TAG at Ten: 2001
January	TAG's Gregg Gonsalves becomes GMHC Director of Treatment Policy. Completion of STI Workshop 2000 report. FDA hearing on salvage therapy trial design. Merck meeting on promising DNA/adenovirus HIV vaccine. TAG mobilizes 600 signatures on global letter to Glaxo decrying its efforts to block generic drug access in Africa. NIH hearing on long-term effectiveness research.
February	TAG cosponsors community meetings on long-term effectiveness and on a new AIDS Treatment Activists Coalition (ATAC). At Retrovirus, Jeffrey Sachs proposes a massive new program to support AIDS treatment globally. This will become the Global Fund to Fight AIDS, TB and Malaria.
March	Global day of solidarity with South Africa on access to affordable medicines. TAG interviews NIH staff for OAR report. ACT UP/Philadelphia demonstration in D.C. against the Pharmaceutical Manufacturers' Association (PhRMA). Activist/drug industry meeting over prices, patents, access.
April	Mark Harrington attends WHO/WTO meeting in Norway on "Differential Pricing and Financing of Essential Drugs" and (along with representative from Médecins Sans Frontières) meets with Merck on global treatment access.
May	Mark attends first World Health Organization (WHO) meeting to develop guidelines for using antiretroviral therapy in resource-poor settings. Senator Jim Jeffords bolts Republican Party due to its extreme domestic policies.
June	Activist/PWA Linda Grinberg diagnosed with primary pulmonary hypertension (PPH). TAG meets with African NGOs before the United Nations General Assembly Special Session (UNGASS) on HIV/AIDS in New York. The ensuing Global Declaration of Commitment seems likely to be honored in the breach.
July	First International AIDS Society (IAS) meeting on HIV Pathogenesis and Treatment, Buenos Aires.
August	Gilead community meeting on tenofovir disoproxil fumarate (Viread), a nucleotide analogue. Twenty-three activists from around the country meet in Houston to found the AIDS Treatment Activists Coalition (ATAC). Richard Jefferys agrees to become TAG's first full-time Basic Science Project Director.
September	AIDS vaccine conference, Philadelphia. Terrorist attacks bring down NYC's World Trade Center. GMHC's Gregg Gonsalves and TAG's Michael Marco are stranded in Kampala (Uganda).
October	FDA hearing on tenofovir. TAG recommends approval, as does the Antiviral Drug Advisory Committee. HHS Guidelines panel debates "When to start?", inching towards a CD4 count threshold of 200. U.S. starts bombing Afghanistan. FDA grants Gilead accelerated approval for tenofovir.
November	Billionaire Michael Bloomberg elected mayor of New York City. Taliban abandons Kabul.
December	Fifth annual Research in Action awards honor pediatrician Art Ammann, writer Michael Cunningham and activist Gregg Gonsalves. The New York Times reports AIDS deaths in New York City have fallen from 6,756 in 1994 to 232 in 2001.

TAG at Ten: 2000
January	NIH workshops on long term effectiveness research, studies designed to look at "when to start" and switch HAART, and for long-term side effects.
	TAG hires Yvette Delph as new Antiviral Project Director. Completion of TAG's AIDS Vaccine Research at the NIH: A Critical Review, by Gregg Gonsalves.
February	NIAID Council/ARAC discuss long-term effectiveness research. The Lancet commissions Mark Harrington to write on the "when to start" controversy.
March	Long-time activist Jon Ende dies in New York. TAG talks on "When to Start" at San Francisco AIDS Update, on STIs at European Community Advisory Board. First International HIV Pharmacology Workshop.
April	Journalist Mark Schoofs wins Pulitzer Prize for his Village Voice "AIDS in Africa" series. Gregg and Mark meet with Zackie Achmat from South Africa's Treatment Action Campaign (TAC) in New York City and start planning South African treatment literacy workshops. TAG/AmFAR New Targets Workshop, Dedham (MA)—designed by Gregg Gonsalves—focuses on potential new HIV drug targets.
May	Philadelphia memorial service for long-time activist Kiyoshi Kuromiya.
	HIV immunologist Janis Giorgi dies of ovarian cancer.
June	HHS Guidelines panel debates "When to start?" Moves reluctantly towards new, lower threshold of 350 CD4 cells/30,000 viral load. Publication of "Hit HIV-1 hard, but only when necessary," by TAG's Mark Harrington and Brown University's Charles Carpenter in The Lancet (vol. 355/no. 9221). TAG founding director Peter Staley honored at AmFAR Ellis Island benefit. Michael Marco completes TAG's The Hepatitis Report.
July	TAG's Exploring the American Response to the Global AIDS Pandemic, by Derek Link.
	Long-time activist Stephen Gendin dies of AIDS-related lymphoma.
	Treatment Action Campaign/Médécins sans Frontières (MSF) workshop on access to antiretroviral treatment, Durban. March for Global Treatment Access. International AIDS Conference, Durban, South Africa. Treatment activism is global now. Nelson Mandela closes the conference.
September	FDA approves Abbott's lopinavir/ritonavir (Kaletra).
October	Second STI Workshop, Shaumburg (IL). Super-philanthropist Irene Diamond donates $50,000 for the TAC/TAG workshops. FDA approves Videx EC (enteric coated ddI).
November	Mark Harrington gives talk on "Brazil: What Went Right?" at 10th Annual Brazilian PWA conference, Rio de Janeiro. NATAF held in Dallas. United States Presidential election deadlock due to disputed Florida vote count.
	FDA approves Glaxo's fixed-dose combo of abacavir, 3TC and AZT (Trizivir). TAC/TAG workshops held in Johannesburg, Durban and Cape Town, South Africa.
December	Fourth annual Research in Action Awards honor activist and TAG board member Lynda Dee, NIAID Director Anthony S. Fauci, M.D., and Broadway Cares director Tom Viola.
	U.S. Supreme Court halts Florida recount, selecting popular vote loser G. W. Bush as President. FDA issues safety alert on unapproved goat serum AIDS treatment.

