To: Cage Rattler who wrote (657 ) 10/30/1998 11:26:00 AM From: Michael Olin Respond to of 1255
Actually, I am an outsider. I am a software consultant who designs and develops database systems. I have developed many systems over the years to support pharmaceutical R&D. Suspect alterations? How technical do you want to get? How would you classify the common practice of "cleaning" CRFs (case report forms) from clinical trials. If data comes across that is suspect, the investigator gets a call from someone at the pharmaceutical company who is looking to confirm that the reported data is indeed accurate. Perhaps the investigator made an error in recording the data on the CRF, or is convinced by the company that he/she must have made an error. Maybe the subject gets dropped from the study. Systems routinely flag impossible data (a patient's age is 98 when the study calls for volunteers between 25 and 35) that could be the result of recording or transcription errors, but how about results that are just a little too far from the expected range of values? Measuring the effects of a drug on memory is a lot more subjective than looking for something as objective as a decrease in T-cell levels or some other readily measured response. I'm sure the investigators have much more leeway in interpreting the results of the Ampakine trials than in measuring response to a new antibody. Perhaps this is part of the difficulty in getting results to report. I agree that there has been absolutely no effort expended by Cortex in getting information out to the public. I don't think that they have been too effective in academic/industry circles either, but I have no independent knowledge of their efforts (or lack thereof) other than to note that they have been talking about partnerships for years with no tangible results. Academics and researchers, for the most part, do not comprehend the importance of getting information out when you are a public company. They concentrate on their research and all the while their stock is getting hammered with no response from the company. If Cortex turns out to be a good investment, it will be solely on the strength of its science. In the long term, I don't think that even the best management can make up for the weaknesses of the science. Unfortunately, good science can be undone by poor management. -Michael