Clinical trials are about odds and risk ratios. Testing to see if new treatments are safe, and making sound judgments without obsessing the what-if’s. In these episodes the NorBAC team is asked to mediate a dispute in a clinical trial. How this plays out is impressively unpredictable.
The dispute is between two researchers in a trial for a gene therapy that cures leukemia. Dr. Julius Booker is the one running the trial, and one of his lead researchers, Dr. Lauren Foley, is claiming that the treatment may not be safe. But then the whole point of a trial is to find out if it’s safe.
Three kids with leukemia have been given the experimental treatment. Two are in remission doing very well, and one is dead. The dead boy, 11-year Maxwell Peterson, died from a stroke four hours after receiving the treatment. Foley thinks that the boy’s immune system over-responded to the treatment — maybe the dosage was wrong, or the timing — and she’s furious that Booker wants to write off the stroke as a normal occurrence in an AML patient. David is skeptical and doesn’t think Booker was necessarily wrong to do that. Kids with leukemia do die, after all, and if two other kids were saved by the treatment, then the Peterson boy could just be a one-off. Foley also thinks it’s about money: her university wants to keep money flowing into research, and Julius Booker is a money magnet. But that’s just capitalism; it doesn’t mean that Booker is making the wrong professional call. But what exactly does the gene therapy do?
Booker’s gene-therapy treatment appears to be cutting edge science. The procedure involves injecting a healthy virus into the patient — a virus that’s had all its nasty bits removed, and replaced with health instead of harm — that goes to the cancer cells and “infects the patient with health”, killing the bad cells. So what happened to the Peterson boy? This is what three members of the NorBAC team debate in pouring over the bio-data of the three kids:
Carlos Serrano: “This shows the cancer cells of the Peterson boy one hour after treatment. [Click.] Two hours, most of the cancer cells are infected with the virus. [Click.] Four hours, the majority of the cancer cells are dead or dying.”
Mayko Tran: “Everything is going great, and then the kid gets a stroke and dies.”
David Sandstrom: “So what went wrong?”
Mayko: “What if the Peterson kid had a hyper-response to the virus? He could have had an allergic reaction, that caused the swelling that led to his stroke. He had high cytokine levels that could have caused vessel damage.”
David: [Looking at Carlos] “You got a problem with that?”
David: “Jesus. So is it the treatment or the disease that killed the kid?”
Carlos: “Maybe Peterson’s brain was set to go, you know, it’s not uncommon in AML [leukemia] patients. He might have suffered a stroke with or without the treatment.”
Mayko: “Are you willing to bet lives on that, Carlos?”
David: “Listen, the question we’re dealing with here is, if 3000 kids get this treatment, will 1 of them die or 1000?”
That’s what it’s about: odds and risk ratios. After extensive research, David can’t find any reason not to proceed with the trials, and he gives the green light to continue. The trials resume… and there’s a repeat tragedy. Five more kids are given the treatment, and four of them go into remission. But the fifth, a boy named Justin Ricci, goes into blast crisis and is left in a coma. Foley, enraged, confronts David at his home, and David mockingly patronizes her until she tells him that Justin Ricci is in a coma, thanks to him. David beats himself up at first, but did he really make the wrong call?
David has Mayko review the bio-scans of the eight kids. They all show the same abnormality: an 8-11 translocation, which is the kind of chromosomal mess-up you’d expect in a leukemia patient, but nothing other than that. There’s no evidence that Justin Ricci’s blast crisis (a phase in leukemia when more than 30% of the cells in the blood or bone marrow become dangerous “blast” cells) or his subsequent stroke were triggered by the treatment. David stands by his judgment, telling Caroline he made the right call at the time, despite what happened to the Ricci boy. There was no good reason to stop the trial.
The assholes being Doctors Julius Booker and David Sandstrom. We’re used to David, as he’s the show’s lead and endearing in his own way. Booker is easily pegged as the callous villain. Against these two, Lauren Foley comes off as a lone voice of caution and compassion. It doesn’t help that David brushes off her concerns with a fair degree of contempt and hardly takes her seriously — except for his attempts to get her in the sack with him. In the Me Too age, David is a politically incorrect protagonist to say the least.
