A different three horse race

An interesting article came up today in the New York Times via Fierce Pharma about comparing effectiveness of the 3 main erectile dysfunction drugs (Levitra, Cialis, and Viagra). The American College of Physicians recently supported the use of such medications to treat ED based on the robust efficacy and safety data after years and years of not only clinical trials, but also clinical practice use. However there are few studies that compare the effectiveness of these medications because a study sponsor (and rightly so) does not want to risk publicizing data that would show its medication is less effective than a competitor. Compounding this situation is that the FDA does not require comparator studies, only that a new drug show superiority to placebo. Isn't is time that that the rules for clinical trials are altered?

I would wager that the patient would benefit from fewer "me too" drugs and the FDA should consider capping the number of similar (pharmacologically) medications on the market at a certain point. After that a new medication would be approved only after proving that it is at least as or more effective than the currently approved therapy (as a side note, I would want new similar drugs to be more effective than the current drugs, but big pharma would not appreciate that I don't think). This ruling would encourage development of better medications for patients as well as better allocation of R&D resources for pharma/biotech. This debate could go on forever, but I don't think that we can continue avoiding the need for comparativeness studies as "me too" drugs continue to developed freely.

Read up on the New York Times article here

On a related note: Medco will be conducting a head to head trial between Plavix and Effient, but it won't but a true head to head trial because it will be looking at the impact of genetic makeup of participants. I believe that Effient would win in a true competitiveness trial, but who knows what the results will show in this situation....

Check out the press release in Fierce Pharma

I would also be remiss if I didn't mention Human Genome Science's announcement of good looking Phase III data on its new treatment for Lupus, Benylsta. If you haven't jumped on board HGS by now, you are behind on the times because the stock continues to impress in 2009.

Read more here