Chapter Eighteen Ava Angelhart #2
“Cooper reached out and asked if a colleague of his could call to discuss a drug trial he had qualms about. Cooper and I had spoken periodically over the years, and he’d never before asked for my help, so I was happy to speak with Devin.
Devin said he was skeptical about a Neurovantix drug trial, and would I look at the data.
I did. I saw nothing wrong. About a week later, he called me and explained that the data I reviewed wasn’t complete, that ten subjects had been removed from the final data set.
He wanted to know how he could prove it.
Because of my background, I gave him some ideas on how to retrieve the original data.
It should be impossible to falsify reports, but it has been done, especially in high-profile drug trials with a lot of money at stake.
It’s one reason the VA insists on reporting all phases to be as transparent as possible.
There should be checks and balances, but in smaller trials with fewer people involved, those checks and balances are thin.
In larger trials, it’s easy to change small details that have an outsize effect on the bottom line. ”
“I don’t understand,” Ava said. “Either there’s a way to check or there isn’t.”
“If you’re running a Phase 1 trial with only a handful of people, such as this trial, you may only have two or three people
managing the entire project. While they should be able to check each other’s work, often it’s rubber-stamped—the trials don’t
have the big money yet, and if one person sees a problem they might cover it up if they think it’ll shut off future phases.
Or, they see a problem and rectify it midway through the trial without documenting the change.”
“Why?” Ava asked. “Wouldn’t a larger trial uncover a problem, such as a serious side effect?”
“It should.” Nadine paused. “Let’s say that you have a trial of one specific formulation of a drug. It goes bad, someone dies
or has a serious adverse reaction. You might say, ‘Oh! He was on heart medication, we’re going to take him out because that
conflict created this side effect, not the experimental drug.’ ”
“That’s unethical,” Ava said.
“Depending on the situation,” Nadine said.
“The information should be in the notes, so that every person and their reactions are documented. Drug interactions are one of the most common side effects, which is why you see on warning labels that if you are taking drug A, you shouldn’t take drug B.
If they know about the problem when they start Phase 2, they will exclude anyone who is on that heart medication.
But if they realize their drug is the problem, either the dosage or the specific formulation, they may attempt to hide that, adjust the drug itself,
and show on paper that it was a successful trial.”
Margo’s mouth opened, and Ava put her hand on Margo’s arm, willing her to not speak. Perhaps she should have told Nadine that
three other people were listening to their conversation, but it was a little late for that now.
Ava said, “I see. And what did you find?”
“I found nothing. I couldn’t prove anything was deleted, I was going on Devin’s word that his patients’ data wasn’t anywhere
in the notes, and when he viewed their medical records there was no mention of their participation in the drug trial. That
could actually be a crime, a felony. I suggested he file a complaint with national headquarters and copy in the two US senators
from Arizona plus the head of the Veterans’ Affairs Committee in Congress. Be open about it, because in my experience, transparency
stops corruption.”
“Did he?”
“I believe he was killed before he had the chance.”
“Why didn’t you come forward?” Mom said, sounding angry.
“I didn’t know what was going on,” Nadine said, sounding defensive.
“Not at the time. I gave him advice, but I have my own career and patients. I had no idea that he had been killed until I received an internal memo saying Cooper had been arrested for his murder. I tried to call Cooper at the time, but didn’t reach him then.
I thought about calling you, asking what was going on, but decided against it.
” She paused. “I should have pursued it, I suppose, but I haven’t seen Cooper since I graduated college.
We had talked only a half dozen times since.
And to be honest, on the phone Devin sounded .
. . well, a bit unhinged. I had no way of knowing that the drug trial may have been a motive for his murder, not when the memo stated that Cooper confessed and took a plea deal. ”
Ava considered. “You thought Cooper had killed him.”
“I didn’t know what to think, but I had no reason to believe he made a false confession. People change.”
“Yet, you visited him in prison three weeks ago.”
“Yes. A month ago, I read an internal report about how the VA had rolled out a full-scale Phase 4 trial of a new PTSD drug
from Neurovantix. I was very interested because that was the same drug and company from the Phase 1 trial in Phoenix that