Chewing up a bad apple?

I received the following in response to my "bad apples" editorial in the July/August issue of Medical Meetings about the potential impact of clinical trial data suppression and manipulation on CME. I have his OK to print it here:

Take heart. The media does amplify anomalies and the politicians love to jump on the opportunity to create more laws that make clinical research more costly for everyone (including the consumer in the form of increased drug costs). I believe most companies do their best in research and clinical investigations and report the finding truthfully. For a small company to be caught doing otherwise is a fatal mistake.

Unfortunately, the aggressive marketing departments of some companies take early data and run with it, the company releases the product, and then 2-3 years later, the data no longer supports the initial claims (Vioxx, Celebrex, etc.). It is also true that some studies are poorly designed/conducted and have to be repeated to obtain data that are truly significant in supporting claims. Conflicts of interest is always a

potential problem, but clinical investigators that are recognized leaders in their field are usually suspicious of early data and insist on more data and longer trial periods, and sponsors seek out such investigators to get the best bang for their test dollar (center known for treatment of the particular disease and large patient population to obtain statistically significant data).

Tom L. Kelly, PE

Director of Engineering

EndoVascular Instruments, Inc.

Vancouver, WA

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