http://www.fda.gov/OHRMS/DOCKETS/98fr/07-141.pdf Information on their meeting and questions found here. Question 5. What are the current gaps in postmarket medical product safety data collection and risk identification and analysis? The Annie Appleseed Project suggests that there is quite a bit of ground to cover on the issue of postmarket product safety data collection, risk identification and analysis before moving onto discussion of hi-tech methods. And those issues include, but are not limited to: a)The biggest gap is that FDA has no ability to change anything about the approved product's dose level, and other aspects, that further use demonstrates to be less than appropriate for the larger community. An example is Xeloda, approved at 2500 mgs BID when doctors 'in the know' are using it at 2000 mgs BID or even less. b)Most products gain approval based on studies in the healthiest segment of whatever population it is intended, for causing its more general use to be truly questionable in our opinion, leading to the current situation in which each individual along with their individual healthcare practitioner has to discover adverse events on their own. From the patient advocate perspective, we suggest a lot more attention be paid to an individual's symptom presentation given b) above. Many consumers report being told that since the trial had no mention of their particular symptom, it could not be caused by the (new) treatment. Common sense alone should dictate that even busy practitioners pay attention when a patient reports numbness or dizziness, headache, rashes, etc. that began with moments, hours or days of a new medication or therapy. Yet we hear many stories of this being completely disregarded and dismissed. But in many cases the drug is being used in situations of co-morbidity with all that THAT implies. Will fancier, hi-tech (albeit needed) systems change this? c) Syptoms and adverse events in clinical trials are examined for relatively short periods of time - will the new system be able to follow human subjects and those who use the (possibly too soon approved) drugs for longer periods to see 'long-term' events? d)We currently lack true standardized assessement of toxicity within studies. Will this be addressed? leading to e)'What is best practice for detecting and monitoring adverse effects in clinical studies'? Will this MOST IMPORTANT aspect be part of the new initiative? It leads directly to the postmarket issues. f) The Cochrane Adverse Events Methods Group, of which I am part, has pointed out that there may be differences in how industry and non industry trials report their adverse events and that there may be differences in how pharmacological and non-pharmacological trials report them as well. For the above reasons, the Annie Appleseed Project has submitted this statement. We support a patient's right to make more informed decisions. We support FDA making changes to allow all of the above issues to be resolved. Thank you for the opportunity to present our viewpoint. Ann F. Remember we are NOT Doctors and have NO medical training. This site is like an Encylopedia - there are many pages, many links on many topics. Support our work with any size DONATION - see left side of any page - for how to donate. You can help raise awareness of CAM.