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December 2007

by Nicole Kidder

© Copyright ColorsNW Magazine

Race on Trial

Researchers debate impact of ethnicity on health as legacy of abusive experiments keeps clinical trial participation low

THE DIAGNOSIS ARRIVED ON APRIL 30, 1997. Sixty-eight days later, Bernyce Edwards lost her 42-year-old daughter to breast cancer. The generally vivacious woman looks back on those days as the most helpless and hopeless time of her life. For a woman of action, the loss of control was almost more than she could bear.

“I wanted a cure and I wanted it now!” says Edwards, a Bellingham resident. “I knew if I didn’t find a way to channel my anger and grief into something positive, it would overtake my spirit.”

When she spotted an ad by Seattle’s Fred Hutchinson Cancer Research Center for a clinical trial studying the effects of exercise on breast cancer, the then 67-year-old Edwards knew she was meant to be part of the solution.

Today, as she watches her family and friends suffer from some of the world’s most perplexing diseases, Edwards is anxious for science to find answers. Her sister died from Sickle Cell Disease and last year her husband was diagnosed with prostate cancer, the third leading cause of cancer death for African-American men. She is also concerned about diseases that affect the elderly, such as Alzheimer’s and Parkinson’s.

“I promised myself I would live five years longer than my dad, who died at 92,” says Edwards, who is now 75. “Being part of that study was one of the best things I’ve ever done for myself and my family.”

Since the aim of clinical trials is to increase the medical community’s understanding of how to prevent and more effectively treat diseases, volunteers can reap personal benefits. In the type of study Edwards participated in, researchers look at how behaviors – such as exercise or smoking – affect healthy people. Edwards and 99 other female participants all lost significant amounts of weight and total body fat, as well as intra-abdominal fat, which is believed to be responsible for the growth of cancer cells and high insulin levels.

Another frequent kind of study is drug trials, which assess treatment interventions in people who already have a specific illness. Researchers might examine the effects of new drugs or measure the difference between treatments. As a result, volunteers often have access to the latest treatment options, sometimes five or six years earlier than the general public.

“If you are sick and don’t think you have enough resources, clinical trials monitor your illness, supply ground-breaking treatments and provide free access to doctors,” says Steve Wakefield, director of the Legacy Project, a joint venture between the Seattle-based HIV Vaccine Trials Network (HVTN) and Fred Hutch that conducts studies and administers HIV vaccines throughout the world.
Clinical trials are also responsible for the bulk of Western medical knowledge about diagnosis, prevention and treatment of disease. These studies have led to the discovery of the polio vaccine, the pneumonia antibiotic and cholesterol-lowering medications.

“Even though the doctors didn’t find a cure, I know in my heart this information is going to help them in the future somehow,” Edwards says. In fact, the researchers believe the data they collected in Edwards’ study may help them find some link between exercise and chronic diseases like cancer.

With nearly $25 billion spent on clinical trials in the U.S. in 2006, researchers have access to more resources, knowledge and technology than ever before. As they delve deeper into the mysteries behind the 21st century’s most devastating illnesses, they are beginning to discover that some serious health disparities exist among racial and ethnic groups.

For example, the debilitating Sickle Cell Disease disproportionately affects African-Americans, while Latinos are more prone to obesity and Asian Americans have higher rates of lung diseases. The Indian Health Service reported recently that American Indians are 500 percent more likely to die from tuberculosis and 550 percent more likely to die from alcoholism.

“To fully understand a disease, we need all ethnic communities to be involved,” says Kit Herrod, director of external affairs at Fred Hutch. “Through these studies, we are starting to realize that certain ethnic groups are more susceptible to particular diseases, are affected at different rates and respond to medications in different ways.”

“The way we live culturally may give us a greater propensity for a disease,” Wakefield says. “Even simple lifestyle differences can have a major affect between populations. For example, the amount of fat content in our diet may impact the absorption rate of nutrients. If we don’t test a new medicine in a particular population, how do we know if it is effective?”

While many scientists are reluctant to embrace race as a valid biological theory for disease causation, there is a growing need to examine how these factors potentially impact the contracting and treatment of certain diseases.

