POST SUMMARY: My post last week on the Actos judgement generated quite a lot of debate over at LinkedIn. While most agreed with my take on the judgement there were of course the people who believe that it’s just pharma’s way of doing business. I can understand that perception with current litigation against brands like Pradaxa who seem to have put sales ahead of clinical trial transparency but there are a lot of very good, hard working people, within the industry and only when their voices are heard louder than those who look at the balance sheet will we ensure patients are always put first.
I spoke to some physician thought leaders last week about the Actos case and as one told me “I can find a common variable between any drug any any common condition, but saying the medication actually caused the chronic condition is another story all together.” However, we went on to say “when it comes to clinical trial data I want to see the good and the not so good. I have stopped prescribing Pradaxa to my patients until I can see ALL the data and read more from independent research”.
In my pharma career I have attended a lot of meetings around DTC/DTP and not once have I seen or been part of anyone trying to minimize risks or hide data. In fact, my M L R teams have taken the opposite approach of being overly cautious around warnings. None of the people I have worked with have ever thought about playing games with clinical trial data and patient safety. What happened at BI around Pradaxa is still up for debate but the eMail trail seems to paint a picture of limiting clinical trial results for FDA approval.
Now think about this for a second. For DTC to be effective we have to get patients in to see their doctor, at a time when less patients are going to see their physician, get them to ask for the brans, and hope the doctor agrees and writes the Rx, and get over the hurdle of ensuring the co-pay isn’t too high or that insurers don’t push patients to another, less expensive, treatments. Is it any wonder that TV advertising is becoming less effective?
DTC/DTP marketers use the product label to test and develop compelling messages to prescribe their brands but are we naive enough to think that people are sitting in these meetings talking about emphasizing the benefits while minimizing or hiding risks? Sure it can and has happened in the past but in today’s matrix organizations it’s almost impossible because there will always be a trail pointing back to the responsible parties.
There are many good, hard working people within the industry and we have to ensure that the organization recognizes these people and that their voices are heard over “bottom line ROI” bean counters. When this happens the ship will be back on course.