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Clinical trials are a lot more common in the Roanoke Valley than you might imagine. Hospitals, clinics and other health organizations are on the lookout for better medications all the time. That can be good news for patients who volunteer.
Lisa McDaniel thought the cancer was gone. She knew there was a chance it would return, but life was smooth. Six rounds of chemotherapy beginning in 2007 and a double mastectomy for her breast cancer seemed to have worked their magic.
Then, in 2013 cancer returned and it had spread to in her bones. It was time for something a little more radical. McDaniel was asked if she would be willing to take part in a clinical trial for a new medication whose goal was to improve standard treatment on her condition. The medication was not completely proven at that point, but it was promising enough to have moved into human trials.
“At the time, I thought it was the best option,” says McDaniel today. “Combining the new drug with the drugs I was taking was a game changer. I actually went to Duke [Hospital in Durham, North Carolina] for a second opinion and Dr. Kimberly Blackwell, who is a world-renowned radiation oncologist, strongly recommended the [trial] and said she couldn’t offer that option. She said she wished she could.”
McDaniel’s cancer was especially difficult for her husband, who had lost his first wife to cancer, and McDaniel’s seven-year-old (at the time it was discovered) stepson, who feared losing another mother. “For my son’s sake, especially, I wanted to leave no stone unturned.”
All of this would, of course, be monstrously expensive, time-intensive, uncomfortable, disruptive and often grueling. It would require a large team of people to administer and monitor the test drugs, as well as the normal care. McDaniel was assigned Jessica Nichols as her personal study coordinator. Nichols would run interference.
As if she needed convincing, there was one more irresistible perk for McDaniel: Her treatment would cost her nothing. The drug company would pick up the total bill. “They cover it all,” says McDaniel. “If my insurance refuses to pick up anything, [the drug company pays] for it, as well.”
Her care became “more frequent and better.” She had an entire team working with her on a regular basis. Checkups increased in number and depth.
“If I had a question, I’d write a text or email and get an immediate answer,” she says.
“Regular patients wouldn’t have me,” to run interference, says Nichols. “I get the information to them.” The Food and Drug Administration (FDA) “requires certain protocols [in drug tests],” she says, and those are followed to the letter.
“When I come for a visit,” says McDaniel, “Jessica is waiting for me, and I have never felt like just an experiment. People hear about these research trials and think of them as a last resort. I think more about a large number of volunteers helping to quicken the result.”
Life at this moment, says McDaniel, is good. “I don’t think a lot about the cancer.”
Centerwatch.com, which keeps an eye on clinical trials across the nation, tells us that 1,444 trials were underway in Virginia in early October, 93 of them in the Roanoke Valley. By state, trials ranged from 5 in Wyoming at that moment to 7,844 in California.
The trials are paid for by pharmaceutical companies, which is one reason drugs are so expensive. Pharma pays for everything, from Carilion’s expenses to the patient’s. Carilion and other testing facilities make a profit, sometimes small, sometimes not, but Carilion R&D senior director Francis X. Farrell says the trials are of considerable benefit to the patients and are “one more way we can serve them.”
Farrell says that because of the nature of oncology, he was “born and raised on research. I am comfortable with it and it is nice to offer patients a treatment we couldn’t offer three or four years ago.”
These trials are required by the FDA, which employs detailed, time and personnel-intensive criteria. After tests in animals, drug tests are structured in four phases: test in humans; test in a larger population; test in expanding population, performed randomly at several sites; post marketing (trial continues after product is on sale).
“We participate in everything but Phase I,” says Andrea Bidanset, trials director at Carilion Clinic Research and Development.
Carilion is the biggest health care organization in this region and is also the largest conductor of clinical research studies. There are a number of other health care companies conducting them, including BRCC, located on the LewisGale Medical Center site. It is not affiliated with LG. Some of the others, according to centerwatch.com, are Vistar, Pediatric Gastroenterology, Professional Education and Research Institute, Roanoke Heart Institute, Oncology and Hematology Associates of Southwest Virginia, Foot and Ankle Associates of Southwest Virginia and Professional Education and Research Institute.
