Even as the University of Illinois at Chicago labors to correct problems that have suspended human research at the school, unprecedented growth in experiments using human subjects nationwide has created a rush for volunteers that touches every segment of the American medical system.
At financially strapped research universities such as UIC, multimillion-dollar clinical studies form the foundation of school budgets, providing incentives to push ahead with projects despite potential risks.
But the collision of money and medicine also has come to influence everyday medical care in ways that few patients may suspect, rewarding doctors with bonuses for every patient they persuade to enroll in a study.
The pace of recruitment has become so competitive that Illinois doctors are receiving retainer fees from for-profit research laboratories for access to all their future patients.
To be sure, human research has benefited countless patients by yielding life-saving techniques and medications. But the demand for speedy results by pharmaceutical firms has created a potential conflict of interest for doctors, tempting them to choose financial gain over patients’ best interests.
In such a climate, established protocols to safeguard patients are stretched and even bypassed, federal investigators have found at UIC and in a probe of Chicago’s Rush-Presbyterian-St. Luke’s Medical Center last year.
The number of clinical trials has doubled nationally in the last decade. More than 5,000 human studies are under way in Chicago today. With pharmaceutical firms’ profits pinched by managed care systems and shorter life spans for drug patents, the drug industry has stepped up the race to deliver the next commercial salvo against death and disease.
The unchecked rush for patients is not limited to universities. From emergency rooms to family doctors’ offices, potential volunteers are being scouted through computerized medical records.
Details of patients’ lives–from smoking habits to level of sexual activity–are being aggressively marketed and offered for sale to pharmaceutical companies by some of Chicago’s large hospitals and prominent doctors in an effort to take advantage of the medical industry’s fastest-growing enterprise.
In a recent promotion, Health Advance in Peoria, a private consortium of family doctors, promised:
“Our full-time marketing and patient-recruitment departments can meet your enrollment requirements. Our database of over 310,000 patients is further enhanced by various speaking engagements, strategically placed advertisements, timely press releases and the private practices of our principal investigators.”
At MacNeal Hospital, a 500-bed teaching hospital in Berwyn affiliated with the University of Chicago, a similar advertisement posted on the Internet promised, “The emergency department is actively involved in identifying potential study subjects and has over 45,000 patient visits annually.”
Aside from the scholarly prestige that comes from conducting research, doctors stand to personally profit–as long as they can supply the patients.
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As an inducement, pharmaceutical firms often offer cash bonuses of up to $7,500 for every patient a doctor refers to a study. Other perks abound for doctors, including free vacations, lucrative consulting work and credit for publication in scholarly journals–with articles actually penned by employees of pharmaceutical companies, according to interviews with doctors and research executives.
Dr. Rajalaxmi McKenna, a former researcher for Rush, said that while she was at that hospital, bonuses for recruiting patients were standard procedure. Doctors are neither legally nor ethically required to tell patients about their financial interest in a study.
But McKenna said that pharmaceutical companies required her to file weekly reports outlining the number of patients interviewed and percentage signed up for studies. Much like baseball players judged by their batting statistics, doctors are tracked by enrollment ratios. Drugmakers typically award their biggest grants to doctors with access to the most patients, she said.
But even doctors with the smallest practices have found ways to tap the research cash pipeline. Increasingly, doctors are being brought together by for-profit companies that work as research brokers to pool physicians’ resources and patients.
Tom Woods Jr., owner of Clinical Investigations Pact of Chatham, Ill., said many doctors do not have the time or staffs to conduct clinical research. His business, launched from his dining-room table, secures grants from pharmaceutical companies, then pays doctors for every patient directed to the study.
Many for-profit research companies–known as site-management organizations–are paying doctors up to $10,000 for the rights to patient rosters, Woods said, but he prefers to offer doctors payments based on demand.
Five years ago, there were about 50 clinical trials being conducted in Springfield. Today, the town hosts more than 200 active trials. A plentiful supply of low-income residents in the Springfield area, often those who cannot afford medical care, provide a lucrative patient market for researchers who offer free examinations and treatment–and sometimes small payments–for those who agree to participate in experimental studies, Woods said.
University medical centers, once the nucleus of clinical research commanding up to 80 percent of grants, are experiencing precipitous declines, capturing just 40 percent of federal and private dollars. Increasingly, pharmaceutical companies are shifting their dollars to private laboratories, such as Woods’ facility, that advertise quicker results.
Another example of this emerging breed of competitors is Affiliated Research Centers in Gurnee, which recently advertised, “As owners, ARC investigators have a vested interest in making studies run faster and easier.”
The advertisement added, “ARC is aggressive in the recruitment of study volunteers. Using computerized databases of over 130 clinical sites, ARC is able to select a specific patient population for specialized trials.”
This shift to private companies has put further pressure on university doctors to expedite their research, sometimes causing them to neglect full compliance with paperwork and other requirements demanded by federal regulators. Whether the regulation is necessary for absolute safety is one issue being debated following the dramatic federal actions against UIC and Rush.
Although speed and results are rewarded, failure to provide patients quickly can bring serious repercussions. Dr. Cathy Helgason, a UIC professor of neurology, said a chunk of her federal grant dollars were withdrawn after she failed to meet monthly patient quotas.
Helgason is participating in a 10-city clinical trial, funded by a multimillion-dollar federal grant, studying the effect of vitamins on stroke prevention. Grant dollars used to hire a study coordinator–who oversees patient records and follow-up examinations–were cut and have not been restored.
“This is a major problem,” she said. “The pressure is so great.”
Other doctors confirmed that such an outcome is common.
The tug of war for patients makes the need for adequate safeguards against abuses all the more urgent, say investigators for the federal Office for Protection from Research Risks, an arm of the National Institutes of Health.
The office ordered the suspension of most research last week at UIC and took similar action last year against Rush.
One of the more serious violations at Rush occurred when researchers received an $8.8 million federal grant to study Alzheimer’s disease and sent employees to three Chicago neighborhoods to recruit patients.
Federal probers found that some elderly residents of Beverly, Washington Heights and Morgan Park were stalked, harassed and coerced into participation.
Most surprising was a written “talking points” guide for door-to-door patient recruiters. A copy of the guide, obtained by federal investigators, told recruiters not to mention that the study was being conducted by Rush.
At Rush and UIC, investigators found substantial flaws in the institutions’ oversight committees.
Every study, whether conducted by a university or a private company, must go through an institutional review board. These boards serve as the gatekeepers to ensure that the foremost concern of any study is patient safety.
But these boards also help to secure grants for doctors. Some former UIC review board members said they felt pressure from this dual role.
Marla Baker, who resigned from the UIC oversight board early this year, said, “In a way, this is all a symptom of a larger problem. The harder people have to compete for fewer dollars for research, the tougher the climate is, the greater the pressures for people to move things along as quickly as they can.”