Sunday, March 13, 2005

Am I Naive?

I suppose I am. After all, perhaps I should expect people to be angry with me.

A fortune 500 company is selling a medicine that is touted by many of my peers as a breakthrough medicine. While it does not generate enough money to affect the bottom line, and therefore, any problems with the drug are unlikely to affect the stock value, there are many people whose livelihood relates to the use of this medicine. If information is revealed that casts doubt on the safety of a medicine, sales are likely to be affected in a way that could impact many people working for this big pharmaceutical company. Many doctors may feel obligated to publically acknowledge that their strong endorsement for the past 2-3 years may have been premature.

So when I started my investigation of this medicine, my goal was pretty simple: get a clinical trial performed to determine whether the data that suggested the possibility of risk was right or wrong. Merely because there was no proof of danger does not mean a drug is safe if no one ever looks to see if there is danger. We should be smart enough to realize that.

Yet several events are starting to make me a bit nervous about the events that could soon unfold. First, I was told (though it is hearsay) that part of a company sponsored teleconference within the past year or so included a discussion focused on defining my goals. Here is evidence I was definitely naive. I figured they would take me at my word, that I wanted to prod them into doing a definitive study. (They say they are doing a study that will answer the question of safety, but in fact, the current study evaluates the effect of the drug in a group of patients that are different than the ones that appear to be at risk.) More recently, a colleague told me that an employee of the company stated very clearly that there were ramifications to what was being done, that is, things that would happen as a result of the studies we are publishing this Spring.

It's hard to imagine that I could do much to stop a company of this size with these resources. So I suppose I'll need to continue with my naive view and hope that an ethical pharmaceutical company will follow the data, not merely consider the business of health as a business that relates to their own financial health.