Economists, Technology, & Clinical Trials


God bless Joseph Stigltz. There is a brief interview with him in the Sunday NY Times Magazine by Deborah Solomon, “Questions for Joseph Stiglitz.” There is a link at the bottom of this post. I have only started paying close attention to what economists have to say in the past few years. This certainly intensified when all hell broke loose in the fall of 2008. Joseph Stiglitz, a professor at Columbia, is a Nobel prize laureate and a very smart man. He also has a dry wit that I find quite funny (some people have doubts about my sense of humor) and I have just ordered his new book, “Freefall: America, Freemarkets, and the Sinking of the World Economy.” I definitely want to know what he has to say about it all.

FDA

Prioritize ???

However, what really caught my attention and led me to write this post is one of the last questions Solomon had for Stiglitz when she asked, “By the way, when I tried you on your cell phone, a voice said, ‘This is the number for Joseph Stiglitz, but he doesn’t check his messages.'” His response? “I just never figured out that part of the cellphone.”

This blog isn’t about economists, its about the regulation of health products by FDA in general and about clinical trials in particular. Clinical trials are very expensive to conduct. In addition, the massive amounts of recordkeeping involved leads to routine mistakes and the destruction of a great many trees. There has been a big push towards electronic medical and regulatory records, electronic case report forms and technology in general. This has generated discussion and debate about how these records should be regulated and whatsteps we need to take. FDA’s initial effort to regulate computerized systems, Part 11; Electronic Records, Electronic Signatures, was met with sharp resistance from industry and enforcement has been scaled back considerably as FDA utilizes “enforcement discretion.” However, most of us understand that these systems need to be dependable and that means, in some way, shape, or form, that they be “validated.”

Unfortunately what I see a lot is that the quality of the system used to maintain records is considered more important than the quality of the actual records that contain the data used to approve new drugs and clinical trials FDAmedical devices. Some folks seem to forget that technology is a means to an end (full disclosure: I am not very tech savvy). As a result, we have seen an increase in the number of FDA enforcement actions. FDA Warning Letters to clinical sites have skyrocketed in the past few years. And in my viewpoint one of the major reasons is the poor quality of clinical trial protocols and recordkeeping. Sometimes you need to take a look at the basics of what you are doing.

Which brings me back to Joseph Stiglitz. Here is a very smart man who is engaged with problem solving. Very Big Problems that impact us all. Yet he doesn’t know how to check his voice mail. As far as I’m concerned, its a question of knowing priorities. Just stop and think about which is a more important activity; understanding the complex economic issues that caused the Wall Street meltdown, or playing with your Blackberry? I appreciate the Stiglitz approach.

Here is a link to the Stiglitz interview by Deborah Solomon:

http://www.nytimes.com/2010/01/31/magazine/31fob-q4-t.html?ref=todayspaper

REMEMBER, YOUR COMMENTS ARE ALWAYS WELCOME !!!

Blogroll Pick: Paul Krugman’s Blog. I’m continuing to list a site on the Blogroll (to your right) each time I publish a post. As long as we are on the topic of economics why don’t we take a look at what another Nobel laureate has to say? Find it on the Blogroll along with a number of other interesting places to visit. Have fun.

http://krugman.blogs.nytimes.com/

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