TAG at Ten: 1999
January	AmFAR's Paul Corser dies after a nine-year struggle with AIDS.
	FDA approves Glaxo's atovaquone (Mepron) for the prevention of PCP pneumonia.
	ACT UP/Needle Exchange activist Rod Sorge dies.
	Retrovirus conference, Chicago. Beatrice Hahn presents on the HIV-1's chimp origins; Joe Sodroski shows how HIV binds to CD4/CCR5.
February	FDA approves alitretinoin gel (Panretin) for KS.
March	FDA approves ultra-sensitive Roche Amplicor HIV-1 RNA PCR test.
	Sally Morrison joins TAG Board.
	Paul Corser memorial: speakers include Mathilde Krim, Sally Morrison and Elizabeth Taylor.
	TAG meets with Bristol Myers on once-daily ddI.
April	FDA grants accelerated approval to Glaxo's protease inhibitor amprenavir (Agenerase).
May	TAG meets with CDC on international AIDS, holds vaccine/microbicide forum in NYC, and attends 2nd International Workshop on Salvage Therapy for HIV Infection, Toronto.
	Veronica Miller presents (controversial) Frankfurt HIV cohort data that suggest drug holidays may encourage drug-resistant HIV to revert to wild type.
	Activist-FDA meeting on Clinical Trial Design in Heavily Pre-treated Populations.
	In Toronto, Ben Cheng, Nikos Dedes, Linda Grinberg, Mark Harrington and Veronica Miller plan first workshop on Structured Treatment Interruptions (STIs).
	HIVNET study 012 results released: nevirapine given as one pill to the mother at delivery and one to baby afterwards reduces HIV transmission by ~45%!
	Start of First International STI Workshop, Newton, Massachusetts.
August	After five years with TAG, Antiviral Project Director Spencer Cox decides to resume his college studies.
September	TAG testifies at NIAID's AIDS Research Advisory Committee (ARAC) on long-term effectiveness research.
	NIH Director Harold Varmus resigns to become president of New York's Memorial Sloan-Kettering Cancer Center.
November	FDA hearing on Gilead's adefovir (Preveon) as an antiretroviral. TAG recommends against approval, as does the European AIDS Treatment (Activist) Group and the FDA's own Antiviral Drug Advisory Committee (AVDAC) itself: by a 13-1 vote. (At a much lower dose, the drug will later be approved to treat hepatitis B).
December	Third annual TAG Research in Action Awards honor activist Spencer Cox, philanthropist Irene Diamond, and retiring NIH Director Harold Varmus.

TAG at Ten: 1998
January	TAG community meeting at which John Moore gives update on vaccine research.
	TAG board member Marvin Shulman says farewell to New York life and heads for a full-time residency in South Miami Beach.
	FDA approves dental dams. Monica Lewinsky scandal erupts.
	Michael Marco finishes The OI Report, version 2.0.
March	Glaxo announces 67% discount on perinatal AZT for the third world-the first in an extended series of AIDS drug price cuts.
April	NIH meeting with Fauci, Killen, Duncan (NIAID), Cox, Marco, Harrington (TAG) to discuss recompetition of AIDS clinical trials networks.
	Vinny McGee and Tim Sweeney of the Royal S. Marks Foundation Fund award TAG $100,000 annually for three years.
June	TAG co-sponsors First International Community Science and Treatment Workshop (ICTSW), Geneva: over 150 international activists attend. Mark Harrington gives plenary on "Cure: Myth or Reality?" at 12th World AIDS Conference, Geneva.
July	France upsets Brazil in World Cup.
	TAG meets new OAR Director, virologist Neal Nathanson.
	U.S. bombs Afghanistan and Sudan after twin Al Qaeda bombings in Kenya and Tanzania.
August	Richard Koup shows how HAART restores number of recent thymic emigrants, Gallo lab meeting, Baltimore.
September	Former WHO Global AIDS Program Director Jonathan Mann and vaccine researcher Mary Lou Clements die in crash of Swissair flight 111 off the Nova Scotia coast.
	FDA approves DuPont's efavirenz (Sustiva), a new NNRTI and the first once daily antiretroviral.
October	Sally Morrison and Paul Corser host dinner party for TAG in Harlem with Natasha Richardson.
	Memorial service for philanthropist Michael Palm, Alice Tully Hall.
November	Fourth International Conference on Drug Therapy in HIV Infection, Glasgow: Mark delivers plenary on, "The role of community activists: lessons from the first decade of treatment activism." David Barr gives excellent speech on adherence.
December	Second annual TAG Research in Action Awards honors amfAR's Mathilde Krim and Columbia/Harlem Hospital's Wafaa El-Sadr.
	U.S. bombs Iraq, postponing House vote on impeaching Clinton.
	FDA approves Glaxo's abacavir (Ziagen), the sixth nucleoside analogue.
	House of Representatives impeaches President Clinton for lying about a blow job.

