NUTLEY, N. J. -- F. Hoffmann-La Roche Inc. said the companyhopes it is close to resolving a dispute with the AIDS activistgroup, ACT-UP, regarding its expanded access program for anexperimental AIDS drug.
ACT-UP wants doctors to boycott Roche's drugs until itsdemands for easier access to the program are met.
ACT-UP claims that bureaucratic delays are keeping thousandsof AIDS patients from receiving dideoxycytidine (ddC). Thedrug is used in patients who are intolerant to AZT, or for whomAZT treatment has failed and who are intolerant todideoxyinosine (ddI).
AZT, ddC and ddI are drugs that mimic the building blocks ofgenes, thus inhibiting the replication of viral genetic materialand slowing progression of infection.
ACT-UP has raised four issues with Roche, said Jesse Dobson, amember of ACT-UP in San Francisco: the mechanism by whichpatients can enroll, the paperwork required for toxicity data,how fast patients receive ddC once they have applied fortreatment, and whether Roche is giving adequate toxicity datato patients.
Roche is discussing with the Food and Drug Administration thekind of enrollment mechanism ACT-UP wants, said companyspokesman Paul Oestreicher. The company is also loweringreporting requirements based on new data.
Oestreicher said ddC is shipped to patients "within days" oncethe company receives documentation. He also said the companyhas not put out much toxicity data because there has been littleunexpected toxicity.
Roche is conducting Phase II/III clinical trials of ddC and willdecide in the next few weeks if it will file an early New DrugApplication with the FDA. -- Karen Bernstein
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