Expanding Access to Investigational Therapies for HIV Infection and AIDS (1991) / Chapter Skim
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7 IMPROVING ACCESS TO CARE
7 IMPROVING ACCESS TO CARE
Pages 63-73
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From page 63... ...
The men, women, and children at greatest risk of acquiring HIV infection through intravenous drug abuse are among the most disadvantaged members of society. The socioeconomic factors associated with high rates of drug abuse in minority populations are also associated with high rates of HIV infection.
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From page 64... ...
Patients who have private physicians with the time and resources to fill out data forms and comply with other requirements of the parallel track will have access to new drugs at the earliest possible moment; patients who do not have primary care providers or who must depend on the overworked staffs of large inner-city hospitals, and those without insurance or other means to pay the costs associated with drug delivery, will be much less likely to gain entry into an expanded access system. To redress this imbalance, efforts to increase access to investigational drugs must be accompanied by broader measures to improve health care for the entire spectrum of AIDS patients.
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From page 65... ...
Then scientists became concerned that the results of such trials might not be applicable to the growing population of individuals infected with HIV through intravenous drug abuse, many of whom were people of color. The latter tended to have more concurrent infections, poorer nutrition, and a different natural history of disease-for example, a lower incidence of Kaposi's sarcoma-all of which may alter how drugs work to fight HIV infection.
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From page 66... ...
He says: Their concerns are about how to keep records confidential; where to get CD4 testing done reliably and at a reasonable cost; how to administer, bill, and get reimbursed for aerosolized pentamidine treatments; and how to get their neighborhood pharmacies to carry AZT. I hope it is clear that if we are to be realistic, the issue of expanding access must be viewed from a broader perspective and has to be considered in the context of our capability to provide primary care generally, our preparedness to provide this for people with HIV infection, and the fact that even when we are doing this, unfortunately, to a great extent, we must weigh competing demands, offering detection, counseling, and initiation of standard antiretroviral therapy versus expanding access to clinical trials.
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From page 67... ...
without offering them treatment. The subjects neither knew nor consented to their role in this "scientifically controlled experiment." Fears associated with both real and imagined abuses by the research community, combined with persistent memories of segregated care, will continue to hamper recruitment efforts for clinical trials unless they are discussed openly.
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From page 68... ...
This sentiment illustrates just one of the problems with the expectation that clinical trials could be a major avenue for increasing access to care for women with HIV infection. In most hospitals, the clinics that monitor AIDS drug trials do not have the resources or facilities-in terms of transportation, babysitting services, and staff members knowledgeable about women's health care issues-to meet the needs of women.
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From page 69... ...
Almost all HIV infection in men is associated with their own personal behavior either homosexual sex or IV drug abuse. Recent decreases in new infections among gay men and IV drug abusers indicate that educators can reach out to these populations and help them alter the behaviors that place them at risk (for example, by practicing safer sex or AIDS-safer" injection)
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From page 70... ...
Such an approach might include greater support for research on the natural history of HIV infection in women, a commitment to include physicians who are knowledgeable about women's health issues in the design of clinical trials, and a unified approach to the scientific, medical, and ethical issues surrounding clinical trials in pregnancy. Women should be viewed as primary recipients of care, and every effort should be made to repudiate the characterization of HIV-infected women as vectors, transmitters, or vessels of disease.
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From page 71... ...
For the average woman with HIV infection, who must worry about feeding, clothing, and housing her healthy children as well as her sick children, it is almost impossible. Future efforts to increase access to investigational drugs for women will be most effective in centers that integrate clinical trials with routine medical care for both women and children.
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From page 72... ...
The multidisciplinary teams developed for pediatric clinical trials could become a model for pediatric AIDS care in other settings. HIV-infected children who have no family support usually enter the foster care system, a circumstance that raises additional issues.
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From page 73... ...
Providing regular health care for these homeless children is extremely difficult; the potential for including them in clinical trials is limited. The most urgent task with regard to teenage runaways is AIDS prevention education; communications skills developed to help adolescents avoid HIV infection might be used later to promote long-term care for this very challenging target group.
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