TAG at Ten: 1997
Jan 20	Bill Clinton's second inaugural. Michael Marco and Mark Harrington finish initial draft of OI Report.
Jan 22	Crisis at Retrovirus re: on-site registration for Linda Grinberg and sixteen other unregistered community members. They are not allowed in. (Relations with Chip and Connie will never recover.)
	Community makes a surprising show of unity, opposing promiscuously early use of antiretrovirals. Fight with John Mellors regarding recommendations for asymptomatic HIV infection.
Jan 27	AIDS deaths down 50% in New York for 1996, and down 66% in British Columbia (where they have a province-wide standard-of-care). In Marty Hirsch's Merck 039 study of people with under 50 CD4 cells, 65% of those randomized to AZT/3TC/indinavir went undetectable; their T cells rose by 85.
Feb 15	TAG board decides to move away from membership structure and towards one of a more traditional CBO.
Feb 20	DSMB stops ACTG 320 (AZT/3TC/indinavir vs. AZT/3TC) early due to a mortality/progression difference.
Mar 14	FDA approves Agouron's nelfinavir (Viracept) for adults and children.
Mar 19	Memorial service for activist Tom Stoddard at the Ethical Culture Society in NYC.
Mar 20	10th anniversary of FDA approval of AZT.
Mar 24	10th anniversary of ACT UP/New York's first big demo, Wall Street, NYC.
Apr 4	FDA approves Pharmacia & Upjohn's delavirdine (Rescriptor), the second NNRTI and probably the least used AIDS drug today—behind even ddC and Invirase!
Apr 18	After eight months of d4T/3TC/indinavir, MH's viral load has gone from 196,000 to <400; his CD4s from 152 to 617.
May 1	In the United Kingdom, Tony Blair's New Labor ejects the Tories after 18 years.
May 8	New draft HHS Guidelines virtually propose putting triple therapy in the drinking water. New papers in Science and Nature by Ashley Haase, David Ho, Bob Siliciano on viral kinetics and reservoirs.
May 9	Mark drafts memo to HHS about the fucked-up treatment guidelines. Talks to Fauci about same. Tries to make his physician's conscience appear. (It doesn't; he keeps his political mask on.)
May 14	Roche meeting, NYC: Yell at them re: Why it took five years to find a potent dose of saquinavir.
May 18	President Clinton says, "Today, let us commit ourselves to developing an AIDS vaccine within the next decade." Being Clinton, of course, he hedges, "There are no guarantees..."
Jun 3	Peter Staley's departure from TAG staff.
Jun 4	TAG demo against the American Heart Association over its "disease vs. disease" NIH budget lobbying.
Jun 7	Mark writes "Cynical Swiss Saquinavir Scam" about Roche's promulgation of subtherapeutic saquinavir formula.
Jun 11	FDA reports protease inhibitors may cause diabetes. Maybe AIDS is not only becoming a "chronic, manageable disease—like diabetes," but actually becoming diabetes!
Jun 12	Mark receives MacArthur Foundation Fellowship for his AIDS work.
Aug 4	FDA approves Bristol-Myers' paclitaxel (Taxol) for second-line treatment of Kaposi's sarcoma.
Sep 6	Funeral for Princess Diana, London.
Sep 7-8	European HIV meeting, Istanbul. Ashley Haase presents new data showing impressive CD4 cell reconstitution in the lymphoid tissue after six months of triple therapy. Doug Richman confides portentously, and not without a trace of Schadenfreude, the death of the eradication hypothesis: three papers are in press at Science on the topic.
Sep 28	ICAAC, Toronto. Bob Siliciano demonstrates the failure of latently infected CD4 cells to decay post-HAART. Lots of posters on what later becomes known as lipodystrophy.
Oct 1	Bill Paul announces his resignation as OAR Director.
Nov 7	FDA approves Roche's "new, improved" saquinavir formulation, Fortovase.
Nov 13	Science and Nature publish articles on HIV persistence in latently infected CD4 cells.
Dec 8	HHS Guidelines panel considers and then rejects delavirdine (Rescriptor) and saquinavir (Fortovase) for first-line therapy.
Dec 29	Mark invited to deliver "shared plenary" at 1998 AIDS Conference on "Cure: Myth or Reality?" with Robert Siliciano.

