Wrongful Death: The AIDS Trial

by Stephen Davis

  * * *

  “Dr. Broad, as Chairman of this panel, you refused to vote in favor of the approval of AZT.”

  “That’s correct. I did. As Chairman of the panel, after all we had heard, I could not in good conscience approve the use of AZT.”

  Messick lets that one sink in with the jury. He just stands at the lectern, silent, for a minute.

  “Were there reasons other than all the problems with the Phase 2 trials that you described before the recess?”

  “That's not enough?”

  The brief laughter stops before Judge Watts can pick up her gavel.

  “Well, let me see.... Two members of my panel were paid consultants for Burroughs Wellcome, the very drug company seeking approval for AZT. The FDA forced me to allow them full voting privileges on the panel anyway, even though I considered that to be a blatant conflict of interest. On top of everything else, there were no studies done on mice, as is routine for FDA approval. And I was concerned that if we approved AZT on these very premature, very poor test results, it would be even more difficult to get better data in the future.”

  “I believe you were quoted as saying it was like ‘letting the genie out of the bottle.’”

  “I think I did say that, as a matter of fact.”

  Dr. Broad now realizes that he’s proud of himself and the stand he took, and although he didn’t remember that exact quote, he was glad he said it and happily took credit for it.

  “And did the rest of your panel agree with you?”

  “Actually, yes.”

  Messick stops because he knows what’s coming next and wants it to have a real impact. “They all voted ‘No’ on AZT?”

  “No. But they were going to, until the late afternoon. When it appeared that the majority of us were not going to approve AZT, the FDA sent over a big gun to literally beg everybody for their vote. And Burroughs Wellcome reassured us that they would provide a very detailed two-year follow-up study, and in the meantime they would not allow AZT to be used for anything except a stop-gap measure for very sick patients.”

  “And is that what actually happened?”

  “No. By the time that two-year study was up, AZT was already in 60 countries, being given to more than 20,000 people.”

  Okay. Time to ‘show me the money’….

  “At how much per patient?”

  “Conservatively, about $8,000 per patient per year.”

  “So that's 160 million dollars a year for Burroughs Wellcome.”

  “Actually, I think they probably made more than that, so that’s a conservative estimate, yes.”

  “160 million dollars a year….” Messick again pauses at the lectern before continuing. “In the end, Dr. Broad, how many of your panel voted against approving AZT?”

  “Only me. And when it was all said and done, it was one of the blackest days of my life. We had approved AZT faster than Thalidomide had been approved in the mid-60’s, which ended up causing massive birth defects. But Burroughs Wellcome received full licensing for AZT within 6 months, and even got special permission to sell it to a wide market – not just very sick patients – while it was waiting for final approval.”

  “Dr. Broad, let me read a statement from another famous AIDS researcher, Dr. Joseph Sonnabend, one of New York City's first and most reputable AIDS doctors, who said, quote, ‘I'm ashamed of my colleagues. I'm embarrassed. This is such shoddy science; it's hard to believe nobody is protesting. Damned cowards. It's all about money, just following the party line and not being critical when there are obviously financial and political forces that are driving this,’ unquote.”

  Dr. Broad looked squarely at Messick. “Damn. I wish I had said that.”