Long windup to a short question: I know all about the theory and practice of double-blinded studies, but I have read in old fashioned printed magazines and newspapers as well as on other biotech boards, where P-3 results were pending, credible-seeming reports purportedly based on anecdotes from clinicians, nurses, orderlies, etc. about the apparent efficacy of this or that experimental drug.
Legal or not, word can and does leak out. This shouldn't surprise us. People directly and indirectly involved in medical treatment, experimental or otherwise, often can tell who is getting certain drugs and who isn't. From this, of course, it's easy for them to reason to certain conclusions about efficacy. The most recent -- but by no means the only -- example is PFE's Viagra. Great story, there. As early as December, pre-approval reports were flying hither and yon including the one about how control group members who were getting the placebo knew* they were getting the placebo (*guess how) and tried to bribe their opposites into sharing their Viagra.
I have seen references, too, to cautionary letters, routine manufacturing spec changes, and other communications between the FDA and drug companies as P-3 studies dragged on, usually about sample dose sizes, manufacturing techniques, etc., from which, I am given to understand, companies often can reason their way to certain educated guesses about how the efficacy trials are going. How much easier it must be to put two and two together when testing an experimental compound like Neuprex which is aimed at acute infections that resolve (or worsen) relatively quickly (relative to, for example, metastacized breast cancer).
All of this is just a long windup to suggesting that there is a high likelihood such reports are out there. Xoma is testing on two continents in many, many different clinical settings. The patient population has been considerably expanded. The patients either get better quickly or not at all. The clinics and locations must be known to Xoma people (and therefore probably a lot of others). Even doing it the hard way -- checking local newspapers and hospital admissions & discharges -- one could figure out much of the rest. There must be easier ways, too.
To paraphrase someone (Mark Twain?) the only way two people can keep a secret is if one of them is dead. So, how about it? How can we go about getting a fix on anecdotal reports of trauma & infections in participating clinics? You can bet a lot of biotech fund managers routinely try to do this. |