TAG at Ten: 1996
Jan 7	NYC: Biggest blizzard since 1947.
Jan 18	Baltimore activist Garey Lambert dies of AIDS; Lynda Dee is there.
Jan 25	Spencer Cox at meeting with FDA Commissioner David Kessler in Rockville on protease inhibitors.
Jan 31	Mark Harrington resigns from Retrovirus Conference Steering Committee due to closed meeting policy.
Feb 1	Retrovirus: Ritonavir presentation by Abbott. They found a 50% reduction in progression + death at six months Spencer in tears.
Feb 12	Gregg Gonsalves starts Agouron protease inhibitor (later nelfinavir)/AZT/3TC in ADARC study.
Feb 20	Abbott meeting, Chicago. Guess what: ritonavir is more toxic than anticipated! "The syrup tasted nasty. The capsules will be OK."
Feb 27	Levine Committee (NIH AIDS Research Program Evaluation Working Group) report finalized. Mark writes intro.
Feb 29	FDA ritonavir hearing: Spencer's on the Antiviral Drug Advisory Committee (AVDAC)!
Mar 1	FDA approves ritonavir (Norvir) in just one day! FDA AVDAC hearing on Merck's indinavir (Crixivan). Also a hearing on Serono's rHGH (Serostim) for wasting syndrome. TAG's Lynda Dee is on the Crixivan panel; Tim Horn speaks at the rHGH hearing.
Mar 13	FDA grants accelerated approval for indinavir. OARAC ratifies the ARPEWG (Levine Committee) report! Laurie Garrett covers the report in Newsday.
Mar 14	Larry Altman covers the Levine Committee report in the New York Times. Harold Varmus endorses it at NIH.
Mar 29	MH gives talk at "Acting on AIDS" conference, London: "A revisionist history of AIDS treatment activism" (later published in Acting on AIDS, Serpent's Tail 1997.
Apr 8	FDA approves DaunoXome (daunorubicin liposome injection) for treatment of advanced KS.
Jun 3	FDA approves Roche's Amplicor brand RT-PCR test for HIV RNA.
Jun 9	Mark Harrington, Michael Marco, Tim Horn edit TAG's Wasting Report.
Jun 12	FDA approves Pfizer's azithromycin (Zithromax) for MAC prophylaxis.
Jun 13	NIH mark-up goes poorly (Pelosi amendment goes down on a party-line vote).
Jun 14	Wall Street Journal cover story on protease inhibitors.
Jun 21	FDA grants accelerated approval to Boehringer-Ingelheim's nevirapine (Viramune), the first approved non-nucleoside reverse transcriptase inhibitor (NNRTI).
Jun 24	Mathilde Krim reception for OAR Director Bill Paul. Nature comes out with two blockbuster papers on CC-CKR-5, HIV's hitherto elusive second receptor.
Jun 26	FDA approves Gilead's cidofovir (Vistide) for IV treatment of CMV retinitis.
Jun 30	NYC Gay Pride. The Economist cover story: "A Solution for AIDS?"
Jun 2	Mark Harrington's T cells have dropped from 320 to 152; viral load is 196,000.
Jun 8	XI International AIDS Conference, Vancouver. AmFAR reception, Vancouver Art Gallery: Liz Taylor appears! Gonsalves confronts Fauci over NIAID's canceling of CHIPS [Correlates of Human Immune Protection Studies] contract to Ho, Steve Wolinsky et al. Harrington confronts Shalala over needle exchange. "We'll fix it after the election!" she says.
Jun 9	Vancouver: John Moore vs. Edward Mbidde debate on vaccine studies now or later.
Jun 10	John Mellors presents famous MACS data on viral load.
Jun 11	David Ho vs. Giuseppe Pantaleo debate on mechanisms of CD4 depletion. Last afternoon's presentations including amazing, fascinating Bill Cameron (Abbott study), Trip Gulick (Merck 033), David Ho and Marty Markowitz (several ADARC studies) presentations on how triple combination therapy can reduce HIV viral load below 25 copies/mm3.
Jun 30	TAG meeting w/ David Ho, Marty Markowitz at PWAC offices on West 17th Street. It's jammed. (Later written up by A. Sullivan for the New York Times Magazine: "When Plagues End.")
Jun 31	Bill Clinton signs welfare reform bill to win re-election.
Aug 6	Mark's second lymph node biopsy performed at NIH clinical center.
Aug 7	In NYC, Peter Staley starts 3TC/d4T/Crixivan. In Bethesda, so does Mark Harrington.
Aug 9	CC-CKR5 paper in Cell on exposed uninfected from ADARC (Richard Koup /Nat Landau).
Aug 17	Mark Harrington finishes report on Vancouver meeting, "Viral Load in Vancouver."
Aug 22	David Baltimore considers running the HIV vaccine program (if only he had). John Coffin considers taking over the NCI Retrovirology Center (he does). Jim Curran will run the new OAR Prevention Sciences Working Group.
Aug 23	FDA approves Serono's rHGH (Serostim) for wasting and cachexia.
Sep 16-18	ICAAC in New Orleans.
Sep 29	Spencer's viral load is virtually back to baseline, 400,000, seven months after starting ritonavir and two months after switching to indinavir. Is this a harbinger of our future?
Oct 1	After a budget compromise, OAR does better than expected.
Oct 6-9	Meeting of NATAF (National AIDS Treatment Activists Forum) in D.C.
Sep 21	Tae-Wook Chun (then of Bob Siliciano's lab at Hopkins, later at NIAID) lectures at ADARC on cellular latency of integrated HIV provirus in resting T cells. This prefigures the end of eradication theory.
Sep 23	Meet Mike Saag to talk about the START protocol ("Strategic Timing of ART," ACTG 355). This study would be labeled "overly ambitious" by the ACTG and withdrawn in March '97. The ACTG will never do a "when to start" study.
Sep 29-30	OARAC meeting on implementing Levine Committee Report.
Sep 30	NIH: OAR panel on Principles of HIV Therapy.
Nov 5	Bill Clinton beats Bob Dole.
Nov 12	TAG benefit at Marvin Shulman's 5th Avenue loft.
Nov 13-14	NIH Principles panel: depressing resistance data. Post-Vancouver bubble pops. Resistance is a one-way street; the virus is "genetically unforgiving."
Nov 17	Ashley Haase cover story in Science.
Nov 22	Spencer back from FDA hearing on delavirdine (unusually, the AVDAC tied, 4-4. TAG was ambivalent as well).
Dec 2	Public Health Service (PHS) panel on Clinical Practice Guidelines for HIV. Spencer and Mark are on it.
Dec 3	AmFAR honors TAG at World AIDS Day, giving Peter Staley a silver plate.
Dec 12	David Baltimore appointed head of AIDS Vaccine Research Committee (AVRC).
Dec 16	OAR Panel to Define Principles of HIV Therapy meeting, Bethesda. The usual arguments about who should start and when, though now they're couched as who shouldn't start and why not?
Dec 17	Cover story in Newsday 'The Curse of the 'Cure' by Laurie Garrett, with Spencer and Mark on the cover (a tale of two TAGlings. Which one has resistance?). Also a Wall Street Journal cover story on DD Ho.
	Charlie Franchino resigns as TAG board President. Succeeded by Barbara Hughes.