But assholes aren’t necessarily wrong, and the NorBAC team can’t find anything unsafe about Booker’s treatment.
David: [Exploding] “Look, we’ve got six kids in remission, two are negatively affected, but without this treatment, eight kids would be dying. If I’m wrong, somebody convince me.”
Caroline: “So Justin Ricci was just unlucky?”
David: “Yeah, maybe!”
Caroline: “Can we be clear about anything here?”
Bob: “I think Justin was unlucky. To have a blast crisis and a stroke, all within four hours. That’s like having two car accidents on the same trip home.”
David: [Leaning forward] “What did you say?”
Bob: “I said –“
David: [Waving him to silence] “Justin Ricci couldn’t have been that unlucky.”
Mayko: “Yeah, it does seem kind of quick.”
David: “Why are we fighting this? If it couldn’t happen in four hours, it couldn’t happen in four hours.”
Bob: “He must have been already in blast crisis when he was given the treatment.”
Mayko: “He wouldn’t have been accepted in the trial in that condition.”
David: “He shouldn’t have been accepted into the trial.”
Mayko: “David, we have his records. Justin wasn’t in blast crisis when he was approved for trial.”
David: [Long pause] “What records?”
David’s hunch is right. Dr. Booker faked the paperwork and admitted Justin Ricci into the trial when he was already in blast crisis. But not out of gross malpractice. He did that only because the kid’s parents begged him to. Justin was dying anyway; the chances of him coming out of blast crisis were zero. His parents thought he had nothing to lose. So Booker gave him the treatment. David — ready to shoot Booker when he realized the paperwork was faked — admits in the end that there’s nothing the treatment could have done at that point to make Justin’s situation any worse.
As David tells Caroline in the end, “We weren’t asked to judge Booker. We were asked to judge his trials.” Once again he advises that the trials should continue. They could end up saving many kids’ lives, and so far there’s no evidence that the treatments caused the death and coma in the two boys. David can be arrogant but he knows his science, and he mediated this dispute by the book.
Which isn’t to say that David Sandstrom does everything by the book. When it comes to his pet obsession, he completely disregards proper channels. In the midst of the leukemia trials, he flies up to Nunavut to retrieve a sample of what he believes to be the Spanish Flu from a corpse that’s been frozen since 1918. This corpse is off the radar of all the known digs, and only an Indian knows of it. David pays the Indian for his help and silence, and then returns back to the lab, putting his new virologist Jill Langston on the sequencing and PCR tasks at once. To their utter astonishment, the RNA is completely intact — all 8 viral RNA segments of the Spanish Flu.
Jill is a bit deflated however, when David refuses to share his results with the World Health Organization. He wants NorBAC to make the vaccine, and gives her strict orders that no data leaves the lab. Jill tells David that their protected patent protects them from being ripped off, and that WHO has the manpower and equipment to crank out a vaccine in less than a year’s time. But David won’t budge; he wants to go all the way with his precious discovery.
David’s ego and recklessness with the Spanish Lady will spell dire consequences by the season’s end. For now he hosts a party at home in celebration. It’s perhaps fitting that right as he’s dancing and boozing it up, Lauren Foley comes crashing in with the news that Justin Ricci is in a coma (see above), and that he is to blame for it. He’s not, as we’ve seen, but an asshole like David Sandstrom surely deserves to have his unpleasant moments of self-doubt.
These two episodes pick up Mick’s story from episodes 1-3, and terminate it dramatically. In the final scene of Faint Hope, he dies in Lilith’s arms — a heartbreaking end on a beach in Quebec.
The subplot of Lilith and Mick’s journey to Quebec complements the main plot of the leukemia trials, as both deal with kids about to die. Mick wants to see a whale before he dies, and so Lilith (much like her father who takes off to Nunavut without accounting for himself) leaves with Mick for Quebec. She has her father’s credit card, and so she and Mick can pay for the bus rides, eat, and stop at a motel along the way.
The motel scene is one of the most touching of the series, where Lilith, breaking down crying, asks Mick if he wants to have sex before he dies. And here is the final moment, Mick’s death on the beach. The scenes speak for themselves.
The Trials and Faint Hope are a great pair of episodes, second only to the double-bill premiere.
Original air dates: November 21 and 28, 2004
Rating: 5 stars out of 5