View Full Version : APhA-ASP Proposal 2005.2 Clinical Trials


Caverject
02-28-2005, 05:02 PM
APhA-ASP encourages legislation that requires pharmaceutical manufacturers and researchers to disclose the results of all clinical trials regardless of outcome through an independently reviewed, publicly accessible, national electronic database.

Background Statement:
Clinical studies with positive findings are more likely to be published than negative studies or studies that are inconclusive. Over the past year, questions about the availability of studies revealing adverse effects have emerged. This raises the concern that the pattern of publication distorts medical literature and ultimately affects decisions made by health care professionals. Although some drug manufacturers have offered to make the results of clinical trials available to the public, it is currently not required. Therefore, we feel it is necessary for legislation that requires all clinical studies, regardless of outcome, conducted by drug manufacturers, academic researchers, and other independent research facilities be compiled in an independently reviewed national electronic database. Such a database would ensure standardization of data, results and information. This database should be made available to both health care providers and to the public.

Caverject
02-28-2005, 05:24 PM
As an American, I have a right to disclose anything I want. The same should be afforded to drug companies. If they created a drug and it killed everyone on the trial, obviously it will be D/C'ed but no need to create a mass hysteria by releasing that result!

rxgal8
02-28-2005, 05:40 PM
I voted yes. Although the drug with negative results will be discontinued, the results from the study may help other health professionals in their research (and sometimes even when diagnosing with other similar products).

young skywalker
03-01-2005, 12:56 AM
I'm worried that this will limit the industries desire and economic viability in researching new drugs. Big pharma already spends more money on PR and advertisement for their products, than for actual research. Won’t this legislation just cause them to spend even more time on PR, advertisement and bureaucracy and less time in the lab doing research? Economic motivation also drives industry in decided which products to research. As such needed research in diseases that may yield a lesser profit are often looked over. Won’t this proposed system only further enhance this problem?
Basically this piece of legislation is an overzealous reaction to the current Vioxx and Cox-2 controversy. I think the system as it stands works pretty well, though it may need some minor adjustment. I think we need to give some more trust to our scientists and government.