TAG at Ten: 1995
Jan 4	Memorial service for writer and ACT UP member David Feinberg.
Jan 8	TAG board decides to bring on Michael Marco and Spencer Cox full-time beginning in April 1995.
Jan 11	Activist and film-maker Steve Brown dies of progressive multifocal leukoencephalopathy (PML).
Jan 14	Activist Lee Schy dies of vancomycin-resistant staphylococcis sepsis.
Jan 29	To D.C. for first meeting of OAR AIDS Research Evaluation Subcommittee (the "Levine Committee").
Feb 8	Mepron (atovaquone) approved for mild to moderate PCP.
Feb 10	Disappointing meeting with Merck on expanded access for indinavir (Crixivan).
Feb 21	Michael Marco elected to ACTG Executive Committee.
Feb 23	Gregg Gonsalves, Spencer Cox, Peter Staley to D.C. for National Task Force on AIDS Drug Development meeting on protease inhibitors. Publish Problems with Protease Inhibitor Development Plans.
Apr	Completion of Michael Marco's The Lymphoma Project Report.
May 13	Memorial service for poet James Merrill, NYC.
Jun	FDA approves expanded access for Roche's saquinavir (Invirase).
Jun 5	Mark delivers keynote talk at NCI KS meeting on "Kaposi's sarcoma and the changing face of AIDS activism."
Jun 6	Michael Marco's plenary on "Do we have a standard-of-care for KS? or, The incredible shrinking ABV response rate."
Jul 5	Gregg's cousin Carl Parisi dies of aspergillosis and lymphoma.
Jul 12	Office of AIDS Research (OAR) budget crisis.
Jul 20	House Appropriations NIH markup. OAR budget line eliminated.
Aug 18	Spencer Cox finishes FDA Regulation of Anti-HIV Drugs: A Critical Review.
Sep 1	FDA approves compassionate use for cidofovir (Vistide) for relapsing cytomegalovirus (CMV) retinitis.
Sep 18	37th ICAAC, San Francisco. Release of final results of ACTG 175, showing that ddI monotherapy, AZT/ddI and AZT/ddC combination therapy are each superior to AZT monotherapy in treatment-naïve individuals. The first study proving the benefit of two-drug combination therapy will rapidly be eclipsed by the development of triple-combination highly active antiretroviral therapy (HAART), as hinted at in an Abbott late-breaker showing that the combination of its protease inhibitor ritonavir plus two reverse transcriptase inhibitors can drive HIV RNA down to "undetectable" levels.
Oct 3	OJ Simpson "not guilty" verdict.
Oct 8	Work on TAG Does ICAAC. FDA approves clarithromycin (Biaxin) for mycobacterium avium complex (MAC) prevention.
Oct 16	National AIDS Treatment Advocates Forum (NATAF), Los Angeles. All TAG staff attend.
Oct 19	OAR Advisory Committee holds first formal meeting to review progress on the Levine Committee report.
Oct 24	Meeting at Roche on saquinavir.
Oct 27	FDA approves oral ganciclovir (Cytovene) for CMV prophylaxis.
Nov 6	FDA hearing on 3TC. FDA Antiviral Committee votes for a broad indication: "for use in combination with AZT."
Nov 7	FDA hearing on saquinavir, which is recommended for approval in combination but not as monotherapy.
Nov 8	FDA hearing on full approval for d4T. Green light given even though trial was too small to show statistical significance.
Nov 14	Newt Gingrich-induced government shutdown.
Nov 17	FDA approves doxorubicin HCL liposome injection (Doxil) for Kaposi's sarcoma (KS).
Nov 20	FDA approves 3TC (Epivir) for use in combination with AZT.
Dec 6	FDA approves saquinavir (Invirase), the first protease inhibitor.
Dec 21	FDA grants full approval for d4T (Zerit, stavudine).

TAG at Ten: 1994
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.
Jun 7	Low-dose saquinavir data emerge from ACTG 229.
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 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.

