The Case of the Pharma Kill Shot
Law Tales #4
As I discussed in my last post,
I worked for a time doing document review while working on my PhD. Then came this case.
We were told the following story: the legal services firm had bid a job based upon what it thought was the number of documents. It turned out that th
e number was the number of files, and each document had hundreds of pages if not more.
As such, the firm was in deep trouble, especially if the reviewers worked their normal pace. The firm specifically staffed the project with its fastest reviewers and told us to go as fast as we could.
And it was a pharma litigation. We got to review original data files for a pharma trial as well as the data going up the ladder, eventually to the FDA. We saw the raw data and it was amazing.
After this project I knew to never trust “rare side effects”, especially of new medications. If pharma admits to side effects, these are common. Then there are side effects that are not disclosed, but found.
In this case, we would see a experimental record, “John, 61, in good health outside of the [condition], ideal candidate. First treatment on Tuesday. Dead on Thursday. Not related to the subject medication.”
We saw this over and over again. Every time a patient got sick or died, they kicked the patient out of the trial. And when they data went up the ladder, it was if it never existed.
The FDA never saw these deaths for this medicine. Even the upper executives could keep a clear conscience because they saw nothing, and heard nothing, and knew nothing, because that was how the system was designed.
The person putting together the submittal to the FDA was not a doctor or scientist, but a guy with a Poli Sci degree who knew how to create the right submittal to get approved. He didn't even get to see the raw data, so he didn't need to lie at all.
And then there were the emails from doctors after approval, about patients getting sick and dying from those excluded side effects. “Did you see kidney failure?” “Did anyone die?”
As you might imagine, there was a bit of gallows humor about all this. “I got another one, “Not related to the subject medication””. We knew it was bad news. Good thing the project was over in three weeks.
Anyway, I worked at warp speed on this project, and I could do it very well. It led to me getting better, higher paying projects, at a higher level.
After this project, I started to listen more to the side effects on drug ads. I paid more attention to how they marketed these drugs, with smiling people and happy music as they went through the “rare” side effects. And I trust pharma to do whatever it can for profits, even if it kills a bunch of us.