“While there are significant opportunities to find therapeutic differences, there are also serious ethical risks that are associated with conducting these types of studies,” warns Dr. Gloria Coronado, a researcher at Fred Hutch. “We must be mindful of how this research information will be used.”

The knowledge gained from looking at these health disparities is especially crucial as the medical industry struggles to keep pace with America’s rapidly shifting demographics. The Washington Health Foundation estimates that by 2010, one in five people in the state will be a person of color. Already, in some communities throughout Eastern Washington, Latinos comprise more than 80 percent of the population.

Despite this, the Intercultural Cancer Council estimates that nearly 89 percent of the more than 1 million U.S. citizens who volunteer to participate in clinical trials are white males. While African-Americans are more likely to volunteer than any other minority group, overall participation by people of color remains alarmingly low.

To be able to effectively recruit people of color into the studies, clinical trial organizers must be highly sensitive to the variety of cultural, political and historical perspectives that people of color bring to a clinical situation. Traditional customs, religious beliefs and economic status can serve as barriers if researchers lack the skills to effectively blend their patients’ practices with those of Western medicine.
“It’s scary we are so underrepresented,” says Edwards, who was the only African-American woman to complete the breast cancer study. “Part of it is that people haven’t been moved yet to find a solution. The other part is that we haven’t taught our people to ask to be included. It is up to us to make our causes a priority. That means we have to donate our blood and organs and get our names on the transplant lists.”

Researchers stepped up their efforts to recruit minority and female participants after the National Institutes of Health Revitalization Act was passed in 1993. Prior to this, volunteer opportunities were primarily limited to white males, ages 30 to 40. Today, federally funded clinical trials are required to map out a strategy for recruitment that will yield meaningful results.

“Our dollars rely on whether or not we are successful in recruiting a diverse participant pool, even if people of color are not the focus,” Herrod says. “If the recruitment section of the proposal isn’t good, you’re probably not going to receive funding.”

Although rare, some trials do single out a specific population for study. A current Fred Hutchinson clinical trial is seeking to examine prostate cancer in African-American men by recruiting entire families with a generational history of cancer. The effort is often worth it, as these types of studies have led to groundbreaking discoveries, such as BiDil, the first and only drug approved by the Food and Drug Administration (FDA) to treat a specific population. The heart failure drug was green-lighted in June 2005 after researchers found it specifically benefited African-Americans.

While groups such as the Association of Black Cardiologists and the NAACP support the use of the drug, there are many opponents. For one, BiDil is not a new medication, but rather two generic drugs that have been combined into a single pill. Yet, in its singular form, BiDil costs nearly six times as much as its generic counterparts. Additionally, there is no firm evidence that BiDil works specifically for African-Americans because the two generic drugs have been effectively used to treat other populations for years.

“BiDil was specifically approved for use in treating African-Americans simply because the trial population was African-American,” says Dr. John Vassall, vice president of medical affairs at Swedish Medical Center. “What’s concerning is that most studies are conducted on overwhelmingly white populations and the outcomes are generally assumed to work on all populations. The unstated implication then is that white subjects are representative of humanity as a whole, while what works for blacks is likely to only work for blacks.”

What the approval of BiDil does achieve is to put the federal government on record as approving race as a pharmacologic variable. The problem is that there are often more genetic variations between individuals within the same racial or ethnic group than between populations. “Classifying dark-skinned people as one race is as scientifically valid as classifying tigers, zebras and raccoons as one species because they are all four-legged mammals with stripes,” Vassall says. “Can we really put race in a bottle?”

The FDA believes it might be possible. Recently, the Office of Special Health Issues began reviewing all the data from the drugs approved between 1998 and 2001 for diseases that disproportionately affect African-American patients. These specialized studies can provide valuable insights into why and how a disease affects a particular group of people or they can lead to important discoveries in treatment. For example, the only known curative therapy for Sickle Cell is bone marrow transplants, an option only available to 20 percent of patients. A larger portion of the population will likely benefit from a new procedure known as Cord Blood Transportation, which does not require a donor sibling.

