[Congressional Record (Bound Edition), Volume 155 (2009), Part 19]
[Extensions of Remarks]
[Page 25379]
[From the U.S. Government Publishing Office, www.gpo.gov]




  RECOGNIZING TIBOTEC THERAPEUTICS FOR CONDUCTING THE GRACE STUDY, A 
GROUNDBREAKING HIV CLINICAL TRIAL FOCUSED ON WOMEN AND PEOPLE OF COLOR 
                          IN THE UNITED STATES

                                 ______
                                 

                          HON. DANNY K. DAVIS

                              of illinois

                    in the house of representatives

                      Wednesday, October 21, 2009

  Mr. DAVIS of Illinois. Madam Speaker, I rise today to commend and 
congratulate Tibotec Therapeutics, part of the Johnson & Johnson family 
of companies, for demonstrating continued innovation and corporate 
responsibility in the fight against HIV/AIDS by conducting the 
groundbreaking GRACE study. GRACE, which stands for Gender Race and 
Clinical Experience, is the largest study to date in treatment-
experienced women with HIV to examine gender and race differences in 
response to an HIV therapy. Findings from this historic study were 
recently presented at the International AIDS Society conference in Cape 
Town, South Africa.
  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. People of color, both women 
and men, have been historically underrepresented in clinical trials in 
the United States, and HIV/AIDS disproportionately impacts our African 
American and Latino communities. In my home State of Illinois, there 
are over 35,000 people living with AIDS: African Americans represent 
50% of these cases, and Latinos represent 13%. In terms of new HIV 
infections, African American women are infected at a rate fifteen times 
higher than white women, and Latino women are infected at a rate almost 
four times as high as white women.
  In recent HIV studies of treatment-experienced patients, women 
accounted for less than 11 percent of the patients being studied, on 
average. This 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 nearly seventy percent women, sixty 
percent African Americans and twenty-two percent Latinos. I am proud to 
say that two of the study sites in this historic clinical trial are 
located in my congressional district.
  Results of the GRACE study showed that there were no statistical 
differences in the safety, tolerability or effectiveness of the HIV 
regimens used in the study between male and female participants, or for 
people of different ethnicities. Importantly, from my perspective, the 
GRACE study clearly showed that, with the appropriate commitment from 
the trial sponsor and input from affected communities and providers, 
clinical trials can, indeed, enroll meaningful numbers of women and 
racial and ethnic minorities.
  With the GRACE study, Tibotec Therapeutics and Johnson & Johnson 
continue to demonstrate their leadership and corporate social 
responsibility as innovators and leaders in the pharmaceutical 
industry. I commend them for their continuing commitment to the fight 
against HIV/AIDS and for their leadership in addressing the 
disproportionate impact of the HIV/AIDS epidemic on women and people of 
color.

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