Teepa's Team Reacts: Aduhelm Lawsuit

Teepa's Weekly Sunday Good News to the PAC Team included some preview articles this week: (Teepa's thoughts coming soon: Teepa For Ten on Facebook daily at 8am ET)

New problems for Aduhelm; now investors are entering the fray: Click here for the McKnight's article. There is a class action lawsuit brewing over the on-again off-again Aduhelm research and FDA approval process with the following fallout and lack of coverage for use of the medication by people early in Alzheimers. Investors are looking at what happened as fraud and are going after Biogen to recoup some of their significant losses.

Beth Nolan's (PAC Team Member) reaction:

Holy cow, Teepa – the article on the lawsuit against Aduhelm! So lemme see if I have this timeline correct for this lawsuit:

1. Biogen works hard on their Alzheimers drug, Aduhelm, and shareholders buy stock.
2. Biogen abandons the drug because a reduction in clinical decline was not observed and shareholders say, “Ah well, that’s the way of investments,” and sell at a loss.
3. Then Biogen conducts closed-door meetings with the FDA, subsequently announcing “Hey! Our drug is approved!” for everyone who has been diagnosed as having Alzheimers. (Biogen was able to show a reduction of beta-amyloid plaques, although clinical improvement was not clearly demonstrated. They will be required to conduct an additional study to prove there is clinical benefit or approval may be withdrawn. The cost for using the drug will be approximately $56,000/year/person.)
4. Stocks skyrocket following FDA approval and the old investors wonder … “If there was nothing in the data making Biogen announce they’re abandoning the drug (aka we lose our investment), then what did Biogen know to cause them to want a closed door meeting with the FDA??”

The real issue is this: Biogen either had something promising in the data or they didn’t. So what’s the truth? It’s one of these two scenarios. Either:

1. Biogen had SOMETHING in the data they shared with the FDA and therefore withheld that information from their shareholders, or
2. Biogen had nothing new in the data and the in meeting with closed door meeting and used leverage other than data to argue that the FDA should approve the drug in spite of the data.

However, a third possibility exists beyond these two: Biogen may honestly not have thought they had anything with this drug, but upon re-examination of the data, found they did have a finding, and talked with the FDA. This third option is where the shareholders have a civil securities fraud case: Biogen’s announcement to abandon the medication, and then subsequently state they were going to apply for FDA approval (following closed door session) gives the shareholders the securities fraud argument they need, because that about-face would amount to Biogen effectively mishandling the account at the expense of the shareholders. (Most successful securities fraud claims in civil action lawsuits involve the mishandling of the accounts.)

 There is a high probability that they’ll settle out of court, say, in 10 years. 😒

In the meantime, at least heat is still being applied to get to more of the truth of what happened.😑

Honestly, I wonder if the truth likely a bit of all three, but who knows? Perhaps Biogen always thought they had a little of something happening with the drug, even if it was not a cure for Alzheimers. By publicly announcing that they were going to abandon Alzeimers research, they launched a domino effect of exodus across the pharma world, with lobby organizations and families crying out for a continued search for a cure. Thus, Biogen now had leverage.

Biogen had their opportunity to come clean. Closed door meetings are not the type of forthright transparency that one would expect from a publicly traded company. Let alone one that is marketing healthcare products to the public. The onus is on Biogen to be open about their reasons for a review, rather than conduct closed door meetings. Instead, we are left wondering if desperate families and the American public will be paying, literally and figuratively for a medication that may cause more harm than good, may have only minimal impact for a short window of time at a high price, or may in fact be something of assistance for a select subset of people who are living with a specific type of Alzheimer type condition.

Perhaps more importantly, for some, encourage other drug companies and researchers to continue their mission and efforts at discovering a combination of medications, monitoring systems, and interventions that can change the quality of life for those who are living with various forms of dementia and those who support and care for those individuals.

What do you think?

How about you medical professionals who are now living with dementia?

Dr. Beth Nolan