TAG at Ten: 1993
Jan 8	TAG meets with NIH Director Bernadine Healy re: the NIH Office of AIDS Research (OAR) legislation. She's non-committal.
Jan 16	Hoffmann-La Roche community meeting disrupted by ACT UP and TAG. Shrimp cocktail goes flying. Two arrests.
Jan 20	Bill Clinton sworn in as 42nd U.S. President.
Jan 21	Senator Kennedy introduces S.1, The NIH Revitalization Act of 1993, including TAG's OAR recommendations, onto the Senate floor. Dr. Healy temporarily reinstated as NIH Director. Panic at the NIH.
Jan 22	Emergency meetings at NIH. Directors propose a one year "study" of the proposed OAR changes.
Jan 22-24	Project "Immune Restoration Think Tank" meeting, Rutherford, CA.
Jan 26	Senate Labor & Human Resources Committee unanimously passes Kennedy's S.1.
Jan 28	NIH/FDA ad hoc committee meets on $20 million Congressional gp160 earmark.
Feb 3	House hearing on OAR legislation. Shalala endorses S.1. The AIDS panel is split: Art Ammann, David Ho, Mathilde Krim support reform; three fossils from professional societies oppose it.
Feb 9	ACT UP and TAG members chain themselves to gates and trucks at Hoffmann-La Roche facility in Nutley, NJ.
Feb 17	Senate attaches Nickles amendment to S.1, barring immigration of HIV+ foreigners. Bill passes, 93-4.
Feb 25	A tearful Healy announces her departure from NIH.
Feb 26	Terrorist bomb set under New York's World Trade Center; six killed, hundreds injured.
Mar 2	OAR legislation passes House committee.
Apr 2	Release of Concorde study results showing no benefit from early AZT. Havoc at Keystone HIV pathogenesis meeting.
Apr 19	TAG meets with Boehringer-Ingelheim about its experimental non-nucleoside, nevirapine.
Apr 25	National gay rights march in Washington, D.C.
May 25	House passes H.R.4 (House version of Senate bill S.1) by a vote of 290-130.
May 31	Gregg Gonsalves completes The Basic Science of HIV Infection: A Report from the Front for the Berlin AIDS conference.
Jun 8	In Berlin, Maxim Seligmann presents the grim results of the Concorde study.
Jun 10	At Berlin, an all-day barrage of negative results on ddI, ddC, the crash of Roche's tat inhibitor, and others. In Washington, D.C., President Clinton signs the NIH Revitalization Act of 1993.
Jul 1	Political funeral for activist Tim Bailey, whose embalmed body is borne in a demonstration at the nation's Capitol.
Jul 11	ACT UP/NY member David E. Kirschenbaum dies.
Jul 12	ACT UP/NY member Jon Greenberg dies.
Jul 16	Public funeral in New York's Tompkins Square Park for Jon Greenberg.
Jul 20	ACT UP/NY veteran, founding TAG member, TAGline co-editor, and composer Chris DeBlasio dies of AIDS.
Jul 30-1	Project Inform sponsors meeting on "Future Directions in AIDS Research" in Madison, WI.
August	President Clinton nominates Nobel Prize winning virologist Harold E. Varmus as NIH Director.
Sep 20	FDA hearing on full approval for Roche's ddC. TAG, having supported accelerated approval the previous year in spite of very limited data, now opposes full approval because ddC appears worse and more toxic than AZT.
Sep 23	Death of Project Inform's Jesse Dobson, founder of Project Immune Restoration.
Oct 12	Activist Andy Zysman, who focused on accelerating research on AIDS-related cancers, dies of AIDS in San Francisco.
Nov 2	Rudolph Giuliani elected Mayor of New York City.
Dec 7	At 17th ACTG meeting, distribution of Mark Harrington's The Crisis in Clinical AIDS Research, a blistering critique of the year's sequential clinical trials fiascos (rgp160, ddC, "convergent combination chemotherapy," inter alia).
Dec 8	At ACTG, Bill Powderly presents results of ACTG 081/981, showing that Bactrim prevents PCP and fluconazole prevents fungal infections in people with low T cells. CCG meets with Fauci. It's a fiasco: they're infantile; he, defensive.

