[Congressional Record (Bound Edition), Volume 155 (2009), Part 18]
[Extensions of Remarks]
[Page 24508]
[From the U.S. Government Publishing Office, www.gpo.gov]




RECOGNIZING THE IMPORTANCE OF CLINICAL TRIALS THAT FOCUSED ON WOMEN AND 
                  PEOPLE OF COLOR IN THE UNITED STATES

                                 ______
                                 

                         HON. MICHAEL M. HONDA

                             of california

                    in the house of representatives

                       Wednesday, October 7, 2009

  Mr. HONDA. Madam Speaker, people of color, both women and men, have 
historically been underrepresented in the medical profession, 
biomedical and biotechnology research, and clinical trials in the 
United States. As we move toward an era of personalized medicine, we 
realize that small differences between people become critically 
important in devising more effective, tailored treatments to improve 
and extend quality of life while helping doctors and patients better 
prevent and treat disease. Language and cultural barriers, stigma about 
participating in studies, and a historical lack of diverse community 
involvement in clinical trials by industry must be overcome so that all 
of our communities can be assured that they equally participate in the 
future of medicine.
  To address this problem, we need more studies that reflect the 
changing face of the HIV/AIDS and other epidemics, both on effective 
messaging and education campaigns for the diverse group of affected 
individuals and on possible vaccines. One notable example of this kind 
of effort is the Gender Race and Clinical Experience (GRACE) study 
conducted by Tibotec Therapeutics, part of the Johnson & Johnson family 
of companies. The GRACE study, findings from which were recently 
presented at the International AIDS Society conference in South Africa, 
is the largest study to date to examine gender and race differences in 
response to an HIV therapy. In addition, the trial was designed to help 
overcome some of the barriers, identified by the advisors, which have 
historically deterred women and people of color from participating in 
clinical studies, including stigma, lack of child care, transportation 
and personal support systems. Based upon advisor and community input, 
study participants could obtain assistance to cover costs associated 
with their participation in the study, including funds for travel and 
childcare, as well as food vouchers. Through innovative strategies like 
these, the GRACE study was able to enroll seventy percent women, sixty 
percent African Americans and twenty-two percent Latinos. I believe 
that the GRACE study is significant for reasons beyond just its 
clinical results. Studies like this, which are designed to overcome the 
barriers to participation and engage affected communities and providers 
show that with greater industry effort, meaningful numbers of women and 
racial and ethnic minorities can be enrolled in important clinical 
trials.
  For example, studies in the United States and across the world are 
seeking an answer to the devastating HIV/AIDS epidemic. The epidemic is 
changing its face, spreading into new populations and presenting new 
challenges to education and outreach efforts. In the United States, 
women are increasingly affected by HIV/AIDS, accounting for more than 
one quarter of all new HIV/AIDS diagnoses, with African American and 
Latina women representing seventy-nine percent of women living with the 
disease. HIV/AIDS disproportionately impacts our African American and 
Latino communities, and the infection rate is rising among Asian 
American and Pacific Islanders as well. In my home state of California, 
there are almost 150,000 people living with AIDS, and Latinos represent 
about one-quarter of these cases. There are over 60,000 people living 
with HIV/AIDS in the greater Los Angeles area alone. In terms of new 
HIV infections, Latina women are infected at a rate almost four times 
as high as white women. African Americans in my district are also 
highly impacted by HIV/AIDS.
  I commend Tibotec Therapeutics, Johnson & Johnson, and all 
researchers and companies actively engaged in diversifying their 
clinical trials and creating new relationships with affected 
communities. As Congress moves forward with health reform, with outcome 
and effectiveness-based reimbursement models, we must strongly 
encourage the expansion of efforts industry and academia are making to 
reflect the diversity of our nation in their workforce and clinical 
trials.

                          ____________________