Merck's AIDS Vaccine Failure: The Fallout
When Merck's AIDS vaccine candidate failed in clinical trials, the National Institute of Allergy and Infectious Diseases (NIAID), in the National Institutes of Health (NIH) called a summit. The drug candidate did not reduce HIV infections, in fact the adenovirus based vaccine seemed to increase the risk of infections.
The meeting of scientists on March 25th in Washington focused on the future of HIV/AIDS research in light of the fallout of Merck vaccine trials. Scientists like Anthony Fauci, who heads the NIAID, agree that funding needs to be redirected towards a broader research agenda and ideas beyond drug development and vaccines. Science last week noted that the decision about whether to proceed with the large NIH clinical trial planned for its HIV vaccine is still pending. ("Review of Vaccine Failure Prompts a Return to Basics" DOI: 10.1126/science.320.5872.30)
Nature reported on the summit last week, pointing out that these clinical AIDS trials went forward not necessarily based on the strength of the science -- one of the vaccine candidates had a unimpressive track record -- but because programs needed to "show the public that progress is being made, thereby justifying the millions of dollars from philanthropists and taxpayers". ("Broken Promises" doi:10.1038/452503a).
The editorial recounted how ambitious commitments made during the flush funding environment earlier his decade in effect short-changed basic research. The journal notes that the choices to heavily fund certain drug development is being reconsidered in light of the trial failures and the budget shortfalls of recent years. Nature warns that other fields, for instance stem-cell research, autism, and Parkinson's disease, are repeating the same mistakes.
The Mythical Man Month, But On Steroids
The business approach to research and clinical trials comes with a high stakes mentality. This can be fanned by ample, vigorous marketing which ratchets up expectations both within organizations, within the field and within the public arena. The business-oriented nature of many philanthropic organizations influences the focus on development and can distort public expectations. They'll deny it, but investors can and do influence the direction of an entire field.
When a field becomes dominated by a few foundations it can gather tremendous productive momentum, but it can also stampede so hard down a particular path that other avenues of research are ignored. We've commented on this not only with recent AIDS and vaccination funding but with autism research and others. If that direction proves to be less fruitful than hoped research cannot turn around on a dime.
Each high-funded disease has its own idiosyncratic pitfalls, but unlike many entrepreneurial ventures, behind the many good works and fine intentions of charities, science research rarely responds to force.
When scientists request research funding, the results don't always yield answers as quickly as businesses might hope. To put it in terms software engineers understand, research is the mythical man month on steroids. Some people investing in biotech and international public health come from businesses very unlike public health with its vagaries of not only politics and human behavior, but biology.
Science as Society's Silver Bullet
In today's fast paced communications and computing climate, intense focus on "results" is inherent to our culture. Expectations carry over from the successful and extraordinarily speedy progress of the genome sequencing. Scientists and politicians built hopes during that era that drug development and an accelerated understanding of human disease would follow. It has, but did we expect more?
How are the public's expectations torqued? TV drug advertising gives the impression that scientists are developing a pill for every insignificant hangnail, when many of these drugs aren't new, just the subjects of new marketing campaigns. Meanwhile tougher diseases and conditions remain elusive.
High profile funding can influence the research environment and lead to a very public dead end. In the larger picture, despite the wisdom that should be accruing from these experiences, politicians, technology leaders, and pundits continue to wax-on about technology's potential to produce solutions not only for specific diseases but for extremely complicated social problems such as global warming and healthcare.
But while science research may yield amazing pharmaceuticals and oil extraction techniques, one cannot look to science or technology to solve the healthcare crisis in the United States. Science and technology contextualize these problems integral in our lives but despite heady declarations, science is not central to the solutions.
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Acronym Required has written previously about these subjects, AIDS and research directions, and vaccines. Here are a couple of our vaccine articles:
Vaccinations -- Why Worry?
Polio Vaccinations - The end of a scourge?
Group B Strep Vaccine Development
Vaccine Development For Infectious Diseases
