SUMMARY:

• The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug.
• Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.
• Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm.
• Biogen’s reputation may be damaged beyond repair.

It’s never good to receive a letter from Congress that begins, “The Committee on Oversight and Reform and the Committee on Energy and Commerce is investigating the approval process for Biogen’s new Alzheimer’s drug.” To make matters worse, the Cleveland Clinic and Mount Sinai won’t administer Aduhelm to patients as six affiliates of Blue Cross, and Blue Shield in Florida, New York, Michigan, North Carolina, and Pennsylvania say in newly adopted policies they will not cover the Cambridge biotech’s drug, Aduhelm, because they consider it “investigational” or “experimental” or because “a clinical benefit has not been established.

No matter how you look at it, this is a major screw-up made worse by the comments of Ms. Woodcock yesterday during an interview. According to STAT News, “acting Food and Drug Administration Commissioner Janet Woodcock acknowledged on Wednesday her agency may have misstepped in the handling of its polarizing approval of a new Alzheimer’s drug.”

Folks, it doesn’t get any worse than this.

Let’s be clear about something first. This approval was NOT about patients; it was about the profits of a pharma company in quicksand and sinking fast. As soon as the FDA gave Aduhelm approval, investors rushed to buy Biogen’s stock, and the executive was spreading Kool-aid about the product’s efficacy.

But it only gets worse:

Recent reporting indicates that in the months following its halted clinical studies, Biogen undertook a secret campaign, termed Project Onyx, to persuade FDA to approve Aduhelm. Contrary to FDA guidance on communication between companies and the agency during drug development, in May 2019 a company official reportedly arranged for an “off-the-books” meeting to explore potential avenues for approval with FDA’s Director of the Office of Neuroscience. That meeting was reportedly followed by a formal meeting between Biogen and FDA in June 2019. According to one press report, in a memo prepared by FDA after that meeting, FDA wrote that development of Aduhelm “should be continued” and that “[a] further possibility that the sponsor may give consideration to, depending on what further analyses demonstrate, is to seek accelerated approval of Aduhelm based on its effect on reducing brain amyloid.” 

Carolyn B. Maloney Chairwoman
Committee on Oversight
and Reform, Frank Pallone Jr.
Chairman
Committee on Energy
and Commerce

Biogen’s reputation is damaged beyond repair, in my opinion. If they are going to survive and thrive, they must clean house of all their top executives, recall the drug until more studies are done (verified by independent reviewers), and possibly sell the company.

It doesn’t seem that long ago that Biogen was the darling of Wall Street. Based in Weston, Massachusetts, they had developed some great products to treat MS. It was a company that I would have been glad to work for, but then things took a turn for the worse. They moved into an expensive new HQ in Cambridge, and other pharma companies developed competing MS therapies that left Biogens in the dust. Today Twitter is filled with MS patients reporting nasty side effects from Biogen’s drug. Biogen’s future was so bad top executives jumped ship, but a new CEO realized the only way to save the company was with the approval of a drug whose data was highly questioned, at best.

I don’t understand how anyone could be the slightest bit proud to be a Biogen employee. Aduhelm’s approval clearly shows that more people are interested in a paycheck than doing what’s morally and ethically right.