tainted from the very beginning because Burroughs Wellcome, who was submitting AZT for approval, paid $10,000 for each patient – a total of three million dollars – to the research clinics. As far as I know, that’s what’s called a conflict of interest. At least, it makes it very difficult for the research clinic to be totally objective in its findings.”
“I would think so.”
But, my good friends in the jury, that’s just the beginning. Messick seems like he’s even enjoying this.
“Secondly, the Phase 2 trials were supposed to last six months. This one was called off early. Only 15 patients – 5% of the original 300 – completed the full 24 weeks of treatment. Twenty-three patients were treated for less than four weeks. On the average, patients had received treatment for about 17 weeks at the time the study was aborted.”
“Why was it aborted?”
“Supposedly there were 19 patients in the placebo group that had died in those 4 months, to only 1 patient in the AZT group. The Director of the study said that it was unethical to continue to withhold AZT from any patients – especially the patients in the trial – when it was obvious that AZT was so effective against AIDS.”
“Was this true?”
“Well, we knew there were some real problems with this. For one thing, The Director of the study also admitted that an undocumented number of patients were permitted to take other medical drugs during the study, and the effects of these other drugs were never taken into consideration.”
Messick stops and looks at every juror to emphasize this point as he summarizes that last statement.
“You couldn't isolate which drug was doing what – good or bad?”
“Correct.”
“Anything else?”
&nb
sp; “The death rate in the placebo group was unusually high – so much so that it raised questions on its own. Even patients with AIDS outside the studies weren't dying in those numbers, at those percentages, in that short amount of time. Something had to be wrong. And then the causes of death provided to the FDA from the various study groups did not match those listed in the research report later printed in the New England Journal of Medicine. That seemed fishy as well.”
“If that were not enough, weren’t there even more problems with the Phase 2 trials, Dr. Broad?”
“Oh, my, yes. I've just gotten started. In a double blind study, for example, neither the patient nor the doctor is supposed to know if the patient is getting the drug being tested or a placebo. Well, this study became ‘un-blinded’ on both sides within just a few weeks....”
Wrongful Death: The AIDS Trial Page 32
