For the physicians at Heartland Research Associates and their patients, medical research can make a personal impact.
Since it was founded in 1994, Heartland has conducted more than 950 research studies. It has a database of more than 30,000 patients and has grown to more than 60 employees, said Cindy Thome, research director for Heartland. It typically has about 1,500 research participants per year, she said.
Founding physicians are Terry Poling, Terry Klein and Thomas Klein. Physicians Tracy Klein and Scott Meyers started conducting trials in 2001 and joined the other three as medical directors in 2005.
“We do everything from the cradle to the grave, with the exception of oncology or HIV,” said Poling, who is the primary investigator for most of Heartland’s research.
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All four of Heartland’s research sites in Wichita and the surrounding area are connected to a family practice: Family Medicine East, 1709 S. Rock Road; Northwest Family Physicians, 3730 N. Ridge Road; Axtell Clinic, 700 Medical Center Drive, Suite 210, in Newton; and Augusta Family Practice, 1601 State St. in Augusta.
By being attached to practices, the physicians have a pool of patients who may want to participate in research.
In some cases, research participants receive care they wouldn’t otherwise be able to get because they are underinsured or uninsured, Terry Klein said, and in turn, the research helps financially stabilize the practices.
“When the economy goes down, the value of our research product is inverse to that and is very high,” he said.
Phases of research
Medical research is conducted in several phases. Before being tested on people, drugs or treatments would undergo studies that could involve testing on everything from individual cells to animals. And the length of each testing period or study could range from a few months to years.
According to ClinicalTrials.gov, phase one of human testing is conducted with usually 20 to 80 healthy volunteers with the goal of finding out a drug’s most frequent and serious adverse events.
Phase two gathers data on a drug’s effectiveness in people with a certain disease or condition, and its safety is still evaluated. In some of the studies, some volunteers are given a placebo. According to the FDA, there are usually a few dozen to 300 volunteers in that phase.
Phase three gathers more information on safety and effectiveness by studying different populations and dosages and combining the drug with other drugs. Hundreds or thousands of people are a part of this phase, according to the Food and Drug Administration.
Heartland participates in phases one through three, but the bulk of its studies are phases two and three, Meyers said.
“By the time we start a research project, we have already a fairly good idea of how the medicine works and what the probable side effects are going to be,” Terry Klein said.
“The studies we choose are ones that have the appropriate patient safety, and we want it to match our patient population,” Terry Klein said. “If we have a lot of obese patients, we want to do obese studies. ... So we try to match what our patients need, because we’re trying to give them that care.”
Heartland has recently started studies in conjunction with the federal government to study bioterrorism agents, Poling said, along with research on a new smallpox vaccine.
Some of the studies may require specialists like psychiatrists or cardiologists, so Heartland has also formed relationships with specialists throughout the area to assist in studies.
In every study that reaches the human-testing phases, participants are closely monitored and all possible reactions or byproducts of treatments noted.
Funding the studies
The majority of studies done at Heartland are funded by pharmaceutical companies.
During the studies, or protocols, drug companies send representatives to the sites every few weeks to evaluate the studies and check quality, Thome said.
There’s generally a standard fee that the clinic assesses for different areas of the study, and part of Thome’s job is to submit the fee schedule to pharmaceutical companies.
“She makes sure we don’t end up underwater,” Poling said.
Thome says the FDA looks at financial disclosures for research studies and frequently audits research facilities such as Heartland. As part of the Affordable Care Act, all pharmaceutical and medical device companies will be required to report their payments to physicians starting in 2014, and the information will be posted on a government website.
ProPublica, a nonprofit investigative journalism group, has compiled payment records from 15 companies that already disclose their payments. Those companies have about 47 percent of the U.S. drug sales market, according to ProPublica.
According to the Dollars for Docs data, Heartland Research and the affiliated doctors listed on its website are among the top recipients of pharmaceutical dollars in the Wichita area, receiving at least $3 million from pharmaceutical companies since 2009. The data show the money went toward things such as research, meals, public speaking, consulting and other related expenses.
The Heartland doctors say that’s not the amount that they pocket. From what they receive, they pay the costs of conducting the studies. The overhead is generally around 85 percent, Poling said.
“We try to make a modest profit,” he said.
Patients are paid stipends for participating in the studies, Thome said. The amount of the stipend depends on the particular study but is typically around $50 a visit.
Screenings and tests associated with the study are not paid for by the patient, and in some cases, the physicians have diagnosed other health issues such as cancer while participants were being screened for research.
“We have to get their baseline history before they start, so if anything happens during the study, they can make a better determination on whether it was related or there at the beginning,” Thome said. “They get things like medical care, lab work and EKGs. We don’t collect insurance for that. It’s all provided by the drug companies”
To avoid potential conflicts of interest, the physicians and staff members cannot participate in the studies at Heartland.
“It’s so important that we keep the data pure,” Terry Klein said.
Meyers said that many of the studies at Heartland are double blind, placebo-controlled ones.
“We don’t know if a particular subject is getting the active medication or a placebo,” he said. “That way we’re not biased in our judgment of its effectiveness.”
However, with some studies, there are additional ethical guidelines, said Terry Klein.
“If we had a strep infection study, we would never give a placebo, because the person would never get treated. ... The things that are placebo are things where if they’re given a placebo, it wouldn’t give them adverse risk.”
“There’s a common misperception that because we’re being paid by pharmaceutical companies that somehow we are influenced to bring about a certain result or end point to make it better for that company, but that would be offensive to us, that we would take any risk to our people, friends or people we value so greatly,” said Thomas Klein.
“What really happens in that scenario is that all the information is blinded. We are not given access to the results of the study. We can get it after the study is done, but not during the process.”
As part of the research process, federally supported clinical studies and all studies of products regulated by the FDA are monitored, reviewed and approved by a board of physicians and researchers. That board is charged with looking out for the safety of the study participants as well as making sure the research is conducted scientifically.
Acting as a research center benefits both the facility and the patients, Terry Klein said.
“Yes, it does help us. Yes, it does reimburse us. But at the same time, it also allows us to take care of the people who would not normally get taken care of, and it allows us to sometimes give them medications that are the best ones out there.”