The story below is a preview from our November/December 2016 issue. For the full story Subscribe today, view our FREE interactive digital edition or download our FREE iOS app!
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).