“This is one of the few situations where race matters because we know people are more likely to find a match within their own racial group,” says Dr. William Hobbs, a hematologist and oncologist who works with the Puget Sound Blood Center and the University of Washington Medical Center.

Overcoming issues of trust is perhaps the largest barrier to recruiting ethnic minority participants. Recent data suggests that while most Americans agree clinical trials are necessary for making significant contributions to science, nearly half of white Americans feel research participants are gambling with their health and nearly 80 percent of African-Americans believe they could possibly be used as guinea pigs.

Many of these beliefs are rooted in a long list of historical abuses, from the horrifying tales of experiments performed on healthy inmates that drifted out of the Nazi concentration camps to the sterilization of Puerto Rican and American Indian women. Perhaps the most significant incident to erode collective trust is the Tuskegee Syphilis Study.

In 1932, researchers from the U.S. Public Health Service (USPHS) began examining the effects of untreated syphilis on 399 African-American men in rural Alabama. The men, most of whom were poor sharecroppers, were simply told they had “bad blood” – not syphilis – and were bribed to participate with promises of free treatment, meals and burial insurance. Even though penicillin became an accepted treatment in 1942 and the USPHS established Rapid Treatment Centers around the country in 1947, the Tuskegee study would continue until 1972.

“The USPHS Syphilis Study has emerged as the most prominent example of medical racism because it confirms, if not authenticates, deeply entrenched beliefs within the African-American community,” says Dr. Vanessa Northington Gamble, a professor at The George Washington University and past director for the Tuskegee University National Center for Bioethics in Research and Health Care. “This great mistrust is why our community is reluctant to join clinical trials and prevention programs, why we oppose needle exchange programs and why we hesitate to donate our organs.”

In an effort to rebuild that trust, the federal government passed the National Research Act in 1974, which is largely responsible for the current federal regulations that protect the rights and welfare of human research subjects. Yet, despite these precautions – which includes the process of informed consent and institutional review boards (IRBs) – ethical enforcement of U.S. clinical trials remains an honor system. For example, the FDA does not require IRBs (or approved third parties) to observe consent interviews or review records, nor do they require access to IRB records. Additionally, IRBs do not have to register with the National Institutes of Health.

“There is a definite need to improve the clinical trial process. Even when we look at consent rates, we have no idea what set of circumstances allowed that participant to join that study,” Gamble says. “We need to quit focusing on participants’ mistrust and start looking at what the industry has done to deserve trust.”

“Informed consent requires an informed community,” Wakefield says. “We cannot underestimate the importance of the ‘I heard network’ – radio, TV, the Internet, family, friends. For instance, 54 percent of African-American gay men and 25 percent of white gay men still believe AIDS is a government conspiracy and that a cure is being withheld. These are powerful beliefs that are difficult to tear down.”
The recent termination of the STEP study a year earlier than planned could reinforce these long-held beliefs. With 3,000 participants in eight countries, the V520 vaccine was the most widely administered HIV treatment to date. Launched in early 2005 by Merck & Co., the highly touted drug trial was brought to an abrupt halt when the HVTN Seattle researchers discovered the vaccine may actually increase recipients’ susceptibility to HIV.

Researchers are nervous that if this turns out to be true, it will likely become even more difficult to recruit people into future studies. However, according to Wakefield, that ripple effect has yet to reach the Puget Sound, despite the fact that the Legacy Project injected the vaccination into 100 local residents.

“There are those ‘I told you so people’, but it’s important to understand that this is a setback for one product, not for the entire field,” Wakefield says. “For 26 years, the HIV virus has taken every opportunity to kill and destroy. It’s going to take time to learn how to kill and destroy the virus. The bad news is that the vaccine did not protect. The good news is that the knowledge we’ve gained will make the next generation of treatment a better product.”

“This is actually a very exciting time because Seattle is at the forefront of having numerous organizations for people of color working on health disparity issues,” says Herrod, of Fred Hutch. “By partnering with organizations like the Cierra Sisters, the Sea Mar clinic and the International District Health Services, we are able to build trust in the African-American, Latino and Asian American communities.”

