Comments on: Testing Drug Efficacy Using Electronic Medical Records http://blog.pharmtech.com/2009/02/10/testing-drug-efficacy-using-electronic-medical-records/ The blog of Pharmaceutical Technology magazine Tue, 07 Feb 2012 17:25:13 -0500 http://wordpress.org/?v=2.8.4 hourly 1 By: Not fooled http://blog.pharmtech.com/2009/02/10/testing-drug-efficacy-using-electronic-medical-records/comment-page-1/#comment-11973 Not fooled Fri, 27 Feb 2009 01:43:26 +0000 http://blog.pharmtech.com/?p=875#comment-11973 Testing the efficacy and safety of a drug via assumptions will prove harmful. This article seemed more of a marketing advertisement for EMR companies. I hope not too many people are falling for the notion. The only way to prove the efficacy and safety of a drug is to try it in real people - not technology. Actually, the research and development of drugs needs to be slowed down not sped up. Big Pharma has got the world fearful that drugs are not available to those who need them. The truth is that Big Pharma just want more profit. What is overlooked is that Pharma uses at huge portion of their clinical research budget for marketing purposes. Especially Phase IV clinical trials which do nothing but get patients using drugs given to them during post-market approved drug studies. It is a marketing technique to get patients hooked on their drugs under the quise of a study. Take away the costs of research that is not used for marketing efforts - the cost of getting drugs to market is a lot less than PhRMA reports. I know enough about research to know that data can be manipulated to reflect any desired result. I am suspicious the "techniques" used by the folks who did the studies on EMRs had everything to gain by using "techniques" that were favorable to them. This is simply another business that is trying to make money from clinical research. I see their advocacy of EMR and technology for what it is - marketing. The other business does not work is Electronic Data Capture systems or EDCs. As a clinical research professional I know these systems only help data managers and allow the data to be more easily manipulated. I have seen EDC allow for more cheating and fraudulant data. EDC do not produce more valid or reliable data - just the opposite. I am sure that wrongful assumptions used with EMRs will get more harmful drugs to market. Better there are fewer good drugs available than a slew of harmful drugs. Technology is not the answer - good clinical trials that actually put the drug through a honest "trial" in real people is the answer. That takes time and honesty not technology. Testing the efficacy and safety of a drug via assumptions will prove harmful. This article seemed more of a marketing advertisement for EMR companies. I hope not too many people are falling for the notion. The only way to prove the efficacy and safety of a drug is to try it in real people – not technology.

Actually, the research and development of drugs needs to be slowed down not sped up. Big Pharma has got the world fearful that drugs are not available to those who need them. The truth is that Big Pharma just want more profit. What is overlooked is that Pharma uses at huge portion of their clinical research budget for marketing purposes. Especially Phase IV clinical trials which do nothing but get patients using drugs given to them during post-market approved drug studies. It is a marketing technique to get patients hooked on their drugs under the quise of a study. Take away the costs of research that is not used for marketing efforts – the cost of getting drugs to market is a lot less than PhRMA reports.

I know enough about research to know that data can be manipulated to reflect any desired result. I am suspicious the “techniques” used by the folks who did the studies on EMRs had everything to gain by using “techniques” that were favorable to them. This is simply another business that is trying to make money from clinical research. I see their advocacy of EMR and technology for what it is – marketing.

The other business does not work is Electronic Data Capture systems or EDCs. As a clinical research professional I know these systems only help data managers and allow the data to be more easily manipulated. I have seen EDC allow for more cheating and fraudulant data. EDC do not produce more valid or reliable data – just the opposite.

I am sure that wrongful assumptions used with EMRs will get more harmful drugs to market. Better there are fewer good drugs available than a slew of harmful drugs. Technology is not the answer – good clinical trials that actually put the drug through a honest “trial” in real people is the answer. That takes time and honesty not technology.

]]> By: CMC Guy http://blog.pharmtech.com/2009/02/10/testing-drug-efficacy-using-electronic-medical-records/comment-page-1/#comment-11881 CMC Guy Wed, 11 Feb 2009 23:32:26 +0000 http://blog.pharmtech.com/?p=875#comment-11881 Maybe I am missing a connection or intent but to implement this type of evaluation would have to run large studies for 10-15 years, collect the data to prove works (or also I presume applied to certain SEs). Data collection via EMR may help gather info faster, and with greater inherent consistency, but still requires patients on the drug with current focused Phase IIIs approach likely exposing less people sooner. Application upfront would lengthen the pathway to approval, raising costs and further diminishing available Patent life post-approval. Time is always (the most?) critical factor in projects which sometimes Academics don't appreciate well. If this is means of demonstrating efficacy can't the reverse correlation be offered that the randomized clinical studies system are providing reliable data on efficacy that is supported by such long term database/analysis with EMR. This all sounds like good Phase IV type monitoring which should be occurring anyway and the more data the better, especially if quality standardized. Maybe I am missing a connection or intent but to implement this type of evaluation would have to run large studies for 10-15 years, collect the data to prove works (or also I presume applied to certain SEs). Data collection via EMR may help gather info faster, and with greater inherent consistency, but still requires patients on the drug with current focused Phase IIIs approach likely exposing less people sooner. Application upfront would lengthen the pathway to approval, raising costs and further diminishing available Patent life post-approval. Time is always (the most?) critical factor in projects which sometimes Academics don’t appreciate well.

If this is means of demonstrating efficacy can’t the reverse correlation be offered that the randomized clinical studies system are providing reliable data on efficacy that is supported by such long term database/analysis with EMR. This all sounds like good Phase IV type monitoring which should be occurring anyway and the more data the better, especially if quality standardized.

]]>