The Middletown Press (Middletown, CT)
‘ACCESS TO ALL PEOPLE’
Cancer doctors drawing minorities into clinical trials
Wendy Ormond was fortunate. As a patient of Dr. Andrea Silber, she was offered a chance to take part in a clinical trial of a new chemotherapy drug.
Long mistrustful of doctors, Ormond, 61, went to see Silber when she felt a lump in her breast. It turned out she had stage 3 breast cancer. She began traditional chemotherapy with Herceptin.
Then Silber offered to enroll Ormond in a nationwide clinical trial of a drug called TDM1. It’s a nationwide trial called Katherine, comparing Herceptin with TDM1. Ormond stands out, however, because she is African American, a group that, along with other minorities, is vastly underrepresented in clinical trials nationwide.
“I’m being honest. I just don’t like going to doctors. But when I felt that lump I got busy and I started going,” said
FROM PAGE 1 Ormond, who lives in New Haven.
“I did it for myself and I also did it for other women, too,” Ormond said. “I’m going to be perfectly honest. … I believe in God; I believe God is a healer. I felt in my heart that I would be all right.”
Ormond said both drugs tired her out, but after having surgery and joining the trial, her cancer is gone.
“Other than a bad knee, I’m fine. She’s phenomenal,” Ormond said of Silber. “That lady took care of me. … She said what she was going to do and it happened. … She fixed everything up for me, and I was all right.” Ormond is back at work now as a certified nursing assistant.
Silber said of Ormond, “I hope Wendy is cured, but I think the really amazing thing about her was she was someone who was really turned off by the medical system” who became “someone who did everything … and really became part of a cutting-edge medical treatment, and that’s really a tribute to her. It was the right thing to do, but she took a leap of faith.”
Silber is director of Smilow Cancer Hospital’s OWN IT! program (Oncologists Welcome New Haven Into Trials), which reaches out to minority communities to recruit them into clinical studies. The program also connects with doctors to raise awareness of trials’ importance and the need to take time to explain them to patients. There is also an effort to enlighten government agencies and pharmaceutical companies, which are not always flexible about who can sign on to a trial.
“When you look at people who are poor, there are so many other things going on in their life: violence, unemployment, all sorts of things,” Silber said. She described one woman whose brother was killed “and she needed to get a break from her clinical trial so she could deal with this. You have to be more flexible. … These are drugs that are going to be used in real life but some of these drugs need to be tested in real life.”
Minorities make up about 10 percent to 12 percent of the participants in clinical trials at Smilow, which recruits participants from across Connecticut, said Dr. Roy Herbst, chief of medical oncology. But, given that New Haven is about two-thirds black or Hispanic, both Herbst and Silber would like to increase the number of minorities who can benefit from new drugs.
“We want to bring the best care to all people; we want to bring access to all people,” said Herbst, who said he’d like to at least double the percentage of minorities in Smilow’s trials of cancer drugs.
There are 160 such trials at Smilow, with 35 more dedicated to prevention and supportive care.
“In cancer care, you’re fighting the worst enemy in the world and it’s constantly evolving to be resistant to drugs,” Herbst said. Clinical trials “offer the most available and innovative therapies, years before drugs are available.”
“We’re a major teaching hospital, [spending] over $100 million of research a year for cancer,” Herbst said. “We’ve been on the cutting edge of immunotherapy and targeted therapies.”
Besides the issue of fairness, including minority groups broadens knowledge of how a particular drug works in people of different cultures.
“There could be genetic differences in how drugs are metabolized and how they work,” Herbst said.
Also, different socioeconomic groups have different lifestyles.
“If the United States smokes at 18 percent … I would be willing to bet it’s more than double that” in New Haven, Herbst said. “We do know that there is precedent that different groups might have different frequencies of abnormalities. There are cultural issues, too, in how people tolerate therapies.”
Like Ormond, some African Americans are mistrustful of the medical establishment and think of participating in clinical trials as taking part in experiments. The most infamous example is the Tuskegee Study in the 1930s, in which black men were given syphilis and left untreated to see the disease’s effects.
Those who don’t get basic medical care may end up seeing a doctor when their cancer is more advanced, Herbst said. “It can become more difficult than someone who has more resources,” he said. Even lack of transportation can be a barrier.
“It’s hard because we recruit the patients and we make appointments and sometimes they don’t show up,” he said.
But including minorities is vital, Silber said. “It can help the individual and a clinical trial can answer questions about why, for example, black women don’t have the same outcome with breast cancer as white women.” For example, rates of triple-negative breast cancer are far higher in African Americans and Hispanics than in whites.
Silber said the Affordable Care Act has helped bring poorer women into trials because coverage under Obamacare — which Republicans have vowed to repeal — mandated that insurers pay for the tests and other costs not covered by the trial’s sponsor.
“You can’t tell me that something is approved for … a well-educated white woman and not approved for someone who is poor and Hispanic,” Silber said.
One of the ways the hospital is reaching out is through the Cultural Ambassadors Program, which partners with Junta for Progressive Action and African Methodist Episcopal Zion churches across the state. “We actually have the church leaders come here once a month,” Herbst said. The program has been so successful that Duke University is planning to implement it.
Herbst praised the efforts of Silber and her associates. “What they’ve done is they’re reaching out to the community; they’re going to churches, social halls,” he said.
“Within the minority community in New Haven there is a tremendous amount of altruism,” Silber said. Many feel that they should take part in a medical trial because “even if it can’t help me, if it can answer some questions or help someone like me.”
Silber has experienced “incredible generosity,” especially from those “in faith-based communities [who] are used to giving when they don’t have a lot, and that works well in a clinical trial. I don’t know that I hear as much of that in more affluent patients.”
Silber said she has brought patients into trials because she knows them or their families from years of working in clinics in New Haven before she joined Smilow. Her involvement in the community “makes a difference,” she said. “You really can’t designate the clinical trial to an assistant. You need to be involved. … It can take a very long time to explain a clinical trial in a way someone can understand it but there is no other way to get by and there are no shortcuts.
“It’s based on trust and you can’t outsource trust.”
One way Smilow is able to reach more people is through its nine satellite centers, including locations in Bridgeport, Derby, Guilford, Torrington and at St. Francis Hospital and Medical Center in Hartford.
“We’re allowing people to get their care near where they live, closer to their friends and family,” Herbst said.
For information about joining a clinical trial at Smilow, go to http://yalecancercenter.org/trials or call 203-785-5702. More information about trials nationwide can be found at http://clinicaltrials.gov.