Would I Give Aducanumab to My Mother?

Dena S. Davis

The Hastings Center

Originally published 11 June 21

Here is an excerpt:

First, it is not at all clear that the drug works, in terms of affecting cognition and slowing decline. As Jason Karlawish explains in an incisive piece in STAT, crucial scientific steps were missed, and the current data are inconclusive and contradictory. 

Side effects include possible brain swelling and bleeds (which appear to be severe in about 6% of patients), headache, falls, diarrhea, and what Biogen describes as “confusion/delirium/altered mental status/disorientation.”  Wait a minute!  I thought the reason to take this drug was that one already had altered mental status and confusion.

Before someone is even considered eligible for aducanumab, they must take a PET scan to ascertain that they have elevated levels of amyloid and then an MRI to make sure they don’t already have brain swelling. MRIs have to be repeated regularly while people are on the drug. I know perfectly competent adults who are freaked out by MRI’s.  How do you explain this to someone with dementia?  Or do you sedate them, thus adding to the risk? Furthermore, the drug itself is not a pill, but a monthly infusion. 

Put that all together, and it just doesn’t add up. How would my mother’s life change for the better? There is little evidence of the drug’s efficacy. Meanwhile, her peaceful life in her rural home with her dedicated caregiver would now be punctuated by trips to the hospital for MRI’s, and monthly struggles to start infusions in her 90-year-old body, with its tiny veins and paper-thin skin. Aducanumab is apparently best suited to people in the early stages of Alzheimer’s, but even in the earliest stage my mother refused to accept that she had a problem. I cannot imagine successfully explaining that we were taking these measures in the faint hope of combatting a problem she insisted she didn’t have. And in the absence of an explanation she could understand, surely the frequent hospital trips would feel to her like unpleasant, even scary, invasions.

The entire info is here.

Hydroxychloroquine RCTs: 'Ethically, the Choice Is Clear'

F. Perry Wilson
medscape.com
Originally poste 5 August 20

Here is an excerpt:

I am not going to say that HCQ has no effect on COVID-19. We can never be 100% sure of that. But I am sure that if it has an effect, it is quite small. Think of a world where HCQ was a miracle cure for COVID-19. Think how different all of these randomized trials would look. It would be immediately obvious.

Straight talk: HCQ is unlikely to kill you. It will kill someone (rare cases of torsades de pointes occur), but it is unlikely to be you or your patients. It really is a relatively well-tolerated drug. But there are adverse effects, as all of these trials show. And given that, our ethical obligation to "first, do no harm" is paramount here. There simply is not good evidence that HCQ has a robust effect, and there is evidence of at least moderate harm. Ethically, the choice is clear.

A few final caveats. Yes, only one of these trials reported on the use of zinc with HCQ (no effect, by the way). But two things on that particular issue: First, we know that many individuals take zinc supplements, so if, as the argument goes, HCQ is a miracle cure when given with zinc, you'd still see a benefit in an HCQ trial because a subset of people — maybe 25% — are taking zinc.

The zinc issue falls into this "no true Scotsman" land of HCQ studies. Any negative study can be dismissed: "Oh, you didn't give it early enough, or late enough, or with zinc, or with azithromycin, or on Sunday," or whatever. That's not how science works. I'm not saying that any of these studies are perfect, just that they are the best evidence we have right now. The burden of proof is to show that the drug works. Though I'm sure that pharma would be stoked to be able to argue that their latest negative trial can be ignored because their billion-dollar drug wasn't given in concert with vitamin C or whatever.

Yes, I know that another Yale professor is saying that HCQ can save lives.

And to those of you who have pointed out that he is a full professor while I am a mere associate professor, you really know how to hurt a guy. I have no idea why he wrote that article and didn't mention any of the randomized trials. But I embrace the academic freedom that he and I both have to present our best interpretation of the data.

The info is here.