GOVERNMENT FUNDING OF NORVIR/RITONAVIR

The National Institutes of Health has been instrumental in funding the discovery of treatments for HIV/AIDS, beginning with its support of the first tests to establish the efficacy of antiretroviral treatment in 1984.

The National Cooperative Drug Discovery Groups (NCDDGs) were established by the NIH's National Institute for Allergies and Infectious Diseases (NIAID) in 1986 to financially support cooperative research between academic and industry-based investigators.

Abbott Laboratories received a multi-year (1988-1993) NCDDG grant to create a drug to slow the spread of HIV by blocking HIV protease enzymes.

John Erickson, Abbott's principle investigator on the NCDDG grant, explains in a submission to Sec. Thompson that "Abbott believed at the time that the market potential for AIDS drugs was too small to justify a major R&D expenditure. The award of the NCDDG-AIDS grant gave the HIV project a much-needed funding boost. In my experience and professional opinion, this research would probably not have been brought to a successful outcome without the involvement of the federal government and its funding."

Norvir was approved on the basis of trials involving 1,500 patients, about a third of the average reported by Tufts Center for the Study of Drug Development.

The time between discovery and marketing of ritonavir was extraordinarily brief. Ritonavir was approved for marketing in 1996, less than one year after the key patents were filed.

None of the clinical trials used for the FDA approval of Ritonavir lasted more than 48 weeks; FDA review was expedited and decided in just 70 days.

The NIH CRISP database lists 574 federal grants to study ritonavir.

ClinicalTrials.Gov identifies 26 clinical trials planned or currently recruiting patients that involve ritonavir. Of these, 21 are sponsored by US government agencies; Abbott is the sponsor of only one; and four are sponsored by other drug companies (including two small firms).

Ritonavir sales topped $1 billion in its first 5 years on the market.