My name is Marie Huber. For over four years I was a healthcare analyst for an investment advisor, until a year ago I quit my job to free myself to try and initiate the long-overdue public discussion of the unpublished Provenge trial data and to share an alternative explanation for the trials which caused me great concern.
I have a BA in Natural Sciences (majoring in biochemistry) from Cambridge University and an MPhil in Bioscience Enterprise also from Cambridge (in collaboration with MIT). My professional and leisure passions have always been science and medicine, problem-solving, understanding the way that things work and making the world a better place.
I was born and grew up in the UK, and moved to New York in 2003 where I have lived to this day.
My full resume is available here: resume.pdf
“Have no respect whatsoever for authority; forget who said it and instead look at what he starts with, where he ends up, and ask yourself, "Is it reasonable?" ”
-- Richard Feynman
I have no financial interest, nor other conflicts of interest related to anything discussed in this website. The reason I didn't look for a new job and pursue publication while working for a firm that allowed me to, was to free myself from (perfectly understandable) accusations of having a conflict of interests. I did not want ad hominem arguments to distract from the facts of a debate in which thousands of lives are at stake. For those interested in my motivations or the path which led me to this decision, I have written the sections below.
Since neither I, nor my former employer, has any financial interest in the fate of Provenge, some readers might be wondering “why?”. I have tried my best to sharemy motivations, both for quitting my job to publish the JNCI paper, and for investing the time and energy into creating this website, here: Why.pdf
My Interest in Provenge
In 2007 I began working as a general analyst for a registered investment advisor.
Whilst still a generalist I began to spend my spare time learning about the latest discoveries and developments in the healthcare industry and over time I was able to shift my work focus towards this interest. As a healthcare analyst I spent most of my time researching new medical therapies that were being developed by biotechnology and medical device companies (and making investment recommendations accordingly). This involved reading hundreds of scientific research papers, attending medical conferences, and speaking with companies and experts, in order to understand how a developmental therapy was supposed to work, what its chances of success were, and what its market opportunity and competition would be if approved.
Although I had been aware of Provenge in 2007 when it was first rejected by the FDA, and again in 2009 when the positive results of its third phase III study, IMPACT, were released, it was always the focus of much controversy, and did not appear to be an appropriate investment opportunity for our conservative clients (primarily pensions and endowments). For personal reasons, however, I was inspired by the huge promise that harnessing the immune system has for battling cancer. Having lost many friends and loved ones to the disease, and watched the suffering caused by chemothrapy, I was eager to learn about this new “miracle” therapy with minimal side-effects. And so I read all of the information I could find about the preclinical and clinical studies of the drug.
Unfortunately there was very little evidence publicly available to support the mechanism proposed by Dendreon. Provenge didn't appear to affect disease progression and there was no published evidence of tumor killing. With most drugs I had previously researched, my comfort in their efficacy was based on studies which provided evidence for the molecular and cellular mechanisms behind the outcomes being tested in trials. Because of this, the available evidence of Provenge’s efficacy came entirely from survival results of its phase III trials.
A complicated history of changing endpoints and enrollment criteria, had left the trials with several design flaws. But the FDA had approved these changes, and since most of the flaws would probably result in relatively small biases, they needed to be weighed against the robust statistical significance of the 4.1 month survival benefit the trials had shown. I knew, however, that the FDA had access to significantly more data than the public, and so, when the FDA approved Provenge on April 29th, 2010, I was fascinated to discover what data and analyses had been available to them to provide insights into the drug’s mechanism.
Typically within 2-6 months after the FDA approves a new therapy, it posts a large set of its internal documents related to that approval on its website. And so it was that on June 9th I was able to begin scanning through these, and came across the confusing age data which sparked my curiosity to dig deeper. Within days, the alternative explanation for the trial results became apparent, and in the weeks and months that followed, I spoke (under confidentiality agreements) with dozens of immunologists, immune aging experts, urologists and oncologists to solicit their opinions and see if there was any flaw in its logic or evidence against its plausibility that would justify dismissing it. While I heard many proposals for such counter-arguments (see FAQ), none of these held up to scrutiny.
The story of the remainder of 2010 is long and complex, because my employer, for many very good reasons which I understood, did not want me to express and defend my concerns in public while I was still employed by the firm. Thus, in January 2011, I quit my job (a great job, with great healthcare benefits and a boss who was, and continues to be, a friend) in order to pursue the publication of the paper detailing the alternative explanation.