AIDSWEEKLY Plus; Monday, June 1, 1998
Daniel J. DeNoon, Senior Editor
The accusation, by an unnamed "leading Japanese researcher" cited in a news article in the journal Nature Medicine (1998;4(5):540), represents the latest salvo in an ongoing squabble among AIDS vaccine researchers.
On one side of the increasingly nasty debate are the empiricists. These tend to be corporate researchers wanting to advance candidate HIV vaccines to large-scale trials and researchers at public health agencies with experience conducting such trials (e.g., the U.S. Centers for Disease Control and Prevention (CDC)).
On the other side are the rationalists. These tend to be basic scientists at research institutions and research-oriented public health agencies (e.g., the U.S. National Institutes of Health (NIH)) who believe that it would be wrong to proceed to large-scale trials before there is established evidence that a candidate vaccine will work.
At stake in the debate are the financial and human resources needed to complete development of an HIV vaccine. One such resource is the established infrastructure for HIV vaccine trials in Thailand, where HIV subtype E is spreading.
Triggering the latest outpouring of invective was Japan's announcement that it had made a deal with the Thai government to develop and test a candidate HIV vaccine. Japan government agencies have committed $5.4 million to the joint project, which will be carried out by Japan's National Institute of Infectious Diseases (NIID) and Thailand's Ministry of Public Health.
The agreement means that the NIID will develop a vaccine based on HIV subtype E. But the Nature article by Tokyo-based writer Asako Saegusa, titled "Are Japanese Researchers Exploiting Thai HIV Patients?" claims that "leading HIV researchers both in Japan and the U.S. have declared that the venture is merely a cover to enable the Japanese to gain a foothold in Thailand - the largest natural testing ground for a vaccine against the disease."
It goes on to quote avowed rationalist John Moore of the Aaron Diamond AIDS Research Center.
"The only reason the Japanese have chosen [subtype] E is because it is convenient for them to test it in Thailand and they are being disingenuous if they claim otherwise," Saegusa quoted Moore as saying.
In the article, Moore also dismisses as "unimpressive" the NIID plan to create a vaccine based on expression of HIV antigens by a bacillus Calmette-Guerin (BCG) vector.
A letter of protest, obtained by AIDS Weekly Plus, has been sent by NIID chief Shudo Yamazaki to the editors of Nature Medicine. In the letter, Yamazaki says that the project is a true collaboration that will focus on preclinical vaccine development.
"Once we get a promising candidate vaccine from these preclinical studies, it will be up to the Thai scientists and authorities to decide whether or not to proceed to Phase I clinical trials in Thailand, in accordance with the established scientific and ethical principles of international research," Yamazaki wrote.
Thailand is also prepared to commence - pending U.S. government approval - advanced trials of VaxGen's HIV envelope-based protein vaccine. Moore opposes such tests.
In an editorial for the Nature Medicine supplement on Vaccines (Nature Med, 1998;4(5S):495-8), Moore and Dennis Burton of the Scripps Research Institute blast plans to test candidate vaccines "however weak the underlying scientific justification or preliminary data."
Burton and Moore argue that there is limited funding for vaccine trials, that patient cohorts are precious resources, and that "a social and political price" would be paid for a vaccine that failed in a large-scale trial.
"There is a disturbing tendency in HIV vaccine research to dress up failure as success, or to design the conditions of the experiment to improve the likelihood of an apparent success," they wrote.
In suggesting how best to proceed, Burton and Moore argued for centralization of vaccine development in the NIH, particularly in the NIH AIDS Vaccine Research Committee headed by rationalist David Baltimore. Pointedly there is no mention of the CDC, historically responsible for U.S. vaccine testing and - not coincidentally - where many researchers favor an empirical approach to HIV vaccines.
Thus far, the rationalist side appears to be making the stronger scientific argument. However, the strongest practical argument clearly belongs to the empiricists: they point out that all current vaccines have been proven effective before their mechanisms of action were fully known.
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