Phase 1 Clinical Drug Trials are ‘Recipe for Abuse’.

A dozen years ago, when he began teaching bioethics and philosophy at the University of Minnesota, Dr. Carl Elliott received a phone call from a local psychiatrist, who asked if he could sit in on Elliott’s bioethics class in order to satisfy a disciplinary order from the state medical board.

Elliott, recounting the tale Thursday at the second annual Shine Lecture at BUSPH, said he did not give much thought to the psychiatrist, Faruk Abuzzahab, who audited his class. But several years later, when a for-profit drug-testing facility opened in St. Paul, he saw that Abuzzahab was one of its researchers. When he checked the psychiatrist’s state disciplinary record, Elliott saw that his license had been suspended by the medical board because of reports that 46 patients under his supervision had been injured or died, 17 of them while enrolled in clinical trials he had conducted.

None of that derailed Abuzzahab’s research career.

“There’s a sense in which his trajectory, I think, is emblematic of the way clinical trials have been progressing,” Elliott told a standing-room-only crowd on the BU Medical Campus. “Today, drug research is an almost completely commercial enterprise” that is not properly regulated or monitored. “We’ve got to fix our oversight system…(or) you’ve got a recipe for abuse.”

Carl ElliottElliott, a physician, author and professor at the Center for Bioethics at the University of Minnesota, delivered the second annual Cathy Shine Lecture, an event sponsored by the Department of Health Law, Bioethics & Human Rights. The lecture is endowed by the family of the late Cathy Shine, who died in 1992 from a severe asthma attack and was a strong advocate for human rights. The gift recognizes the scholarly work of department Chair George Annas, who wrote about the Shine case in 1999 in arguing for the importance of respecting patients’ rights.

Elliott’s talk, “The Dark Side of Research: Exploitation in Clinical Trials,” drew from his 2010 book, White Coat, Black Hat: Adventures on the Dark Side of Medicine. He argued that drug testing by pharmaceutical companies preys on low-income, minority and mentally ill people, who are lured as test subjects, for minimal compensation, without adequate protections. The pharmaceutical industry has fostered what he called “an underground drug-testing economy,” composed largely of students, the poor, undocumented immigrants and others who are employed as temporary workers, but who lack the basic protections extended to other workers.

Elliott spoke of a drug-testing company in Philadelphia that recruited people with mental illness directly from homeless shelters for Phase I clinical trials, which are meant to determine whether drugs are safe. Fueled by the rising popularity — and profitability — of antipsychotics, companies now recruit test participants with diagnosed psychosis and other mental illnesses, rather than the healthy volunteers who were used for testing in the past, he said.

“In effect, we’ve developed a system of drug testing where we’ve decided it’s OK to test drugs on poor subjects for money,” he said. “Some people are living in such desperate financial situations, they could be persuaded to do just about anything.”

By offering participants some compensation — but not enough to live on — the drug industry is ensuring that “the poorest people participate in these trials. That’s not an undue influence; it’s exploitation,” Elliott said.

Elliott said drug research is no longer an enterprise dominated by academic institutions, as it once was. In 1994, 63 percent of clinical trials were conducted in academic settings; in 2004, that share dropped to 26 percent. The shift was driven largely by the pharmaceutical industry’s need to recruit more subjects, more quickly, to keep a flow of new products on the market, he said.

The regulatory system has not kept up with the shift. Only about 1 percent of clinical trial sites are inspected by the FDA, Elliott said, and the Office for Human Research Protections is rarely involved, since it oversees only publicly-funded studies.

Most Phase I clinical studies are conducted in secrecy, with no public reporting of how much subjects are paid, how they are recruited, or how much clinical investigators earn, per patient, for conducting the trials.

“What little scrutiny there is, is being driven by investigative reporting” by a handful of media outlets around the country, Elliott said.

In introducing the lecture, health law Professor Wendy Mariner said Elliott’s perspective was not intended as an attack on medicine, but as an examination of medicine’s ties to industry. BUSPH Dean Bob Meenan said the topic was fitting for the annual lecture, given that Cathy Shine had encountered “the dark side of medicine, in a different way,” when she was traumatized by being forcibly intubated for asthma. She died two years later, after refusing to go to the hospital during a severe asthma attack.

Elliott acknowledged that his perspective is not exactly popular in academia, and said he was grateful for the chance to speak on the BU medical campus.

“It is the dogma of academic health centers that research is good,” he said. “I’m in the minority.”

submitted by: Lisa Chedekel

chedekel@bu.edu