TAG at Ten: 1992
Jan 22	Treatment Action Group (TAG) splits off from the Treatment + Data (T+D) Committee of ACT UP/New York. Our media debut: Catherine Woodard's "AIDS Hit Squad Seeks More Than Attention," Newsday, 1.22.92.
Jan 27	Eight Treatment Action Guerillas chain themselves to trucks at the entrance to Astra Pharmaceuticals (now part of AstraZeneca) in Westborough, Massachusetts, protesting excessive prices for the anti-CMV drug foscarnet. Tipped off by drug-maker Hoffmann—La Roche, which refused to provide a substantial parallel track program for ddC, FDA investigators seize batches of underground ddC from numerous PWA Buyers' Clubs nationwide.
Feb 4	TAG Astra zap covered on Sixty Minutes, including interview with TAG co-founder Peter Staley. ACT UP and TAG member Bob Rafsky is also featured.
Feb 5	FDA reports underground ddC contained between 0-200% of the putative dose.
Feb 19	TAG's Mark Harrington replaces Project Inform's Martin Delaney on the ACTG's Primary Infection Committee.
Feb 24	Debate in ACT UP about whether Peter Staley is colluding with drug companies by requesting money from industry for community-based clinical trials.
Feb 25	TAG's Gregg Gonsalves, Mark Harrington and Derek Link meet with Deputy Director Jack Whitescarver at the NIH Office of AIDS Research (OAR), instigating the landmark TAG research critique.
Apr 12-15	14th AIDS Clinical Trials Group (ACTG) meeting, Bethesda. New drugs under discussion include FTC, d4T, tat inhibitors, protease inhibitors, hypericin and nevirapine.
Apr 16	Burroughs-Wellcome sponsors "Day of Dialogue," one of the first drug-company community junkets.
Apr 30	Riots in Los Angeles over Rodney King verdict.
May 29	Community meeting with Syntex pharmaceuticals (now part of Roche) about oral ganciclovir for CMV retinitis.
Jun 19	FDA approves ddC (Hivid) using its new accelerated approval regulations.
Jul 14	At Madison Square Garden, the Democratic National Convention prepares to nominate Bill Clinton for president.
Jul 20	8th International AIDS Conference in Amsterdam. (Originally scheduled to take place in Boston, the meeting was moved to the Netherlands after the first Bush administration banned HIV-infected foreigners from entering the USA.) TAG's Mark Harrington debates NIAID's Anthony Fauci on The MacNeil/Lehrer Newshour.
Jul 22	Mark Harrington gives plenary lecture on "Pathogenesis & Activism" in Amsterdam. Later he and Gregg Gonsalves present AIDS Research at the NIH: A Critical Review at a press conference. Media coverage: a front page story in The New York Times as well as "Activists home in on basic research" in The New Scientist, 7.18.92.
Sep 10	TAG meets with NIH Director Bernadine Healy and institute directors to discuss OAR recommendations. Later we meet privately with Healy, Broder and Fauci to discuss a Manhattan Project for AIDS.
Sep 30	TAG letter to ACTG principal investigator Ann Collier protests the failure of Roche to define a maximum tolerated dose for the first HIV protease inhibitor, Ro 31-8959, later known as saquinavir (Invirase).
Oct 5	FDA approves a parallel track program for Bristol-Myers's d4T, later known as Zerit.
Oct 19	TAG meets with Fauci and Whitescarver to discuss OAR recommendations.
Nov 2	Political funeral for ACT UP's Mark Lowe Fisher. Activist funeral march to Bush NYC headquarters on 43rd Street.
Nov 3	Bill Clinton defeats George H. W. Bush in national elections and becomes president-elect of the United States.
Nov 4	Post-election meeting between TAG and Fauci about the OAR.
Nov 5	First meeting of FDA/NIH Panel on $20 million Congressional rgp160 earmark.
Nov 20	TAG meets with Tim Westmoreland from the office of Congressman Henry Waxman to discuss turning TAG's NIH recommendations into law.
Dec 7	TAG meets with Michael Iskowitz in Senator Ted Kennedy's office to discuss implementing TAG's OAR recommendations in the forthcoming Senate bill 1, "the NIH Revitalization Act of 1993."
Dec 15	TAG meets with Sam Broder at NCI and Fauci and Jim Hill of NIAID about the impending OAR legislation.
Dec 22	FDA approves Unimed's dronabinol (Marinol) for the treatment of weight loss in people with AIDS.
Dec 23	FDA approves Adria's rifabutin (Mycobutin) for prevention of disseminated mycobaterium avium complex (MAC).

Article introducing TAG at 10 series reprinted from TAGline Vol 9 Issue 1
Annals of Crisis
A Peek Back At TAG's First Year Shows How Much, And How Little, Has Changed

The beginning of this year marks TAG's tenth anniversary as the nation's only organization focused exclusively on advocating for more and better AIDS research, speeding discovery, development, approval, and distribution of better treatments, a cure and a vaccine. While the latter two goals remain elusive, the past ten years have seen significant progress—much of it instigated or accelerated by TAG. The NIH AIDS research budget has tripled in size, from $800 million to $2.4 billion per year. After TAG's pivotal 1992 report, AIDS Research at the NIH: A Critical Review, the AIDS research program at the National Institutes of Health was reformed and reorganized.

In the mid-1990s, TAG played a major part in forcing the drug companies developing protease inhibitors to study the drugs more rapidly and to provide more reliable information on how to use them. TAG also played a critical role in speeding up research on the opportunistic infections and cancers which were the leading killers of people with HIV. Since 1996, with the introduction of highly active antiretroviral therapy (HAART), protease inhibitors, non-nucleoside reverse transcriptase inhibitors, and viral load testing, antiretroviral treatment strategies have undergone a revolution.

Over the past seven years AIDS mortality dropped by two-thirds in the U.S. and other industrialized countries. Nonetheless, significant problems remain with anti-HIV drug adherence, cost, resistance, and toxicity. As people with HIV live longer, new problems such as lipodystrophy and liver disease now cause more problems among people with HIV living in the United States. Meanwhile, internationally, despite several years of intensified mobilization, the HIV pandemic spreads unchecked by effective prevention and existing treatment, let alone an HIV vaccine. TAG remains committed to completing our mission.

As we move forward in 2002, we will also look back at the work which brought us here, investigating key TAG projects and campaigns, interviewing leading researchers and activists who worked with TAG, and remembering those we have lost. Our first article focuses on TAG's formation in 1992, its dual missions of direct action and critical research analysis and oversight, our critique of the NIH AIDS research program and our call for an increased emphasis on the basic science of HIV infection—all themes which remain timely despite the progress of the past ten years. Mark Harrington transports us back to the dark days of the early 1990s.

Nineteen ninety two was a year of crisis for people with AIDS. Twelve years into the epidemic, despite the mobilization of thousands of activists, the deployment of millions of dollars in federal and pharmaceutical research funds, and significant accomplishments in speeding development and approval of three drugs for HIV and several more for its associated opportunistic infections, AIDS research was at a low point.

AZT had been approved by the FDA in 1987 and recommended for wider use in 1991, the same year that the FDA approved ddI (Videx), the second antiretroviral. These drugs extended life and health by just a year or two, and failed to durably suppress the virus. In 1992 it was still unclear whether hoped-for new therapies such as inhibitors of the HIV tat or protease enzymes would prove effective. In the meantime, the AIDS and death tolls mounted relentlessly.

Activists had won entr&eactute;e into the councils of the Food & Drug Administration (FDA) and the National Institutes of Health (NIH) AIDS drug development programs and oversight bodies, and had helped to broaden the research agenda to include more research on the opportunistic complications of HIV—and on women and children with HIV. Nonetheless, the prospects for treatment looked unpromising.

