SUMMARY:

• The debate around Biogen’s Alzheimer’s drug continues to rage.
• The clinical evidence supporting the approval of the drug is at best “weak.”
• How could the FDA approve a drug with such poor clinical data?
• How can Biogen’s employees continue to work for a company that is raping taxpayers for a drug that doesn’t work?

A couple of years ago, I was working with a client who was in the process of developing an anti-depressant that could be taken once a week. As clinical trials were ongoing, we tested positioning and DTC channels. During Phase III trials, however, we got some disturbing news. People who had taken the drug vs. placebo reported no significant improvement in their symptoms. Although the team tried to analyze and reanalyze data, they thought they had something that could lead to approval. During a contentious meeting later that month, an SVP finally stood up and said, “there is not enough data to support continued investment in this product.” It was dropped.

The more I read about Aduhelm, and its hotly debated approval, the more I keep asking how people at Biogen could work for a company that will cost taxpayers billions?

According to Axios, “the evidence that the drug works is fragile. The FDA’s own statisticians said it didn’t meet the agency’s usual standards”. Aduhelm hasn’t been proven to work and will not have been proven to work before millions of people start taking it. Hell, there isn’t any proof of the causes of Alzheimer’s!

Scientists still don’t know for sure what causes Alzheimer’s. Aduhelm is based on one prominent but unproven theory. With that drug on the market, it’ll get harder to meaningfully explore other possibilities, some experts warn.

Axios

“This might be the worst approval decision that the FDA has made,” Aaron Kesselheim, one of the resigned panelists, told The New York Times.

And here is Biogen’s CEO saying the usual corporate speak. If he bevies what he is saying, then he needs a new job. But what about other Biogen employees? Have they convinced themselves that this drug works? Can they honestly say they are proud to be a Biogen employee?

If corporations are people, then it’s the people who need to speak up with actions and words. It takes courage to say, “this drug doesn’t work, and I can’t work here,” but it takes the kind of people we don’t need in the industry to drink a lot of Kool-Aid and act like this drug is great.

Our industry needs people ready to lay their careers on the line to do what is morally right, not what is said in press releases. Somewhere within Biogen, there were people; I’m willing to bet, that said this drug does not show statistical proof that it works, but they were undoubtedly fired or reassigned. They need to quit and become whistleblowers.

I used to know some people at Biogen, but they’re gone now. One told me, “when the company moved to Cambridge, a lot changed, including the culture.” Another told me, “we had one drug that was a blockbuster, and from that one drug, senior management became slaves to the financials.”

Too bad because this is going to be some damn expensive Kool-Aid for all of us.