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TAG at 10: The Year 1994

April 2002

Jan 7: FDA approves Bactrim and Septra (trimethoprim/sulfamethoxazole) for prevention against PCP -- fourteen years after the first AIDS PCP cases were reported.

Jan 18: TAG meets with Genetics Institute about IL-12 study results. (The IL-12 treated monkeys had died.)

Jan 21: Obscure struggles in D.C. over OAR's consolidated budget authority resolved in OAR's favor, this time.

Jan 23-29: Keystone Pathogenesis meeting, Hilton Head, NC. Depressing news on all fronts.

Protease inhibitors are associated with the emergence of drug resistance just like all previous anti-HIV drugs.

Gregg speaks on vaccine trials, and Mark on "the crisis in clinical trials."

Feb 9: Mark's ex-lover, Jay Funk, dies of AIDS-related pulmonary KS in New York at the age of 35.

NIH Director Varmus asks immunologist William E. Paul to become first full-time OAR director.

Mar 1: TAG meets with Harold Varmus, Bill Paul, Tony Fauci, to discuss OAR implementation.

Mar 2: TAG meets with Liposome Technology Inc., makers of the KS drug Doxil, to discuss expanded access.

Mar 11: Mark Harrington and Michael Marco meet at NCI with Sam Broder and Bob Gallo.

Mar 14: 7:30 a.m. "City AIDS Actions" demo at NYC City Hall over the Giuliani budget cuts.

Apr 4: TAG's Peter Staley named to National Task Force on AIDS Drug Development (NTFADD).

Apr 14: Mark testifies at NTFADD on "20 action items for the NTFADD." Tense TAG/GMHC dinner with NIAID's Tony Fauci, Jim Hill.

May 20: Gregg Gonsalves ad hoc rep to FDA Antiviral Drugs Advisory Committee.

June: TAG works on proposal for large, simple trial of saquinavir, to combine larger sample size with greater statistical power and a randomized expanded access program.

Jun 7: Low-dose saquinavir data emerge from ACTG 229.

Jun 24: FDA grants Bristol-Myers accelerated approval for d4T (Zerit).

Jun 30: TAG's Gonsalves, Harrington, Staley profiled by Laurie Garrett as "Toxic Avengers" in New York Newsday.

Jul 11: Notorious TAG/FDA meeting to discuss TAG's proposals for larger, faster protease inhibitor studies.

Jul 22: Michael Marco completes "The KS Project Report" for TAG.

Jul 28: Disappointing meeting with Merck about their protease inhibitor indinavir. "No access, no answers."

Aug 5: FDA grants Hoffmann-La Roche approval for ddC (Hivid) as monotherapy. No one will ever know why.

Aug 7-11: Yokohama AIDS Conference. Never have so many traveled so far for so little.

Aug 8: In the year's only treatment-related good news, FDA grants Burroughs-Wellcome approval for the use of AZT for prevention of mother-to-child HIV transmission, based on the surprising results of ACTG 076.

Aug 10: In Yokohama, Gregg gives talk on his Basic Science report.

Aug 11: In Yokohama, Mark debates Joep Lange on "When to Start" antiretroviral therapy, likening early treatment to "Burning your last candle at noon and being left in the dark at night when you might really need the light."

Aug 13: Business weekly Barron's misinterprets TAG's position on accelerated approval. National controversy erupts.

Sep 12-13: FDA antiviral drugs advisory committee hearing on accelerated approval. Activist pie fight.

Oct 17: TAG calls for saquinavir parallel track, and larger clinical trials.

Nov 1: Meeting in Nutley, New Jersey, with Roche CEO Jurgen Drews to discuss saquinavir.

Dec 3: Activist, PWA, and Pediatric AIDS Foundation co-founder Elizabeth Glaser dies of AIDS in Los Angeles.

Dec 9: Michael Marco and Mark Harrington present TAG's KS policy recommendations to NCI leadership in Bethesda. (NCI is taking over funding of the AIDS oncology effort from NIAID.)

Dec 22: FDA approves Cytovene (oral ganciclovir) for treatment of CMV retinitis. Unfortunately, the drug is not as effective as the intravenous form.

Dec 28: OAR Director Bill Paul invites Mark to join the AIDS Research Program Evaluation Working Group ("the Levine Committee") to do the first comprehensive outside evaluation of the $1 billion NIH AIDS research program.


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