Scientists did not yet have a clear picture of the pathogenesis of HIV infection. It was still widely and incorrectly believed that HIV "hid" somewhere in the body in the period between acute infection and the development of AIDS ten years later. Available tests to quantify viral levels in the body were crude at best. Only a few researchers were looking for the virus in body compartments such as the lymphoid tissue, as opposed to the easier to sample bloodstream. It was not yet known how HIV destroyed the immune system and led to AIDS.

Without a better understanding of how HIV led to disease, it would be difficult to develop better treatments. Yet at NIH, despite an AIDS research budget that had steadily mounted to almost $800 million per year, the research effort was poorly coordinated. It lacked a central place where the overall research agenda could be planned, budgeted, and evaluated. Eighteen different NIH institutes each conducted their own AIDS research programs as they saw fit. Scientists in the field were depressed about the lack of progress on both the therapeutic and on the preventive vaccine fronts.

The political situation was also troubling. During twelve years of Republican presidencies, most federal action on AIDS had been instigated by—and sometimes obstructed by—Congress. The country had just emerged from a distracting war in a far-off Islamic country, and it was in recession. Health care costs were rising uncontrollably, and increasing cries were heard for the government to do something to broaden access to health care. It was difficult for AIDS and health care activists to get the attention of President George Bush.

Meanwhile, the AIDS activist movement itself was in crisis. The largest activist group, the AIDS Coalition to Unleash Power or "ACT UP," was increasingly riven by infighting, while many of its leaders and members were falling ill or dying.

Within ACT UP's Treatment + Data (T+D) Committee, a dozen treatment activists were determined to focus their efforts on research and treatment advocacy. Infighting was getting in the way of that focus, and so in January 1992 they split off from ACT UP and formed the Treatment Action Group. TAG's early focus included a series of direct actions targeting drug companies whose development plans were too slow: Dai-Ichi pharmaceuticals, for their glacial development of an anti-Kaposi's sarcoma (KS) angiogenesis inhibitor; whose expanded access programs were inadequate: Hoffmann-La Roche, for refusing to provide expanded access to ddC; or whose prices were too high: Astra, for the excessive price of the anti-CMV drug foscarnet. Despite widespread publicity, these civil disobedience "zaps" were becoming less effective than they had been in ACT UP's early days.

The litany of drugs which the FDA did approve over the course of 1992 showed just how slow the research progress was, and how grim the prognosis for most people with HIV. The third anti-HIV drug, Roche's ddC (Hivid), was approved in June—even though there was no evidence that ddC improved health or prolonged life. It was approved based on minute and transient increases in CD4 cell counts. ddC would go on to be the least widely used drug of its class. Then, in a rush of year-end drug approvals, the FDA approved two drugs for advanced AIDS—Adria's rifabutin for prevention of mycobacterium avium complex (MAC) and Unimed's dronabinol (Marinol), an appetite stimulant, for treatment of HIV-associated anorexia and weight loss.

An additional TAG focus was analyzing and reforming the AIDS research program of the NIH. Starting in February 1992, TAG's Gregg Gonsalves and Mark Harrington gathered information on every NIH AIDS research grant and program. By the International AIDS Conference that July in Amsterdam, they published AIDS Research at the NIH: A Critical Review. The report called on Congress and the Administration to strengthen the NIH Office of AIDS Research (OAR) and to provide it with the authority and ability to plan, evaluate, and budget a coordinated, streamlined, accelerated AIDS research program across all the NIH institutes and centers.

We also called on the government to double the entire NIH budget for biomedical research. That summer and fall, TAG worked on building an alliance with AIDS researchers across the country who would be willing to support the reform efforts when legislation was introduced in Congress during early 1993. TAG also met with NIH Director Bernadine Healy and the directors of the NIH institutes—particularly Tony Fauci at NIAID and Sam Broder at the National Cancer Institute—although the institute directors generally were opposed to any plan which would subject them to evaluation or oversight. With the election of Bill Clinton as President in November 1992, the stage was set for Congress to enact sweeping reforms of the NIH AIDS program in the reauthorization legislation of early 1993.

Finally, during 1992 TAG was the first activist organization to call on researchers to refocus the AIDS research effort on fundamental basic research dedicated to elucidating the pathogenesis of HIV disease and AIDS. TAG's pathogenesis project met monthly. We began working with basic scientists as well as with clinical researchers as we had in the past. In his 1992 speech at the Amsterdam AIDS conference, TAG's Mark Harrington spoke on "Pathogenesis and Activism" and showed slides of his own HIV-infected lymph node as an example of how activists and people with HIV could contribute to and participate in basic research as well as in clinical trials.

It was clear that progress would be slow. Over the course of 1992, 79,595 Americans were diagnosed with AIDS and 41,623 of them died of the disease. At the time it seemed that those numbers would only go up for the foreseeable future.

Many of TAG's founding members were ourselves HIV-infected. Among the many activists who died of AIDS in 1992 were ACT UP/San Francisco's Michael Wright in January, TAG's Scott Slutsky in May, artist/writer David Wojnarowicz in July, and ACT UP/New York's Mark Fisher—just before the November elections. When we marched uptown on election eve, 1992, bearing Mark's body to Bush's New York City campaign headquarters in midtown, most of us felt that it would only be a matter of time—and not too long—before we too died of AIDS. But we were determined to push for changes in the research system so that later generations of the infected would have a better prognosis and a chance for a longer life. ¤