I’ve posted often about my reluctance to accept as gospel data derived from studies on animals. Animals aren’t just furry little humans–they are different genetically than we are and, despite the fact that animals have cholesterol, insulin, blood sugar, and all the rest, their systems behave differently. Even studies using monkeys or other primates, which are certainly closer to humans genetically than rats, don’t always provide data that is applicable to humans. A few humans learned this the hard way in a recent study done in the UK that went horribly awry.
I was reading through some back issues of the New York Times when I came upon an article entitled British Rethinking Test Rules After Drug Trial Nearly Kills 6 about a trial study done testing a new immune stimulant drug. The six healthy men recruited for the study who took the drug almost paid for it with their lives. I’ll excerpt the basics of what happened.
In February, when Rob O. saw the text message from Parexel International pop up on his cellphone in London — ”healthy males needed for a drug trial” for £2,000, about $3,500 — it seemed like a harmless opportunity to make some much-needed cash. Parexel, based in Waltham, Mass., contracts with drug makers to test new medicines.
Just weeks later, the previously healthy 31-year-old was in intensive care at London’s Northwick Park Hospital — wires running directly into his heart and arteries, on dialysis, his immune system, liver, kidneys and lungs all failing — the victim of a drug trial gone disastrously bad.
One of six healthy young men to receive TGN1412, a novel type of immune stimulant that had never before been tried in humans, Rob O. took part in a study that is sending shock waves through the research world and causing regulators to rethink procedures for testing certain powerful new drugs.
Within an hour of receiving the milky white drug in a Parexel research ward in the hospital on March 13, the volunteers were racked with chills, pain and nausea, said Rob O., who asked that his last name not be used, for fear that he might be hurt professionally. A doctor informed him he was ”seriously ill.”
”But no one’s going to die?” Rob O. recalled saying, believing he was participating in a fairly standard trial of a painkiller for arthritis.
The chilling response: ”Two of you might. Who’s your next of kin?”
The trial began Monday, March 13, at 8 a.m., when the men began receiving TGN1412, each 10 minutes after the last. Within half an hour, the first patient had a headache and chills, said Ann Alexander, a London lawyer who is representing him. Nevertheless, doctors continued injecting new patients. About the time Rob O.’s infusion started, at 9:10 a.m., the first patient had passed out in an adjacent room, according to Ms. Alexander.
Before long, Rob O. said, he began to ache and shiver, feeling as if he had been ”submerged in arctic ice.” For the rest of the day, six previously healthy men moaned in uncontrollable pain, vomited and struggled for breath, Rob O. and other participants said. Though a dose of steroids temporarily blunted the symptoms, their vital signs steadily deteriorated, and they were transferred to the intensive care unit.
Two of them were placed on ventilators. Uniformed men wheeled in blood filtering machines, Rob O. recalled, to cleanse the blood of acid. Doctors told him that his immune cells were attacking his organs.
The patients’ families were summoned to the hospital at 3 a.m.
As it turned out all six survived, but not without some emotional and physical baggage. Their immune systems are still abnormal and the experience has left them with a sense of dread about future health problems.
With his immune system now essentially disabled, Rob O. says he cannot work, or even take the subway, for fear of infection. His liver and kidney tests are still abnormal. Britain’s National Health Service covers his doctor’s bills, but he has to pay the $87 cab fare.
”I can’t believe that nobody will pay and nobody will be punished,” Rob O. said. ”If I’ve lost 20 years of life because my liver packs in at 60 rather than 80, who will cover that?”
Why were these poor people subjected to this torture? Why were they given this drug that ended up almost killing all of them?
The British Medicine and Healthcare Products Regulatory Agency, which approved the trial at Northwick Park, announced Wednesday that ”the way the trial was run” had not contributed to patient injuries, according to its preliminary investigation. The men experienced cytokine release syndrome, which involves an outpouring of toxic molecules when the immune system’s T cells are activated, the report said; it could not have been predicted from previous animal studies using the drug[my italics], the association, TeGenero and Parexel agree.
Tests of TGN1412 in monkeys showed no significant trouble…
So, this drug was thoroughly tested in monkeys, close kin to us, and found not to cause problems. But when injected in humans it comes within an inch of killing them almost immediately. Humans and humans are the same; monkeys and humans are different.
Remember this cautionary tale the next time you hear or read about the results of a study using rats as subjects. Ask yourself if the data really apply to you.