“Having recruiters who are indigenous to the culture makes a huge difference. You need people who reflect the population that you want in the study because they can answer questions in a language that is meaningful,” Wakefield says. “A health worker might ask a young black man to please check in with the office at his convenience. A peer educator is going to send a text message to his cell phone saying, ‘Holla back on Tuesday.’ ”

Logistics, such as transportation and childcare, are often cited as major obstacles to participating in a study. “If researchers can’t provide the necessary resources to bring people into the research center, they may want to consider taking their educational programs and prevention studies to the community,” says Coronado, who recently completed a successful prevention study in the Yakima Valley to educate migrant farm workers and their children about the harmful effects of pesticides used in the fields.

“When a health worker is seen dropping their kids off at school or shopping at the grocery store, there is a built-in trust that cannot be underestimated,” says Coronado. “And, when the topic is of great interest to the community, there are higher participation rates. These parents clearly wanted to know the answers to our research because they have a personal stake in the outcomes.”

While having a member of the community as an authority figure in the study goes a long way in establishing trust, there is growing evidence that increasing the cultural competency of medical professionals can also strengthen the patient-physician relationship. For this reason, in 2000, cultural competency became a requirement for medical school accreditation. As a result, student participation in international health experiences has shot up from six percent in 1984 to more than 27 percent in 2006.

However, professionals in the field are often responsible for their own continuing education. Programs like Swedish Hospital’s Thompson/Russell Lecture Series, which assembled some of the nation’s leading experts to speak on the topic of minority participation in investigational trials in October, provide a tremendous service to the community.

“Health professionals can connect with the patients they serve if they understand how a person’s beliefs affect their interactions with the health community,” says Cindy Hamilton-Ellis, founder of Kaleidoscope Community, a Spokane-based company that offers health facilities and individual practitioners a solution for understanding the diverse patients they serve.

A subscription to The Bridge provides in-depth information, as well as abridged articles, on the health beliefs of 75 cultures and religions around the world. “It’s important for health professionals to understand how culture and religion shapes definitions of health and how customs affect the way people lead their lives,” Hamilton-Ellis says.

Federal initiation of policies that mandate the use of culturally appropriate messages and materials are necessary for supporting the efforts to build trust in communities of color. While Title VI requires health professionals to provide people with limited English proficiency meaningful access to health services, there is little federal support to develop policies or resources to implement such a mandate.
Good news is on the horizon. In May 2007, the Houston-based Intercultural Cancer Council and the Chronic Disease Prevention and Control Research Center at Baylor announced plans to apply the National Standards on Culturally and Linguistically Appropriate Services (CLAS) to the clinical trials process. By April 2008, the CLAS-ACT research study will release guidelines to utilize the federal CLAS standards when recruiting minority patients for clinical trials. To support that effort, the BackPack project will provide a set of tools for implementing minority recruitment and retention strategies.

Washington State’s leaders also recognize the importance of implementing the CLAS standards in the local health community. The Governor’s Interagency Coordinating Council on Health Disparities is scheduled to present its Top 5 recommendations for improving the availability of culturally appropriate health literature and interpretive services to the Governor by next spring. The council is urging Washington residents to attend meetings or submit their feedback on its Web site; written comments will be accepted in all languages.

“This council raises the visibility of health disparities in the general public and makes it a priority of the government,” says Council Chair Vickie Ybarra, who serves as the director of planning and development for the Yakima Valley Farm Workers Clinic, one of the largest community/migrant health-care systems in the country. “In order to eliminate disparities in health care, we must take a hard look at the social factors, including employment, education, housing and poverty that determine if a person actually has access to that care.”

“How we treat our underserved populations speaks volumes about who we are as a country,” says Dr. Garth Graham, deputy assistant secretary for minority health in the Office of the Minority Health at the U.S. Department of Health and Human Services. “We are at a point, more than ever before, to affect real change. The browning of our country makes health disparities not just a minority issue, but an American issue. The solution must come from the collective thoughts and experiences of all our citizens. Each of us needs to ask ourselves what our roles will be in pushing this forward.”