WHAT ARE PEOPLE SAYING: STAT news article “I used to work on Biogen’s Alzheimer’s drug. Is the company spinning bad data?” is generating quite a debate. Some people support Biogen’s submission of the drug, while others are skeptical. This could be settled very quickly if Biogen would allow people outside the company to review ALL the data.
“I too am skeptical. My wife was in one of their clinical trials. It failed to work with her. No improvement whatsoever. I do know that she was getting the active drug rather than a placebo. That was when her MMSE was over 20. Now, 5 years later, it’s too late for anything to work.” Another person wrote “I was in the study and I fear the same. The way it was shut down in the dark of night and then up doe FDA? I also have a marker and had the negative side effect of brain swelling.” Ouch.
Yet some people are supporting Biogen. One person who worked in R&D said that it’s common to look at data again, but in an era when we are hoping for a drug to treat AZ and failed pharma transparency, can we trust anyone in pharma?
When I first started to work in pharma I did a six-month rotation working with R&D people. At the time they were reviewing data on a new drug for depression but the data didn’t look good. Before writing a report and informing management, however, the data was submitted to two outside companies to ensure we hadn’t missed anything. One has to wonder why Biogen’s CEO, when the drug initially failed, didn’t require the folks in R&D to not only look hard at the data but also submit it to outside reviewers for comments.
Biogen has had a problem holding on to key executives and rumors have been circulating they were looking to either purchase a company or that they were for sale. The PR on the AZ drug did wonders for their stock price and I have to wonder if that was the goal all along. A Hail Mary pass to try and salvage an expensive drug that failed.
Biogen could easily settle this argument. Simply allow people outside the company to review the data and their findings. A continued approach to acting in secrecy is only going to lead to more questions. My guess is that insurance companies are ready to reject the drug and what’s to be sure a hefty price tag.
I hope the drug works because