Natasha Holt, who manages BRCC’s clinical trials, and Bidanset must filter through the requests from drug companies to find the right fits for their organizations. BRCC physicians treat a lot of different types of cancers, so there is no shortage of requests because of the single-disease nature of the facility.
“This past week,” says Holt, “we had a [patient] referral from Johns Hopkins because we had a trial it didn’t have. We have as many as some academic centers.” She says the most successful trial centers “have proven records of success before cancer [drug manufacturers] will come to you.”
BRCC Medical Oncologist Dr. Paul Richards says physicians get to “hone down to various aspects of the disease” with their research. One drug might ultimately be used in treatment of “several different diseases,” he says. “You find a treatment for one type of cancer and immediately ask, ‘What about another?’”
“Success” with the trial, says Richards, “means the medication has been approved or that it goes forward, proving to be more effective with it than without it.” In the 35 years BRCC has operated, says Holt, about 50 drugs it has tested have made it to market. She says the percentage that represents is high. Richards points out that “it takes about $500 million to get approval” of an important cancer drug and that figure helps explain the reason drug costs are so high.
A completely different approach to clinical trials is taken by the Alzheimer’s Association, which has a central presence in Roanoke. It does not conduct trials, but matches patients with a variety of trials all over the region—and even nationally.
“People who have Alzheimer’s and their families are passionate about finding a cure,” says Family Services Director Annette Clark.
“Many people want to be involved,” she says. “We are a gate keeper as a leading funder of Alzheimer’s research. We have well volunteers, those with some memory concerns and others with Alzheimer’s. We focus on families because [the disease] genetically runs in families.” Some of the trials run through Carilion, says Clark and volunteers can find a lot of information at alzheimers.org.
There are a lot of angles for trials, among them the effort to reduce agitation in patients, which often leads to them remaining at home longer. “The only way we will find a cure,” says Clark, “is through research.”
Carilion’s Bidanset emphasizes that patients are never pressured into taking part in trials: “Everything is based on protocol we must follow.” Farrell says, “We explain [procedures and risks] to patients—in layman’s terms—and they are given as much time as they need to decide if they want to be part of it.” There is an Institutional Review Board—not affiliated with clinical testing facilities—that can look into any test at any time and which has the authority to reject a test. Checks and balances “make sure subjects are protected,” says Farrell.
A small stipend is frequently offered to patients, but it is not enough to influence the decision to take part in the trial.
Holt stresses that there “is a lengthy consent form” for patient volunteers. “Physicians and research coordinators go over them, and all trials are totally voluntary. The patients can stop any time they choose. … It takes a village to run these trials.”
Farrell pointedly emphasizes that patients “are not guinea pigs. The standard of care [in the trials] is probably better because several people are closely watching. There is the chance that the patient will be the first person to use a successful drug.” Although patients are not paid, their medical bills are and they can use the small stipend for gas, meals, time missed from work and the like.
“It is a bit of a commitment” for the patients, says Farrell.
Sandra Collins, an RN at Catawba Hospital, was a certified clinical coordinator at Carilion for 10 years at the turn of the century. That was before the pharmaceutical companies’ marketing to medical professionals came under heavy congressional scrutiny and, thus, regulation.
“They were sending us to places like Montreal where there were great hotels and meals and it would have been difficult for professionals not to be influenced to use their products,” she says.
“The pharmaceutical companies were quite aggressive [with marketing]. They were holding lunches for education, all-expenses-paid trips for education about products. They were all at nice places. I was always uneasy then. It is very different now. I went to some great places and had some of the finest meals during that period.”
Although professionals have been strongly supportive of the relationship with the drug and device developers, says Collins, “some didn’t like that relationship. I think we all understood that this was a business and drug companies were out to make money.” Still, “The trials didn’t and don’t cause harm; they provide patients with a greater understanding of their disease and its process. [The trials] help them deal with it.”
Farrell and Bidanset are relatively new in their jobs at Carilion and “we want to increase awareness of” the trials, he says.
Patients, says, Richards, “are being offered treatments that are not available elsewhere. It is tomorrow’s treatment today.”