Of Astrology and Access: Public Hearings At FDA Juxtapose Old Cries of Access With Those of Integrity, Accountability

The FDA recently held hearings about the perceived shortcomings of its Accelerated Approval program. Among many soul-searching and provocative addresses delivered over the two days of testimony (September 12-13), was this one, of TAG's Dennis Davidson.

"Good morning, my name is Dennis Davidson. I am HIV positive and currently asymptomatic. I appreciate the opportunity to speak. I would like to speak to an underlying issue which, I believe, characterizes the debate before you. This debate has become polarized into two opposing camps: those who favor wider access to new drugs regardless of their efficacy or clinical benefit and those who favor access to new drugs with proven efficacy and clinical benefit based. I would like to frame it in a larger context of our society as a whole rather than just the subset of people in immediate need of new drugs."

"The underlying issue is one of process based upon belief versus process based upon reason. It is a conflict which goes beyond drug development, and is in many cases intractable." "In my professional work-day life I am a science educator and visualizer specializing in astronomy and space science. A similar polarity exists within my constituency. There are those who choose to understand the universe using a belief system called astrology versus those who choose to utilize reason and analysis to interpret their observations of the universe. I have found that the former is by far the larger and more vocal. Astrology columns, for example, are more common in newspapers than are astronomy columns."

"It disappoints me to see the same trend away from reason and towards belief in the HIV treatment community. I am not here to name names or organizations. I am speaking from personal experience derived from conversations with people I encounter on a daily basis. It has become too common for people with AIDS to rely exclusively on anecdotal information and hearsay when making important treatment decisions. The clinical and research establishment has lost all credibility with a significant number of people with HIV largely because clinical trials have heretofore failed to provide clear-cut answers to our treatment questions."

"In this light, the notion that every citizen with HIV has the right to access new and reasonably safe drugs which show some promise of efficacy, however meager or ambiguous, is certainly appealing. Given the cult of individuality which the American culture has so efficiently enshrined, it seems almost patriotic to demand universal access. However, should new and perhaps more informative clinical trials be held hostage to this demand? Should improvements to an inadequate clinical trials system be sacrificed for this individualistic need? I think not. Access and answers need not be mutually exclusive." "No one is saying that we should deny access to drugs, especially to those who need it the most, and are usually excluded by design, from many clinical trials. What I am saying is that perhaps the time has come to defer immediate, individualistic, hypothetical 'benefit,' often couched in terms of rights-of-access, to near-term and long-term benefits for everyone. This is known as altruism, and by definition it means that individuals give up some immediate benefit for the longer term benefit of the group. It may be harsh to frame this debate in terms of selfish individualism versus altruism, positive versus negative, or symptomatic versus asymptomatic, but demanding access for the individual without insuring a process to benefit the entire group becomes just that: the individual and perhaps a small circle of friends in the know might benefit while the majority is left with nothing."

"Where is this trend leading? I believe that this is part of a national trend towards 'scientific illiteracy' and is leading to a chaotic process of individualized testing of new drug products. There seems to be a conceptual blurring between individualized treatment programs versus individualized testing. (Many of us use individualized treatment programs and we all follow hunches or listen to our intuition when making treatment decisions.) How will we learn anything from a sample size of one? This is where belief clashes with any process which might obtain useful information for the group as a whole. It is a fundamentally different approach to obtaining knowledge than the scientific method."

"The power of the scientific method is evident in its process. One does not have to even believe in it for it to work. Just be rigorous and objective in the process of testing and analysis, follow a specific set of rules, and take good notes for others to duplicate your process. Yet this rigor and objectivity is what is often rejected by those who base their decisions solely on belief. I would like to see many of the so-called 'alternative' therapies subjected to the same rigor in testing and analysis which we expect of traditional drugs. Perhaps we will learn something there of clinical value which can benefit everyone."

"A point I'd like to conclude with is this erroneous label of 'elitism' which has been thrown around in this debate. It's time to stop and have a reality check. In terms of the world's population of HIV infected, everyone in this room and their constituents are the elite: positive or negative, symptomatic or asymptomatic. The majority of people infected with HIV worldwide will never have access (accelerated or otherwise) to any of the treatments we are discussing. So let's discard the inflammatory rhetoric and start working together in a reasoned and cooperative manner."

"Yes, belief in a treatment and hope for our survival are an integral part of our healing process, but our hopes and beliefs must be tempered by the realism of analysis and reason. We have all given so much in this epidemic. Yet we must give more. I want to live as long as I can: to learn, to lead a productive life, to create art; but I want my death to be meaningful (and even useful) to the future generations of the infected. We in the industrialized world have a special responsibility to the many in the rest of the world who will not have the opportunities we have. It is a responsibility which places the good of the planet above the individual need. Of course, we need clear, unambiguous answers but we are not going to get these answers with studies which have a sample size of one. Saving lives and acquiring data are not mutually exclusive.