The agency that runs Cook County’s public hospitals is spending millions of dollars to start a new medical research arm after it launched an investigation of the nationally prominent nonprofit that has overseen the county’s medical research for decades and paused new trials there.
Cook County Health has investigated the nonprofit, the Hektoen Institute of Medicine, for more than a year over how it has managed the county’s medical research that “partly” involves patient safety, according to a county health spokesperson.
Critics of the county’s move call it nothing more than a smokescreen for a county money grab of the millions in grants the nonprofit manages. A county health spokesperson disputes that but declined to provide any details about the findings of the investigation or whether the county was required to make any reports to any oversight agencies as a result of what it has found.
One research staff member at Ruth M. Rothstein CORE Center said the pausing of new trials has hollowed out the department and is hurting already vulnerable populations who depend on medical research trials for affordable treatment.
That staff member and others who spoke with the Illinois Answers Project requested anonymity over fears of retribution.
“They’re currently bleeding us out, and I don’t believe it has anything to do with patient safety — I believe it has everything to do with money,” the research staff member said. “The fact is, the county saw how much money was coming into research programs during the pandemic and they weren’t seeing a cut of that. They wanted in.”
That research staff member believes this because they’re unaware of any major patient safety issues and the investigation was announced after an influx of grant dollars.
Hektoen saw its contribution and grants grow from $6.9 million in 2019 to nearly $21 million in 2020, according to the nonprofit’s tax filings. That number fell to $10.5 million in 2021, according to the most recently available filings, but is still higher than the annual $5 million to $6 million in contributions and grants the nonprofit has received since 2011.
Alexandra Normington, a spokeswoman for Cook County Health, rejected those claims and maintained the investigation partly involves patient safety.
“The health and well-being of trial participants is our first and foremost priority,” Normington said. “By conducting this investigation we are ensuring the safety of clinical trials.”
The investigation is also believed to involved billing and regulatory issues with Hektoen.
For decades, Hektoen has managed grants and provided staff for medical research in the county. One of the major clinics doing research for the county is the CORE Center, which is home to one of the nation’s leading HIV/AIDS and other infectious disease research centers.
The CORE Center, which is a partnership between Cook County Health and Rush University Medical Center, also started research efforts into COVID-19 during the pandemic.
The Chicago Sun-Times reported early this year that Cook County Health had stopped clinical trials as it investigated “concerns” about how Hektoen managed the county’s medical research grants.
Normington said temporarily pausing new clinical trials was necessary to ensure that all clinical trials are compliant with all applicable regulations. Active clinical research projects are still being funded and ongoing, Normington said.
County pays health care law firm over $5 million
Last Year, Cook County Health recruited one of the nation’s largest health care law firms, Hall, Render, Killian, Health and Lyman, PC, to lead the internal investigation into its research and clinical trial work. The contract, worth $149,000, would run until Sept. 30.
The county refused to release information on the conclusion of that investigation but it did go back to the Cook County Health and Hospitals System’s finance committee in February looking to extend the contract another year and by $5 million.
The new contract would go through September 2024 and Hall Render would use the bulk of that money to pay another consultant group called Huron to help establish the new research arm dubbed the Life Sciences Department, county officials said.
Cook County Board President Toni Preckwinkle supports the move to have an in-house research program.
“It’s preferable to have [Cook County Health] leadership build a best-in-class research program while following the best practices and standards from across the country,” Preckwinkle said in a statement. “I’m glad Cook County Health is taking this matter on and is handling it in an appropriate and responsible manner.”
An examination of Cook County Health’s contracts with Hall Render doesn’t spell out the scope of its investigation nor does it mention Huron or the creation of the Life Sciences Department.
Dennis Ronowski, Hektoen’s fiscal and operations administrator, said Cook County Health has left them in the dark. What is clear is crucial clinical trials are up for renewal but the future of those trials is cloudy.
“No new grants have come our way for one year and no communication from Cook County on all existing Cook County grants which are coming up for renewal,” Ronowski said. “Which would mean that potentially 40 to 60 Hektoen employees would have to be laid off that work on Cook County grants.”
Hektoen, which has been working as a research affiliate for the county since 1943, not only manages grants but also provides staffing for clinical trials, so without new or renewing grants, the nonprofit would be forced to lay people off. The first round of layoffs started June 1, with about a dozen employees, with more expected to begin in July.
Ronowski said this new department would essentially replace the work they do. Ronowski didn’t respond to questions about how much funding was lost during the investigation.
Hektoen also has a Centers for Disease Control and Prevention-funded grant through the Illinois Department of Public Health. It also provides early intervention services to children on the West Side of Chicago with the state’s Department of Human Services. Hektoen still receives grants and manages those programs from the state.
In March, Cook County Health launched its Clinical Research Office which would be housed under the Life Sciences Department. This office is designed to do everything that Hektoen does and Cook County Health is hiring additional staff to support the new office, Normington said.
Normington would not confirm if the new department would sever Cook County Health’s ties with Hektoen but said the county “has maintained our relationship with Hektoen to support our current clinical trials” and its relationship with Hektoen in the future will depend on Cook County Health’s needs.
“Through the establishment of our Clinical Research Office, we are hardwiring a robust structure that will promote growth and sustainability for research at Cook County Health,” Normington said. “We committed to doing this right, and our patients deserve nothing less. Once complete, [Cook County Health] will have a state-of-the-art research program with the highest clinical standards that will contribute to the future of medicine.”
One Hektoen employee who was laid off in June was disappointed about how Cook County Health managed the events.
“I’m upset with the way Cook County Health handled the situation from the start until now and the way they’re disregarding decades of hard work and research that has been completed here at the CORE Center,” the research staff member said.
Vital care paused
Jim Pickett is a senior advisor with the AIDS Vaccine Advocacy Coalition and a HIV research advocate who had worked with the CORE Center for nearly three decades in various capacities. Pickett said the lack of “transparency and level of arrogance is pretty breathtaking — even by Cook County standards.”
“No formal report or recommendations have been provided by the investigators about the outcome of the investigation,” Pickett said. “However, the understanding is that millions of taxpayer dollars have been spent on an outside consulting firm … rather than just using such funds to shore up the Hektoen infrastructure.”
“Every clinical trial has a set of protocols that it has to follow like it’s a Bible,” a research staff member at CORE said. “Any deviation from those protocols, whether it’s an adverse reaction with patients or anything else of the slightest, we have to report that to the proper oversight board.”
The National Institutes of Health is the country’s primary medical research agency and helps fund critical research across the nation — including Cook County Health. The NIH must be notified of any adverse events, unanticipated problems or risk to participants in any NIH-funded clinical trial activities, the NIH Office of Extramural Research said.
The Cook County Health’s Institutional Review Board should also be notified of any adverse events in a clinical trial as well as the U.S. Food and Drug Administration in certain instances.
The NIH and the Cook County IRB declined to comment on whether they have been notified by Cook County Health regarding an adverse event during a CORE clinical trial.
Cook County Health refused to say when asked if it reported any adverse events to the appropriate regulatory agencies. Clinical trials have a responsibility to report any adverse reactions to the proper regulatory body and are usually required to do so within 24-to-48 hours after the event
“Once our investigation is complete, we will report any findings that we may have identified to the appropriate agencies,” Normington said.
