Left Field by Patricia Nell Warren
It’s three years since the big VaxGen scandal broke. Years of buzz had surrounded this HIV vaccine, which VaxGen founder Donald Francis theorized would work on antibodies to gp120, a virus protein. But in 2003 VaxGen’s much-touted Phase III clinical trial came up with disappointing results. There was a brief uproar, with VaxGen being sued for securities fraud by angry investors who lost their shirts when VaxGen’s stock plunged. Investors alleged that VaxGen had concealed facts and made misleading statements about the research in order to keep the stock selling. Their outrage joined a larger surge in stockholder lawsuits against other biotech companies.
But amazing things can happen in pharmaceutical politics. The Justice Department never filed its own charges against VaxGen. The lawsuits disappeared from the headlines. Two years later, in 2005, Francis and his long-time research colleague Philip Berman quietly left VaxGen to start an HIV vaccine nonprofit. VaxGen, which had been struggling financially, suddenly got back on its feet as the government gave it some lucrative contracts for vaccines linked to national security (anthrax, etc.). Last year, in a decision that the major news media ignored, the consolidated lawsuits were dismissed by a federal district judge, pending a proposed settlement on a derivative lawsuit.
With VaxGen gone from the scene, others have been rushing to get their vaccine theories on the map. The fact is, glowing preliminary reports have become a staple of HIV vaccine research, to keep funding flowing and the public interested. According to The Seattle Times: “An experimental HIV vaccine, which scientists say is the most promising in 20 years, has had such good results recently that researchers are doubling the number of volunteers involved in the trials.” This one has been developed by Merck, tested on some 3,000 volunteers in Seattle and thirteen other cities and six other countries.
Meanwhile, another glowing report came from Europe, on a therapeutic vaccine that reportedly uses anti-HIV immunity. According to Daniel DeNoon of AIDS Weekly, “It worked in mice. It worked in monkeys. And now in humans, a therapeutic vaccine has stopped HIV in its tracks….Wei Lu, Jean-Marie Andrieu, and colleagues at the University of Paris in France and Pernambuco Federal University in Recife, Brazil, tested the vaccine on 18 Brazilian patients.”
Developing countries get on board with their own initiatives. Zambia just launched its first clinical trials for a preventive HIV vaccine. The candidate drug is tgAAC09, developed by Targeted Genetics in Seattle, said to be based on subtype C, the strain of HIV said to be dominant in that part of Africa. The Zambian government is working with the South African and Ugandan governments, as well as the International AIDS Vaccine Initiative (IAVI), on this trial.
Not to be outdone, China recently started her own HIV vaccine trials, according to Xinhua, the Chinese government’s official news agency.
Despite glowing reports, HIV vaccines have traveled a rocky road. More than 100 different drugs, using a variety of strategies, have been tried for over two decades. The Seattle Times commented: “Early vaccine attempts have focused on using antibodies, another major player in the immune system, to fight off HIV. But more recently, scientists have concentrated on stimulating killer cells to do the job. Some 15 different vaccines are now in trial with the HIV Vaccine Trials Network.” Merck is attempting to use a common cold pathogen, adenovirus, to do the job. Yet many experts still question whether an HIV vaccine can ever be gotten to work.
Sad to say, vaccine research is getting its own bad rap for lapses in ethics. The Alliance for Human Research Protection reports that the same abuses of children—especially foster children—recently reported in AIDS-drug research are also surfacing in some vaccine trials. For example, the DHHS recently was compelled to send a letter to Columbia-Presbyterian Hospital in New York, notifying them of the allegedly illegal nature of their use of foster children in HIV-related vaccine research. According to AHRP, “Given the current stage of development of preventive HIV vaccines and the lack of understanding about immunity to HIV, scientific and ethical issues are paramount when considering the timing, design, and conduct of studies of HIV vaccine candidates in pediatric populations.”
Based on the government’s failure (so far) to prosecute any researchers for violations of child-safety regulations, I wonder if anybody is listening. Yet these vaccines are supposedly intended to benefit the world’s children.
Author of fiction bestsellers and provocative commentary, Patricia Nell Warren has her writings archived at www.patricianellwarren.com. Reach her by e-mail at patriciawarren@aol.com.
June 2006
Copyright (c) 2006 by Patricia Nell Warren. All rights reserved.
