A must-read for every doctor and patient is an article in this Sunday’s NY Times Magazine called Dr Drug Rep.
It’s a first person account from a psychiatrist who is recruited by Wyeth Pharmaceuticals to speak on Effexor, an anti-depressant, but whose relationship to the company sours as he begins to respond honestly to questions and criticisms of the drug from prescribers.
Several days later, I was visited by the same district manager who first offered me the speaking job. Pleasant as always, he said: “My reps told me that you weren’t as enthusiastic about our product at your last talk. I told them that even Dr. Carlat can’t hit a home run every time. Have you been sick?”
As disturbing as it was to read about how drug reps influence the message, what was most upsetting was learning how peer-reviewed and published meta-analysis was used by industry-paid researchers to help Effexor stand out among its competitors. Analysies in which new measures of outcome were defined, while standard measures were either ignored or never used.
In his study, he emphasized the remission rates and not the response rates. As I listened to his presentation, I wondered why. Was it because he felt that remission was the only really meaningful outcome by which to compare drugs? Or was it because using remission made Effexor look more impressive than response did?
Originally designed as a method for mining much-needed information from multiple studies to answer important medical questions, it appears that meta-analysis is now just another tool for the pharmaceutical industry to market drugs.
Why had I not realized this till now? Have I really been that naive?
I feel like I need to go back to Go, pay my $200 and start all over again. This game is one I really haven’t fully understood until now.
The big guys do what they need to do to get the data that they want. Sometimes it is sound statistics, but sometimes it’s just a guess, and it can be very wrong. This is the circumstance with Vioxx as well. In the main Phase III trial, Merck compared Vioxx to naproxen and a placebo control group. In that study, Merck found that Vioxx trended with the control group for cardiac events, and that naproxen was lower because there must be a cardiac benefit to naproxen. The FDA accepted this argument, but here is the flaw – the innovators of naproxen NEVER claimed a benefit, but Merck massaged the data to show that it was beneficial compared to placebo. Ultimately, a trial of naproxen showed a cardiac problem if taken chronically. In the trials we learned that Merck was able to eliminate a good number of data points gathered through the trial based on mathematical anomolies. So, they presented what made the case, which was very refined and polished data – no where near the raw data.
My sense is that most companies are approaching data the same way.
As for Wyeth, this is nothing new. Unfortunately they have not learned from their experiences with phen-phen and HRT troubles of the past. Shame on them.