Swapped Blood, Faked Data, and a Lab Gone Bad

WI110121 FF Drug Trials 01 Tech

The email that Joe Hagood received in August 2017 was vague and brief, but too unsettling to ignore.

Hagood worked at Medpace, a Cincinnati company that tests new drugs for pharmaceutical manufacturers. His job was to supervise the independent research centers that Medpace pays to handle the nitty-gritty of human trials: finding volunteers, dispensing medications, tracking side effects. The author of the unsettling email, Justina Bruinekool, was a staffer at one of those centers. She claimed to have an urgent reason for writing: Her employer was fraudulently conducting a major trial that Hagood was overseeing.

The email contained no evidence to support this jarring allegation, so Hagood thought it wise to tread cautiously; he worried that Bruinekool might be a disgruntled employee out to make trouble. In his reply, he thanked her for the tip and politely encouraged her to reach him on his cell phone.

A week passed before Bruinekool called. As soon as he picked up the phone, he could tell by her voice that she was genuinely frightened. A 36-year-old mother of three, including a daughter who would soon be off to college, Bruinekool could not afford to lose her $17-an-hour position at Mid-Columbia Research, the center where she worked. She asked for assurances that Medpace would never reveal her identity to her company’s owner, whom she knew had a vindictive streak.

After Hagood agreed to do his best to keep her name in confidence, Bruinekool spent the next hour detailing the transgressions she’d witnessed—and committed—while helping to study CAM2038, a medicine being tested on people with chronic back pain. She said Mid-Columbia recruited test subjects who shouldn’t have been in the trial, including several who had no back pain at all. When those patients missed appointments, as happened every day, she and some of her colleagues would squirt the medications down the sink and fabricate vital signs to cover up the absences. The binders that Mid-Columbia used to chronicle the study’s progress, she said, were filled with lies.

Throughout his long career, Hagood had never encountered a scandal like the one Bruinekool described, and a piece of him wanted to believe she was exaggerating. But Bruinekool’s stories were so vivid, so specific, that he sensed they must be true. That meant the entire CAM2038 trial, which was blending anonymized data from multiple research centers, could be in peril. As soon as he hung up, Hagood started to help organize a team to fly out to Richland, Washington, a desert town just 30 miles north of the Oregon border. They needed to find out what was going on at Mid-Columbia.

Since Medpace’s main purview was to safeguard the CAM2038 study, its investigators would uncover just a fraction of Mid-Columbia’s scientific wrongdoing. The research center had, in fact, been willfully churning out false data for years, thereby tainting the clinical trials for more than two dozen prescription drugs. The fraud was blatant enough to draw scrutiny from time to time—Medpace was not the first watchdog to learn of the mess in Richland. But Mid-Columbia kept dodging meaningful consequences because the clinical-trials industry, like so many of our most vital institutions, operates on the assumption that even the most grievous errors are made in good faith. It is a system ill-equipped to identify and stop those rare individuals—and the scale of Mid-Columbia’s misconduct was exceedingly rare—who consider the trust of others a vulnerability to exploit.

While Hagood was orchestrating Medpace’s crisis response in Cincinnati, Bruinekool sat in her car outside Mid-Columbia’s beige stucco headquarters, trying to compose herself before clocking in at work. A reserved woman whose ruddy face and sun-worn hair hint at her love for the outdoors, she had struggled to muster the courage to blow the whistle. Now that she’d done so, she hoped better days lay ahead. There were plenty of decent people at Mid-Columbia, people like her who were wracked with guilt over what they’d done to keep their paychecks coming. Perhaps the inevitable Medpace audit would give the company the nudge it needed to let its employees do honest research.

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