A case in point: The Ad Hoc Coalition on Drug Pricing has developed a document demanding a reduction in the cost of antiviral drugs and improved access to combination antiviral therapy for children and pregnant women. While the document defines a few access issues, I question the solution. In regard to pregnant women and children, there are two principal obstacles to access to clinical trials. First is the pharmaceutical industry's legitimate fear of claims involving birth defects and adverse drug reactions in children. In our litigious society, memories of thalidomide claims haunt the board rooms of many pharmaceutical manufacturers. Until the industry is protected by appropriate legislation to control such claims, little will change to open clinical trials to women of childbearing age.
Second, in the United States there is a disproportionate incidence of HIV in women of color, and many black women trust neither the government nor the pharmaceutical industry. The dehumanization of African Americans in the Tuskegee trials coupled with the endemic dishonesty of government and corporate America may provide adequate justification to some African American women for not enrolling in clinical trials.
While the pharmaceutical industry has an ethical obligation to keep the price of life-saving drugs reasonable, I'm not convinced that demanding lower prices for protease inhibitors will have any significant impact on access. The introduction of a second generation of protease inhibitors produced at lower costs will help shape the market forces that ultimately determine drug pricing. Also, with an increasing number of antivirals, pharmaceutical manufacturers have a continually shrinking share of the combination antiviral market. Gone are the days when a single antiviral drug can capture the predominant market share. Some, possibly many, of the new antiviral candidates may not recoup development costs.
The Ad-Hoc Coalition also demands that Glaxo-Wellcome rescind its recent 2.9 percent price increase on ZDV and 3TC. A fractional reduction in drug pricing is not going to solve the problem of access. I would rather see a 10 percent increase in the cost of ZDV and 3TC if Glaxo-Wellcome would also make the drugs available worldwide to all pregnant women and children and take the lead in eliminating maternal-fetal HIV transmission by the year 2000. I would also recommend that pharmaceutical manufacturers disclose how much free drug they provide through indigent drug programs. Indigent drug programs, not pricing, are the litmus test of the social consciousness of the pharmaceutical industry.
But rather than just griping about what others do or not do to address the issue of access, in the fall of 1997 our association will be calling together a congress of thought leaders from communities of faith, government, the pharmaceutical industry, and the community of people with life-threatening diseases to develop a global strategy, premised on the sanctity of human life, that addresses issues of access and the possible need to ration our healthcare resources to meet the needs of those who have the greatest right to them.